Dealings in Clinigen shares are expected to commence on AIM at 8.00am on Tuesday 25 September 2012, under the ticker symbol CLIN





Clinigen is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time.




To achieve our aim, we have built a group of complementary businesses which can operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. Through three businesses, Clinigen SP, Clinigen GAP, and Clinigen CTS, we acquire, license and revitalise niche, hospital-only critical care medicines, and source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.





Clinigen Clinical Trials Supply (CTS):

We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials. This requires excellent knowledge of the global pharmaceutical market, the regulatory processes and customs authorities of countries all over the world, along with a high tech supply chain with guaranteed quality and safety standards that can deliver swiftly.

Clinigen Global Access Programs (GAP):

On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.

Clinigen Specialty Pharmaceuticals (SP):

We acquire niche medicines that don’t fit into the portfolio of larger pharmaceutical companies. These are typically hospital-only treatments for rare or life-threatening diseases, and we specialise in revitalising them – finding new treatment areas; new markets where we can get them licensed; or, potentially, new formulations. All the while, we’re ensuring that patients already using the medicine continue to get the treatment they need, while the company whose product we have acquired can feel confident that its reputation is being well looked after.

We are currently 100+ people, headquartered in Burton-on-Trent in the UK, with facilities in Philadelphia, US, and Tokyo, Japan, and an office in London. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while doctors and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.




http://www.clinigen.co.uk/

Investors chronicle - Clinigen lists on AimMajor Alternative Investment Market (Aim) floats for medical companies have been a rare sight over the past few years as the credit crunch and dearth of private equity deals combined to starve the market of new entrants. That is about to change with the listing of Clinigen, a medical company that sources products for medical trials, in an IPO that could value the company at £170m.

Clinigen was established by serial entrepreneur Andrew Leaver, who is also selling most of his stake, and specialises in delivering secondary drugs to clinical trials and organising the logistics for studies involving thousands of patients across many locations. It also buys up drugs that are too small for big pharma companies to bother with and sells them into new markets, as a recent deal with AstraZeneca for HIV drug Foscavir illustrates. Sales to 30 June were £82.1m, with cash profits of £17.3m. Chief executive Peter George said the IPO would give the company a war chest of £25m for product acquisitions; it has about 27 potential targets.

IC VIEW:
Clinigen is unique in the sector, as far as we can tell, in combining a variety of outsourcing services with direct product sales. The free float will be about 60-70 per cent. One to watch.

Clinigen is now officially number 1 in the Fast Track 100
Clinigen is the fastest-growing private company in the UK. We’re delighted to be ranked first in the Sunday Times Virgin Fast Track 100, which was published on December 4th 2011.

This award recognizes the exceptional sales growth we have achieved over the past three years. It also sets a high benchmark for the future success of the Clinigen Group. We’re looking forward to fresh new challenges as we evolve our business in the years ahead.

Major interest in shares

http://www.moneyam.com/action/news/showArticle?id=4453273

Clinigen had its £50 million market debut on the 25th Sept . The 135million cap, which provides pharmaceuticals and related services from its offices in the UK, US and Japan, is using the proceeds of the first pharmaceutical initial public offering in London for 5 years to build a £25 million war chest to expand its product range.
Chief executive Peter George is looking at 27 potential acquisitions involving niche hospital drugs that he believes the group can revitalise. Five of these discussions are at advanced stages and George hopes to announce one deal in the next few months. Any transaction would compliment the groups antiviral drug Foscavir,bought from AstraZeneca in 2010.
Interest in the company has been strong, Shareholders put £50 million in the Numis Securities-managed placing and the price jumped by 10p to 174p hours after the shares started trading on the Aim.
Clinigen, which names 13 of the worlds top 20 pharmaceutical companies by sales among its clients, has grown its revenues by 242% since it was established in 2010.
The topline jumped 135% to £82.1 million in the year to July 2012 alone. This generated earnings before interest taxes depreciation and amortisation (EBITDA) of £17.3 million, a year-on-year increase of 109%
Driving these figures is the organic growth of its US business, which generated sales of more than $50 million last year, up from $10 million in the prior 12 month period.
Arobust balance sheet leaves Clinigen with plenty of scope to implement its strategy.
It has just £1.6 million of shareholders loans, which George expects to clear by year end.

http://www.edisoninvestmentresearch.co.uk/researchreports/Clinigen011112QV.pdf

A buy in this weeks shares mag - Revenues have increased 242% since 2010 driven by investment in its sales teams.

up 7.5%

Tipped I hear by SCSW this weekend.

A buy in this weeks share mag. The proceeds from the Sept flotation have helped to create a £20m war chest, which includes cash and £10m of debt from the Royal Bank of Scotland. Chief executiver Peter George is hoping to add a second treatment to his sales forces in the UK, the USA and Japan by the end of the year.
Only established in 2010, Clinigen is expected to record £97.1m in sales for its fiscal year to June 2013 and £17m in pre-tax profit. That points to earnings per share of 14.5p, which leaves the stock on a tempting earnings multiple of 14.1 times .
The healthy balance sheet could even fund a dividend and further acquisitions should complement strong organic growth.

A buy in this weeks IC mag.

RNS Number : 7451W

Clinigen Group plc

31 January 2013




RNS Announcement:





31 January 2013



Clinigen Group plc



Notification of Interim Results Date



Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and pharmaceutical services business, will be announcing its interim results for the period ended 31 December 2012 on Wednesday, 27 February 2013.

There will be an analyst meeting on 27 February 2013 at the offices of College Hill, The Registry, Royal Mint Court, London EC3N 4QN. Analysts who wish to attend should contact Stefanie Bacher on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register.

On the move

Clinigen declares maiden divi after impressive stock market debut
By Benjamin Chiou | Sharecast – 1 hour 36 minutes ago.. .





LONDON (ShareCast) - Clinigen, the speciality pharmaceuticals company which listed on the AIM market last autumn, saw shares surge on Wednesday after the firm reported a massive jump in first-half sales and declared a maiden dividend.

Sales soared by 86% from £32.7m to £61.0m in the six months to December 31st, while underlying profit before tax surged 54% from £6.3m to £9.7m.

Chief Executive Peter George told Sharecast that the company is "very pleased" with its trading performance in the first six months of the year after successful stock-market debut in September.

The board decided to declare the company's first interim dividend of 0.6 per share and said it is targeting progressive dividend growth.

Shares were up 11.21% at 234.65p by 11:12 on Wednesday morning, compared with the placing price of 164p.

George hailed "significant organic growth from all three operating divisions", but highlighted the standout performance of the Clinical Trial Supply (CTS) division, the dominant revenue generator of Clinigen.

CTS, which provides commercial medicines for use in clinical trials, saw an impressive 113% sales increase driven by its expansion into the US markets and new business wins. However, George did say that CTS's second half growth will likely not be as strong, though this is to be expected given the "lumpiness" of seasonality in the industry.

Meanwhile, the Global Access Programs (GAP (NYSE: GPS - news) ) division is on track to deliver three-fold growth this year, George said, after a whopping 222% increase in sales in the first half. GAP provides early-market access to medicines before regulatory approval or provides drugs to patients after discontinuation or withdrawal. It currently is the exclusive supplier of 32 drugs across the world.

The third division, Speciality Pharmaceuticals (SP), targets niche, hospital-only, end-of-lifecycle drugs previously owned by large pharma firms, by acquiring or in-licensing them. The company's first product is Foscavir, acquired from AstraZeneca (NYSE: AZN - news) in 2010, which achieved 22% sales growth in the first half.

Group cash and cash equivalents totalled £22.3m by the end of the half, up from just £5.2m at June 30th 2012.

Optimistic outlook

The company said that trading in the second half of the financial year has "started well".

George told Sharecast that he is confident that full-year sales would beat current market forecasts due to the strength in CTS, though expected margin reductions will likely mean that the bottom line would be in line with estimates.

He said that there is potential for good synergies between the three divisions, saying that "one plus one plus one is greater than three".

Clinigen Group: Numis ups target price from 240p to 265p, while its buy recommendation is reiterated

Clinigen Group and Theravance Entered into Excl...
BZW
Clinigen Group and Theravance Entered into Exclusive Commercialization Agreement in the EU for Antibacterial VIBATIV®


Clinigen Group plc


Clinigen and Theravance Announce Exclusive Commercialization Agreement in the EU for VIBATIV® (telavancin)

Clinigen Group plc (LSE: CLIN) (AIM: CLIN) and Theravance, Inc. (NASDAQ: THRX) today announced that they have entered into an exclusive commercialization agreement in the European Union (EU) and certain other countries located in Europe for VIBATIV® (telavancin) for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. VIBATIV® is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as MRSA.

Under the terms of the agreement, Theravance has granted Clinigen exclusive commercialization rights to VIBATIV® in the EU and certain other European countries (including Switzerland and Norway). In exchange, Theravance will receive a $5 million upfront payment from Clinigen and is entitled to receive tiered royalties on net sales of VIBATIV®, ranging from 20% to 30%. The agreement has a term of at least 15 years, with an option to extend exercisable by Clinigen.

��SWe are pleased to have Theravance, a leader in antibiotic development, as a license partner,⬝ said Peter George, Chief Executive Officer of Clinigen. ��SThis agreement is of strategic importance to us as it not only strengthens our anti-infective offering with a product that has patent protection into the next decade, but it is an exciting opportunity to commercialize VIBATIV® and Foscavir® while leveraging their operational synergies. VIBATIV® is a second product for Clinigen��"s Specialty Pharmaceuticals (SP) portfolio, complementing the division��"s anti-viral product, Foscavir®.⬝

��SWe are very excited to partner with Clinigen and we believe that its innovative business model and experience in specialty pharmaceuticals provide an ideal platform to maximize the growth opportunity for VIBATIV®,⬝ said Rick E Winningham, Chief Executive Officer of Theravance. ��SWe look forward to working with Clinigen in making VIBATIV® available to patients with nosocomial pneumonia in the EU."

Gone long.

http://www.investegate.co.uk/clinigen--clin-/bus/clinigen-group-and-theravance-entered-into-excl---/20130311070000Z6247/

Should get these figures upgraded over next 48 hours.


Date Rec Pre-tax (£) EPS (p) DPS (p) Pre-tax (£) EPS (p) DPS (p)

Numis Securities Ltd
27-02-13 BUY 17.20 15.40 1.80 19.80 17.30 2.30

2013 2014
Pre-tax (£) EPS (p) DPS (p) Pre-tax (£) EPS (p) DPS (p)

Consensus 17.20 15.40 1.80 19.80 17.30 2.30
1 Month Change 0.20 0.90 -0.05 0.20 0.60 0.07
3 Month Change 0.20 0.90 -0.05 0.20 0.60 0.07


GROWTH
2012 (A) 2013 (E) 2014 (E)
Norm. EPS 52.96% 92.58% 12.34%
DPS % % 27.78%

INVESTMENT RATIOS
2012 (A) 2013 (E) 2014 (E)

EBITDA £11.76m £12.30m £20.10m
EBIT £10.54m £17.20m £19.40m
Dividend Yield % 0.71% 0.90%
Dividend Cover x 8.56x 7.52x
PER 31.83x 16.53x 14.71x
PEG 0.60f 0.18f 1.19f
Net Asset Value PS 17.64p p p

Clinigen Group: Numis revises target price from 265p to 310p and stays with its buy recommendation.

CLIN - Numis Buy; Ups target to 310p

Speciality pharma firm Clinigen (CLIN:AIM) improved 6.9% to 272p as management delivered on its promise to add a new drug to its portfolio within six months of the £210 million cap’s listing on Aim. The company has secured the European rights to Vibativ, a treatment for pneumonia caused by MRSA, from US firm Theravance. Charles Weston at Numis expects sales to commence in the first half of 2014 and expects the treatment to generate up to £6 million a year.

A buy in this weeks SM - Antibiotic resistance is very much in the news, which adds a timeliness to a deal between clinical product supply specialist Clinigen and US biotech company Theravance. Clinigen has tied up the European rights for vibativ, a treatment for drug-resistant pneumonia resulting from an MRSA super-bug infection.
For $5m (£3.3m) upfront fee, Clinigen has acquired the EU rights to Vibativ, as well as rights for Switzerland and Norway, and will pay a royalty to Taheravance of between 20% -30%, dependiing on sales.

RNS this morning should cream the SP north. Will try and add.

Clinigen Group plc acquires oncology support th...
BZW
Clinigen Group plc acquires oncology support therapy Cardioxane for US$33 million

Clinigen Group plc


Clinigen Group plc acquires oncology support therapy Cardioxane® from a world-leading pharmaceutical company

Burton-on-Trent, UK 26 March 2013 Clinigen Group plc (Clinigen" or the Group") (LSE: CLIN) (AIM: CLIN) today announced the acquisition of Cardioxane® (dexrazoxane) from Novartis for US$33 million in cash, payable in two tranches. Under the terms of the agreement, Clinigen will assume responsibility for manufacturing, registration, distribution, and commercialization of the product in countries where current marketing authorizations exist, including key European, Asian and Latin American territories.

Cardioxane, an oncology support therapy, is a cardioprotective agent used to prevent the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer.

Clinigen believes there is an opportunity to revitalize Cardioxane, which has no direct licensed competition in the anthracycline therapy cardioprotection space, by utilizing new commercialization, market and indication strategies over the next five years. Historic revenues for Cardioxane have been c.US$11-12 million per annum. Clinigen is targeting a gross margin of 60%. Latin America is a strong market for Cardioxane which is of particular interest to Clinigen, being a territory in which the Group wishes to expand its reach and which may improve access routes for existing portfolio products such as Foscavir®, as well as products that Clinigen may acquire in the future.

Cardioxane is the third addition to Clinigen"s Specialty Pharmaceuticals (SP) business complementing Foscavir, its anti-viral active against Cytomegalovirus (CMV) and commonly used in the support of leukemia patients undergoing bone marrow transplants, acquired from AstraZeneca in March 2010. Recently, the Group in-licensed VIBATIV®, an anti-bacterial for the treatment of nosocomial pneumonia caused by MRSA, for commercialization in the EU from Theravance. All three are highly specialized, hospital-only drugs which Clinigen SP supplies into licensed markets and Clinigen Global Access Programs (GAP) supplies into pre- or unlicensed markets on a named patient basis.

SAcquiring Cardioxane from Novartis is another major step forward for us,⬝ said Peter George, Chief Executive Officer of Clinigen. SCardioxane fits particularly well within our portfolio. We have been looking for medicines that complement Foscavir and Cardioxane does this by extending our role in oncology support. Together with our recent addition of VIBATIV, which further builds on our anti-infective capability, we are delivering on our mission to supply the right drug to the right patient at the right time.⬝

About Cardioxane® (dexrazoxane)

Cardioxane is a cardioprotective agent used to prevent chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300mg/m2 of doxorubicin or 540mg/m2 of epirubicin when further chemotherapy treatment is required. Cardioxane is administered by intravenous infusion. It is believed to work by binding to metal ions, thus decreasing the formation of intracellular superoxide radicals and preventing cardiotoxicity. Cardioxane was initially licensed in 1992. Subsequently, Novartis acquired the product as part of the 2006 acquisition of Chiron. The product is currently licensed for sale in 43 markets around the world, including 18 in Latin America.

Within the European Union Cardioxane underwent a revision to its label in 2011, restricting its licensed use to advanced and/or metastatic breast cancer. The change brought the EU label in line with the dexrazoxane indication that exists within the United States.

About Clinigen Group

Clinigen is a specialty global pharmaceutical products and services business headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). The SP business focuses on acquiring and in licensing specialist, hospital-only medicines worldwide and commercializing them within niche markets. For more information, please visit www.clinigengroup.com.

Forward-looking statement

This announcement contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Clinigen Group plc (SClinigen⬝). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. The forward-looking statements include statements regarding Cardioxane, its development, potential and financial performance. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Clinigen undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

Contact Details

Clinigen Group: Numis moves target price from 310p to 340p and retains a buy recommendation.

A buy in this weeks Shares mag, nothing new really said.

http://www.edisoninvestmentresearch.co.uk/researchreports/Clinigen_02042013_QV.pdf

A buy in this weeks IC - The future is bright for Clinigen. The company has been on a product acquisition spree by adding Theravance's Vibativ, to treat hospital-acquired pneumonia, and Novartis' Cardioxane, an oncology drug that mitigates the side effects of chemotherapy. If either drug proves to be as successful as Foscavir, then the future is bright for Clinigen.

New ?20m banking facility

RNS


RNS Number : 4315D

Clinigen Group plc

29 April 2013








Clinigen Group plc agrees a new £20 million banking facility

Burton-on-Trent, UK - 29 April 2013 Clinigen Group plc ("Clinigen" or the "Group") (AIM: CLIN) has agreed a new £20m banking facility which replaces its previous £10 million facility. This new banking facility is for a period of 2 years and 3 months, maturing on 31 August 2015.

The facility comprises a £20 million multi-currency Revolving Credit Facility (RCF) and has been provided by the Group's existing bankers, The Royal Bank of Scotland PLC. The Group now has total debt facilities of £20 million, providing, along with cash reserves, a cash base for the future trading requirements of the Group and for making future product acquisitions. The facility is secured on the intangible and the tangible assets of the Group and future revenue generation.

Interest is payable on the drawn down element of the RCF at 2.25% above LIBOR or EURIBOR, as determined by the currency drawn down.

Robin Sibson, Clinigen's Chief Financial Officer, said: "This increased facility gives us the flexibility to continue to develop through earnings enhancing acquisitions of high quality products, as well as supporting strong organic growth for the future."

Investec starts buy on Clinigen Group, target 290p.

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 298.80. Since the IPO on Sep 25, 2012, the share price is up 64.77%.

Good 5.5% rise today

Consensus recommendation






As of Jun 14, 2013, the consensus forecast amongst 3 polled investment analysts covering Clinigen Group PLC advises investors to purchase equity in the company.
.

Extension of agreement with Accord Healthcare

RNS


RNS Number : 4279H

Clinigen Group plc

20 June 2013






Clinigen Group plc



Clinigen Group Extends Agreement to Exclusively Supply Clinical Trials
with Accord Healthcare's EU Oncology Products



Burton-on-Trent, UK - 20 June 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that Clinigen Clinical Trial Supply ('CTS') has extended its exclusive clinical trial distribution agreement with Accord Healthcare ('Accord'), a wholly-owned marketing subsidiary of Intas Pharmaceuticals, to supply clinical trials with Accord's European injectable oncology drug portfolio for a further two years.



Under the terms of the extended agreement, CTS will continue to distribute Accord's EU portfolio of more than 15 injectable oncology drugs including cisplatin, cytarabine, doxorubicin and fluorouracil to manufacturers, CROs, clinical re-packagers, and other specialist providers for use in clinical trials. CTS will remain the sole point of contact for all clinical trial supply enquiries and orders.



"The quality and efficiency of Clingen's services has been excellent and therefore, we are keen to renew our distribution agreement," said Daniel Green, Hospital Director UK & Ireland at Accord. "Faced with an increasing demand for our products, the Clinigen team has ensured a seamless, controlled management of our injectable oncology portfolio. This has resulted in improved access to our products and a level of support to our customers that we were previously unable to provide."



Shaun Chilton, Chief Operating Officer, Clinigen Group said, "We look forward to the continuation of our partnership with Accord and are pleased that they have chosen to extend our agreement. It is testament to the successful combination of Accord's international manufacturing capabilities and Clinigen's expertise in managing the increasingly complex challenges in clinical trials supply. As a Group we are able to provide both the resources and insight into our clients' needs. This allows us to offer the highest level of service on a global scale."



- Ends -

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 320.00. Since the IPO on Sep 25, 2012, the share price is up 81.82%.

Schroders purchase of 6.8m shares


http://www.moneyam.com/action/news/showArticle?id=4626696

Schroders purchase of 6.8m shares


http://www.moneyam.com/action/news/showArticle?id=4626696

Organizational Changes to Scale up for Growth

RNS


RNS Number : 8587I

Clinigen Group plc

09 July 2013








Clinigen Group Makes Organizational Changes to Scale-up
for Future Business Growth

Burton-on-Trent, UK - 9 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that it has made organizational changes to prepare and support the Group to scale-up in line with its five year growth strategy and support recent organic growth and the integration of two new products in the Specialty Pharmaceuticals business.

Under the new structure, Shaun Chilton, formerly the Chief Operating Officer in charge of the Clinigen CTS (Clinical Trial Supply) and Clinigen GAP operational businesses, has been appointed Chief Operating Officer for the Group and will add management of the Specialty Pharmaceutical business to his responsibilities. He will be supported in this role by the appointment of new Senior Vice Presidents to run each of these three operating businesses.

Clinigen GAP (Global Access Programs) will be led by Mark Corbett, formerly Vice President of GAP. Lorann Morse will become Senior Vice President of Clinigen CTS (Clinical Trial Supply) having joined Clinigen from Myoderm where she was Director of Client Services. She will be based in Philadelphia and brings valuable regional expertise and insight to the CTS business. David Bryant will move from his role as Business Development Director to head up Clinigen SP (Specialty Pharmaceuticals). Anton Jenkins, previously COO of Clinigen SP, has been appointed to Business Development Director, performing a key role that is focused on the further in-licensing and acquisition of new products.

Peter George, Chief Executive Officer, Clinigen Group said, "Over the past three years, we have seen significant organic growth of CTS and GAP and the expansion of our product portfolio with the acquisition of Cardioxane from Novartis and in-licensing of VIBATIV from Theravance. Now is a logical time for us to ensure we have the right infrastructure and people in place to be able to scale-up further for future growth and achieve our ambitious plans. I am extremely happy with these appointments; we have high quality people running our operational businesses with a wealth of sector experience."

- Ends -

Clinigen reveals AIM success story is primed for further growth
By Proactive Investors July 09 2013, 8:24am
Clinigen (LON:CLIN) was unique for an AIM float. When it came to the market last September it was not only the first pharmaceutical IPO in almost five years, but it was profitable and cash generative. It is also now a dividend payer. Chief executive officer Peter George and chief financial officer Robin Sibson reveal how this drug sector hybrid will continue on its exponential growth trajectory.


http://www.proactiveinvestors.co.uk/companies/stocktube/2091/clinigen-reveals-aim-success-story-is-primed-for-further-growth--2091.html

Appointment of Executive Director

RNS


RNS Number : 1068J

Clinigen Group plc

11 July 2013






Group COO joins the Clinigen Board

Burton-on-Trent, UK - 11 July 2013 - Clinigen Group plc ("Clinigen" or the "Company") (AIM: CLIN) is pleased to announce the appointment of Shaun Edward Chilton (45) to the Board of Directors with effect from 11 July 2013.

Shaun Chilton has been employed by the Group since January 2012 as Chief Operating Officer and is a director of Clinigen CTS Limited and Clinigen CTS Inc., subsidiary companies of Clinigen Group plc. He will now join the Board of Clinigen Group plc as an Executive Director. Before joining Clinigen, he was the President within KnowledgePoint360 Group, a global pharmaceutical information and services operation.

He has over 20 years' commercial, strategic and operational experience in senior leadership positions in product- and service-oriented businesses within the pharmaceutical industry. He has a proven track record of creating and successfully driving business strategies delivering substantial sales, profit and market share growth in a number of international businesses; driving business transformation / change programmes and building, developing and coaching highly motivated, professional multidisciplinary teams.

Peter George, Group Chief Executive Officer said, "Since joining the Group in 2012 Shaun Chilton has been instrumental in driving the business forward, particularly in the CTS business which has grown substantially. His operational and strategic experience will be an asset to the Board as we continue to grow the business."

Shaun holds 607,600 Ordinary Shares of 0.1 pence each in the Company ("Ordinary Shares"), representing 0.74% of the Company's issued share capital. He has share options over a further 412,778 Ordinary Shares, representing 0.5% of the Company's issued share capital.

There is no further information required to be disclosed pursuant to paragraph (g) of Schedule 2 of the AIM Rules.

- Ends -

Clinigen: Profitable and cash generative; in fact a real rarity for the junior market
By Ian Lyall July 12 2013, 10:10am Opening bell: Clinigen team gather at the LSE for the company's stock market debut last September.Opening bell: Clinigen team gather at the LSE for the company's stock market debut last September.

Clinigen (LON:CLIN) was unique for an AIM float. When it came to the market last September it was both profitable and cash generative. In February it announced it would begin paying a dividend, marking it out as a real rarity of the junior market.

The suspicion at the launch of the flotation (done at 164p a share) was that Clinigen might have been dressed for market to give founder and former chairman Andrew Leaver an exit.

Part of this is true; Leaver was able to realise some of his investment (though he still holds around 30% of the speciality pharma and pharmaceutical services group).

However, Clinigen’s performance since listing suggests only a fraction of its full potential has been tapped, leaving plenty on the table for new investors.

This has begun to be reflected in the share price, which is now hovering around the 300p mark and should be seen in the full-year results if, as expected, they match analysts’ forecasts.

“What we have done since the IPO is demonstrated organic growth is quite strong,” chief executive (CEO) Peter George told Proactive Investors.

“We looked at the private equity route, but we didn't want to burden the company with too much debt.

“If we had burdened it with debt then cash would have gone to service debt rather than investing in the future products.”

Clinigen is a three-wheeled hybrid of a business that is unique, not just on AIM and in the UK, but across the world.

But the business model works and has synergies that will be the catalyst for growth for some years to come.

The first wheel, which generates around 65% of revenues, is Clinical Trials Supply (CTS).

Big pharma and the large contract research firms, when carrying out clinical studies on new blockbuster treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products.

The second business, Global Access Programs (GAP), is described by CEO George as the “glue in the middle” of Clinigen. By this he means it binds CTS with the speciality pharma arm.

GAP provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy to patients who are very ill and not responding to current treatments.

It will also supply life-saving products in markets where a company doesn’t have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.

All of these sound like niche areas, but with an international network, GAP generates significant, high margin sales.

Just as CTS’s role of supplier to big pharma creates opportunities for the GAP business, so GAP has been key to identifying potential drugs for its speciality pharma arm.

“The last two opportunities came from our access programme business,” said George.

In March, the group bought cancer support product Cardioxane for US$33mln from Novartis, and the plan is to revitalise this product with the aim of doubling sales. The company also in-licensed the rights to anti-bacterial VIBATIV in Europe, which it plans to launch Q1 2014.

Privately, George and the team will be hoping to weave the same magic they have with Foscavir, an anti-viral and the company’s first drug.

Bought from AstraZeneca three years ago, its sales have jumped from £4.5mln to £22mln under Clinigen’s ownership.

This is due in no small part to Clinigen’s ability to sell Foscavir into markets where it isn’t currently licensed, as well as those where it is, and demonstrates just how potent the firm’s international network is.

Cash generative and with a £20mln revolving credit facility, the group has the financial headroom to make further acquisitions. However, chief financial officer (CFO) Robin Sibson said the group might also consider issuing equity if the right opportunity came along.

However, the group has some very specific criteria a candidate drug must have before is added to the Clinigen medicine cabinet, reveals George.

“We acquire drugs that are hospital-only and that are in niche areas; at the moment we are targeting oncology, infectious disease and haematology,” he said.

“I think we have gone beyond the proof of concept that was Foscavir and we are now driving growth.”

For the CTS business the story is a very different one. “I’m not interested in buying market share in services,” says George.

“It is about what you do better than your competitors and gaining market share. All three bits of the business have very good organic growth potential. There’s a lot of value in focusing the growth on the higher margin end.”

For CTS, there is plenty more headroom for expansion as it currently has relationships with just 26 of the top 100 pharma companies, and it has demonstrated its potential by expanding turnover from £16mln to £80mln in just two years.

In GAP, it has relationships with 10-11 companies with the “potential for lots of organic growth there”, adds George.

“We have been spending our time in the last nine months ensuring this business has scalability to take advantage of the huge growth opportunities,” adds CFO Sibson.

“We have been investing in the management team and ensuring we have the structures that enable us to cope as we grow. This goes for the distribution network, too.

“We think we have de-risked the business a lot by making it more scalable, global and spreading our risks around lots of different pharma companies.”

The City broker Investec is predicting pre-tax profits will be £18.8mln in the year just ended, up from £16.9mln, rising to £24.4mln in 2014 and then to £28.1mln.

Analyst Nicholas Keher said: “We think Clinigen has a broad range of organic growth opportunities and a business model set up to maximise value from recycling cash from lower-margin divisions into higher margin activities.

“There are risks, but management appear aware of these and, on balance, we believe the shares are too cheap when looking into full-year 2014 and beyond.”

CEO George adds: “Even during a financial year where we had the IPO we have still delivered significant organic growth and we will be in line with market expectations.

“It has been an interesting year. Talk about learning on your feet; but it has been fascinating.”

INVESTMENT EXTRA: Clinigen paying dividend less than a year after AIM float

By Ian Lyall

PUBLISHED: 21:55, 12 July 2013 | UPDATED: 21:55, 12 July 2013



Opening bell: The Clinigen team at last September's market debut


Niche pharmaceutical stock Clinigen was unique for an AIM float. When it came to the market last September it was both profitable and cash generative. In February, it announced it would begin paying a dividend, marking it out as a real rarity of the junior market.


The suspicion at listing was that Clinigen might have been dressed for market to give founder and former chairman Andrew Leaver an exit.


Part of this is true: Leaver was able to realise some of his investment (though he still holds around 30 per cent of the speciality pharma and pharmaceutical services group). However, Clinigen’s performance since listing suggests only a fraction of its full potential has been tapped – leaving plenty on the table for new investors.

This has begun to be reflected in the share price, which has advanced from 164p on listing to 320p. The financial results, meanwhile, should reveal that the group is positively thriving as a quoted company.


‘What we have done since the IPO is demonstrated organic growth is quite strong,’ said chief executive Peter George.


‘We looked at the private equity route, but we didn’t want to burden the company with too much debt. If we had burdened it with debt then cash would have gone to service debt rather than investing in the future products.’


Clinigen is a three-wheeled hybrid of a business that is unique not just on AIM and in the UK, but across the world.


But the model works and has synergies that will be the catalyst for growth for some years to come.


The first wheel, which generates around 65 per cent of revenues, is Clinical Trials Supply (CTS).


Big pharma and the large contract research firms, when carrying out clinical studies on their latest new blockbusters treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products. The second business, Global Access Programs (GAP), is described by CEO George as the ‘glue in the middle’ of Clinigen. By this he means it binds CTS with the speciality pharma arm.

GAP provides patients who are very ill and not responding to current treatments with access to drugs that are still in clinical trials but are showing encouraging signs of efficacy.


It will also supply lifesaving products in markets where a company does not have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.


All of these sound like niche areas, but with an international network, GAP generates significant, high-margin sales.


Just as CTS’s role of supplier to big pharma creates opportunities for the GAP business, so GAP has been key to identifying potential acquisition targets for its speciality pharma arm.


Earlier this year it bought a cancer drug for £22m and in-licensed an anti-bacterial to go with an anti-viral it bought three years ago. Sales of the latter have jumped from £4.5m to £22m under Clinigen’s ownership and George and the team will be hoping to repeat the trick with the two new products.


The City broker Investec is predicting pre-tax profits will be £18.8m in the year just ended, up from £16.9m, rising to £24.4m in 2014 and then to £28.1m.


Analyst Nicholas Keher said: ‘We think Clinigen has a broad range of organic growth opportunities and a business model set up to maximise value from recycling cash from lower-margin divisions into higher-margin activities.


‘There are risks, but management appear aware of these and, on balance, we believe the shares are too cheap when looking into full-year 2014 and beyond.’


OUR VERDICT: Trading at 12 times 2014 earnings the shares offer decent value, particularly if Clinigen can increase the sales and profitability of its two newly acquired drugs.


Definitely worth a look, but set a stop loss at around 260p.

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 333.00. Since the IPO on Sep 25, 2012, the share price is up 89.20%.

Pre-Close Trading Update

RNS


RNS Number : 0870K

Clinigen Group plc

25 July 2013






Clinigen Group plc

Pre-Close Trading Update

Burton-on-Trent, UK - 25 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global specialty pharmaceuticals and services company, today announces its pre-close trading update for the year ended 30 June 2013.

During the second half of the year, Clinigen continued to perform strongly across its three operational businesses, Clinical Trials Supply (CTS), Global Access Programs (GAP) and Specialty Pharmaceuticals (SP). Overall, the Board expects revenue and gross profits to show significant organic growth over prior year and to be slightly ahead of market expectations. Administrative costs have been lower than expected which has led to a further positive impact on underlying EBITDA.

CTS continues to be the main revenue generator with significant growth year on year. The most significant percentage growth was in the GAP business, where full year sales will be more than six times higher on a like-for-like basis. The SP business continues to show organic growth from sales of Foscavir. Significantly , however, we expanded the SP portfolio, through acquisition, from one to three products with the benefits of these acquisitions expected to be felt next year and beyond . The $33m acquisition of Cardioxane (dexrazoxane) from Novartis in March 2013, did, however, make a small contribution to profits in the final quarter of this year.

The Group is in a good position to continue its strategy of acquiring niche, hospital-only products into the SP business with available cash funds and a bank facility.

Peter George, Chief Executive Officer of Clinigen said:

"Since we listed last September, the Group has been transformed by a combination of continued global expansion, strong organic growth and the acquisition of two new products for the Specialty Pharmaceuticals portfolio. We have re-organised the senior management and continue to invest in the infrastructure to scale-up for our next stage of growth."

The Group expects to publish its final results for the year to 30 June 2013 on Wednesday 25 September 2013.

25 Jul Numis 430.00 Buy

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 355.00. Since the IPO on Sep 25, 2012, the share price is up 93.18%.

Clinigen Group marching at the double - worth watching


http://www.proactiveinvestors.co.uk/companies/news/59434/clinigen-group-marching-at-the-double-59434.html

Investment summary: Impressive update

http://www.edisoninvestmentresearch.com/researchreports/ClinigenQV2607013.pdf

Yesterday’s pre-close trading update from Clinigen (LON:CLIN) had brokers queuing up to praise the fast-growing speciality pharmaceuticals firm.

Management indicated revenue and gross profits for the year just finished should show significant organic growth year-on-year, coming in slightly ahead of market expectations. Administrative costs have been lower than expected which has led to a further positive impact on underlying earnings (EBITDA).

That prompted City broker Investec to admit its earnings forecast for this year might be a bit below par.

“It appears Clinigen has delivered organic growth slightly ahead of our estimates and with lower operating costs, we expect profits will be some 10% ahead of our FY13E forecasts,” Investec said in a ‘buy’ note.

At the time of its interim results the company said the division's margins were down to 13% from 17% the year before, but management is confident of reaching a gross profit margin of 15%, according to Investec, while house broker Numis expects margins to have recovered by the end of the current financial year.

Numis has bumped up its full-year revenue estimates for 2013 and 2014 for the Clinical Trials Supply business by 3%.

The performance of the Global Access Programs (GAP) division seems to have caught Investec on the hop, with growth well ahead of the broker’s forecasts. It is not expecting a six-fold increase in GAP’s revenue every year, however.

“We understand that one or two of the division’s high profile contracts have reached peak potential ahead of our expectations, hence we do not see all the outperformance flowing into FY14E,” the broker said.




http://www.proactiveinvestors.co.uk/columns/broker-spotlight/13673/broker-round-up-ii-noricum-gold-clinigen-green-dragon-gas-13673.html

Clinigen to Manage Third Access program for BTG

RNS


RNS Number : 5245K

Clinigen Group plc

31 July 2013










Clinigen Group to Manage Third Access Program for BTG

Supplying Potentially Life-Saving Oncology Antidote in 37 European Countries

Burton-on-Trent, UK - 31 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that Clinigen Global Access Programs ('Clinigen GAP') has extended its existing distribution agreement with Protherics Medicines Development Ltd, a BTG International group company ('BTG'), to exclusively manage a named patient program in 37 European Countries for uridine triacetate for use as an antidote to overexposure to the chemotherapy drug 5-fluorouracil ('5-FU'). Wellstat Therapeutics Corporation ('Wellstat') is seeking approval in the US and Europe for its investigational drug, uridine triacetate, and granted named patient supply rights to BTG in the 37 European Countries in 2012. Uridine triacetate is the third product that BTG has placed under Clinigen GAP's management.

Under the named patient program, uridine triacetate will be available for healthcare professionals to treat patients who are overexposed to the widely-used cancer chemotherapy 5-FU due to dosing errors, an inability to breakdown 5-FU normally, and other forms of impaired clearance. According to data from the European Medicines Agency ('EMEA') the number of patients in the European Union affected by a 5-FU overdose each year is over 10,0001. Uridine triacetate has orphan drug designation from the EMEA and the US Food and Drug Administration ('FDA').

Although uridine triacetate is not yet approved in Europe, this program operates within regulatory compliant mechanisms to allow healthcare professionals to prescribe uridine triacetate to individual named patients. Clinigen will provide access to uridine triacetate 24 hours a day, 7 days a week.

Mark Corbett, Senior Vice President, Clinigen GAP said, "We are pleased to be extending our current agreement with BTG to add a third program to the portfolio already handled by Clinigen. We are committed to ensuring that our bespoke access program delivers uridine triacetate to health care professionals for their patients within a critical time period. 5-FU overexposure is an important unmet medical need and making available the supply of uridine triacetate on a named patient basis will provide healthcare professionals access to this investigational antidote to treat patients."


1European Medicines Agency (2009). Public summary of positive opinion for orphan designation of 2', 3', 5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose. EMEA/COMP/231352/2009

- Ends -

1 Aug Investec 313.00 Hold

A buy in this weeks IC - Burton-on-Trent based specialist medicines supplier Clinigen (CLIN) looks to be performing well after the company reported that it looks on course to beat forecasts for earnings this year. Clinigen reports its full year results on Wednesday 25 Sept 2013. The run should continue with the first substantial contributions from acquired products.

Up 10.36% - Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 396.75. Since the IPO on Sep 25, 2012, the share price is up 125.43%.

A buy in this weeks shares mag - House broker Numis reckons Clinigen can spend £40m on acquisitions over the next year. The shares deserve their high rating - trading on 19.4 times forecast earnings for 2013 - because of growth momentum, management expertise and market opportunities.

Notice of Results

RNS


RNS Number : 3324N

Clinigen Group plc

06 September 2013






Clinigen Group plc

Notification of Full Year Results Date

Burton-on-Trent, UK - 6 September 2013 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its full year results for the period ended 30 June 2013 on Wednesday, 25 September 2013.

A group analyst briefing will be held at 09:30am GMT on Wednesday, 25 September 2013 at the Group's London offices at 1 King Street, London EC2V 8AU. Analysts who wish to participate should either contact Claire Dickinson on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register.

- Ends -

Clinigen Group PLC




Clinigen Group plc is a fast-growing specialty global pharmaceuticals and services business, dedicated to serving patients, the medical community and the healthcare industry to supply critical life saving treatment. With offices in the UK, US and Japan, Clinigen is focused on delivering the right drug to the right patient at the right...



Clinigen seals epilepsy drug deal with Eisai
By Jamie Nimmo September 09 2013, 7:38am Epilepsy is a common neurological condition that causes seizuresEpilepsy is a common neurological condition that causes seizures

AIM-listed pharma company Clinigen (LON:CLIN) has unveiled a deal with Eisai that will see it manage an access programme for its anti-epilepsy drug Fycompa in Germany.

The agreement will mean an uninterrupted supply of the drug at no cost to the German healthcare system following the temporary suspension of commercial distribution in the country.

The programme will be managed by Clinigen GAP (Clinigen Global Access Programs) and will begin when stocks of the drug run out in Germany, which is not expected to happen until the end of this calendar year.

Fycompa is the only drug approved in Europe for countering the effects of epilepsy, a common neurological condition that causes seizures.

Chief executive Peter George said: “We look forward to assisting in the provision of continued access to Fycompa in Germany and are pleased with the confidence entrusted in us by Eisai.

“As a specialist provider of global access programmes we have the experience and expertise to deliver this bespoke access programme within Germany.”

He added: “This programme represents the addition of another major pharmaceutical company to our expanding client base.”

In Shares this week - Clinigen is in good health, better than expected results on the way a year after aim listing.

On the year to the day it joined Aim (25 Sept) the group will report sales and growth profits that could well exceed expectations, owing to robust organic growth and lower than expected costs. The market is looking for sales of £120.6 m and £20.8m pre-tax profit, double that achieved last year. It will also declare its maiden dividend of 1.8p per share, equivalent to a 0.5% yield.

European Marketing Authorisation transfer on track
RNS
RNS Number : 0396O
Clinigen Group plc
16 September 2013





Clinigen Group on Track with European Marketing Authorization Transfers for Cardioxane® and VIBATIV®

Burton-on-Trent, UK - 16 September 2013 - Following the acquisition of Cardioxane® from Novartis and the in-licensing of VIBATIV® from Theravance, Inc. in March 2013, Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today reported significant progress in the handover of these products with the transfer of key Marketing Authorizations in Europe to Clinigen. The transfers have progressed according to internally agreed timelines and both projects are continuing on schedule.

For oncology support therapy Cardioxane® (dexrazoxane), Marketing Authorizations in France, the UK, the Netherlands, and Poland have been transferred from Novartis to Clinigen. As Marketing Authorization holder Clinigen has assumed responsibility for manufacturing, registration, distribution, and commercialization of Cardioxane® in these countries, ensuring a smooth transition and an uninterrupted supply of the drug to patients. Clinigen plans to transfer all Marketing Authorizations from Novartis and fully manage supply globally by the end of 2014, which is a similar timeline to Foscavir® when it transferred from AstraZeneca to Clinigen.

Furthermore, the European Commission has approved the transfer of Marketing Authorization for the anti-bacterial VIBATIV® (telavancin) from Theravance, Inc. to Clinigen. VIBATIV® has been suspended for use in the European Union since 2012 following a suspension of operations at the contract manufacturer. Having completed the technical transfer to a new contract manufacturer, Clinigen is working closely with the European Medicines Agency to remove the marketing suspension and expects to have European product available, as planned, in the first quarter of 2014.

For countries where Cardioxane® and VIBATIV® do not have Marketing Authorization, Clinigen will leverage the capabilities of its Global Access Programs business (Clinigen GAP) to supply the medicines on a named patient basis.

"The transfer of the European Marketing Authorizations to Clinigen marks an important step in the integration of both Cardioxane® and VIBATIV® into our Specialty Pharmaceuticals business," said Peter George, Chief Executive Officer, Clinigen Group. "Clinigen has now assumed full control of all key commercialization activities and will provide further updates as we begin to realize the benefit of supplying Cardioxane® directly. In addition, our priority for the remainder of the year is to work towards lifting the current suspension of the Marketing Authorization for VIBATIV®."



- Ends -

Sun, 22 September 2013


Since floating on AIM almost a year ago, Clinigen has done just what it said it would, Matthew Goodman wrote in the Sunday Times. The pharmaceutical company has produced new drugs, such as a breast cancer treatment, and has boosted its income. The shares have been rewarded by more than doubling in price since being traded. Management’s lock-up period ends soon but if they decide to cash in this may be offset by pent-up demand, Goodman said.


http://sharecast.com/news/share-tips-foxtons-unite-ag-barr/21172803.html

Nice write up in The Sunday Times.

Final Result
25 Sep 13 Clinigen Group [CLIN]

Preliminary Results

RNS


RNS Number : 8086O

Clinigen Group plc

25 September 2013












Clinigen Group plc

Preliminary Results for the year ended 30 June 2013

Burton-on-Trent, UK - 25 September 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN), the global specialty pharmaceuticals business, has today published its preliminary results for the 12 months ended 30 June 2013.

Financial highlights

- Group revenue up by 49% to £122.6m (FY12: £82.1m) driven by strong organic growth across all three operational businesses

o Clinigen CTS full year sales up 49% to £87.8m and full year gross profit up 13% to £11.4m

o Clinigen GAP revenue grew more than six-fold to £10.5m; full year gross profit was up more than five-fold to £3.9m

o Clinigen SP full year sales of £24.3m (+12%) and full year gross profit of £19.8m (+8%)

- Underlying EBITDA increased by 30% to £22.4m (FY12: £17.3m)

- Underlying pre-tax profit increased by 29% to £20.4m (FY12: £15.8m) and reported pre-tax profits increased by 42% to £14.5m (FY12: £10.3m)

- Underlying earnings per share up 38% to 18.5 pence (FY12: 13.4 pence) and reported earnings per share 15.1 pence (FY12: 13.2 pence)

- Cash generation continues to be strong; cash and cash equivalents at 30 June 2013 were £11.3m, up from £5.2m at 30 June 2012

- Final dividend of 2.0 pence per share proposed, bringing the total dividend to 2.6 pence per share



Business highlights

- Clinical Trial Supply ("CTS")

o Sales performance driven by sizable anti-viral studies and increased activity in the US

o In June, extension of exclusive EU supply agreement with Accord Healthcare

- Global Access Programs ("GAP")

o Awarded Sanofi's Campath and Astellas' MDV3100 early access programs

o In July, BTG awarded a third access program to Clinigen and, in September, Eisai selected Clinigen to manage an access program in Germany

- Specialty Pharmaceuticals ("SP")

o Foscavir® sales volume continued to grow, with further expansion into the US and new indications in Europe

o Exclusive commercialization agreement in EU for Antibacterial, VIBATIV®

o Acquisition of oncology support therapy, Cardioxane® for US$33m





Peter George, Chief Executive Officer, said:



"We have over-delivered on our commitments made at the time of the IPO last September. In turn, the listing on AIM has lived up to our expectations. It has provided a stronger platform from which to drive our organic growth, both in the UK and internationally, as well as giving us additional financial flexibility to support our acquisition plans and the acceleration of our international growth strategy. The IPO has also enabled greater investment in the infrastructure and recruitment of additional high quality people to the business.



"Our ambition for the next financial year is to maintain this momentum across all three operating businesses; principally organic growth for CTS and GAP, and through further acquisition of products for SP. Geographically, we are focusing our attention on the US, Latin America and Asia.



"With a sound financial base, an increasing international footprint, as well as the recent organizational changes, we have the right foundations to continue the scale-up of the business and maintain our growth."



-Ends-

Clinigen: Investec places both its target price (prev.: 313p) and its hold recommendation unchanged


25 Sep Numis 485.00 Buy

City analysts hail Clinigen results
By Giles Gwinnett September 25 2013, 11:31am All three of the firm's divisions - Clinical Trial Supply (CTS), Global Access Programs (GAP) and Specialty Pharmaceuticals (SP) - saw an increase in sales or revenue.All three of the firm's divisions - Clinical Trial Supply (CTS), Global Access Programs (GAP) and Specialty Pharmaceuticals (SP) - saw an increase in sales or revenue.

---ADDS BROKER COMMENT AND SHARE PRICE---

Global pharma and services business Clinigen (LON:CLIN) posted full year results on Wednesday that beat analysts' forecasts.

The group unveiled a 49% increase in group revenues, driven by strong growth across all three of its operations.

In the year to end June, revenue stood at £122.6mln compared to £82.1 mln in 2012, while underlying pre-tax profit was up 29% to £20.4mln compared to £15.8mln last year.

Investors welcomed the numbers and Clinigen shares zoomed further upwards - 6.7% to 430p. The shares are now at an all time high and have doubled since the beginning of 2013.

The firm also ended the year in a good cash position, having £11.3mln - more than double the £5.2mln it had at June 20, 2012, and declared a final divi of 2p a share, making the total dividend for the year 2.6p a share.

All three of the firm's divisions - Clinical Trial Supply (CTS), Global Access Programs (GAP) and Specialty Pharmaceuticals (SP) - saw an increase in sales or revenue.

CTS, the largest contributor to sales, saw sales rise 49% to £87.8mln. This arm sources and supplies comparator drugs for use by big pharma and large research organisations when they are carrying out clinical trials.

GAP, whose revenue grew more than six-fold to £10.5mln, provides drugs that are still in trials but showing signs of efficacy.

SP, as the name suggests, is focused on acquiring medicines, developing and registering them before onward marketing. In the year, it saw sales increase 12%.

Broker Numis, which rates the shares a 'buy' targeting 485p, highlighted the firm's stated ambition to become the market leader in both CTS and GAP through organic growth, and to add a further 5-7 speciality pharmaceutical (SP) products over the next three to five years.

"If it accomplished this, we see over 100% upside to our 5-year earnings forecasts," says analyst Charles Weston.

As well as revenue and EBITDA beating forecasts, the broker said the full year dividend of 2.6p was considerably better than its 1.8p estimate, and net cash was £4mln better than expected, at £11mln.

Meanwhile, Investec said: "Clinigen’s preliminary results have come in ahead of our, and consensus, expectations in spite of 10% upgrades only two months ago."

The broker notes that although the share price has risen sharply in recent months, it believes the current ratings are "not a stretch given these results".

"We place our price target and recommendation under review,” it adds.

Earlier, the group's chief executive Peter George told investors: "We have over-delivered on our commitments made at the time of the IPO last September.

"In turn, the listing on AIM has lived up to our expectations. It has provided a stronger platform from which to drive our organic growth, both in the UK and internationally, as well as giving us additional financial flexibility to support our acquisition plans and the acceleration of our international growth strategy.

"The IPO has also enabled greater investment in the infrastructure and recruitment of additional high quality people to the business.

“Our ambition for the next financial year is to maintain this momentum across all three operating businesses; principally organic growth for CTS and GAP, and through further acquisition of products for SP. Geographically, we are focusing our attention on the US, Latin America and Asia.

“With a sound financial base, an increasing international footprint, as well as the recent organisational changes, we have the right foundations to continue the scale-up of the business and maintain our growth.”

Clinigen says momentum has carried into the new financial year
By Jeremy Naylor September 25 2013, 1:03pm

Well worth a watch.

http://www.proactiveinvestors.co.uk/companies/stocktube/2204/clinigen-says-momentum-has-carried-into-the-new-financial-year-2204.html

Thanks dreamcatcher

Pleased I can help

A buy in this weeks IC - Clinigen just the medicine.

Clinigen's share price has doubled since Jan 13 but rated on 16 times June 2015 earnings estimates, there should be more to come.

Clinigen directors to sell shares via placing
By Jamie Ashcroft September 30 2013, 5:16pm Books open on the placing right away and the pricing will be announced ‘as soon as practicable’ once the books close.Books open on the placing right away and the pricing will be announced ‘as soon as practicable’ once the books close.

Specialty pharmaceuticals firm Clinigen (LON:CLIN) announced on the AIM close that 10.6% of the group’s shares will be sold via a share placing.

Through the placing, which is being run by Numis and Peel Hunt, just over 8.7mln shares will be sold by the company’s directors.

Books open on the placing right away and the pricing will be announced ‘as soon as practicable’ once the books close.

It is planned that chief executive Peter George will sell just over 30% of his stake in the company, leaving him with a 7.3% shareholding (6mln shares).

Chief financial officer Robin Sibson and chief operating officer Shaun Chilton are also named as selling directors – each halving their stakes leaving them with 3% and 0.4% respectively.

Other un-named employees are also participating and those sales will account for around 3mln of the placing shares.

Last week Clinigen posted full year results that beat analyst forecasts.

It unveiled a 49% increase in group revenues, driven by strong growth across all three of its operations.

In the year to end June, revenue stood at £122.6mln compared to £82.1 mln in 2012, while underlying pre-tax profit was up 29% to £20.4mln compared to £15.8mln last year.

Clinigen placing completes at 410p per share
By John Harrington October 01 2013, 12:35pm Clinigen placing completes at 410p per share

Institutional investors have bought up just under 11% of the issued share capital of Clinigen (LON:CLIN) through a placing of shares at 410p each.

The shares have been sold by directors and employees of Clinigen at a 19.75p discount to the closing mid-market price on the day before the results of the share placing were announced.

Chief executive Peter George sold just over 30% of his stake in the company, leaving him with a 7.3% shareholding (6mln shares).

Chief financial officer Robin Sibson and chief operating officer Shaun Chilton both halved their stakes, leaving them with 3% and 0.4% respectively.

The directors have undertaken not to sell any more shares in the 180 days following the day the share placing was completed.

Last week Clinigen posted full year results that beat analyst forecasts.

It unveiled a 49% increase in group revenues, driven by strong growth across all three of its operations.

In the year to end June, revenue stood at £122.6mln compared to £82.1 mln in 2012, while underlying pre-tax profit was up 29% to £20.4mln compared to £15.8mln last year.

Clinigen CEO sells a further 0.5m shares post placing

Wed, 02 October 2013

Pharmaceuticals and services business Clinigen said Wednesday that Peter George, its Chief Executive Officer, has sold a further 0.5m shares in addition to the 2.8m disposed of on Monday.

The shares, which were all sold for 410p each, were part of the 8.7m placed with a number of directors on Monday.

George pocketed £2.050m from the most recent sale, and £11.6m from Monday's disposal.

The placing follows last week's full year results, which revealed a 49% jump in group revenue to £122.6m (FY12: £82.1m), which the firm said was driven by strong organic growth across all three operational businesses.

Underlying earnings before interest, tax, depreciation and amortisation (EBITDA) climbed 30% to £22.4m (FY12: £17.3m), while underlying pre-tax profit increased by 29% to £20.4m (FY12: £15.8m) and reported pre-tax profits increased by 42% to £14.5m (FY12: £10.3m).

Holding(s) in Company - Schroders plc gone above 10%

http://www.moneyam.com/action/news/showArticle?id=4681387

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 494.25. Over this period, the share price is up 148.19%.

Clinigen: Investec increases target price from 313p to 469p reiterating its hold recommendation.

Flag on the chart showing stock is in consolidation phase. Reckon itl take off early november on a monday. Ill check my system and predict which monday. Bet I get it right.

Clinigen participating in the
BIO-Europe® Conference Vienna Nov 4-6




BIO-Europe® is Europe's largest partnering conference serving the global biotechnology industry. The conference annually attracts leading dealmakers from biotech, pharma and finance along with the most exciting emerging companies. Produced with the support of BIO, it is regarded as a “must attend” event for the biotech industry

Then -



WODC Geneva

Geneva

14 November 2013 - 15 November 2013



ASH

New Orleans

5 December 2013 - 10 December 2013


http://www.ebdgroup.com/bioeurope/index.php

Interesting, watch out for my systems monday call. Not this monday.

In IC this week, one of thirteen red hot soaring shares.

With the consultancy business growing particularly strongly and new drugs on the roster for the coming year, there is a clear buzz about prospects.

Oh dear. Another one that has a huge sp.
BTW, didn't Directors do well to sell when it looked like a generous act....(recent News)...

Currently;- too high for me.

Even higher now, broken £5.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 515.00. Over this period, the share price is up 162.40%

In Shares - Pharmaceutical, biotech and medical technology spending driving trend.

Clinigen and Venn Life Sciences are both companies set to benefit from strong growth in the contract research space. The global contract research industry, which provides research services to pharmaceuticals, biotechs and medical technology companies, is set to expand 11.4% a year until 2017.. Based on these growth estimations the market will be worth $43 billion in 2017, up from $25 billion in 2012.
Clinigen , which has operations in Europe, the US, and Japan, has enjoyed phenomenal success since it went public last year (25 Sept 12) This reflects the £396 million caps stellar growth prospects with pre-tax profits set to rise 67% this year to £24.2 million from the £14.5million recorded in the 12 months to July 2013.

5 to 7 more drugs to be bought over the next 3 to 5 years say the management.

Looks like its got far further to go.

In IC - Game changers . A company with 10 bagger innovations.




Clinigen, which listed on the aim in late 2012 , must count as one of the junior markets best success stories barely a year into its stock market life. The company is a game changer not so much for what it does, which is supply drugs around the world for comparison purposes in clinical trials, but for how it has set up its business model. Simply put, there are hardly any companies in the world that combine both the supply of medicines - this is more of a wholesale function - with pharmaceutical services such regulatory advice and the selling of wholly-owned products.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 555.00. Over this period, the share price is up 164.39%.


As of Nov 23, 2013, the consensus forecast amongst 5 polled investment analysts covering Clinigen Group PLC advises investors to purchase equity in the company. This has been the consensus forecast since the sentiment of investment analysts improved on Nov 18, 2013. The previous consensus forecast advised that Clinigen Group PLC would outperform the market.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 564.00. Over this period, the share price is up 175.12%.

In Shares - Consensus expects the company to make £24.2m before tax this year, enough for 22.1p in earnings per share, a figure that leaves the stock on 23.3 times earnings . The 2.6p a share dividend offered to investors in 2013 is expected to grow to 3.3p in the year to June 2014 and 4p in the fiscal 2015.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 573.50. Over this period, the share price is up 179.76%.

On Friday, Clinigen Group PLC (CLIN:LSE) closed at 579.50, 0.60% below its 52-week high of 583.00, set on Dec 06, 2013.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 604.50. Over this period, the share price is up 201.51%.

:-))

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 607.50. Over this period, the share price is up 205.28%.

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 613.00. Over this period, the share price is up 172.87%.

IC today - Success of drug and consultancy divisions are powering ongoing upgrades.

Good positive start to 2014

Edison today - Valuation: Organic growth deserves a premium
We value Clinigen using a combination of earnings-based metrics (P/E and EV/EBITDA), PEG ratio and a DCF valuation. These suggest Clinigen is worth £564m (683p a share) using P/E and £570m (690p a share) on EV/EBITDA. Once the higher growth prospects are factored in, the PEG ratio analysis suggests a value of £650m (785p a share). The DCF-based method, based on conservative assumptions, yields a valuation of £575.6m (688p a share).

Clinigen to provide Vibativ in Europe

RNS


RNS Number : 1338X

Clinigen Group plc

08 January 2014






Clinigen Group to Provide VIBATIV® to Patients with Hospital-Acquired Bacterial Pneumonia in Europe via Access Program


Burton-on-Trent, UK - 8 January 2014 - Clinigen Group plc (AIM: CLIN) today announced the initiation of an early access program, managed by Clinigen Global Access Programs (Clinigen GAP), to provide the anti-bacterial VIBATIV® (telavancin) to patients in Europe with hospital-acquired bacterial pneumonia (HAP) known or suspected to be caused by MRSA. HAP is an area of considerable unmet need; for the first time VIBATIV® will be available to physicians in Europe to treat eligible patients on an individual named patient basis.

In March 2013 Clinigen in-licensed VIBATIV® into its Specialty Pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialization in Europe. Although the product had been approved in Europe in 2011 by the European Commission, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug was not launched into the market and therefore has never previously been available in Europe. With the technical transfer to a new contract manufacturer completed by Theravance, Clinigen is working closely with the European Medicines Agency (EMA) to remove the Marketing Authorization suspension and to make the product commercially available in 2014.

Clinigen SP has drawn on the Group's unique business model, enabling it to provide early access to VIBATIV® utilizing its dedicated Global Access Programs business, Clinigen GAP. With the time between a patient contracting pneumonia and receiving VIBATIV® a critical factor, Clinigen will use its comprehensive European logistics network to ensure that the drug reaches patients swiftly, providing 24/7 access to the drug for individual named patients.

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "VIBATIV® is a drug that can be used when other alternatives for HAP are not suitable. Our ability to provide access to VIBATIV® on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients. While we are working with the EMA to lift the Marketing Authorization suspension for VIBATIV®, the Group is able to respond to unmet medical need and provide access to this drug through our Clinigen GAP division."

Mark Corbett, Senior Vice President, Clinigen GAP added: ''We are pleased to be able to implement an access program for the newest of Clinigen's portfolio products, as we already do for Foscavir® and Cardioxane® in markets where they are not commercially available, in addition to the 30+ other programs we are already managing for other leading pharmaceutical and biotech companies."

Clinigen GAP will continue to provide access to VIBATIV® via an access program on a named patient basis until Marketing Authorization is restored across the European markets. For information or enquiries about the access program contact Clinigen GAP:

Clinigen European green light to use VIBATIV on hospital-acquired bacterial pneumonia

By Ian Lyall

January 08 2014, 8:19am
Known or suspected to be caused by MRSA, HAP is an area of considerable unmet need.


Speciality pharma group Clinigen (LON:CLIN) said Wednesday that its Global Access Programs arm will provide the anti-bacterial VIBATIV to patients in Europe with hospital-acquired bacterial pneumonia (HAP).

Known or suspected to be caused by MRSA, HAP is an area of considerable unmet need, and for the first time VIBATIV, in-licensed from Theravance last March, will be available to physicians in Europe to treat patients on an individual named patient basis.

Clinigen’s Global Access business will also supply life-saving products in markets where a company doesn’t have a presence but where there is demand, or where a treatment has been discontinued but is still relied on by certain patients.

It also provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy to patients who are very ill and not responding to current treatments.

The company’s chief operating officer Shaun Chilton said: "VIBATI is a drug that can be used when other alternatives for HAP are not suitable.

“Our ability to provide access to VIBATIV on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients.”

Notice of Interim Results Date

RNS


RNS Number : 2220X

Clinigen Group plc

09 January 2014






Clinigen Group plc

Notification of Interim Results Date

Burton-on-Trent, UK - 9 January 2014 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its interim results for the six months ended 31 December 2013 on Wednesday, 26 February 2014.

A group analyst briefing will be held at 09:30am GMT on Wednesday, 26 February 2014 at the Group's London offices at 1 King Street, London EC2V 8AU. Analysts who wish to participate should contact College Hill on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register

Clinigen Extends Accord Agreement to Capecitabine

RNS


RNS Number : 5537X

Clinigen Group plc

14 January 2014






Clinigen Group Extends Exclusive Agreement with Accord Healthcare to Supply Anti-Cancer Drug Capecitabine into Clinical Trials in Europe



Burton-on-Trent, UK - 14 January 2014 - Clinigen Group plc (AIM: CLIN) today announced that its Clinical Trials Supply business (Clinigen CTS) has extended its exclusive European Union (EU) clinical trial distribution agreement with Accord Healthcare ('Accord'), a wholly-owned marketing subsidiary of Intas Pharmaceuticals, to include capecitabine, an orally administered chemotherapeutic tablet.

Accord's capecitabine tablet adds to the company's EU portfolio of more than 15 injectable oncology drugs, including cisplatin, cytarabine, docetaxel, doxorubicin and fluorouracil currently distributed by Clinigen CTS to manufacturers, CROs, clinical re-packagers, and other specialist providers for use as comparator, co-therapy, rescue and adjunctive drugs in clinical trials. In June 2013 Clinigen CTS renewed its agreement with Accord to supply these products for a further two years and is the sole point of contact for all clinical trial supply enquiries and orders.

The Capecitabine Accord tablet, which is a hybrid generic version of Xeloda®, is available in a new strength of 300mg in addition to existing strengths of 150mg and 500mg. It was launched in Europe, a market worth almost US$400 million, in December 2013. The chemotherapeutic is indicated for the treatment of a range of cancers including breast, colon, rectum and stomach and can be used in combination with other oncology products from the Accord portfolio supplied by Clinigen CTS.

"Capecitabine is a key product for Accord," said Daniel Green, Hospital Director UK & Ireland at Accord. "We see clinical trials as an important area into which we can supply the drug and extending our exclusive agreement with Clinigen will allow us to maximize the impact and potential of the product in this area. The partnership is working well and we believe that the addition of capecitabine will serve to develop it further."

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "The extension of our exclusive agreement with Accord to include capecitabine is confirmation of the strength of our clinical trials supply business and the partnership we have built with Accord. We pride ourselves on the quality of our service and delivery capabilities and are pleased that Accord has chosen us to manage the distribution of another important product."

- Ends -

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during today's trading session when it reached 690.00. Over this period, the share price is up 217.49%.

Strong gains today, going great guns. Let this one run I think.

Interim results for 6 months end 31 December 2013

RNS


RNS Number : 9228A

Clinigen Group plc

26 February 2014






Clinigen Group plc

Half year results for the six months ended 31 December 2013

Underlying half year pre-tax profits up 12% at £10.9m, underlying EBITDA up 20% at £12.5m

Burton-on-Trent, UK - 26 February 2014 - Clinigen Group plc (AIM: CLIN, Clinigen or the Group), the global specialty pharmaceuticals and pharmaceutical services business, has today published its half year results for the six months ended 31 December 2013.



Financial highlights

- Group revenue of £61.8m (H1FY13: £61.0m); like for like* sales up 6.5%

- Underlying** EBITDA up 20% to £12.5m (H1FY13: £10.5m)

- Underlying** pre-tax profit 12% higher at £10.9m (H1FY13: £9.7m)

- Reported pre-tax profit of £9.6m (H1FY13: £3.7m)

- Underlying earnings per share*** up 7.8% to 9.7p (H1FY13: 9.0p)

- Reported earnings per share of 8.7p (H1FY13: 3.5p)

- Interim dividend of 1.0p per share (H1FY13: 0.6p per share)

- Cash and cash equivalents of £16.8m at 31 December 2013 (30 June 2013: £11.3m)



Business highlights

- CTS: margins improved through better supplier terms. Post period end, exclusive agreement with Accord Healthcare extended to supply capecitabine in Europe

- GAP: large GAP programs running as planned, with new access programs signed up with Eisai for Fycompa® and a third program for BTG for uridine triacetate

- SP: integration of Cardioxane® and Vibativ® on track



* H1FY13 included circa £3m of Foscavir stock fill for the US market which has been adjusted to give like-for-like sales

**Underlying earnings excludes share based payments and one off exceptional costs in FY13 arising as a result of the IPO

***Underlying EPS excludes share based payments and one off exceptional costs and is based on the weighted average number of shares in issue post IPO



Peter George, Chief Executive Officer, said:

"Our focus on value creation has resulted in another strong financial performance.

"We are particularly pleased with the gross profit improvement in the CTS business and that we continue to add new customers.

"GAP continues to go from strength to strength, and our growing reputation is attracting not only important new clients such as Eisai but also returning customers like BTG.

"In SP, the integration of our new products Cardioxane and Vibativ is going well with some of the commercial activities ahead of plan, and Foscavir sales, as expected, are levelling out. Acquisitions for SP are a priority and our activity in this area is high; we are confident we will add further to our portfolio in CY2014.

"In summary, a good start to FY14, with full year expectations on track."

-Ends-

Having already taken half my profit it's very tempting now to be topping up imo.

Clinigen: Numis increases target price from 485p to 620p, but downgrades from buy to hold. Investec ups target price from 469p to 560p, while downgrading from hold to sell.

UPDATE - Clinigen first half earnings rise 20%; investors given a dividend boost

By Ian Lyall

February 26 2014, 2:33pm
The group, whose main business clinical trial supply (CTS), made two key bolt-on buys in the period and said acquisitions remain very firmly on the agenda.


--adds broker comment--




The speciality pharma and pharmaceutical services group Clingen (LON:CLIN) revealed itself to be in rudefinancial health, posting a 20% rise in underlying first half earnings.




The group, whose main business clinical trial supply (CTS), made two key bolt-on buys in the period and said acquisitions remain very firmly on the agenda.




The integration of Cardioxane, a cancer support treatment and Vibativ, for hospital acquired pneumonia, is on track, it added.




“Acquisitions remain a key priority, with the aim of acquiring a further five to seven products over the next three to five years whilst simultaneously ensuring proper integration of new products and newaccounts ,” the group told investors.




Results for the six months to the end of December revealed a 6.5% rise in sales to £61.8mln, which translated to a 20% increase in earnings before interest tax , depreciation and amortisation (EBITDA) to £12.5mln.




Underlying pretax profits were £10.9mln, for a rise of 12%. Confidence was shown in the outlook with a 1p a share interim dividend – up two-thirds on the same time last year.




The group remains on a strong financial footing with £16.8mln of cash.




Clinigen said profit margins from its main CTS business had improved as the result of better supplier terms.

Meanwhile, its global access programmes (GAP) arm, which gains patients access to pre-launch and pre-licence drugs, is “running as planned”. Speciality pharma was boosted by sales of Cardioxane.




Two brokers upgraded their price targets following the interims.




House Peel Hunt said the first half was strong overall though illustrated the lumpy nature of CTS and GAP. The broker added it still sees lots of potential to leverage the Clinigen platform further through additional bolt-ons, which are key catalysts for further upgrades.




Its new 12-month target price is 700p (490p), reflecting "clear distance deserved between Clinigen and lower growing healthcare names such as Dechra and Consort".




Numis raised its target to 620p, adding the rapid growth in profit from the service businesses, coupled with diversification within Specialty Pharmaceuticals, continues to mitigate Foscavir risk.




After the strong run for the shares ahead of the interims, its rating is now ‘hold’.

New buy recs, Peel Hunt tp 700p and Oriel Securities tp 610p. Oversold if you ask me and topped up.

Thinking the same, oversold.

They also have a war chest of cash.

Exactly, they'll be acquiring more niche treatments that unlike big pharma they can add value to - just like they have been doing.

:-))

Clinigen Announce Vibativ Suspension Lifted

RNS


RNS Number : 5416C

Clinigen Group plc

18 March 2014








Clinigen Group Reports Pan European Lifting of Marketing Authorization Suspension for VIBATIV® (telavancin)

Plans for phased Europe-wide launch starting in Q2 2014

Burton-on-Trent, UK - 18 March 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that the European Commission (EC) has ratified the positive opinion in January 2014 from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for VIBATIV® (telavancin).

Clinigen anticipates the commercial launch will begin in the second quarter of 2014 and continue over the next 18 to 24 months as local pricing and reimbursement positions are agreed. In March 2013, Clinigen in-licensed telavancin into its specialty pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialization in Europe.

Telavancin is a bactericidal, once-daily injectable antibacterial agent for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable1.

In 2011 telavancin had been approved in Europe by the EMA. However, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug had not been launched into the market and therefore was never previously available in Europe. Following the technical transfer to a new contract manufacturer, Clinigen has worked closely with the relevant EMA authorities to lift the suspension.

HAP caused by MRSA is an area of considerable unmet need; there is a limited choice of antibiotic therapies available to treat such serious Gram-positive infections and rates of clinical cure are considered to be low2, together with increasing rates of resistance being reported.

"The addition of this novel anti-bacterial to the arsenal of possible therapeutic options for HAP may provide a lifeline for those seriously ill patients who have not responded to previous treatments," said Professor Robert Masterton of the Institute of Healthcare Associated Infection at the University of the West of Scotland and advisor to Clinigen. "Telavancin's safety profile compares well with first line treatment vancomycin and it is highly potent against MRSA including the organisms with reduced susceptibility to vancomycin."

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "The lifting of the suspension is an important step in the phased commercial launch of telavancin throughout Europe. The decision by the EMA follows many hours of work and demonstrates the dedication and expertise of our Specialty Pharmaceuticals team. We are working closely with the contract manufacturer to produce stock to prepare for the launch and beyond."

He added, "In the period before the commercial launch our global access program business, Clinigen GAP, will continue to manage a named patient program in Europe to provide access to telavancin for individual eligible patients via their healthcare professional."

1 Annex I: Summary of Product Characteristics - VIBATIV.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001240/WC500115364.pdf
Accessed: 14 Mar 2014
2 Muscedere J. Which antibiotic for hospital acquired pneumonia caused by MRSA? BMJ 2014;348:g1469

- Ends

Clinigen Group upgraded as broker anticipates deployment of firepower

By John Harrington

March 25 2014, 11:45am
Clinigen has the wherewithal to augment organic growth through selective acquisitions


Investec has upgraded its rating on Clinigen (LON:CLIN) following the recent market correction in the share price of the high-flying pharmaceutical company.

The broker reckons the shares are now a ‘hold’, with the current share price, which is about 30p below the broker’s target price of 560p, reflecting a broadly equal balance of risk and reward for investors.

Observing the “rule of three”, Investec has identified three risks to the stock’s valuation and three upside scenarios.

On the risk side, Investec thinks Clinigen’s clinical trials supply (CTS) business could lose market share if competitors are prepared to sacrifice margin, as customers are not tied to long-term contracts.

Although not an immediate risk, the broker also continues to see risk on the company's key product, Foscavir, whether from generic or branded competitors.

Lastly, while Clinigen’s Global Access Programs (GAP) division has performed well thus far in Investec’s view, it is a relatively new market outside the US with the sort of growth rates that could attract competition.

On the plus side, the CTS division has beaten market expectations in recent years by providing for large ‘one-off’ tenders.

Investec also believes the GAP division “has the potential to deliver earnings upgrades” as it continues to benefit from increased outsourcing by customers.

Meanwhile, Clinigen has the wherewithal to augment organic growth through selective acquisitions.

“Management is keen to make further product acquisitions, which could diversify risk from key product Foscavir and drive growth rates higher in our view. We do not model acquisitions, but, with c.£25mln of cash on the balance sheet by end-FY14E, the company obviously has the firepower to execute,” Investec’s Nicholas Keher asserts.

“As such, we advise waiting for now until either acquisitions can be made that will lower specific risk or the group’s service divisions gain further scale,” Kelleher said.

Clinigen acquires Savene

RNS


RNS Number : 5151D

Clinigen Group plc

31 March 2014






Clinigen Group Acquires Oncology Support Therapy SAVENE®
(dexrazoxane) from SpePharm AG

Acquisition strengthens Clinigen's position in dexrazoxane market

Burton-on-Trent, UK - 31 March 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (LSE: CLIN) (AIM: CLIN) the specialty global pharmaceutical company today announces the acquisition of SAVENE® (dexrazoxane) from SpePharm AG, a majority owned affiliate of Norgine B.V. The Financial terms of the acquisition are not being disclosed.

SAVENE is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. SAVENE is the only authorized treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment.

SAVENE has Orphan Drug status and protection until late 2016 with a worldwide method of use patent until 2020. In 2013 the sales were approximately €3.8million.

Under the terms of the agreement, Clinigen will assume full responsibility for SAVENE's manufacturing, registration, distribution, and commercialization in all markets globally excluding the Americas, Israel and South Africa. In Japan, Clinigen will provide SAVENE through an existing supply and license agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorization holder.

In 2013 the Group also acquired Cardioxane® from Novartis which, like SAVENE, has dexrazoxane as its active substance and is also an oncology support therapy; used to prevent the cardiotoxicity of anthracyclines for patients with advanced and/or metastatic breast cancer. The acquisition of SAVENE allows Clinigen to exploit synergies between the two products.

Peter George, Chief Executive Officer, Clinigen Group, said: "In acquiring both SAVENE and Cardioxane, Clinigen will expand its strategic options in oncology support and consolidate its supply chain. The acquisition was a natural move for us and is in line with our stated strategy to expand our specialty pharmaceuticals portfolio."

David Bryant, Senior Vice President, Clinigen SP, said: "This is the fourth product to be added to our specialty pharmaceuticals portfolio. This acquisition has helped strengthen our position in the oncology support area, adding SAVENE to Cardioxane and Foscavir®. We continue to focus on the acquisition of niche, hospital-only therapies which have the potential to save the lives of critically ill patients."

- Ends -

Clinigen Group: Numis takes target price from 620p to 650p upgrading to buy

Went long again today, its a certainty for a write up in tip sheet SCSW either this sat or the sat after.

Cheers gf.

Think its this saturday DC ill be keeping an eye out on advfn this coming weekend.

Dont have to subscribe just look for the leaks.

CLIN could be in for a very bullish phase. Ive added this afternoon. When this one rises it rises fast. looking for upside to previous highs. as featured on the chart.

Excelent financial news for CLIN..........

RCS - Clinigen Group plc - Clinigen agrees new £35 million banking facility

04 Apr 2014 - 07:00
For best results when printing this announcement, please click on the link below:
http://pdf.reuters.com/Regnews/regnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20140404:nRSD0321Ea
RNS Number : 0321E
Clinigen Group plc
04 April 2014
Clinigen agrees a new £35 million banking facility
Burton-on-Trent, UK - 04 April 2014 Clinigen Group plc ("Clinigen" or the
"Group") (AIM: CLIN) has agreed a new four year £35 million multi-currency revolving credit facility. An accordion option has also been agreed under which Clinigen can request an additional £15 million on the same terms.
The facility, provided by the Group's existing bankers, The Royal Bank of Scotland PLC, replaces the existing £20 million facility. It is secured on the tangible and intangible assets of the Group.
Robin Sibson, Clinigen's Chief Financial Officer, said: "This significantly increased facility will provide us with the flexibility to continue to deliver our strategy of adding to our SP product portfolio whilst we continue to drive the business forward through organic growth."
- Ends –

Acquisitions should keep coming.

Should do now yep.

Hoping it gets tipped tomorrow.

Think tip sheet SCSW is out and cant see it not reporting the new drugs.

Monday COULD be explosive.

don't think it's out for another week gf

DRAT...............double drat.

Out now.

Is it........good. Bet its got a mention.

Good full page article in today's Shares mag - buy.

Clinigen to manage Nerixia named patient program

RNS


RNS Number : 7288E

Clinigen Group plc

14 April 2014














Clinigen Group to Manage International Named Patient Program for
Abiogen Pharma's Nerixia® (Neridronic Acid)


Burton-on-Trent, UK and Pisa, Italy - 14 April 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) and Abiogen Pharma SpA ('Abiogen') jointly announced today the initiation of a Named Patient Program, managed by Clinigen Global Access Programs (Clinigen GAP) to provide Nerixia® (neridronic acid), owned by Abiogen to individual patients with Osteogenesis imperfecta (OI) through their Healthcare Professional.

Clinigen GAP will supply the drug to countries within the European Union (EU), except for in Italy where the drug is currently licensed and commercially available. Nerixia, an aminobisphosphonate, is indicated for the treatment of OI, a congenital disorder characterized by brittle bones that are prone to fracture, which is estimated to affect 1-9 people per 100,000 worldwide1. No other bisphosphonate is currently licensed for the condition in Europe.

Nerixia is not licensed outside of Italy but under the Named Patient Program, Healthcare Professionals in the EU will be able to request the drug for individual patients suffering from OI who have no other approved therapeutic option.

Dr. Massimo Di Martino, President and CEO of Abiogen said, "Securing a trusted, specialist partner to manage access for Nerixia is key. Our collaboration with Clinigen GAP will ensure responsive, efficient supply of the drug to those patients who need it until we can make Nerixia commercially available. Clinigen GAP has extensive experience in the design and management of access programs on a global scale and we look forward to working with the team."

Mark Corbett, Senior Vice President, Clinigen GAP said, "Nerixia has the potential to make a huge difference to the lives of individual patients and we are very pleased to be able to implement an access program for this important therapy. With an expanding client base of international pharmaceutical companies and over thirty access programs ongoing we have the expertise, capabilities and regulatory know-how to deliver this bespoke program."

1 Orphanet portal for rare disease and orphan drugs www.orpha.net
Search: Osteogenesis Imperfecta
Accessed on 10 March 2014

- Ends -

Clinigen raised to buy at Investec. Not sure of price target.

7 Jul Investec 497.00 Buy

Clinigen shares upgraded by Investec

By Ian Lyall

July 07 2014, 11:38am
Investec's new price target points to significant upside.


Investec said it was time to buy shares in speciality pharma group Clinigen (LON:CLIN) after the broker upgraded from ‘hold’ and revised its earnings targets.

Analyst Nicholas Keher tweaked down his earnings per share (EPS) forecast by 3% and 7% respectively for the next two financial years.

The valuation was also shaved back - to 497p a share - to reflect the change.

“Even against our lower target price, we think the shares offer an attractive opportunity,” said Keher.

Clinigen is a three-wheeled hybrid of a business that is unique, not just on AIM and in the UK, but across the world, but the business model works and has synergies that will be the catalyst for growth for some years to come.

The first wheel, which generates around 65% of revenues, is Clinical Trials Supply (CTS).

Big pharma and the large contract research firms, when carrying out clinical studies on new blockbuster treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products.

The second business, Global Access Programs, which provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy.

It also has a growing speciality pharma arm.

Shares in the business, which is valued at £317mln, were changing hands this morning for 385p each.

11 Jul Numis 650.00 Buy

year end trading update

RNS


RNS Number : 1683N

Clinigen Group plc

24 July 2014






Year end trading update

Profit growth strong; underlying EBITDA up at least 17%

Burton-on-Trent, UK - 24 July 2014 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the specialty global pharmaceutical company, today provides the following trading update for the year ended 30 June 2014.

Highlights

· Like for like revenues* on a constant currency basis up in excess of 7% on prior year and reported revenues not less than £126m.

· Gross margins increased to over 30% delivering growth in excess of 17% on prior year.

· Underlying EBITDA up at least 17% on prior year.

· Closing net cash position of £5.3m; combined with the borrowing facility of £35m, provides opportunity for continued expansion.

· Significant growth in GAP; good new business pipelines for both GAP and CTS.

· Acquisition of Savene complements Cardioxane, and strengthens dexrazoxane market position for SP.

* Like for like sales represent revenues adjusted for Foscavir stock fill (£3m) in FY13.

Group performance

Clinigen continues to drive strong organic growth, demonstrated by in excess of 50% growth in GAP revenues, greater than 10% growth in SP revenues and revenues up more than 11% in H2 on H1 in CTS. This, combined with improved gross margins and lower than expected administrative costs, has resulted in over 17% growth in underlying EBITDA.

Foscavir in-market sales are matching the global growth of the transplant market. The integration of two new products during FY14, Cardioxane and Savene, is running to plan and they are expected to complete their transition to Clinigen during FY15. Both of these brands are formulated from the active ingredient dexrazoxane, and going forward Clinigen's revitalization opportunities are enhanced by acquiring both of these products.

The Group continues to have strong cashflows, which this year have funded the acquisition of Savene and the second staged payment for Cardioxane. The closing net cash position combined with the bank facility provides funding for further product acquisitions.

Peter George, Chief Executive Officer, Clinigen said,

"This has been another great year for Clinigen. All three operating businesses have contributed to a strong trading performance and we have seen good organic growth, especially in GAP. We're particularly pleased with the increased gross margins and, yet again, the excellent growth of EBITDA.

"We are also seeing good acquisition and complementary product opportunities for SP, which supports our strategy to focus on niche, hospital-only, specialty pharmaceutical products. This strategy plays well in the current environment where big pharmaceutical companies are looking to divest more mature products.

"At this early stage, we are confident of another strong year ahead and we remain on track to be the leading provider of CTS and GAP services."



Operational businesses

· CTS

CTS continues to be the main revenue generator of the Group albeit the revenues are lumpy. Revenues in FY14 will be lower than the prior year due to the previously explained anti-viral studies in FY13 which were not repeated this year.

A recent market research report estimates the clinical trial supply market to be $1.5-2.0bn globally, with spend on individual clinical trial comparators ranging from $200K to $20m. Clinigen is in a good position, with its regulatory and global distribution expertise, to target this large market. The goal for the Group is to become the global leader in clinical trial supply and continued growth is supported by the division's strong sales pipeline.

· GAP

GAP continues to be the fastest growing Clinigen business. A measure that reflects this significant growth is the number of drug units delivered, which has increased to 58,000 in FY14 from 31,000 in the prior year.

As previously announced, H1FY14 saw the winding down of one large high revenue, lower margin program which has not been replicated in the second half of the year. Despite this, GAP has maintained its gross profits.

Clinigen GAP's growing reputation in the delivery of global access programs places it in a strong position to increase market share in the outsourced global access market, estimated to be in excess of $500m. This position is reflected in the division's robust new business pipeline.

· SP

Revenues have been boosted as a result of a full year's ownership of Cardioxane and a small contribution from newly acquired Savene in the final quarter of this year. SP remains the largest contributor to the Group's gross profits.

Foscavir continues to be a reliable generator of revenue and profits. Year on year revenues and volumes were impacted last year by stock fills and this year by new bulk supply distribution agreements, which benefit cashflow but mean actual sales do not accurately reflect in-market sales. For the full year results, the Group will report on underlying in-market sales which are expected to reflect the growth of the transplant treatment area. There has also been improvement in the average selling price of Foscavir.

Under the agreement for Cardioxane with Novartis, sales are not recognized at the market value until the Marketing Authorization (MA) for the specific territory has been transferred. All MAs for Cardioxane have now been transferred, apart from Latam and South Korea which are on schedule. The integration of Savene into the operational business also remains on track. More detail on the revitalization plans for these two dexrazoxane products will be provided at the full year results.

The lifting of the suspension on the European Marketing Authorisation for the antibiotic Vibativ, in March 2014, was an important milestone in the development of the European launch of the product. This launch is now anticipated to be October/November this year following unforeseen delays in product availability and sensitivity testing.

Overall, Clinigen continues to deliver on its objective of building its specialty pharmaceutical portfolio and is on track to have ten products over the next four to five years.



The information contained in this statement has not been audited and may be subject to further review. The Group expects to publish its final results for the year to 30 June 2014 on Wednesday 24 September 2014.



-Ends-

UPDATE - Clinigen Group sees opportunities arising from sector consolidation

By John Harrington

July 24 2014, 11:42am
UPDATE - Clinigen Group sees opportunities arising from sector consolidation

---ADDS CHIEF EXECUTIVE'S COMMENTS AND SHARE PRICE---

Speciality pharmaceutical company Clinigen (LON:CLIN) saw strong profits growth last year, with all three divisions pitching in.

Though it is early days, management is confident of another strong year this time round as it strives to become the leading global clinical trial supply (CTS) and global access programmes (GAP) company.

For the group as a whole, like-for-like (LFL) revenues on a constant currency basis in the year to 30 June are likely to be up by at least 7% year-on-year once the numbers are totted up, with reported revenues set to come in at £126mln or higher.

Gross margins during the year increased to more than 30%, delivering growth in excess of 17% on the previous year, while underlying earnings (EBITDA) were up at least 17% on the previous year.

The CTS division continues to be the main generator of revenue. This is the division that sources and supplies comparator drugs and medicines to the big pharmaceutical and contract research firms when those firms are carrying out their all-important clinical trials.

CTS revenues in fiscal 2014 (FY14) were lower than they were in FY13, as per the previously explained situation with anti-viral studies in FY13 that were not repeated in the fiscal year just finished.

The GAP division provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy to patients who are very ill and not responding to current treatments.

It continues to be the fastest growing part of the business, and despite the winding down of one large high revenue, lower margin programme in the first half of the financial year, GAP maintained its gross profits, and has a robust new business pipeline.

The third leg of the business is Specialty Pharmaceuticals (SP), where the company has been bedding down the Cardioxane acquisition and integrating the recently acquired Savene unit. SP remains the largest contributor to group profits, Clinigen revealed.

Overall, Clinigen continues to deliver on its objective of building its specialty pharmaceutical portfolio and is on track to have ten products over the next four to five years.

“We have seen good organic growth, especially in GAP. We're particularly pleased with the increased gross margins and, yet again, the excellent growth of EBITDA,” said Clinigen’s chief executive officer, Peter George.

A lot of trading updates from companies recently have grumbled about the strength of sterling, and with just 5% of its revenues derived from the UK, Clinigen is exposed to currency fluctuations, particularly in respect of sterling’s performance against the euro, the US dollar, the Swiss franc and the Japanese yen.

George was sanguine about sterling’s strength, however, saying the effect has not been huge – it’s lopped a couple of million off the top line – and it has not affected EBITDA, he told Proactive Investors.

The group ended the financial year with cash of £5.3mln, plus it has a borrowing facility of £35mln, thus providing plenty of firepower for continued expansion, particularly if the recent wave of consolidation in the pharmaceuticals sector leads to companies pruning their portfolios.

“I love it when big pharma goes into mergers & acquisitions mode,” George revealed. “The merged companies outsource more, they often have duplicate products in their portfolio, or they review what they’ve got.”

Unfortunately, while recent mergers might eventually see some interesting drugs come up for grabs, in George’s experience it won’t be for 12 to 18 months, as the merged companies go into a kind of stasis, with no one quite sure who is responsible for making the decisions.

“Once they work out who is entitled to make the decisions, you get a burst of activity, with the new decision makers determined to make their mark,” George suggested, adding that if the Shire/AbbVie merger goes through, he expects some interesting drugs to become available for purchase.

Shares in Clinigen rose 11.25p to 406p on the trading update before drifting back to 387.48p at midday.

Clinigen: N+1 Singer initiates with a target price of 439p and a buy recommendation.

MIDAS SHARE TIPS: Drugs firm Clinigen comes off boil but has right chemistry to be a winner

By Joanne Hart, Financial Mail On Sunday

Published: 22:21, 16 August 2014 | Updated: 22:46, 16 August 2014


Speciality drugs group Clinigen was founded in 2010 and within two years, it had joined AIM with a stock market value of £135million. The shares, which floated at 164p, became a market favourite and by the start of this year they had risen to more than 625p.


Since then, the stock has almost halved to 3833⁄4p. At this level, it offers real potential.


Chief executive Peter George is fiercely ambitious and has a welldefined growth plan for the business over the next three to five years. A biochemist turned entrepreneur, George spent many years working in private equity, delivering top results for demanding paymasters. He now intends to continue in that vein on AIM.


Niche: Clinigen has targeted one drug at patients receiving bone marrow transplants



The company has three divisions. It runs drug-testing programmes for large pharmaceutical groups. It acquires highly specialised medicines, with the aim of doubling their sales. And under its global access programme, it makes drugs available to patients when they have been extensively tested but have yet to receive regulatory approval.


Clinical testing of new drugs has traditionally been carried out by pharmaceutical groups themselves. Regulators need to know that a new product really is an improvement on existing treatments so new drugs are tested against market leaders. Testing conditions need to be rigorous, however, to ensure that true comparisons are made – otherwise the trial becomes invalid.




Hundreds of millions of pounds are wasted every year in clinical trials because conditions are subsequently deemed to have been sub-optimal, but Clinigen can help to cut this figure. It takes considerable care with procedures and sourcing to ensure that trials are acceptable and its testing division has increased turnover from £4million in 2010 to more than £80million.



Revenues can fluctuate from year to year. In 2013, for example, a single trial produced revenues of £24million, but larger trials often have lower profit margins than smaller ones, so profits have been growing steadily and George expects to double the size of the division by 2019.


Clinigen has also started to acquire niche drugs that have been neglected by their previous owners. The company then tries to revitalise the products by working out which patients might benefit most from them. The first drug it bought, Foscavir, was being offered to patients who had been diagnosed as HIV positive, but Clinigen realised that it would be far more helpful for those receiving bone marrow transplants, and sales have soared from £4.5 million in 2010 to more than £20 million. The company has four niche drugs today, but intends to take that up to ten over the next five years.


Clinigen’s global access programme, which makes drugs available before they are licensed, is the fastest growing division in the group. It can take years for regulators to approve new drugs, particularly in Europe, where governments are trying to cut public sector costs. In Greece, Spain and Italy, for example, very few new drugs have been licensed since the financial crisis, as health services face growing pressure to keep the lid on spending.


This can be hugely frustrating for patients – highlighted in this country by the recent outcry over the £90,000 breast cancer drug Kadcyla, which was deemed too expensive to be approved.


However, patients can access these drugs through schemes like Clinigen’s. The company cannot promote medicines that have not been approved, but top doctors, many of whom will have been involved in testing the products, already know of their existence and can apply to Clinigen for supplies.


Some pharmaceutical groups interact directly with the medical profession. Many prefer to take a step back so they are not accused of active promotion. Clinigen supplies 30 such medicines to 85 countries, including Britain, and George is keen to triple the business by 2019, making it the number one player worldwide.


Results for the year to June will be released at the end of September and are expected to show profits rising 19 per cent to £23.5million with a further increase to almost £27million forecast for 2015. Unusually for a small biotech business, Clinigen pays a dividend, which is poised to increase 15 per cent to 3p this year and a further 10 per cent to 3.3p next year.


Midas verdict: Clinigen came to the stock market in a blaze of glory and suffered at the hands of a merciless City earlier this year when it said that growth would not be quite as racy as analysts had hoped for. However, the underlying business has sound, long-term prospects and the shares offer good value at 3833⁄4p. Buy.


Traded on: AIM Ticker: CLIN

Another oncology treatment added from AstraZeneca. Investec out yesterday with buy, tp 497p and Numis today, tp 650p

Share price is waking up finally.

CLIN, RNS out today new drug. Now with the SP off the high of the day is an opportunity to jump abroad. Just bought.

CLINIGEN GROUP BROKER VIEWS

Date Broker Recommendation Price Old target price New target price Notes
20 Aug Investec Buy 429.50 497.00 512.00 Reiterates
20 Aug Numis Buy 429.50 650.00 650.00 Reiterates
20 Aug N+1 Singer Buy 429.50 439.00 439.00 Reiterates

@360 seems to be support?

360ish yep, unless 'I should have gone to specsavers'.

And Peel Hunt today 710p. I'm seeing consensus tp 577p

Been well oversold throughout the year I reckon.

Clinigen Acquires Ethyol

RNS


RNS Number : 5595P

Clinigen Group plc

20 August 2014








Clinigen Group Further Strengthens Oncology Support Portfolio with Acquisition of Ethyol® (amifostine), from AstraZeneca

Clinigen Specialty Pharmaceuticals division expands to five products

Burton-on-Trent, UK - 20 August 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (LSE: CLIN) (AIM: CLIN) the specialty global pharmaceutical company today announces the acquisition of the global rights to the oncology support therapy, Ethyol® (amifostine) from AstraZeneca.

Ethyol is a cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New Drug Application ('NDA') and in 2013, Ethyol revenue was approximately $4.9million.

This is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir® in 2010), and the Group's third oncology support product adding to Cardioxane® and Savene® bringing the Specialty Pharmaceuticals portfolio to five products in total.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug ('IND') authorizations are transferred and the technical transfer to a third party manufacturer is completed. The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing. The financial terms of the agreement are not disclosed.

Peter George, Chief Executive Officer, Clinigen Group, said: "I am very pleased to be working with the AstraZeneca team again. In acquiring Ethyol, as well as bringing our total number of products to five, we now have a portfolio of three oncology support products, adding to Cardioxane® and Savene®. This acquisition is in line with our stated strategy of acquiring niche, hospital-only therapies which have the potential to save and improve the lives of critically ill patients. Ethyol was originally identified through our acquisition database of large pharma product candidates as a very good fit for Clinigen's business model; whilst it was one of the original 12 targets and took some time to close, it is further evidence that the Clinigen model works."

- Ends -

Clinigen - Acquisition
Today (2014-08-20 11:23:08)Print this Article
by James Faulkner

Clinigen (CLIN), the specialty pharmaceuticals and services company, has announced the acquisition of the global rights to the oncology support therapy, Ethyol (amifostine) from AstraZeneca. Ethyol is a cytoprotective (cell protecting) drug indicated as an adjuvant therapy (i.e. one that modifies the effects of other agents) to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer.

It also reduces the cumulative renal (kidney) toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer. In 2013, Ethyol revenue was approximately $4.9 million.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug (IND) authorisations are transferred and the technical transfer to a third party manufacturer is completed. The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing. The financial terms of the agreement were not disclosed.

Assessment...

We see it as a positive that Clinigen continues to reduce its reliance on its Foscavir product, especially given the recent weakness seen in this area. Ethyol is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir in 2010), and the group's third oncology support product adding to Cardioxane and Savene bringing the Specialty Pharmaceuticals portfolio to five products in total.

Although we are disappointed by the lack of financial details in today's announcement, if Clinigen can come anywhere close to replicating the success of Foscavir with Ethyol shareholders could see decent returns. Clinigen acquired Foscavir for £9.15 million - a price to sales ratio of 2 times - from AstraZeneca in early 2010. Through its local knowledge and global reach Clinigen has successfully increased pricing around threefold in most countries, has sought (and started to receive) additional regulatory approvals, and is broadening the product's geographic footprint. Sales have grown rapidly from £4.6 million in 2009 to £21.7 million in FY2012.

We retain our belief that Clinigen has a unique combination of businesses that delivers a whole greater than the sum of the parts, which sets it in good stead to realise its ambition of becoming the number one global provider of CTS and GAP services and a major global specialty pharmaceutical company. Furthermore, the cash generative nature of the business means that acquisitions, for the most part, should be able to be funded internally from cashflow.

Valuation...

House broker Numis has noted the potential for "over 100% upside to its 5-year forecasts", should the company meet its stated ambition to become the market leader in both CTS and GAP through organic growth, and to add a further 5-7 specialty pharmaceutical (SP) products over the next 3-5 years (it has now added two since we tipped the shares in April 2013). In this context, we believe the current rating of c.15.1 times 2015 consensus forecast earnings looks like good value, especially when one factors in the rapid earnings growth anticipated over the foreseeable future (PEG <1).

Key risks include further margin erosion, acquisition risks and revenue visibility. We believe recent share price weakness has been overdone, and that the current valuation is well underpinned by the combination of a strong and unique business model, rapid earnings growth and upgrade potential. We therefore keep our stance at 'buy', at 415p.

Clinigen cancer drug acquisition keeps plan on track
Pharmaceutical company Clinigen (CLINC) has added to its cancer care portfolio after the purchase of a chemotherapy drug from AstraZeneca.

Peel Hunt analyst Stefan Hamill retained a ‘buy’ recommendation and increased the target price from 690p to 710p following the purchase of the drug, which reduces the side effects of chemotherapy. Shares jumped 3.7% yesterday on the news to 416.1p.

‘Clinigen’s acquisitions of Ethyol from AstraZeneca fits well into the portfolio, bringing its cancer supportive care portfolio to three and its total portfolio to five products, representing further execution of the plan laid out at initial public offering, when it had just one,’ he said.

‘We factor in modest numbers for Ethyol in advance of an update on the portfolio strategy at the prelims, seeing 3% earnings per share accretion from full year 2016, and moving our valuation up to 710p.’

Clinigen Group: N+1 Singer ups target price from 439p to 488p and keeps a buy recommendation.

2 Sep Oriel... 650.00 Buy

Looks ready to break that 450p level tomorrow!

Could well be tipped this weekend by SCSW, they should have something to say about the new drug.

Notice of Results

RNS


RNS Number : 8184Q

Clinigen Group plc

04 September 2014






Clinigen Group plc

Notification of Full Year Results Date

Burton-on-Trent, UK - 04 September 2014 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its full year results for the year ended 30 June 2014 on Wednesday, 24 September 2014.

A group analyst briefing will be held at 09:30am BST on Wednesday, 24 September 2014 at Instinctif Partners' offices at 65 Gresham Street, London EC2V 7NQ.

- Ends -

Tipped in today's Investors Chronicle.

Wondered why it was going so strong. cheers Greyhound.

Hopefully tip sheet article this weekend aswel.

The I. C. article;

Buy ahead of Clinigen re-rating
Bull points
High margins Undervalued Experienced management Strong order book
Bear points
Lumpy revenue stream Disappointing 2013
After listing in late 2012, pharmaceutical group Clinigen (CLIN) fast become the darling of London’s junior Aim market. The listing price – 164p
– surged to 690p early this year but some disappointments in half-year results in February led to a substantial share price fall. But with strong full-year numbers looking likely when the company reports its figures later this month, we think there is now considerable ground to make up on the upside. Investors therefore have a second opportunity to buy the stock, this time at a significant discount to 2013 levels.
There are two main reasons Clinigen won rapturous support from investors when it arrived on the London Stock Exchange. The clinical trials market into which Clinigen supplies third-party material is growing at about 15 per cent a year. Secondly, Clinigen’s management had a proven track record in understanding the complex regulation surrounding specialist access to certain drugs – encompassed by its global access programme (GAP) division.
But at the start of 2014, when Clinigen released half-year results for the six months to December, concerns started to build about the shares overheating. The clinical trial supply (CTS) division – responsible for more than 64 per cent of first-half sales – revealed a 13 per cent fall in sales to £39.5m, and it didn’t help that management admitted that a near four percentage point rise in the CTS gross profit margin – to 16.5 per cent – was ‘unsustainable’. Consequently, the shares crashed 17 per cent on the morning the news came out.
But the company still holds substantial promise for future growth and increasing shareholder returns. The specialty pharmaceuticals division, which provides a solid backbone and accounted for just over half gross profits for the first six months of the year, is still in an early stage of development, with management aiming to add six new drugs over the next three to five years. Meanwhile, the CTS segment is forecast to grow 5 per cent in 2015, and GAP, which accounted for 16 per cent of first-half sales, continues to be Clinigen’s fastest-growing division.
Encouragingly, chief executive Peter George says the lumpy nature of the CTS business and the drop in half-year sales was solely the result of strong comparative figures last year, which included a large number of low-margin anti-viral study sales. He also believes an overdependence on CTS revenues as the bulk of sales will soon be a thing of the past.
A bullish trading update released at the end of July has already begun the re-rating of the stock. In it, Clinigen said it expects like-for-like sales growth of more than 7 per cent for 2014, with total revenues of no less than £126m. The GAP division is expected to report 50 per cent sales growth, and CTS should see revenues up more than 11 per cent in the second half compared with the first half.
Continued improvement in gross margins across all the divisions also contributed to a 17 per cent improvement in underlying cash profits as at the end of June, suggesting full-year results should beat analysts’ expectations. Such a solid performance could be down to lower operational costs, and the keen prices paid for two newly acquired speciality pharma drugs: Cardioxane and Savene. And management says there is also potential in Clinigen’s new business pipeline for CTS and GAP, which broker N+1 Singer puts at about £200m.
Come the 2014 annual results on 24 September, investors should glean further clarity on Clinigen’s new business pipeline and how the new speciality pharma products will help drive growth. This could provide the re-rating catalyst the stock needs. We think investors would do well to boost their stake in Clinigen while the shares trade on 16 times 2015 earnings. Buy. HR

After losing its ‘hot stock’ status at the time of its half-year results in February, Clinigen looks set to re-rate

Cheers g. :-)

Clinigen Launch Antibiotic, Vibativ in Europe

RNS


RNS Number : 0710S

Clinigen Group plc

18 September 2014






Clinigen Group launches New First-in-Class Antibiotic VIBATIV® (telavancin) for MRSA related Hospital-Acquired Pneumonia across Europe



Burton-on-Trent, UK - 18 September 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN), the specialty global pharmaceutical company, today announced that the new first-in-class bactericidal, once-daily, injectable antibiotic VIBATIV® (telavancin), is now available to prescribe in Europe for the treatment of adults with nosocomial pneumonia (also known as hospital acquired pneumonia - HAP), including ventilator associated pneumonia (VAP), known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable.



In March 2013, Clinigen, in-licensed V IBATIV® from Theravance, Inc. for commercialization in Europe, however, at that time the European Marketing Authorisation for the drug was suspended due to stopped operations at the previous manufacturer. Clinigen worked closely with a new contract manufacturer and the relevant European authorities to have the suspension lifted. The European Commission (EC) confirmed this in March 2014 enabling Europe-wide, licensed supply to commence. This will be the first time the licensed product will be available in Europe.



VIBATIV® is an innovative treatment for HAP, the most common cause of death among infections acquired in a hospital setting, in that it offers a dual mechanism of action enabling it to kill even drug resistant strains of Staphylococcus aureus.[1]The drug's dual mechanism of action means that even a strain resistant to one of the mechanisms of action may still be affected by the other mechanism, suggesting that VIBATIV® may be less prone to resistance than other antibiotics. HAP caused by MRSA is a considerable unmet need, recognised as a public health priority in the EU. MRSA is estimated to cost EUR380 million every year in extra hospital costs.[2] As a result of these high costs, both economic and human, there is increasing demand for new tools to combat infections caused by drug-resistant bacterial strains and the availability of new antibacterial agents is recognised as playing an important role in treating MRSA.



30-70% of patients who acquire HAP currently die despite early and appropriate treatment, and the condition places a large burden on healthcare systems.[3] There is a limited choice of licensed antibiotic therapies able to treat HAP/VAP caused by MRSA and therefore this launch provides an important, alternative, effective agent in the fight against the growing problem of resistance by bacteria.









"HAP caused by MRSA is often more serious and difficult to treat than similar infections with more drug susceptible strains," said Professor Matteo Bassetti, Professor of Infectious Diseases, School of Medicine and Postgraduate School of Infectious Diseases, University of Udine, Italy. "We are increasingly seeing bacteria acquire resistance to antibiotics previously considered last resort treatments; we need more options to treat these extremely serious infections. The widespread availability of a new and effective antibiotic such as VIBATIV® is therefore very good news for Europe."



"The emergence of so-called 'super bugs' and increasing resistance among microbes to existing antibiotics has been recognised internationally as a major clinical challenge," said Peter George, Group Chief Executive Officer at Clinigen Group plc. "We are therefore extremely proud to be making this potentially life-saving medicine available across Europe for people who may have no other suitable option to fight a life-threatening infection."



- Ends -

Clinigen Group plc Clinigen Launch Antibiotic, Vibativ in Europe
Date : 18/09/2014 @ 16:15
Source : RNS Non regulatory
Stock : Clinigen (CLIN)
Quote : 463.75 2.0 (0.43%) @ 16:20
HOME » LSE » LSE » Clinigen share price

Clinigen Group plc Clinigen Launch Antibiotic, Vibativ in Europe
Share On Facebook Print
Alert
TIDMCLIN

Clinigen Group plc

18 September 2014

Clinigen Group launches New First-in-Class Antibiotic VIBATIV(R) (telavancin) for MRSA related Hospital-Acquired Pneumonia across Europe

Burton-on-Trent, UK - 18 September 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN), the specialty global pharmaceutical company, today announced that the new first-in-class bactericidal, once-daily, injectable antibiotic VIBATIV(R) (telavancin), is now available to prescribe in Europe for the treatment of adults with nosocomial pneumonia (also known as hospital acquired pneumonia - HAP), including ventilator associated pneumonia (VAP), known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable.

In March 2013, Clinigen, in-licensed V IBATIV(R) from Theravance, Inc. for commercialization in Europe, however, at that time the European Marketing Authorisation for the drug was suspended due to stopped operations at the previous manufacturer. Clinigen worked closely with a new contract manufacturer and the relevant European authorities to have the suspension lifted. The European Commission (EC) confirmed this in March 2014 enabling Europe-wide, licensed supply to commence. This will be the first time the licensed product will be available in Europe.

VIBATIV(R) is an innovative treatment for HAP, the most common cause of death among infections acquired in a hospital setting, in that it offers a dual mechanism of action enabling it to kill even drug resistant strains of Staphylococcus aureus.([1]) The drug's dual mechanism of action means that even a strain resistant to one of the mechanisms of action may still be affected by the other mechanism, suggesting that VIBATIV(R) may be less prone to resistance than other antibiotics. HAP caused by MRSA is a considerable unmet need, recognised as a public health priority in the EU. MRSA is estimated to cost EUR380 million every year in extra hospital costs.([2]) As a result of these high costs, both economic and human, there is increasing demand for new tools to combat infections caused by drug-resistant bacterial strains and the availability of new antibacterial agents is recognised as playing an important role in treating MRSA.

30-70% of patients who acquire HAP currently die despite early and appropriate treatment, and the condition places a large burden on healthcare systems.([3]) There is a limited choice of licensed antibiotic therapies able to treat HAP/VAP caused by MRSA and therefore this launch provides an important, alternative, effective agent in the fight against the growing problem of resistance by bacteria.

"HAP caused by MRSA is often more serious and difficult to treat than similar infections with more drug susceptible strains," said Professor Matteo Bassetti, Professor of Infectious Diseases, School of Medicine and Postgraduate School of Infectious Diseases, University of Udine, Italy. "We are increasingly seeing bacteria acquire resistance to antibiotics previously considered last resort treatments; we need more options to treat these extremely serious infections. The widespread availability of a new and effective antibiotic such as VIBATIV(R) is therefore very good news for Europe."

"The emergence of so-called 'super bugs' and increasing resistance among microbes to existing antibiotics has been recognised internationally as a major clinical challenge," said Peter George, Group Chief Executive Officer at Clinigen Group plc. "We are therefore extremely proud to be making this potentially life-saving medicine available across Europe for people who may have no other suitable option to fight a life-threatening infection."

- Ends -

About VIBATIV(R) (telavancin)

VIBATIV(R) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV(R) both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV(R) is approved in the United States (US) for the treatment of adult patients with (i) complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains, and (ii) hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In September 2011, the European Commission granted Marketing Authorization for VIBATIV(R) for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. VIBATIV(R) was discovered and developed by Theravance, Inc., and transferred to Theravance Biopharma, Inc. in connection with the separation of the two companies in June 2014.

In May 2012, the European Commission suspended Marketing Authorization for VIBATIV(R) because the previous single-source drug product supplier did not meet the current Good Manufacturing Practice ("cGMP") requirements for the manufacture of VIBATIV(R). In March this year the European Commission reinstated the marketing authorisation for VIBATIV(R) as consistent product supply was re-established in accordance with European Commission requirements. Theravance Biopharma Antibiotics, Inc. has granted Clinigen exclusive commercialization rights to VIBATIV(R) in the EU and certain other European countries (including Switzerland and Norway).

For further information, for healthcare professionals please visit www.vibativ.eu

About Clinigen

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP).

Clinigen SP is focused on acquiring its own intellectual property in licensed, niche, hospital-only critical care medicines, increasing the value of these medicines by developing new formulations and indications, then registering and marketing them in defined global markets.

For more information, please visit www.clinigengroup.com

Contact Details

Clinigen Group plc Tel: +44 (0) 1283 495 010

Peter George, Group Chief Executive Officer

Shaun Chilton, Chief Operating Officer

Results at the very high end of expectations.

Clinigen Group plc: Underlying EBITDA up 19.8% and EPS up 22% CLINC.L
24 Sep 2014 - 07:10

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20140924:nBw236824a BURTON-ON-TRENT, England--(Business Wire)-- Clinigen Group plc (`Clinigen` or the `Group`, AIM: CLIN), the global specialty pharmaceuticals business, has today published its preliminary results for the 12 months ended 30 June 2014.

Financial highlights

Like for like revenues* on a constant exchange rate basis up 7.5%. Reported revenues up by 3% to £126.6m (FY13: £122.6m)
Gross margin improved in all three operating businesses, increasing to over 30% overall and delivering growth in excess of 17%
Underlying EBITDA** increased by 19.8% to £26.8m (FY13: £22.4m)
Reported pre-tax profits up by 47% to £21.3m (FY13: £14.5m)
Adjusted underlying earnings per share*** up 22% to 24.5 pence (FY13: 20.1 pence) and reported earnings per share up 30% to 19.6 pence (FY13: 15.1 pence)
Cash generation continues to be strong. Net cash of £5.3m combined with the borrowing facility of £35m, provides opportunity for continued expansion.
Final dividend 2.1 pence per share proposed; total dividend 3.1 pence per share (FY13: 2.6 pence per share), up 19%.
Business highlights

Specialty Pharmaceuticals (SP)
Total number of products increased from three to five following the acquisition of two oncology support products; Savene in March 2014 and Ethyol in August 2014.
Suspension of Marketing Authorization lifted for Vibativ and product launched September 2014.
New indications and price increases applied to Foscavir.
Clinical Trials Supply (CTS)
Gross margins returned to 15.1%; deeper penetration of customer base with requests to supply and product sourced both up more than 30%.
New exclusive supply agreement signed.
Global Access Programs (GAP)
58,000 units of drugs shipped to more than 75 countries, an 87% increase, coming from both growth in existing programs and new programs.
Cliniport launched and applied to all programs.
Like for like sales represent revenues adjusted for Foscavir stock fill (£3m) in FY13. ** Underlying EBITDA is defined as earnings before interest, tax, depreciation and amortization excluding share based payments. *** Underlying earnings exclude share based payments, and are adjusted for amortization and associated tax.
Peter George, Chief Executive Officer, Clinigen Group,said "We have had another strong year of growth, with all three operational businesses increasing their contribution.

"Organic business has increased in both CTS and GAP, with a significant improvement in margins for CTS. In SP, we have seen steady growth in in-market sales from Foscavir and revenue streams beginning to come on board from Cardioxane and newly acquired Savene. Vibativ has been revitalized and, in September 2014, launched into the European market. The acquisition of Ethyol brings the total SP drug portfolio to five.

"In the next financial year, the priorities for the Group are two fold; the revitalization of SP`s dexrazoxane asset portfolio (Cardioxane and Savene) and the strengthening of our global capabilities, particularly in pharmerging markets.

"Both strategic goals are important to our long term growth and will support our ambition to become a recognized world leading specialty pharmaceutical company with unrivalled global distribution capability for licensed and unlicenced medicines."

-Ends-

For the full release, please visit the Group`s website at www.clinigengroup.com

What they were expecting......note

2013 (A) 2014 (E) 2015 (E)
EBITDA £19.98m £25.00m £28.69m

OUTPERFORMED

Clinigen Group PLC

Date Rec Pre-tax (£) EPS (p) DPS (p) Pre-tax (£) EPS (p) DPS (p)

N+1 Singer
22-09-14 BUY 23.49 21.80 3.00 26.66 24.10 3.30
Peel Hunt LLP
18-09-14 BUY 26.05 23.42 3.50 28.97 25.99 4.00
Edison
18-09-14 None 19.40 18.30 2.80 22.20 20.90 3.10
Numis Securities Ltd
17-09-14 BUY 26.00 23.50 3.39 29.00 26.10 4.03
Investec Securities
04-09-14 BUY 25.10 22.61 4.00 29.80 27.45 4.43
Westhouse Securities
10-04-14 BUY

2014 2015
Pre-tax (£) EPS (p) DPS (p) Pre-tax (£) EPS (p) DPS (p)

Consensus 25.15 22.82 3.29 28.60 25.38 3.77
1 Month Change -0.34 -0.16 -0.15 -0.08 -0.60 -0.35
3 Month Change 0.54 1.24 -0.04 -0.86 -1.10 -0.24

GROWTH

2013 (A) 2014 (E) 2015 (E)
Norm. EPS 107.38% 26.45% 11.22%
DPS % 449.00% 14.51%

INVESTMENT RATIOS

2013 (A) 2014 (E) 2015 (E)
EBITDA £19.98m £25.00m £28.69m
EBIT £18.10m £m £m
Dividend Yield 0.13% 0.71% 0.81%
Dividend Cover 30.08x 6.93x 6.73x
PER 25.79x 20.39x 18.34x
PEG 0.24f 0.77f 1.64f
Net Asset Value PS 14.21p 78.80p 98.60p

CLIN CLINIGEN

What Brokers were expecting, I bet we get some upgrades and updates later today....

Date Broker Recommendation Price Old target price New target price Notes
02 Sep Oriel Securities Buy 458.50 - 650.00 Reiterates
26 Aug N+1 Singer Buy 458.50 439.00 488.00 Reiterates
20 Aug Investec Buy 458.50 497.00 512.00 Reiterates
20 Aug Numis Buy 458.50 650.00 650.00 Reiterates

A group analyst briefing will be held at 09:30am on Wednesday, 24 September 2014 at the offices of Instinctif Partners, 65 Gresham Street, London EC2V 7NQ.

An audio replay file will be made available shortly afterwards via the Group's website: www.clinigengroup.com.

A wall of Blue Buys for CLIN after todays results......Broker update and upgrades to come after analyst meeting 9.30

">

First of the Brokers......

24 Sep 2014 Clinigen Group CLIN N+1 Singer Buy 466.00 456.00 488.00 488.00 Retains

24 Sep 2014 Clinigen Group CLIN Numis Buy 465.50 456.00 650.00 650.00 Reiterates

650p SP TARGET

24 Sep 2014 Clinigen Group CLIN Oriel Securities Buy 463.50 456.00 650.00 650.00 Reiterates

SP target 650p

Peel Hunt few days ago, buy tp 710p

I.C. today

Clinigen still clinical
When drugs fail to obtain licenses or are pulled off the market, clinicians can miss out on vital elements of medical treatment. Clinigen (CLIN) fills this gap, acquiring, revitalising and then distributing the drugs. This focus helped it record a 20 per cent rise in underlying cash profits for the year to June.
Sales at Clinigen’s key clinical trials supply division fell 5 per cent to £84m, reflecting a one-off bump in antiviral sales in 2013. But it did record a 45 per cent increase in supply requests, as the company widened its market share, so sales should rebound. It also signed an exclusive supply agreement for an oncology drug with an international pharmaceutical company.
Clinigen’s specialty pharmaceuticals division grew its product range by acquiring Savene and Ethyol, two oncology support products. That should help to compensate for slowing sales of Foscavir now its revitalisation is largely complete. Clinigen also convinced European regulators to lift the suspension order on its injectable antibiotic Vibativ, which combats hospital-acquired pneumonia.
Meanwhile, sales surged by more than half at its global access programs segment, as it shipped 58,000 drug units – up 87 per cent – to over 75 countries. The division also added AstraZeneca (AZN) and Eisai to its client list.
Broker Numis Securities expects pre-tax profit of £29m, giving EPS of 26.1p, rising to £35m and 31.6p in 2015-16.
C Clinigen’s growing product range and diversified business model should serve investors well. Its shares trade at 18 times forecast earnings – a discount to the sector average of 21. We reiterate our buy tip. TM

Clinigen Group plc Receives FDA Award

RNS


RNS Number : 8240S

Clinigen Group plc

29 September 2014












Clinigen Group plc Receives FDA's First Ever Drug Shortage Assistance Award



Burton-on-Trent, UK - 29 September 2014 - Clinigen Group plc ('Clinigen' or the 'Group', AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection.



Clinigen's efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. These actions by Clinigen resolved a critical drug shortage affecting patients.



This award also recognizes companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.



Peter George, Chief Executive Officer, Clinigen Group, said: "To be the recipient of this new award from the FDA is a great honor and absolutely reflects Clinigen's mission to ensure that the right drug reaches the right patient at the right time. Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages."



Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013. There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.



- Ends -

Ex dividend Thurs 16 Oct 2.1p

Jim Slater: Escape death taxes with my perfect portfolio of shares

Shares listed on the Aim market are exempt from inheritance tax. Our expert stock picker Jim Slater names three of the best


My next recommendation for your IHT-friendly portfolio is Clinigen Group at 507p. This speciality global pharmaceuticals company, headquartered in Britain and with offices in America and Japan, floated on the stock market in late 2012.

Since then, with the help of astute acquisitions and organic growth, the company has performed very well – profits have risen from 8.7p per share in 2012 to a predicted 26p for 2015.

The group has three main divisions, one of which, “global access programs”, has signed significant contracts with two leading companies, AstraZeneca and Boehringer Ingelheim, and seen its sales rise by 54pc last year.

However, what interests me now is that the main focus of the Clinigen story is shifting to the “speciality pharma” division, which makes high gross profit margins and has developed from one product at the time of the flotation to five products today, with more planned. Two of its products are in “anti-infectives” and three are in oncology support.

In particular, two of the latter, Cardioxane and Ethyol, have strong potential for revitalisation – although before I get carried away I must confess that, even though my wife tells me I am a bit of a hypochondriac, I am not an expert on drugs.

I am therefore happy to rely on the enthusiasm of the stockbrokers’ technical analysts who follow Clinigen and their favourable view of the company’s drugs portfolio.

Now for the numbers. According to brokers Numis, Clinigen’s estimated p/e ratio for next year is about 19.5, falling to about 16 in 2016 and then to 13.3. Numis expects profit growth percentages in the 20s in 2016 and 2017 with further acquisitions adding “incremental upside” to give a forward Peg ratio of just under 1.

Both brokers make the point that the company is acquisitive, produces very strong cash flows and has a substantial amount of cash in the bank, so they confidently expect more acquisitions.

Certainly Numis and Peel Hunt have high hopes for its future, with price targets of 650p for Numis and 717p for Peel Hunt. The three other brokers that cover Clinigen also rate the shares as a “strong buy”.

During recent market weakness – last month’s “flash crash” – I managed to buy more than £1.5m worth of Clinigen shares at an average price of about 470p.

However, I should warn you that the market in them can be narrow at times, so if you decide to buy I suggest that you set a firm limit with your broker and if necessary be prepared to wait a few days for your order to be filled.





http://www.telegraph.co.uk/finance/personalfinance/investing/shares-and-stock-tips/11217454/Jim-Slater-Escape-inheritance-tax-with-my-perfect-portfolio-of-shares.html

Signal Update

Our system’s recommendation today is to STAY LONG. The previous BUY signal was issued on 04/11/2014, 14 days ago, when the stock price was 480.5000. Since then CLIN.L has risen by +13.84%.

Market Outlook

The market is uncertain with a negative tilt. The traders seem to be in disagreement. The negative sentiment, however, is increasing as evident from the last bearish pattern. So, it is better to be on alert.


http://www.britishbulls.com/SignalPage.aspx?lang=en&Ticker=CLIN.L

Half year trading update
RNS
RNS Number : 2048C
Clinigen Group plc
15 January 2015



Half year trading update

Burton-on-Trent, UK - 15 January 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the specialty global pharmaceutical company, today provides a half year update for the six months ended
31 December 2014.



The Group continues to perform strongly, in line with the Board's expectations:

· Revenues at £72.6m are up 17% on H1 FY14 (21% on a constant exchange rate basis)

· Gross profit is up 11%, with overall margins at 30%

· Net cash has more than doubled to £12.9m from £5.3m at 30 June 2014



Revenue growth over the period has been driven by a combination of significant organic and new customer growth in CTS - demonstrating the progress of Clinigen CTS towards global leadership - with the additional contribution from new product acquisitions within Clinigen SP (Savene and Ethyol). Also within SP, Foscavir in-market sales are up 5%, in line with disease treatment activity.



The Group's CTS activity measures: growth in current customers, number of customers, number of products shipped and the sales pipeline, all continue to grow.



The number of units shipped by GAP, the primary measure of growth in that business, continues to increase and a number of new programs will go live in Q3 FY15. H1 FY15 GAP revenues were, as expected, affected by the closure of the French Enzalutamide program, but this also led to an improvement in gross margin, returning to expected 40% levels from H1 FY14 at 28%.



The Group continues to evaluate new opportunities for both product acquisitions and global expansion.



Peter George, Chief Executive Officer, Clinigen Group said,



"I am really proud of the team's first half performance; all three operating businesses have contributed to strong trading. I am particularly pleased with the CTS performance and the early contributions from new product acquisitions.



"The integration of the new products acquired in FY14 and H1 FY15 continues on track and I expect the current investment in the revitalization plans to start to have a positive impact during FY16.



"This strong half year performance is in line with the Board's expectations and puts us in a good position to meet our full year targets."

-Ends-

UPDATE - Clinigen first half revenues up 17%, boosted by clinical trials supply arm and new products

By Ian Lyall

January 15 2015, 11:41am
Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.
Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.


Clinigen (LON:CLIN) said it performed strongly in the first half of its financial year as its clinical trials supply business (CTS) cemented its place as a global leader in the sector.

The specialty pharma group’s trading in the six months to the end of last year was also boosted by the contribution from new additions to the portfolio, and two in particular: oncology products Savene and Ethyol.

Revenues rose 17% year-on-year to almost £73mln; gross profit was up 11%, margins ahead 30% and net cash more than doubled at £12.9mln.

Clinigen said the financials were in line with expectations, leaving the business on track to meet full-year forecasts.

Chief executive Peter George told investors: "I am really proud of the team's first half performance; all three operating businesses have contributed to strong trading.

“I am particularly pleased with the CTS performance and the early contributions from new product acquisitions.”

George added that the integration of the new products acquired recently is “on track” and the current investment in revitalising them will have a “positive impact” next financial year.

Analysts at Peel Hunt said the overall result appears slightly ahead at the top line, at a lower gross margin, with the result in line at the gross profit level.

“With cash now mounting on the balance sheet, the firepower to add to the portfolio is there with the ambition to accelerate Clinigen’s global footprint growing,” added the broker.

Peel Hunt has a 717p share price target.

Shares are currently trading at 495p.

22 Jan Clinigen Group N+1 Singer Buy 492.63 500.00 549.00 Retains

Jim Slater -

Clinigen’s half-year trading update in January confirmed that the company had been performing strongly, with revenues up by 17pc, gross profit up by 11pc and cash more than doubled to £12.9m. Peter George, the chief executive, said: “This strong performance is in line with the board’s expectations and puts us in a good position to meet our full-year targets.”

Peel Hunt has Clinigen as another of its top growth picks for 2015, with a juicy target price of 717p. Like me, Peel Hunt looks forward to the day when Clinigen deploys its cash and £35m debt facility to add to the global footprint of its growing pharmaceuticals portfolio. With this exciting prospect in mind, I bought a few more shares at 500p.





http://www.telegraph.co.uk/finance/personalfinance/investing/shares-and-stock-tips/11376838/Jim-Slater-two-more-IHT-free-Aim-shares-to-add-to-your-portfolio.html

3 Feb Investec 546.00 Hold

Clinigen to Manage GAP Program for AZ's CAZ-AVI
RNS
RNS Number : 6030E
Clinigen Group plc
11 February 2015



Clinigen appointed by AstraZeneca to Manage International Global Access Program for New Combination Antibiotic, CAZ-AVI

Burton-on-Trent, UK - 11 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) announced today the initiation of an international global access program for AstraZeneca's investigational antibiotic, CAZ-AVI (ceftazidame-avibactam), through its specialist Clinigen GAP division.

CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing risk to public health. It is being investigated as a new treatment option for patients with g complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs) and nosocomial pneumonia. Complicated urinary tract and intra-abdominal infections are often attributed to drug-resistant bacteria. Gram-negative bacteria such as Escherichia coli (E. coli) are particularly adaptive. E.coli commonly causes urinary tract infections affecting nearly three million people per year and has become resistant to an increasing number of antibiotics. cIAI is an important cause of morbidity and mortality, and is the second most identified cause of severe sepsis in intensive care units.

The program is the first for Clinigen GAP with AstraZeneca and will provide access to CAZ-AVI to eligible patients for all countries world-wide with the exception of the US and Canada.

Healthcare Professionals will be able to request the drug for patients who have no other licensed therapeutic alternatives.

CAZ-AVI consists of ceftazidime, a well-established third generation injectable cephalosporin antimicrobial agent, and avibactam, a next generation non-beta lactam beta-lactamase inhibitor. Increasingly, infections have reduced the activity of ceftazidime. However, the addition of avibactam protects ceftazidime from breakdown, restoring the activity and enabling CAZ-AVI to better meet current and future needs for tackling serious gram-negative infections. CAZ-AVI has been granted a Qualified Infectious Disease product (QIDP) designation by the USA FDA which enables priority review and fast track status.

Shaun Chilton, Chief Operating Officer, Clinigen Group said, "I am very pleased to announce the launch of this first program for AstraZeneca, further strengthening the relationship with Clinigen. We now work with AstraZeneca across all our operating businesses. The continued growth within Clinigen GAP demonstrates the increasing need for early access to drugs in areas of critical unmet need."

Mark Corbett, Senior Vice President, Clinigen GAP said, "The war on antimicrobial resistance relies on the development of novel and improved therapies effective against serious infections, such as CAZ-AVI. We are pleased to be able to use our experience in the provision of international access programs to supply patients with what could be a very important drug. We look forward to working with AstraZeneca to provide access to CAZ-AVI and meeting this area of unmet need."

- Ends -

11 Feb Oriel... 650.00 Buy
11 Feb N+1 Singer 549.00 Buy

Clinigen’s Corbett says more to come after AstraZeneca alliance

http://www.proactiveinvestors.co.uk/companies/stocktube/3469/clinigens-corbett-says-more-to-come-after-astrazeneca-alliance-3469.html

Clinigen GAP to Manage Raptor's PROCYSBI Program
RNS
RNS Number : 1615F
Clinigen Group plc
18 February 2015



Clinigen Group Adds New Named Patient Program to
Global Access Portfolio

Burton-on-Trent, UK - 18 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM:CLIN) announces the latest program to be managed by Clinigen Global Access Programs (Clinigen GAP). The program will provide access to Raptor Pharmaceuticals Corp.'s PROCYSBI® (cysteamine bitartrate) for individual patients with nephropathic cystinosis. Through the program PROCYSBI® will be available worldwide, except for the USA where the drug is already commercially available, LATAM and a small number of European territories.

Nephropathic cystinosis is a rare, inherited condition caused by a build up of cystine that affects every cell in the body. Without treatment, patients can suffer from kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles. Approximately 2,000 people worldwide are currently diagnosed with the disorder1.

PROCYSBI® is a delayed-release form of cysteamine bitartrate that can be used to manage cystinosis by continually reducing the toxic levels of cystine in the cells. This can help to prevent cellular damage and delay the progression of cystinosis and its complications.

Mark Corbett, Senior Vice President, Clinigen GAP said: "Nephropathic cystinosis is a serious, progressive disease and the initiation of this program for PROCYSBI® is a key step in getting an important new therapeutic option to patients with limited treatment options. We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access program. We are able to utilize our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

1Gahl WA, Kuehl EM, Iwata F, Lindblad A, Kaiser-Kupfer MI. Corneal crystals in nephropathic cystinosis: natural history and treatment with cysteamine eyedrops. Mol Genet Metab. 2000;71:100-120.

- Ends -

18 Feb Oriel... 650.00 Buy
18 Feb N+1 Singer 549.00 Buy
/////////////////////////////////////////////////////////////////////////////////////////////////


UPDATE - Clinigen drug access programme gaining traction with second deal in a week

By Ian Lyall

February 18 2015, 1:26pm
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.


---ADDS SHARE PRICE AND BROKER COMMENT---

Speciality pharma group Clinigen (LON:CLIN) is gaining significant traction for its global access programme, which provides patients with the opportunity to receive drugs not yet on the market.

This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.

This is a rare inherited condition, affecting 2,000 people worldwide, and is caused by the build-up of an amino acid called cysteine.

Untreated it can lead to kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles.

Clinigen will run its global access programme outside the US and a number of other territories where the drug already has full regulatory approval.

"Nephropathic cystinosis is a serious, progressive disease and the initiation of this programme for PROCYSBI is a key step in getting an important new therapeutic option to patients with limited treatment options,” said Mark Corbett, senior vice president of Clinigen GAP.

“We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access programme.

“We are able to utilise our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

Last week Clinigen said had been appointed by AstraZeneca to manage a global access programme for its new antibiotic.

The Anglo-Swedish pharma giant is developing ceftazidame-avibactam, or CAZ-AVI for short, to combat drug-resistant Gram-negative bacterial infections.

It is still under investigation by scientists assessing its potential to tackle these tough-to-treat infections.

However, the Clinigen-run programme will offer certain patients with complicated urinary tract infections, complicated intra-abdominal infections and nosocomial pneumonia the opportunity to access the next-generation antibiotic.

It is the first time it has managed such an operation for AstraZeneca.

The shares, up 35% in the past six months, marked time at 537p.

Oriel Securities pointed out the stock trades at a discount to its peers while having “superior” growth prospects at it repeated its ‘buy’ advice.

Also a ‘buyer’ of the stock is N+1 Singer, whose analyst Elizabeth Klein said:

“This is the second win for the Clinigen GAP business in a few weeks, and we expect more business wins over the rest of this year.

Clinigen Signs Distribution Agreement with MSD
RNS
RNS Number : 0338G
Clinigen Group plc
27 February 2015



Clinigen Group Signs Distribution Agreement with MSD UK for Clinical Trial Supply Services

MSD Products Further Strengthen Clinigen's Clinical Trial Supply Services

Burton-on-Trent, UK - 27 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) today announces that its Clinical Trials Supply business (Clinigen CTS) has entered into an agreement with Merck Sharp & Dohme Limited ('MSD'), to distribute their human health products for use in clinical trials carried out in Europe. This agreement now represents the fourth arrangement Clinigen CTS has with manufacturers to distribute products.

Under the terms of the agreement, Clinigen CTS will be a preferred distributor and manage enquiries, order receipts and distribution of MSD's products to manufacturers, contract research organizations (CROs), clinical trial contract packagers and other specialist service providers looking to source pharmaceutical products as comparators, rescue and adjunctive drugs for use in clinical trials.

Steve Glass, Senior Vice President Clinigen CTS said: "The addition of this agreement further strengthens our position within the clinical trial supply market as we continue on our path to become the no.1 global clinical trial supply service provider."

- Ends -

About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering 'the right drug, to the right patient at the right time', has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen CTS sources commercial medical products for use in clinical studies only. These include comparator drugs, where existing medical treatments are used as benchmarks to assess the effectiveness of investigative products, adjuvant drugs, which improve the effectiveness of the product being trialed, and rescue therapies, which help patients who have experienced a worsening of symptoms or insufficient therapeutic benefit during a trial.

For more information, please visit www.clinigengroup.com

Interim results for 6 months end 31 December 2014
RNS
RNS Number : 3140G
Clinigen Group plc
03 March 2015



Clinigen Group plc

Half year revenues up 17% to £72.6m, underlying EBITDA up 8% to £13.5m

Burton-on-Trent, UK - 3 March 2015 - Clinigen Group plc (AIM: CLIN, Clinigen or the Group), the global specialty pharmaceuticals and pharmaceutical services business, has today published its half year results for the six months ended 31 December 2014.

Financial highlights

- Group revenue up 17% to £72.6m (H1FY14: £61.8m); on a constant exchange rate basis up 21%

- Gross profit up 11% to £22.0m (H1FY14: £19.9m)

- Underlying EBITDA* up 8% to £13.5m (H1FY14: £12.5m), despite significant additional new product integration investment

- Adjusted underlying earnings per share** up 12.6% to 12.5p (H1FY14: 11.1p). Reported earnings per share up 5.7% to 9.2p (H1FY14: 8.7p)

- Interim dividend up 10% to 1.1p per share (H1FY14: 1.0p per share)

- Net cash of £12.9m at 31 December 2014 (30 June 2014: £5.3m)

Business highlights

- CTS: 28% revenue growth, 14 new customers, underlying activity up (requests up 11%, medicines supplied up 13%)

- GAP: 51% increase in units shipped, seven new programs to start in CY15 including first program for AstraZeneca for their product CAZ-AVI. Fycompa program extended for a further 18 months

- SP: SP sales and gross profit up 21% driven by new products and underlying volume growth in Foscavir. Ethyol acquisition (August 2014) already contributing to revenues. Revitalisation plans for dexrazoxane portfolio of products, Cardioxane and Savene on track. Final Marketing Authorisations for Cardioxane transferred from Novartis, in February 2015.

* Underlying EBITDA is defined as earnings before interest, tax, depreciation and amortisation excluding share based payments and associated Employer's National Insurance

** Underlying earnings exclude share based payments, associated Employer's National Insurance costs, amortization and are adjusted for associated tax

Peter George, Chief Executive Officer, said:

"After another strong first half, with all three divisions making good profit contributions, we are in a great position to continue our ambitious pursuit to become the world leaders in Clinical Trial Services, Global Access Programs and have a Specialty Pharmaceutical portfolio with 10 revitalized products.

"For the second half of the year gaining regulatory clearance for our dexrazoxane portfolio of drugs is a priority, along with the constant drive to convert the pipeline of new business and extend current customer relationships within CTS and GAP. In addition, we continue to explore opportunities to extend our global footprint and unlicensed supply market position.

"We anticipate another busy six months ahead."

-Ends-

An analyst briefing will be held at 9:30am today at the offices

3 Mar Investec N/A Hold
3 Mar Numis 770.00 Buy

Clinigen Extends Foscavir US Distribution Contract
RNS
RNS Number : 0764H
Clinigen Group plc
11 March 2015



Clinigen Group Extends Exclusive Foscavir® US Distribution Agreement
with Hospira to 2019

Burton on Trent, UK - 11 March 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) today announces the extension and renegotiation of the exclusive license and distribution agreement with Hospira, Inc ('Hospira') for its anti-viral product Foscavir® (foscarnet sodium) in the US. This is expected to be beneficial to both parties.

The original distribution agreement with Hospira established in July 2011 was due to expire in May 2017. The new agreement is for five years extending the term to 31 December 2019.

Foscavir® is Clinigen's lead product. Foscavir® received FDA approval in May 2012 for the treatment of HIV/AIDS-related cytomegalovirus infections and herpes. In September 2014, the FDA recognized the determined efforts made by Clinigen in providing Foscavir® to patients in the US by awarding Clinigen the first Drug Shortage Assistance Award.

Peter George, Chief Executive Officer, Clinigen Group said: "Hospira has been an excellent partner in the US, working closely with Clinigen since we acquired Foscavir®. The new five year agreement recognizes the strength of this partnership and shows the commitment of both Hospira and Clinigen to the continued supply of Foscavir® to US patients."

- Ends

UPDATE - Clinigen extends US distribution agreement for lead product

By John Harrington

March 11 2015, 4:39pm
The original distribution agreement with Hospira expired in May 2017, but this has now been extended until the end of 2019.



---ADDS BROKER COMMENT---

Clinigen (LON:CLIN) has renegotiated and extended its exclusive licence and distribution agreement with Hospira for its Foscavir treatment for HIV.

The agreement was due to expire in May December but not runs to the end of 2019 in a move that Clinigen said is expected to be beneficial to both parties.

Peter George, Clinigen’s chief executive, said: "Hospira has been an excellent partner in the US, working closely with Clinigen since we acquired Foscavir. The new five year agreement recognizes the strength of this partnership and shows the commitment of both Hospira and Clinigen to the continued supply of Foscavir to US patients."

Broker N+1 Singer reiterated its ‘buy’ recommendation and said: “Last week, in our sector piece, we upgraded our target price on Clinigen to 590p. At the time, we highlighted that we expected its portfolio of Specialty Pharma therapies to see good ongoing growth. Today’s announcement supports this.”

11 Mar N+1 Singer 590.00 Buy

Finally some appeal returning here. A new 52 week high today and more importantly we've broken the Nov14 high. Next stop 650P? - and perhaps quite rapidly after not having done much since the autumn.

Peel Hunt - buy - 717p
Investec - hold - 546p
N+1 Singer - buy - 590
Numis - buy - 770p

17 Apr Investec 550.00 Hold

Broker spotlight - Investec has put a hold rating on drugs distributor Clinigen (LON:CLIN).

A review of its competitive situation and key products suggests it can continue to grow its portfolio, but services is not growing as fast as expected so the broker downgrading earnings estimates down the road. Target price is 550p. Hold is the view.

Acquisition

£225 million Acquisition of Idis and £135 million Vendor Placing

It had to come soon, next shift upwards. Great news - haven't digested it all yet.

Blue sky coming...

Numis target price 860p

ROUNDUP – Clinigen shares jump as investors give £225mln acquisition the thumbs-up

By Ian Lyall

April 24 2015, 2:51pm
Some £2.5mln of revenue and cost synergies have been identified


---ADDS BROKER COMMENT---

Shares in the speciality pharma group Clinigen (LON:CLIN) jumped over 7% after it unveiled the £225mln acquisition of Idis Group - a deal that will create a market leader in the ethical unlicensed supply of medicines.

The purchase will be funded from Clinigen’s new debt facility and a £135mln vendor placing and is expected to be ‘significantly’ earnings enhancing in the first full year after the transaction.

Some £2.5mln of revenue and cost synergies have been identified.

But chief executive Peter George told Proactive Investors: “The real savings in this business are about driving growth through the business and changing some of the commercial terms in our business.

“So I think we will drive profit through the gross profit line much faster than we would through synergy savings because this is about a growth plan, not a cost saving plan.

“We want to hit the ground running and take the market by storm. This isn’t going to be done by making cuts in the business. That’s not what this is about.”

The companies will be filling a gap in the market by bringing potentially life-saving medicines to countries where they are not currently licensed.

A quirk of the current system is that many drugs and treatments that might have regulatory and safety clearance in the major developed or developing countries, remain unsanctioned in other territories.

“We want to become the healthcare professional solution for hospital pharmacies and clinicians to access unlicensed medicines in an ethical and completely controlled way,” George said.

Clinigen believes there is a major growth opportunity in combining the two businesses to create the biggest player in the ethical unlicensed supply market, which is estimated to be worth in excess of US$5bn a year.

“On completion, Clinigen, as the market leader, will be well placed to shape and define this fast growing and critically important market,” the company told investors.

Following the news, broker Numis repeated a 'buy' rating and upgraded its price target by 12% to 860p.

Meanwhile, broker Stifel said the acqusition would diversify Clinigen's business away from its over dependence on the antiviral drug Foscavir.

"However, Clinigen has retained the flexibility to make further bolt-on acquisitions of specialty pharma products. The deal clearly makes financial sense since it is earnings enhancing from the start as well as making Clinigen by far the largest player in the supply of unlicensed medicines."

Headquartered in Weybridge, in Surrey, Idis has established a significant business over the past 25 years supplying drugs predominantly on an exclusive basis through managed access programmes and on-demand through its general access division.

In the year ended February its revenues were just under £197mln, while earnings before interest, tax, depreciation and amortisation were £15.6mln.

“This acquisition satisfies a number of our key strategic goals - achieving the market leader position in the $5bn-plus unlicensed medicine supply sector and strengthening our leading position in the $2bn clinical trial supply market,” George said.

"The acquisition will also accelerate our growth and gives us a much better balanced portfolio of businesses, whilst extending our unique business model.

"The enlarged entity creates an incredibly exciting business with tremendous opportunities for growth.

“I am confident that, together with Idis, we have the right people to define and shape the unlicensed medicine supply market - an increasingly important health care sector for patients with unmet needs."

The deal is a particularly good one for CBPE, the private equity owner of Idis, which invested £9.4mln buying the business in 2005.

Idis managing director Tony Dutta said: “IDIS is now the clear market leader in a market with highly attractive long term growth fundamentals.

“CBPE have been an outstanding, partner, fully supporting us as we have grown the business over the long term.

“The acquisition by Clinigen marks the beginning of a new and exciting chapter in the continued development of the business.”

Clinigen’s investors reacted positively to the acquisition, helping push the stock up 47p to 572.5p, valuing the business at £466mln.

We've not seen the 6 big figure for some time. Rapidly up to life highs now?

Stifel new buy today, tp 650p

Yehaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa

Nice write-up in this week's IC before Idis acquisition.

easily missed this one :-(
congrats to all those who did not

cynic, notwithstanding the current spike, the latest acquisition could be a game changer, so you may not have missed it on a correction. And then how long before big pharma sniff around...

thanks you old dog .... i'll keep a weather eye open

Good to see this one at number 16 in Investors Chronicle top AIM 100.

Clinigen Group's Idis acquisition prompts sharp rise in Peel Hunt's price target

By John Harrington

May 06 2015, 1:26pm
Idis and Clinigen are both early market entrants in outsourced management and have played a role in shaping the development of this market, but each has adopted a slightly different pricing model, with Clinigen’s resulting in a higher gross margin.
Idis and Clinigen are both early market entrants in outsourced management and have played a role in shaping the development of this market, but each has adopted a slightly different pricing model, with Clinigen’s resulting in a higher gross margin.


Peel Hunt is a fan of Clinigen (LON:CLIN), only more so after the speciality pharmaceuticals company's £225mln acquisition of Idis, a supplier of unlicensed medicines.

The broker notes that the acquisition has long been on the cards and is “one of the more strategically sensible transactions in the sector in recent years”.

Clinigen is paying around 14.4 times Idis's underlying annual earnings (EBITDA), so the deal is not cheap as chips, but Peel Hunt said the synergies available from merging the two companies made Clinigen the only company that could potentially justify paying such a price.

The deal will strengthen Clinigen's clinical trials supply (CTS) business, the global access programmes division (now named MAP) and will also increase the product acquisition radar for the speciality pharmaceuticals arm.

“The deal also added a new division in on-demand access (GAD). This is synergistic with the other three divisions and will benefit from Clinigen’s greater ambition and fire-power, bringing the vision to become the global go-to provider of ethical access to such medicines, a significant market of c$2.2bn today, with the potential to grow to c$5bn+, reflecting the shift to more specialist niche therapy, together with the increasing need for a legitimate 'ethical' and secure supply chain,” opined Dr Stefan Hamill, an analyst at Peel Hunt.

The acquisition should enhance earnings, with Peel Hunt pencilling in a 10% uplift in the year to end-June 2016 and a 33% rise in the following year, prompting Peel Hunt to crank up the price target to 1,000p from 717p previously.

“The potential for increased traction toward our blue-sky scenario, which models acceleration of on-demand, drives our scenario-based valuation to £10, making Clinigen our sector top pick,” the broker said.

Shares in Clinigen currently trade at 616p.

Peel Hunt, buy tp 1000p

Nice rise today, back up to highs...

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during Friday's trading session when it reached 670.00. Over this period, the share price is up 50.22%.

Clinigen Group and Pharming Initiate GAP Program
RNS
RNS Number : 4049N
Clinigen Group plc
18 May 2015







Clinigen Group and Pharming Initiate "HAEi GAP" Global Access Program for RUCONEST®

Unique patient organization-driven program will enable patients with HAE who cannot access effective treatments to receive medication for the first time

Burton-on-Trent, UK and Leiden, Netherlands - 18 May 2015 - Clinigen Group plc ("Clinigen" or the "Group", AIM: CLIN) and Pharming Group N.V. ("Pharming or the Company", Euronext: PHARM) have entered into an international global access collaboration for HAEi, the International Patient Organization for C1- Inhibitor Deficiencies. The "HAEi GAP" will provide access to RUCONEST® (conestat alfa) to eligible patients with hereditary angioedema (HAE), who currently do not have access to effective medication to treat acute attacks of the disease.

HAEi GAP is the first global access program for HAE and the first to be driven by a patient organization. The program enables patients in countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant "Named Patient Program" mechanism.

"HAEi is committed to securing access to HAE medications for patients across the globe," said Anthony J. Castaldo, President of HAEi. "We are extremely proud to have established HAEi GAP with our current partners and will continue to work with other manufacturers with the hope of expanding the program in the future."

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: "HAEi's ground-breaking program will ensure that HAE sufferers worldwide can gain access to effective and potentially life-saving treatment. Our secure supply chain and regulatory expertise will enable us to work closely with Pharming to supply patients with RUCONEST ethically and legitimately, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug. We look forward to working with both HAEi and Pharming on this unique project."

Sijmen de Vries, CEO, Pharming said: "We are delighted to be the first partners of HAEi and to initiate this program by providing access to RUCONEST, a recombinant human C1- inhibitor, approved by EMA and FDA for the treatment of acute attacks of HAE in patients. In this way we can help to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease."

- Ends -






About HAE

Hereditary Angioedema (HAE) is a rare genetic disorder. It is characterized by spontaneous and recurrent episodes of swelling (edema attacks) of the skin in different parts of the body, as well as in the airways and internal organs. Edema of the skin usually affects the extremities, the face, and the genitals. Patients suffering from this kind of edema often withdraw from their social lives because of the disfiguration, discomfort and pain these symptoms may cause. Almost all HAE patients suffer from bouts of severe abdominal pain, nausea, vomiting and diarrhea caused by swelling of the intestinal wall.



Edema of the throat, nose or tongue is particularly dangerous and potentially life-threatening and can lead to obstruction of the airway passages. Although there is currently no known cure for HAE, it is possible to treat the symptoms associated with edema attacks. HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide. Experts believe that a lot of patients are still seeking the right diagnosis: although HAE is (in principle) easy to diagnose, it is frequently identified very late or not discovered at all. The reason HAE is often misdiagnosed is because the symptoms are similar to those of many other common conditions such as allergies or appendicitis. By the time it is diagnosed correctly, the patient has often been through a long lasting ordeal.



About RUCONEST®
RUCONEST® (C1 Esterase Inhibitor Recombinant/ conestat alfa) 50 IU/kg is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST contains C1 esterase inhibitor at 50 IU/kg.



When administered at the onset of HAE attack symptoms at the recommended dose, RUCONEST works to return a patient's C1-INH levels to normal range and quickly begins to relieve the symptoms of an HAE attack with a low recurrence of symptoms. RUCONEST is the first and only plasma-free, recombinant C1-INH approval from the U.S. Food and Drug Administration (FDA) and was approved in July 2014 and by the European Medicines Agency (EMA) in October 2010.



About Global Access Programs

Global Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.


About HAEi

HAEI - International Patient Organization for C1 inhibitor Deficiencies - is a global organization dedicated to raising awareness of C1 inhibitor deficiencies around the world. It is a non-profit international network of national HAE patient Associations. HAEI is established to promote co-operation, co-ordination and information sharing between HAE Specialists and National HAE Patient Associations in order to help facilitate the availability of effective diagnosis and management of C1 inhibitor deficiencies throughout the world. Our purpose is to join the efforts and experience of the global HAE community to achieve optimal standards of care and treatment for all those patients affected by C1 inhibitor deficiencies.



For more information, please visit: www.haei.org






About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering 'the right drug, to the right patient at the right time'. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines. The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.



The Managed Access Programs business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.



For more information, please visit www.clinigengroup.com



About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the USA, Israel all 27 EU countries plus Norway, Iceland, and Liechtenstein.



RUCONEST is commercialized by Pharming in Austria, Germany and The Netherlands. RUCONEST is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia, and Ukraine.



RUCONEST is partnered with Salix Pharmaceuticals, Ltd. ("Salix") in North America. Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX) completed its acquisition of Salix Pharmaceuticals, Ltd. on April 1, 2015.



RUCONEST is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE, in a phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications.



Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe, Fabry's and Gaucher's diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilize this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A.



For more information, please visit http://www.pharming.com

Clinigen Group and Clovis Initiate GAP Program
RNS
RNS Number : 4247O
Clinigen Group plc
28 May 2015

Clinigen Group Appointed as Specialist Partner to Manage Global Access
Program for Clovis Oncology's Rociletinib for the Treatment of
EGFR Mutant Non-Small Cell Lung Cancer

Burton-on-Trent, UK - 28 May 2015 - Clinigen Group plc ('Clinigen', AIM: CLIN) today announce the initiation of a global access program in Europe for rociletinib (CO-1686) which is being developed for the treatment of advanced non-small cell lung cancer (NSCLC).

This program is intended to allow access to rociletinib for individual named patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutant T790M-positive NSCLC who have previously been treated with an EGFR-targeted therapy and for whom their physician determines that there is no satisfactory alternative therapy or rociletinib clinical trial available.

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually. Of these, approximately 85% of cases are NSCLC. This is a rapidly progressing cancer with a five-year survival rate of less than 5% in advanced patients.

Patients with an EGFR activating mutation often respond well to marketed EGFR inhibitor therapies, including Tarceva® (erlotinib), Iressa® (gefitinib) and Gilotrif® (afatinib). However, most will ultimately see their cancer progress, with approximately 60% developing acquired resistance from a second "gatekeeper" mutation, T790M. Currently, there are no therapies approved for the treatment of this mutation. Clinigen's Managed Access Programs division will provide rociletinib to individual patients in selected countries in Europe initially, until the approval and launch of the drug.

Rociletinib is an oral, potent, mutant selective inhibitor of EGFR, which is currently in Phase II/III development for the treatment of NSCLC. In 2014, rociletinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: "Non-small cell lung cancer is a devastating disease affecting a huge number of people worldwide. Our experience in managing access programs on a global scale will enable us to provide critically ill patients with rapid access to rociletinib before it is commercially available. We look forward to working with Clovis to address this area of unmet medical need."

"At Clovis, we are preparing our near-term regulatory submissions seeking approval in the U.S. and E.U. for rociletinib for patients with advanced EGFR-mutant lung cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are very pleased to be working with Clinigen to make rociletinib available for patients until this therapy is commercially available in Europe."

- Ends -

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.



About Global Access Programs

Global Access Programs, also known as Managed Access Programs, provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.



About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering 'the right drug, to the right patient at the right time'. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines. The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.

The Managed Access Programs business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.

For more information, please visit www.clinigengroup.com

29 May Numis 840.00 Buy
29 May N+1 Singer 714.00 Buy
29 May Numis 840.00 Buy

Company site -

Thursday, May 28, 2015 - 10:45




Burton-on-Trent, UK – 28 May 2015 – Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN), the specialty global pharmaceutical company, has been named the winner of the Business of the Year Award with Turnover of €26-150m at Tuesday’s 2014/15 European Business Awards Gala Ceremony in London.

Peter George, Chief Executive Officer, Clinigen Group said: “I am immensely proud that Clinigen has been recognized as Business of the Year across all of Europe. This is a huge achievement and testament to how far the Group has come over the last year as we continue in our mission to deliver the right drug to the right patient at the right time.”

Clinigen was one of only 10 companies in Europe to be shortlisted for the Business of the Year with Turnover of €26-150m category and one of 11 overall category winners out of over 20,000 applicants from 33 countries.

The Group has been previously been named as one of over 700 European ‘National Champions’ by a judging panel consisting of European business and political leaders, academics and entrepreneurs. It was also recognized by the European Business Awards as one of only 110 Ruban d’Honneur finalists in February.

Adrian Tripp, CEO of the European Business Awards said: “Our winners are shaping the face of European business and helping keep Europe’s position as a leading player on the global business stage. Huge congratulations to Clinigen Group for their success. ”

The Business of the Year Award recognizes companies that successfully demonstrate financial returns, strong growth, innovation and market leadership in their sectors. In 2011 Clinigen was named the fastest growing company in the UK by the Sunday Times Virgin Fast Track 100. The Group joined the London Stock Exchange’s AIM in September 2012, the first UK healthcare company to list in London in five years, and won Best Newcomer at the AIM Awards in 2013. In April 2015 Clinigen acquired Idis, creating the market leader in the ethical unlicensed supply of medicines.

Clinigen has seen six-fold revenue growth over the past four years and has increased profit margins from 8% to 20%. The Group is committed to best practice and operating as an award-winning company.

– Ends –

HAEi Global Access Program for RUCONEST� Now Live
RNS
RNS Number : 5738T
Clinigen Group plc
21 July 2015

HAEi Global Access Program for RUCONEST® Now Live

Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time

Clinigen Group plc ("Clinigen" or the "Group", AIM: CLIN) and Pharming Group N.V. ("Pharming" or the "Company"), Euronext: PHARM) today announce that their global collaboration to provide access to Pharming's RUCONEST® (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies.

RUCONEST is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of acute attacks of hereditary angioedema (HAE). The "HAEi GAP" program enables patients in all countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant "Named Patient Program" mechanism.

Physicians wishing to request RUCONEST through the HAEi GAP program should contact the Clinigen customer services team at customer.services@clinigengroup.com or on 0044 1283 494340.

"HAEi is committed to securing access to HAE medications for patients across the globe," said Anthony J. Castaldo, President of HAEi. "We are extremely proud to have established HAEi GAP with our current partners and to be able to announce that, from today, physicians are able to request RUCONEST to meet the needs of their patients."

Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: "We are very pleased to work with Pharming to help HAEi realize their mission to ensure that sufferers of hereditary angioedema worldwide can access this effective and potentially life-saving treatment. The ground-breaking program provides RUCONEST to patients in an ethical and compliant way, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug."

Sijmen de Vries, CEO, Pharming said: "As the first pharmaceutical company to partner with HAEi and provide access to RUCONEST through HAEi GAP, we are leading the charge to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease."

- Ends -

Year end trading update
RNS
RNS Number : 7047T
Clinigen Group plc
22 July 2015

22 July 2015

Year end trading update

Strong profit growth with underlying EBITDA up at least 20%; integration of Idis well underway



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, today provides a trading update for the year ended 30 June 2015.



Highlights

· Revenues increased in excess of 45% to not less than £183.6m (2014: £126.6m).

· Gross profit increased in excess of 30%, mainly driven by greater than 25% growth in Specialty Pharmaceuticals (SP) gross profits and the acquisition of Idis.

· Underlying EBITDA up at least 20% to not less than £32.2m (2014: £26.8m).

· Notable year for acquisitions:

o August 2014, SP strengthened the oncology support portfolio with the acquisition of Ethyol® (amifostine) from AstraZeneca.

o April 2015, acquired Idis for £225m, establishing the enlarged Group as the market leader in the ethical supply of unlicensed medicines.

o Both acquisitions are performing strongly in line with expectations.

· Strong cash generation and, as at 30 June 2015, closing net debt was £78.0m (2014: net cash £5.3m).



Group performance

Clinigen continues with its strategy of organic growth supplemented with acquisitions.



The acquisition of Idis, with its established Global Access (GA) and Managed Access (MA) businesses, has positioned the Group as market leader in the ethical supply of unlicensed medicines. These businesses are being integrated into the Group and the operational and financial benefits are already clearly apparent.



The Group's Clinical Trial Services (CTS) and SP businesses delivered organic revenue growth in excess of 30% and 25% respectively.



All divisions have shown revenue and gross profit growth in H2 compared to H1, with Group full year gross profit increasing by in excess of 30%.



Group underlying EBITDA growth was more than 20% to not less than £32.2m, of which half the growth was due to acquisitions and the other half was organic.



Peter George, Chief Executive Officer, Clinigen said,

"This has been another tremendous year for Clinigen. Organic growth has been significant and the £225m acquisition of Idis has propelled us into market leader position in the fast growing ethical supply of unlicensed medicines and strengthened our CTS business.



"Ethyol has strengthened the SP portfolio and we are seeing further product acquisition and complementary opportunities which supports our strategy to focus on niche, hospital-only, specialty drugs.



"The enlarged Group of four operating businesses is integrating well and the Idis businesses are already contributing to the overall strong trading performance. Strategically, the focus for the current financial year is to strengthen our global footprint."



Acquisition of Idis

The acquisition of Idis on 24 April 2015 was financed by a vendor placing raising gross proceeds of £135.0m and £105.8m drawn down under new debt facilities.



Clinigen now operates as four synergistic businesses across the full spectrum of supply for unlicensed and licensed medicines - from early stage products still in clinical trials to approved products that may not be accessible due to lack of regional licenses or market withdrawal.



Acquisition and integration costs relating to Idis will be shown as non-underlying costs. Taking these costs into account, the reported profit before tax and earnings per share is expected to be lower than the prior year.



Operational businesses

· Clinical Trial Services (Clinigen's Clinical Trials Supply and Idis' Clinical Trial Procurement businesses)

CTS is performing well against the parameters by which it is measured. There has been significant growth in sales for FY15 compared with the prior year, with revenue growth in excess of 30% driven by the US.



The business has also seen in excess of 10% growth in the number of medicines delivered and the number of customers has increased from 73 to 85. The number of customers with sales greater than £5.0m has risen from five to seven. Overall, absolute gross profit has grown in excess of 5%.



· Managed Access (Clinigen's Global Access Programs and Idis' Managed Access Programs)

This business has grown significantly over the year. The key measure that reflects this growth is the number of drug units delivered. Combining Clinigen and Idis for a full year, MA has seen an increase of deliveries to 418,000 units delivered through 62,000 shipments; this is up from 263,000 units across 40,000 shipments in the previous year on a comparable basis.



Clinigen is now the global market leader of the exclusive managed access market which is valued at c.$500m-$600m.



· Global Access (Idis' General Access)

The business has shown solid growth in gross profits, with margins in excess of 20%.



The ethical unlicensed medicine market is estimated at $8-$10 billion. The Idis GA business provides a stable footing for Clinigen to secure a large proportion of this ethical market. Clinigen plans to build on the Idis brand and relationships beyond the UK into Europe. Over time the Group will move into the global space through strategic acquisition.



Clinigen also intends to develop the Idis e-commerce system - an online platform that is essential to the GA business and will be instrumental in driving global reach.



· Specialty Pharmaceuticals (Clinigen's SP)

SP remains the largest contributor to the Group's gross profits accounting for in excess of 50%, and showed gross profit growth of over 25% in the year.



All five products in the portfolio contributed to revenue and gross profit growth, notably Ethyol, where its revitalisation is on track. The SP team also continues to pursue overturning Article 31 with respect to the dexrazoxane portfolio and progress so far is positive.



Overall, Clinigen continues to deliver on its objective of building its SP portfolio and is on track to have 10 products over the next three to four years.



Management Team

In light of the Idis acquisition, Clinigen has taken the opportunity to review and restructure its management team to ensure effective management across the enlarged business. Consequently, Shaun Chilton has been promoted from COO to Deputy CEO of the Group. As previously announced, Martin Abell will join at the beginning of August 2015 as a director, and CFO elect during a period of handover from Robin Sibson.



Additionally the Group now has significant leadership experience in all four divisions. The managing directors of each business are as follows: Simon Estcourt (MA), Mark Corbett (GA), Steve Glass (CTS) and David Moran (SP).



The information contained in this statement has not been audited and may be subject to further review. The Group expects to publish its final results for the year to 30 June 2015 on Tuesday 22 September 2015.



-Ends-

Going great guns here, soon to be breaking the 700p. Broker target prices:

23/07 Edison 871p
22/07 Stifel 740p
22/07 Numis 840p
05/06 Peel Hunt 1000p

Nicely breaking £7 now.

29 Jul N+1 Singer 800.00 Buy

A quick romp higher to 800p looks quite possible before a pause.

Strong performance again today.

Jim Slater - Clinigen

Following its game-changing acquisition of a rival firm, Idis, for £225m, Clinigen is now a market leader in the supply of ethical unlicensed medicines – which have the potential to become a very large international market. The deal, which was financed by a £135m share sale and debt, will be earnings-enhancing in the first full year, with cost savings to come in later years.

A trading update on July 22 for this financial year was very positive.

At 761p Clinigen shares are on a forward p/e ratio of 24 with a forecast growth rate in earnings per share of 26pc and a further 20pc increase to follow in 2017.

Numis Securities, the company’s broker, has a target price of 840p and Peel Hunt is more optimistic with £10.

The shares are expensive but they are a strong hold.

1 Sep Numis 840.00 Buy

Notification of Full Year Results Date
RNS
RNS Number : 9190X
Clinigen Group plc
03 September 2015

3 September 2015



Notification of Full Year Results Date

Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, will announce its full year results for the year ended 30 June 2015 on Tuesday, 22 September 2015.



A group analyst briefing will be held at 9:30am on Tuesday, 22 September 2015 at Instinctif Partners' offices at 65 Gresham Street, London EC2V 7NQ.



Analysts who wish to participate should contact Instinctif Partners on +44 (0)20 7457 2020 or email clinigen@instinctif.com to register

New alliance with Cumberland Pharmaceuticals
RNS
RNS Number : 3074Z
Clinigen Group plc
17 September 2015

17 September 2015



Clinigen Group signs strategic alliance with Cumberland Pharmaceuticals



Partnership strengthens Clinigen's global footprint

and gives Cumberland Pharmaceuticals access to new international markets



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, has agreed to a strategic alliance with Cumberland Pharmaceuticals Inc. ('Cumberland', NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care. The alliance will combine Clinigen's and Cumberland's respective strengths, expertise and geographical footprints to maximize the commercial potential of future products.



As part of Clinigen's continuing strategy to extend its global presence, this collaboration will build on Clinigen's existing North American relationships by providing complementary support from Cumberland in the development, marketing, promotion and distribution of future products in the US.



Clinigen will be responsible for the marketing, promotion, distribution and sale of selected Cumberland pharmaceutical products, enabling Cumberland to use Clinigen's strong international reach to enter in to new markets outside of the US.



Peter George, CEO of Clinigen Group plc, said:

"A key strategic initiative this year has been to develop our Group's global distribution footprint. The US is a particular area of focus where we are looking to initiate a long term strategic partnership and Cumberland was a natural fit as a partner. Working together is a logical move for both companies as we will mutually benefit from each other's distribution expertise and capabilities in our respective regions."



AJ Kazimi, Chairman and CEO of Cumberland, added:

"This alliance with Clinigen creates a new growth driver for both companies that builds on our strengths. We look forward to working closely with Clinigen to bring its future products to patients in the US through our established commercial infrastructure. In turn, our products will gain access to new markets in other parts of the world."



Clinigen is focused on delivering the right drug to the right patient at the right time by providing medicines to patients with high unmet needs through clinical trials, licensed and ethically unlicensed supply. As part of this it acquires and revitalizes essential niche medicines to ensure pharmacists and doctors can continue to use the treatments their patients rely on and the business is always looking for new products to develop the pipeline.



Cumberland Pharmaceuticals acquires, develops and commercializes branded prescription products designed to improve quality of care and address unmet medical needs. The company focuses on underserved niche markets in the US and currently markets five FDA approved products. These products include Acetadote® (acetylcysteine) injection for the treatment of acetaminophen poisoning and Vaprisol® (conivaptan) injection, for the treatment of hyponatremia. Cumberland also has a development pipeline with candidates in Phase II studies.



-Ends-

Final results - Tues 22 Sept

Good results and heading back towards the highs. Some good business alliances being formed too.

New MA program with Neuraltus Pharmaceuticals
RNS
RNS Number : 5825Z
Clinigen Group plc
21 September 2015

21 September 2015



Clinigen Group and Neuraltus Pharmaceuticals Announce Partnership to Initiate a Managed Access Program for Investigational ALS Therapy in Europe

Clinigen Group plc's ('Clinigen' or the 'Group', AIM: CLIN) Idis Managed Access (MA) division and Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused on the development of drugs to treat neurodegenerative diseases, announced today that the companies are partnering to initiate a Managed Access program for NP001, Neuraltus' investigational therapy for amyotrophic lateral sclerosis (ALS). The partnership makes the Managed Access program immediately available in selected European countries and is expected to gradually expand over the next year.



ALS, or Lou Gehrig's disease, is a rare and fatal neurodegenerative disease characterized by the degeneration of motor neurons in the spinal cord and brain. There are approximately 400,000 ALS patients worldwide, including 50,000 patients in Europe. Most patients and physicians report only modest slowing of ALS progression from existing treatments for ALS, underscoring the need for new and effective drug therapy.



"By partnering with companies like Neuraltus, Idis Managed Access plays a vital role in providing ethical access to unapproved medicines, like NP001, for patients with unmet medical needs," said Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group. "Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician inquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options."



"Managed Access programs are about giving patients timely access to potential new therapies for devastating diseases, before the therapies are approved for general use," said Rich Casey, President and Chief Executive Officer at Neuraltus Pharmaceuticals, Inc. "We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001. The planned Phase 2 study in the United States, coupled with our ability to provide NP001 to qualifying patients under a Managed Access program in Europe, underscores our commitment to the ALS community."



Access to NP001 will be provided by Idis MA to individual ALS patients who meet the established eligibility criteria via a regulatory compliant mechanism, following a physician request. European healthcare professionals can obtain details about the NP001 Managed Access program by calling +44 (0)1932 824 123 or via email at global@idispharma.com. Additional information can also be found on Neuraltus' website.



- Ends -

7% fall today - Director's dealings

07 Oct 2015 Clinigen Group Peter Allen 91,464 0 0
07 Oct 2015 Clinigen Group Peter Allen 91,464 685 626,528
07 Oct 2015 Clinigen Group Peter George 825,556 0 0
07 Oct 2015 Clinigen Group Peter George 825,556 685 5,655,059
07 Oct 2015 Clinigen Group Robin Sibson 1,000,000 685 6,850,000
07 Oct 2015 Clinigen Group Shaun Chilton 412,778 0 0
07 Oct 2015 Clinigen Group Shaun Chilton 412,778 685 2,827,52

Looks overdone, on director sales. Hopefully will hold the gains today.

So the gains didn't last long, back to the 200 day moving average. I took my profits out not so long ago but still running my initial outlay, which might also be coming out very soon.

Is that another "knifecatcher"?

I don't believe so, the business is doing well but when the CFO realises £6m...
You could also argue that a good price to get in at this level.

Some useful reasons:
Is now on a dowtrend
I do not like shares on a forward PE of 15 though is on a good growth path and although it has come down a lot recently is still on a prospective of 20
There is always a "cat bounce " but the trend is your friend also.
take it or leave it the choice is yours @ 623.25p

This isn't a dead cat though! Could easily put the money somewhere else, plenty on the watch list.

Took my last tranche out to put into metals. Still like the stock though and will be watching. Suspect this is just a correction on director sales.

AGM Statement
RNS
RNS Number : 4909D
Clinigen Group plc
27 October 2015

27 October 2015

AGM Statement

Clinigen Group plc (AIM: CLIN, "Clinigen" or the "Group"), the global specialty pharmaceuticals business, is holding its Annual General Meeting ("AGM") at 10.00am today at Instinctif Partners' offices, 65 Gresham Street, London EC2 7NQ.

At the meeting Peter Allen, Clinigen's Chairman, and Peter George, Group Chief Executive Officer, will cover the following areas:

This has been a strategically transformational year for the Group. During the year, Clinigen has doubled the size of the business, strengthened its global capabilities, become the global market leader in the ethical supply of unlicensed medicines and continued the revitalization of its speciality products portfolio.

Through the acquisition of Idis, the Group has extended its unique, synergistic business model and created a better balanced portfolio of businesses. Clinigen is now the market leader in the $5+ billion unlicensed medicine supply sector and the $2 billion clinical trial supply market. The proposed acquisition of Link, due to complete shortly, will also substantially broaden the Group's international distribution footprint across the AAA region - Asia, Africa and Australasia.

As reported at Clinigen's full year results in September, all of its newer specialty pharma assets - Cardioxane, Savene and Ethyol - continue to progress to plan. The lifting of the EMA Article 31 referral for Cardioxane also remains on track.

Having completed the CFO handover period, described previously, Robin Sibson will step down from the role of CFO after the AGM and Martin Abell will now assume that role with immediate effect. The Board welcomes Martin and thanks Robin for the important role that he has played in the success and development of the Group. Robin will continue to work with the Group in his new role as a Non-Executive Director of Clinigen.

Clinigen's strong financial performance demonstrates its strengthened international position in growing markets. The Group is on track in advancing its underlying philosophy of getting the right drug to the right patient at the right time, regardless of where they are in the world.



-Ends-

products-the-priority-for-clinigen-says-deputy-chief-after-transformational-2015

Half yearly report


HIGHLIGHTS

§ Adjusted gross profit* doubled, reflecting change in scale following acquisitions

§ Adjusted EPS* up 21% to 15.1p (2014: 12.5p)

§ Interim dividend up 18% to 1.3p (2014: 1.1p)

§ £22.1m cash generated from operations, up 96%

§ Revitalisation of newer products has driven strong Specialty Pharmaceuticals performance

§ All commercial and most of operational integration complete for Idis

§ Link Healthcare acquisition builds global footprint, adding capability in Australia, Africa and Asia

§ Further extension of Dexrazoxane product line with the acquisition of Totect from Biocodex, opening up the US market for Clinigen (see separate announcement for further details)

§ Positioned for good growth in H2, in line with Board expectations

2 Mar Stifel 800.00 Buy
2 Mar Numis 916.00 Buy
2 Mar Peel Hunt 1,000.00 Buy

Trading statement Wed 20th

Trading update

RNS


RNS Number : 6704E

Clinigen Group plc

20 July 2016




20 July 2016





Year end trading update



Strong second half performance completes transformational year for Clinigen



Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the 12 months ended 30 June 2016.



Highlights



· Revenue and gross profit up 87% and 90% respectively driven by acquisitions and organic growth*

· Significant step up in performance in H2, driven by Clinical Trial Services, Specialty Pharma and Managed Access

· Specialty Pharma portfolio enhanced by acquisition of Totect and product line extension for Foscavir

· Integration of Idis and Link acquisitions substantially complete



Peter George, Chief Executive Officer of Clinigen Group said:



"The integration of Idis and Link Healthcare has transformed the Group into the global market leader in the management and supply of both unlicensed and Clinical Trial medicines.



"We had a strong second half performance, completing a transformational year. The newer products in our Specialty Pharma portfolio are making good progress, demonstrating the effectiveness of our revitalisation model and we saw another excellent year in the Clinical Trial Services division.



"We are entering the new financial year in an excellent position, having delivered on our key strategic objectives. A major focus for FY17 will be to develop our Global Access on-demand unlicensed offering to hospital pharmacists, an exciting opportunity for the Group.



"Our priorities now are to capitalise on our market leader positions, drive organic growth and continue to progress the revitalisation of our products."





Group performance



Revenue and gross profit increased by 87% and 90% respectively versus last year. The growth has been delivered by a combination of the acquisitions of Idis in April 2015 and Link Healthcare in October 2015, as well as organic growth in the underlying business.



The Specialty Pharma division, representing 31% of Group gross profits, achieved good growth. Foscavir performed as expected during the year and the Foscarnet in bags product line extension, announced in May 2016, enhances the product and is expected to extend its lifecycle.



The newer products, Cardioxane, Savene and Ethyol made excellent progress in the year, collectively increasing gross profits by over 30%. The expansion of the Dexrazoxane franchise saw the addition of Totect in March 2016. Totect provides an important entry into the US and is expected to start providing revenues in the second half of FY17.



The Managed Access division, representing 26% of Group gross profits, had a good year after taking account of a complex integration following the Idis acquisition. As expected, the start of a number of important new programs resulted in a stronger performance in the second half, positioning the division well going into FY17.



The Global Access division, representing 14% of Group gross profits, recorded gross profits marginally ahead of last year. This is after taking account of the planned disposal of the low margin commercial contract discussed following the acquisition of Idis. The Group's market leading positions in the Managed Access space and the local capability and expertise provided by the Link acquisition, will enable us to capitalise on the considerable long term international opportunity in the 'on-demand' unlicensed medicine market.



The Clinical Trial Services division, representing 19% of Group gross profits in the year, delivered excellent growth combining strong activity within its existing customer portfolio with some important new customer wins through the year. Good levels of clinical trial activity, a widening customer base and the continued roll out of our value added services are expected to drive further strong growth in FY17.



Link Healthcare, representing 10% of Group gross profits in the year, had a solid underlying performance with the strongest growth coming from the developing Asian business. Whilst reported results for Link Healthcare have been affected this year by the depreciation of local currencies, particularly in South Africa, these effects are expected to reverse in the current financial year following the recent depreciation in sterling.



Integration of acquisitions



The integration of both the Idis business and Link Healthcare is substantially complete. Acquisition and integration costs relating to Idis and Link will be shown as non-underlying costs.



Net debt



Net debt has decreased from £76.2 million as at 30 June 2015 to around £67 million as at 30 June 2016 with the cash consideration for the Link Healthcare acquisition and the product acquisitions funded from the free cash flow of the Group.





EU Referendum



Brexit is not expected to have any adverse effects on the Group in the short term. Whilst the outcomes are not yet clear, the Group's flexible operating model, the team's deep understanding of multinational regulatory process and with around 85% of revenues being from International markets, it is expected that any medium to long term implications will be manageable.



Outlook



Overall the Group has traded in line with the Board's expectations and all divisions are well positioned for good growth next year.



The Group expects to publish its final results for the year ended 30 June 2016 on Wednesday 28 September 2016.



*Revenue and gross profit growth rates include Clinigen's share of the South Africa Joint Venture and exclude the impact of the release of the fair valuation of inventory acquired with Idis and Link Healthcare. Under IFRS, the Joint Venture is excluded from revenue, gross profit and profit before tax and the Group's share of the Joint Venture's profit after tax is included in the Profit and Loss Account as 'other income'. The release of the fair value element of inventories is included in the non-underlying costs of the Group.



- Ends -

20 Jul Stifel 800.00 Buy
20 Jul Numis 916.00 Buy
20 Jul Peel Hunt 1,000.00 Buy

Notice of Results

RNS


RNS Number : 8709I

Clinigen Group plc

07 September 2016




7 September 2016



Notification of full year results date



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, will announce its full year results for the year ended 30 June 2016 on Wednesday, 28 September 2016.

Final results wed 28 Sept

Should be an upbeat set of results according to Shares.

Proactive investor -Clinigen/Cumberland launch oncology treatment in US
Share
14:56 26 Sep 2016
Shaun Chilton, Clinigen’s deputy chief executive said Ethyol’s US launch formed a key part of its global revitalisation strategy for the drug.

Drug will be Cumberland's first oncology treatment
Clinigen Group PLC (LON:CLIN) and its US partner Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) have launched the first product following their strategic licence last year.
Ethyol (amifostine) for injection is one of Clinigen’s key Specialty Pharmaceuticals brands and as well as being the first product Cumberland has licensed through the alliance, it is also its first oncology product in the US.
Ethyol helps to reduce xerostomia or dry mouth in patients receiving post-operative radiation treatment for head and neck cancer.
It can also reduce toxicity in women receiving cistplatin chemotherapy for ovarian cancer.  
Cumberland will distribute and market the drug and provide support services.
Shaun Chilton, Clinigen’s deputy chief executive said Ethyol’s US launch formed a key part of its global revitalisation strategy for the drug.
 AJ Kazimi, Cumberland’s chief executive, added: “We have worked diligently to prepare for the introduction of Ethyol and are excited to expand our activities into hospital-based oncology and this new patient population."

Full year results


HIGHLIGHTS
·     Adjusted gross profit* up 90%, driven by acquisitions and organic growth
·     Adjusted EPS* up 25% to 35.0p (2015: 28.0p)
·     Net debt decreased £8.1m to £68.1m, after £28.5m spent on acquisitions
·     Full year dividend increased 18% to 4.0p (2015: 3.4p)
·     Strongest performances by Specialty Pharmaceuticals, driven by revitalisation of newer products, and CTS
·     Integration of Idis and Link acquisitions substantially complete
·     Acquisition of Totect and Foscavir bag line extension enhances Specialty Pharmaceuticals portfolio
·     Shaun Chilton to become CEO on 11 November 2016, when Peter George steps down
(see separate announcement)

28 Sep
Stifel
800.00
Buy

28 Sep
Numis
933.00
Buy

28 Sep
N+1 Singer
800.00
Buy
28 Sep
Peel Hunt
1,000.00
Buy

Clinigen launches Japanese business
RNS
RNS Number : 7557M
Clinigen Group plc
18 October 2016
 
18 October 2016

Clinigen launches Japanese business to strengthen Asian presence
Clinigen Group plc (AIM: CLIN, 'Clinigen' or 'the Group'), the global pharmaceuticals and services group, has launched its Japanese business with the opening of an office in Tokyo, Japan. The establishment of Clinigen KK further expands the Group's presence in Asia, following Clinigen's acquisition of Link Healthcare in 2015.
Alongside the launch, Clinigen KK will transfer the Marketing Authorisation for its lead Specialty Pharmaceutical (SP) product Foscavir® (foscarnet sodium) back from Nobel Pharma on 1 November 2016. Nobel Pharma has been the distribution partner for Foscavir in Japan since 2011.
Foscavir is indicated to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) or Cytomegalovirus viremia and cytomegalovirus disease in hematopoietic stem cell transplant (HSCT) patients. Japan was the first market where Clinigen successfully achieved a new license extension for HSCT patients in 2011.
Japan remains an important market for Foscavir with more than 2,000 patients treated annually. Clinigen will assume full marketing and distribution responsibility for Foscavir from November, to supply the product to healthcare professionals and patients across Japan. 
Clinigen KK is a significant milestone for the Group in expanding its global footprint as Japan is the second largest pharmaceutical market globally. The Japanese business will allow the Group to supply and distribute both licensed and unlicensed medicines in the country, providing additional infrastructure to support Clinigen's mission to deliver the right medicine to the right patient at the right time.
Clinigen employs over 500 people globally, across 11 locations. The opening of the Japanese office further expands its international supply chain and operational network.
Shaun Chilton, Chief Executive Officer-designate, said:
"We are focused on building our market leadership positions by expanding in key geographic regions to drive sustained organic growth and better address unmet patient needs for access to critical medicines.
"The opening of our Japanese business helps support our goals and will enable us to effectively serve the Japanese market by supplying our own products, beginning with Foscavir.
"At a time when many pharmaceutical and biotechnology companies are looking for specialist partners to work with them in Asia, the opening of our Japanese office gives us more opportunities to provide customers with our global expertise combined with local knowledge."


- Ends -

18 Oct
Peel Hunt
1,000.00
Buy

7 Nov
Peel Hunt
1,000.00
Buy

7 Nov
Numis
933.00
Buy

AGM Statement
RNS
RNS Number : 9093O
Clinigen Group plc
11 November 2016
 
11 November 2016
 
 
 
 
AGM statement
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, is holding its Annual General Meeting ("AGM") at 10.00am today.
At the AGM, Peter Allen, Clinigen's Chairman will say:
"The year to 30 June 2016 marked the completion of our transformation into the global market leader in the management and supply of both unlicensed and clinical trial medicines.
"Alongside significant strategic progress, we delivered a strong financial performance with good levels of organic growth combining with acquisitions to increase adjusted EPS* by 25%. Trading for the current financial year remains in line with the Board's expectations.
"At the management level, as you know, Peter George will step down as CEO after the AGM and Shaun Chilton will now take over. We are pleased Peter will continue to work with the Group as a Non-Executive Director.
"Our focus is now fixed on leveraging our global leadership positions, and we will continue to drive organic growth supported by acquisitions and the revitalisation of products."
*Adjusted basic earnings per share is excluding share based payment costs, non-underlying costs, amortisation and associated tax credit.
 
- Ends-

Clinigen collaborates with Eisai in South Africa
RNS
RNS Number : 6197Q
Clinigen Group plc
01 December 2016
 
RNS Reach
1 December 2016
 
Halaven® (eribulin) receives registration in South Africa for treatment of women with advanced breast cancer
Collaboration between Eisai and Clinigen provides women in South Africa with access to eribulin for advanced breast cancer
Halaven® (eribulin) is now registered by the Medicines Control Council (MCC) in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Eribulin was discovered and developed by Eisai and will be available to people in South Africa through a partnership with Equity Pharma, part of Clinigen's Link Healthcare division.
Approximately 7,000 women are diagnosed with breast cancer in South Africa each year.1 Eribulin monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.2
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This is the first distribution agreement of this kind for Clinigen following our acquisition of Link Healthcare in 2015, and marks the continuation of a successful relationship with Eisai. As partners in the distribution of eribulin, we can leverage our comprehensive South African distribution network and local expertise to deliver this important medicine to eligible women across the country, marking an important moment in the fight against advanced breast cancer in the region."
Gary Hendler, Chairman and CEO EMEA & Global Chief Commercial Officer, Oncology Business Group, Eisai, said:
"Through our close partnership with Clinigen South Africa, Eisai will officially enter the South African market with the launch of eribulin and together we strive to make a meaningful difference to the lives of patients with advanced breast cancer."
Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.
- Ends -

Clinigen signs agreement with BioQ Pharma
RNS
RNS Number : 8919R
Clinigen Group plc
15 December 2016
 
15 December 2016
CLINIGEN GROUP PLC
Clinigen signs Global Access agreement for BioQ Pharma's post-operative pain management product, Ropivacaine Readyfusor
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Idis Global Access (GA) division has signed a supply and distribution agreement with BioQ Pharma, a developer of large volume ready-to-use infusible products. The deal covers the on-demand supply and distribution of BioQ Pharma's pre-filled Ropivacaine Readyfusor for post-operative pain management in Europe, excluding France and Germany.
Under the terms of the agreement, Idis GA will make the Ropivacaine Readyfusor available, prior to it receiving its national marketing authorisation, on an exclusive on-demand basis to physicians and pharmacists in the UK. Idis GA will also supply the product to other European territories prior to approval and will manage distribution to provide ethical access to the product.
The Ropivacaine Readyfusor is a disposable, single use infusion product which is pre-filled by the manufacturer with 0.2% Ropivacaine, a non-narcotic local anaesthetic. It is a self-contained drug and administration system for delivery at the point of care, activated by a single touch. The Ropivacaine Readyfusor contains a sterile drug that is hermetically sealed until time of use.
The ready-to-use product delivers Ropivacaine at a pre-determined rate to provide pain control for at least
48 hours after surgery.
Steve Glass, Chief Commercial Officer (North America and Europe) of Clinigen said:    
"As the global leaders in providing trusted, ethical access to unlicensed medicines, this agreement means that we can enable healthcare professionals to access the Ropivacaine Readyfusor on-demand for their patients.
"This partnership with BioQ Pharma marks another important supply agreement for Idis GA. It demonstrates the continuing demand from pharmacists and physicians for a compliant route to obtain medicines that are unlicensed or unavailable in their country. There is also an increase in engagement from manufacturers to work with us to help provide continuous access to their products, to better serve patients with unmet medical needs."
Walter Cleymans, Vice President of Europe of BioQ said:                                                                  
"We are pleased to make Ropivacaine Readyfusor available to patients in Europe with the assistance of Idis GA. The Readyfusor is intended to provide effective pain relief following surgery, while providing a convenient, self-contained, and ready-to-use presentation that should reduce the number of steps needed to administer the drug to the patient."
The Ropivacaine Readyfusor comes completely ready-to-use from the manufacturer, it is intended to help avoid filling errors and breaches in sterility often associated with conventional elastomeric "pain pumps". The Ropivacaine Readyfusor's proprietary design precludes the risk of overdosing due to delivery malfunctions. The product should be prescribed post-surgically for medically appropriate procedures that require at least 48 hours of pain relief. Ropivacaine can be administered as a continuous surgical site infusion or continuous peripheral nerve block.
Healthcare professionals can obtain details about the Ropivacaine Readyfusor pre-filled infusion product by emailing customer.services@clinigengroup.com.
- Ends-

Clinigen and Cumberland enter agreement for Totect
RNS
RNS Number : 6909T
Clinigen Group plc
09 January 2017
 
9 January 2017
 
  Clinigen and Cumberland Pharmaceuticals enter exclusive U.S. commercialisation agreement for Totect®

Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company announce an exclusive agreement to commercialise the oncology support drug, Totect® (dexrazoxane hydrochloride) in the U.S.
This is the second product Clinigen has licensed to Cumberland under the strategic alliance established in 2015, following the launch of Ethyol® (amifostine) in the U.S. in September 2016.
Totect is an FDA-approved emergency oncology intervention which is indicated to reverse the toxic effects of anthracycline chemotherapy in case of extravasation. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body causing severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment.
Under the terms of the agreement, Cumberland has been granted an exclusive U.S. license and will manage all marketing, promotion, and distribution of Totect in the U.S. Clinigen will retain responsibility for manufacturing, regulatory and clinical management of the product. Preparations are now underway for the U.S. launch of Totect later this year.
Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP) division in 2016 to expand its dexrazoxane portfolio and enter the U.S. market. Clinigen SP will continue to commercialise its existing dexrazoxane products, Savene® and Cardioxane®, in Europe and other territories outside of the U.S.
Shaun Chilton, Chief Executive Officer of Clinigen said:
"This agreement marks an important milestone for Clinigen. Totect is the second Specialty Pharmaceuticals product that we have exclusively licensed to Cumberland as part of the strategic alliance signed in 2015. Cumberland is a valuable partner, providing us with the opportunity to expand our dexrazoxane portfolio into the sizable U.S. market and enabling patients to access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"It's good to see another product emerge from our strategic partnership with Clinigen, as we continue to selectively expand our line of marketed hospital brands. We are keen to help yet another group of oncology patients with Totect, which reflects our mission of delivering products that help improve patients' quality of care."
 
-Ends

Clinigen initiates program for TESARO's niraparib
RNS
RNS Number : 3742U
Clinigen Group plc
17 January 2017
 
17 January 2017

  Clinigen initiates U.S. Managed Access program for TESARO's niraparib for patients with ovarian cancer

Clinigen Group plc's (AIM: CLIN, 'Clinigen') Idis Managed Access (MA) division has partnered with TESARO Inc. (NASDAQ: TSRO), to launch a Managed Access program (also known as an expanded access program (EAP)) for the investigational PARP 1/2 inhibitor, niraparib.
Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.
Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Despite high response rates to platinum-based chemotherapy, 85% of women with advanced ovarian cancer will recur after first line treatment, at which point, the disease is treatable but incurable.
Most patients who recur after first or second line therapy are treated with a further round of platinum-based chemotherapy, if they responded to the previous one. However most do not receive any type of treatment post-response to the platinum-based treatment regimen and must watch and wait for the inevitable recurrence. Unfortunately, the efficacy of chemotherapy diminishes over time and most women will recur again quickly.
Niraparib is an oral, once-daily PARP 1/2 inhibitor. It is administered following a response to platinum-based chemotherapy which may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer after the completion of chemotherapy, in between cycles of platinum-based chemotherapy. Niraparib has been accepted for priority review by the U.S. Food and Drug Administration.
The Managed Access program allows physicians to request niraparib for individual, eligible U.S. patients who may not be able to participate in a clinical trial nor have any other treatment option, but who may benefit from access to this investigational therapy prior to approval.
Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:
"As the global leader in providing access to unlicensed medicines, we have delivered over 220 Managed Access programs which have benefited thousands of patients.
"There is a clear area of unmet medical need in the treatment of ovarian cancer, the fifth most common cause of death from cancer among women in the U.S. We are pleased to be partnering with TESARO to deliver this Managed Access program for niraparib, providing women with the opportunity to gain access to this important investigational therapy at the earliest possible moment."
 
U.S. based Healthcare Professionals can obtain details about the niraparib Managed Access program by calling a Clinigen representative at: 1-877-786-4303, or emailing niraparibUSEAP@clinigengroup.com.

-Ends-

HY trading update

RNS


RNS Number : 0139V

Clinigen Group plc

25 January 2017




25 January 2017


HY trading update: strong H1 performance with gross profit up 34%



Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the six months ended 31 December 2016.



Highlights

· Gross profit* up 34% driven by a combination of good organic growth across all divisions, a full six months contribution from Link Healthcare and currency benefits

· Excellent growth by Link Healthcare and Clinical Trial Services

· Strong growth in Managed Access and Specialty Pharma



Shaun Chilton, Group Chief Executive Officer of Clinigen, said:



"We have delivered good growth across all divisions following the successful integration of the Idis and Link Healthcare acquisitions.

"Link Healthcare has achieved an outstanding performance, demonstrating the value of its acquisition by the Group. Among the other divisions, Clinical Trials Services has again delivered a standout performance. Managed Access and Specialty Pharma also delivered strong growth.

"We are trading in line with our expectations and are well positioned to deliver good performances across all divisions in H2.

"Our priorities remain to drive organic growth by capitalising on our international market leading positions and expanded geographical footprint. We will also continue to look for selective acquisitions that meet our return criteria in order to enhance our product portfolio and / or service capabilities."



Group performance



Gross profit* increased approximately 34% compared to last year. The increase was driven by good levels of organic growth across all business divisions, a full six months contribution from Link Healthcare, which was acquired in October 2015, and favourable exchange rate effects following the depreciation of Sterling.



The Specialty Pharmaceuticals division, representing approximately 29% of Group gross profit, achieved strong growth in the first half with each of the products in the portfolio performing as expected.



The transfer of the US license for Ethyol to the Group's US strategic partner, Cumberland Pharmaceuticals, was completed in H1 of the financial year and the benefits are expected to be seen in H2. Totect, purchased last year, is on course to start generating sales in Q4 of the financial year.



Discussions with the regulator continue to move in a positive direction on Article 31 in respect of lifting the restriction of using Cardioxane with certain adult patient populations.



The Managed Access division, representing approximately 23% of Group gross profit, had a strong first half benefiting from the ramp up of a number of programmes won in the last financial year.



The Global Access division, representing approximately 12% of Group gross profit, made solid progress. The number of exclusive supply agreements increased and the first key contract converted from early access to on-demand 'point of care' access.



The Clinical Trial Services division, representing approximately 17% of Group gross profit, achieved excellent growth. Activity within its existing customer base was strong and the division achieved some important customer wins in H1. Whilst the visibility for Clinical Trial Services is always more limited, the current pipeline positions the business to complete another good year of growth.



Link Healthcare, representing approximately 19% of Group gross profit, delivered significant organic growth across all geographies and benefited from the translation effects from the depreciation in Sterling (more than 35% pro forma growth for six months versus six months last year). The launch of the Japanese business further strengthens Clinigen's presence in Asia.



Group overheads increased in line with budget as Clinigen continues to strengthen the infrastructure and management team to support its long term growth ambitions.



The implementation of the Group's ERP system, which will make the business more efficient and scalable, is progressing to plan. Cliniport, which strengthens our market proposition by providing enhanced online access to unlicensed medicines, is ready to be launched in H2 of this financial year.



Net debt



Net debt at the period end is approximately £71 million (31 December 2015: £81.5 million). As expected, net working capital increased in the first half due to the timing of cash flows around period ends and the completion of a large contract with favourable working capital characteristics. As previously guided, capital expenditure has been higher than usual due to budgeted spend on the IT system, which is currently being implemented.



Outlook



The Group is trading in line with the Board's expectations and all divisions are well positioned to drive good levels of organic growth in the second half of the financial year.





The Group expects to publish its interim results for the six months ended 31 December 2016 on Wednesday 15 March 2017.



*Gross profit growth rates include Clinigen's share of the South Africa Joint Venture and exclude the impact of the release of the fair valuation of inventory acquired with Idis and Link Healthcare. Under IFRS, the Joint Venture is excluded from revenue, gross profit and profit before tax and the Group's share of the Joint Venture's profit after tax is included in the Profit and Loss Account as 'other income'. The release of the fair value element of inventories is included in the non-underlying costs of the Group.



- Ends -

25 Jan Numis 933.00 Buy
25 Jan Stifel 900.00 Buy
25 Jan N+1 Singer 895.00 Buy
25 Jan Peel Hunt 1,000.00 Buy

Proactive investor - Clinigen, Convatec and Sinclair Pharma stand out among mid-cap pharmas says Peel Hunt
Share
12:47 24 Feb 2017
Clinigen is a core pick as a defensive GARP (growth at reasonable price) play.

Multiple headwinds have keep sector depressed
Clinigen PLC (LON:CLIN) is one of only a few bright spots in a subdued healthcare sector according to broker Peel Hunt.
Headwinds such as the outlook for US drug pricing, broader macro concerns such as taxation policy and a strengthening US Dollar have kept the yoke firmly on mid-cap pharma shares over the past year.
In response, investors have been switching out of “riskier” pharma/biotech stocks into perceived safer havens such as lab tools and services players.
The broker sees little evidence that these trends will turn soon but argues companies where growth is relatively secure but with potential for some upside surprise still have appeal.
Clinigen fits the bill suggests Peel Hunt, which has a buy rating and has upgraded its target price to 1,015p.
Since June last year the share price has risen by 58% but there is more to come argues the broker and Clinigen is a core pick as a defensive GARP (growth at reasonable price) play.
“Defensive from being pharma aligned without significant pricing risk, while delivering solid EPS growth (2016- 20: 14%).
“Growth is being driven by increasing pharma out-sourcing and deeper synergies between divisions.
“The stock also offers exposure to faster growing pharmerging markets with potential for balance sheet utilisation through specialty product acquisition.”
Other companies to consider are ConvaTec PLC ( LON:CTEC), which is a buy with a 300p target, and Sinclair Pharma PLC (LON:SPH) with a target price of 68p.
ConvaTec’s secure mid single-digit top-line growth derives from its leading positions (1-3) across medtech consumables sub-segments and geographies.
“Low working capital and capex burdens see strong cash conversion, supporting a 35-45% dividend payout for a mid single-digit yield by 2020.”
Sinclair Pharma, meanwhile, is Peel Hunt’s favourite growth story in UK small & midcap healthcare.
“We see Sinclair as a way to play the “luxury goods” consumer market through healthcare.
“Sinclair is a pure-play on aesthetic dermatology, selling next generation minimally-invasive (injectable) products that provide subtle yet noticeable cosmetic enhancement (lifting and plumping) for significantly better results vs traditional fillers.”
Share prices today were 32p fpr Sinclair, 232p for ConvaTec and 825p for Clinigen.

Halaven� (eribulin) launches in South Africa
RNS
RNS Number : 9895X
Clinigen Group plc
28 February 2017
 
28 February 2017
RNS Reach
 
Halaven® (eribulin) launches in South Africa for the treatment of women with advanced breast cancer
Eisai and Clinigen enter partnership to provide eribulin in South Africa for women with advanced breast cancer
 
Halaven® (eribulin) is now available in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their advanced disease. Prior therapy should have included an anthracycline and a taxane, unless patients were not suitable for these treatments1.
Approximately 7,000 women are diagnosed with breast cancer in South Africa each year and 30% will develop recurrent advanced or metastatic disease2. Metastatic breast cancer is deemed incurable and only one third of women with metastatic breast cancer will be alive five years after diagnosis2.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This is the first distribution agreement of its kind for Clinigen following our acquisition of Link Healthcare in 2015, and provides access to eribulin in South Africa. This launch builds on our strong relationship with Eisai allowing us to further demonstrate our local distribution knowledge and expertise."
Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA, Eisai, said:
"We are excited and pleased to launch eribulin to South Africa for patients with advanced breast cancer. Eisai discovered and developed eribulin, and have partnered with Equity Pharma from Clinigen Group's Link Healthcare division to introduce eribulin in South Africa. We hope that this launch will make a meaningful difference to the lives of patients and their families."
 - Ends -

First-in-class Fycompa� approved in South Africa
RNS
RNS Number : 0799Z
Clinigen Group plc
10 March 2017
 
10 March 2017
RNS Reach
  
First-in-class Fycompa® (perampanel) approved in South Africa for partial-onset seizures
Partnership with Clinigen to provide perampanel in the region
 
Eisai is pleased to announce that perampanel has been approved in South Africa for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.1 Perampanel is the first anti-epileptic drug to be approved in South Africa in recent years.
Perampanel is the only licensed anti-epileptic drug to selectively and non-competitively target AMPA* receptors. These receptors play a critical role in the onset and spread of seizures.2
Epilepsy affects one in every 100 people in South Africa, which amounts to an estimated half a million people living with the condition in the country.3 In addition, 20-40 per cent of people with newly-diagnosed epilepsy can become refractory to currently available treatments, which require further adjunctive medication.4
 
Dr Dave Anderson, Specialist Adult Neurologist, Wits Donald Gordon Medical Centre, said:
 "Many epileptic patients have poorly controlled seizures despite the plethora of treatments available. It is exciting to see the approval of a new treatment such as perampanel in South Africa. It will be a welcome addition to the clinician's arsenal of treatments and patients could benefit from its unique mode of action."
 
The approval of perampanel is based on three pivotal Phase III studies (304, 305 and 306)5,6,7 and an open extension study 307,8 which show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in patients with partial-onset seizures, with or without secondary generalisation. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.8
To ensure access of perampanel to patients with epilepsy in South Africa, Eisai is collaborating with its regional partner Clinigen.
 
Johann Willemse, Chief Commercial Officer, Rest of World, Clinigen, said:
"Perampanel is the second product we are working on together with Eisai in South Africa. We have forged a strong partnership, based on Eisai's innovative products and our ability to leverage our extensive distribution network in the region and local expertise. Together, we can enable access to perampanel where it is needed most."
 
Neil West, Vice President Global Neurology Business Group, Eisai, said:
"Eisai is committed to the therapeutic area of neurology and to addressing the unmet medical needs of people with neurological conditions and their families. Ensuring patient access to new treatments underlines Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide."
*AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionate
- Ends -

10 Mar
Numis
933.00
Buy

Half year report

HIGHLIGHTS
§ Adjusted gross profit* up 34% driven by organic growth across all divisions, a full six months contribution from Link Healthcare and currency benefits
§ Adjusted EPS* up 31% to 19.0p (2015: 14.5p)
§ Interim dividend increased 23% to 1.6p (2015: 1.3p)
§ Excellent performances by Link Healthcare and Clinical Trial Services
§ Launch of Japanese business, enhancing licensed and unlicensed presence in Asia
§ Global Access added further exclusive supply agreements
§ First contracts converted from Managed Access to Global Access

Launch of a European Patient Access programme
RNS
RNS Number : 6197Z
Diurnal Group PLC
16 March 2017
 
16 March 2017
 
Diurnal Group plc
("Diurnal" or the "Company")
 
Diurnal appoints Clinigen to launch a European Patient Access programme for Infacort® and Chronocort®
 
Infrastructure and supply chain now in place to provide Infacort® and Chronocort® as unlicensed medicines to patients on a Named Patient basis
 
 
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a partnership with Clinigen Group plc's (AIM: CLIN) IDIS Managed Access ("IDIS") division to launch a Patient Access programme in Europe for the Company's lead products, Infacort® and Chronocort®, for patients with diseases of cortisol deficiency.   
 
The Patient Access programme will enable physicians in Europe to prescribe Infacort® and Chronocort® as unlicensed medicines on a Named Patient basis for patients who have no other treatment options, ahead of anticipated European approval and commercial launch of the products.
 
Infacort® is a preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from adrenal insufficiency (AI), including the related disease, congenital adrenal hyperplasia (CAH). Chronocort® is a modified release hydrocortisone preparation that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen for the treatment of adult CAH.
 
AI and CAH are characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. AI is identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six. Poor control of the disease can result in premature puberty in young children, virilisation in girls and chronic fatigue leading to a poor quality of life in adulthood resulting in increased morbidity and mortality.
 
CAH is the most common inherited (genetic) hormone disorder affecting both men and women. Approximately two thirds of CAH patients are estimated to have poor disease control. The condition is estimated to affect approximately 51,000 patients in Europe. Poor disease control can lead to increased mortality, infertility and severe development defects including ambiguous genitalia, premature sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. 
 
Martin Whitaker, CEO of Diurnal, commented: 
"Our first product, Infacort®, is currently undergoing regulatory review with the EMA. Whilst this is ongoing, we are focused on putting in place the appropriate infrastructure to ensure that patients with cortisol deficiency but no other treatment options can access this medicine as efficiently as possible. As a global leader in providing unlicensed medicines to patients on a Named Patient basis, Clinigen is well placed to help us make Infacort® and Chronocort® accessible to patients ahead of their potential approval."
 
Steve Glass, Group Managing Director of Clinigen, said:
"The effective treatment of patients with CAH and paediatric AI represents a significant unmet need. As the global leader in providing Managed Access programmes, we can leverage our international reach to support these patients by enabling their physicians to access these therapies safely, ethically and quickly, ahead of approval and launch."  
 
Diurnal submitted a Paediatric Use Marketing Authorisation (PUMA) application for Infacort® to the European Medicines Agency (EMA) in late 2016. Diurnal anticipates that the EMA review process could take up to one year to complete. 
 
Chronocort® is currently in Phase III clinical development with the trial scheduled to complete in 2018. If the results of the Phase III trial are supportive, Diurnal plans to submit Chronocort® for market approval in Europe.

16:50 04/04/2017
Broker Forecast - Numis issues a broker note on Clinigen Group
Numis today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add) and set its price target at 951p. Story provided by StockMarketWire.com

4 Apr
Stifel
970.00
Buy

Clinigen and Onxeo initiate MA programme in Europe
RNS
RNS Number : 1822D
Clinigen Group plc
25 April 2017
 
RNS Reach
25 April 2017
Clinigen and Onxeo initiate Managed Access programme for belinostat in Europe for patients with peripheral T-cell lymphoma (PTCL)
 
Clinigen Group plc's (AIM: CLIN, 'Clinigen' or the 'Group') Idis Managed Access ('MA') division and Onxeo S.A (Euronext Paris, Nasdaq Copenhagen: ONXEO, 'Onxeo'), have agreed to launch a Managed Access programme for belinostat (Beleodaq®) in Europe. Belinostat is for use in patients with relapsed or refractory peripheral T-cell lymphoma ('PTCL').
PTCL is a form of blood cancer comprising of a group of rare and aggressive non-Hodgkin lymphomas ('NHLs'), a malignant lymphoproliferative disorder. PTCL accounts for approximately 10%-15% of all NHL cases.
Belinostat is a histone deacetylase inhibitor used to treat refractory or relapsed PTCL. The product received accelerated approval* by the US Food and Drug Administration ('FDA') in July 2014 due to the unmet medical need in this rare disease. There are no approved treatments for PTCL in Europe.
The programme allows physicians to request belinostat for individual patients for whom alternative treatment options are not currently available. This enables patients on a named patient basis in Europe** to benefit from belinostat treatment ahead of a potential European approval.
Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:
"There is a huge unmet need for patients with aggressive blood cancers such as PTCL. As the trusted global leader in access to unlicensed medicines, Clinigen is working in partnership with Onxeo to help patients gain access to this important medicine.
"As Clinigen and Idis MA, we have delivered over 220 Managed Access programmes to thousands of patients. We help physicians access medicines when no other treatment options are available reducing unmet clinical need. This aligns with our mission of getting the right medicine to the right patient at the right time."
Judith Greciet, Chief Executive Officer of Onxeo said:
"Consistent with our efforts to address the unmet needs of people diagnosed with relapsed or refractory PTCL, we are pleased to partner with Clinigen to establish this Named Patient programme. In selected European countries in which local health authorities permit the programme, the belinostat Managed Access programme will allow healthcare professionals to prescribe belinostat to specific patients."
Healthcare Professionals can obtain details about the belinostat Managed Access programme by calling a Clinigen representative at: +44 (0) 1283 44 347, or emailing customer.services@clinigengroup.com.
*Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
** Programme will be launched in: United Kingdom, Germany, France, Spain, Italy, Denmark, Sweden, Norway, Finland, Belgium, The Netherlands, Luxembourg, and Austria.
- Ends -

Clinigen achieves positive Cardioxane CHMP opinion
RNS
RNS Number : 7353F
Clinigen Group plc
22 May 2017
 
RNS Reach
22 May 2017
Clinigen achieves positive CHMP opinion concerning Cardioxane in Europe
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Specialty Pharma (SP) division has achieved a positive CHMP opinion in Europe to modify the current product information for Cardioxane.  It is expected that the European Commission (EC) will accept the CHMP opinion and will issue its approval later this year. This is a significant step forward in the assessment of the regulatory application which should ultimately allow physicians to consider use in paediatric patients where high dose anthracycline therapy is planned.
Since Clinigen acquired Cardioxane in March 2013, the Group has actively engaged with paediatric oncologists and cardiologists in the European Union (EU) and United States (US) to understand new data which supported a change to the product information. This work has been driven by a common desire for physicians in the EU to be allowed to use Cardioxane in children who previously did not have that option due to the paediatric contraindication introduced during the Article 31 referral (2011). 
Once final EC approval is obtained, physicians will be able to consider using Cardioxane to protect the hearts of paediatric cancer patients when they plan to administer a cumulative dose of more than 300mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline. 
The safety profile of the product was also reassessed in the adult population. The regulatory authorities have agreed that the new data demonstrates a more favorable safety profile for Cardioxane, which will also be reflected in the updated product information.
This represents a major regulatory achievement for the Group and is a key milestone in the revitalisation of the Cardioxane brand by Clinigen SP.  Clinigen will implement appropriate safety measures to ensure the continued safe use of the product and to expand the clinical understanding in the paediatric population.
Ivo Timmermans, Chief Medical Officer of Clinigen said:
"Paediatric oncologists and cardiologists have been limited in their options to effectively manage cardiotoxicity associated with anthracycline chemotherapy when used to treat certain childhood cancers. I am proud of the fact we have been able to work with EU and US experts and the regulatory agencies to reach this positive CHMP opinion, which should result in changes to the Cardioxane product information."
Shaun Chilton, Group Chief Executive Officer of Clinigen said:
"The CHMP positive opinion on Cardioxane follows a significant international effort between Clinigen, paediatric oncologists and cardiologists. This clearly demonstrates our capabilities in revitalising our products so that they can benefit more patients. It is a significant milestone in our history to be part of a change that could offer Cardioxane as an additional option for children being treated for certain types of cancer."
- Ends-

22 May
Stifel
970.00
Buy
22 May
Numis
951.00
Buy

Broker Forecast - Peel Hunt issues a broker note on Clinigen Group
BFN
Peel Hunt today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and raised its price target to 1200p (from 1015p).

Story provided by StockMarketWire.com

Clinigen and Cumberland: FDA approval for Totect
RNS
RNS Number : 6070K
Clinigen Group plc
10 July 2017
 
RNS Reach
10 July 2017
 
  Clinigen and Cumberland Pharmaceuticals obtain
FDA approval for Totect® in the U.S.
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company, today announce they have obtained FDA approval for Totect® (dexrazoxane hydrochloride) in the U.S.
Totect is an emergency oncology intervention, which is indicated to reverse the toxic effects of anthracycline chemotherapy in case of extravasation. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body, causing severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment.
In January 2017, Clinigen and Cumberland entered an exclusive U.S. agreement to commercialise Totect, the second such agreement under their Strategic Alliance, established in 2015. The FDA approval of Totect is an important milestone in the preparation for the U.S. launch of the product later this year.
Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP) division in March 2016 to expand its dexrazoxane portfolio for the U.S. market. Clinigen SP also continues to commercialise its existing dexrazoxane products, Savene® and Cardioxane®, in Europe and other territories outside of the U.S.
Shaun Chilton, Chief Executive Officer of Clinigen said:
"Totect is the second SP product that we have exclusively licensed to Cumberland as part of the Strategic Alliance, and the FDA approval of Totect is an important milestone in its revitalisation strategy.
"Approval paves the way for launch, which will enable patients to access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"We are delighted by the FDA approval of Totect for the United States, and we are looking forward to expanding the number of patients that will benefit from this important oncology support product.
"This is a significant next step for Cumberland as we build our position in oncology supportive care and further strengthen our Strategic Alliance with our partner, Clinigen."
 
-Ends-

Year End Trading Update
RNS
RNS Number : 3083L
Clinigen Group plc
18 July 2017
 
18 July 2017
              
 
Year end trading update
 
Strong full year performance with profits up over 20%
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the 12 months ended 30 June 2017.
 
Highlights
 
§ Gross profit* expected to be up 22% driven by a combination of organic growth across all operations, a full year's contribution from Link Healthcare and currency benefits
§ Strong growth across Clinical Trial Services (CTS), Unlicensed Medicines, and Commercial Medicines
§ Outstanding performance in Africa and Asia Pacific
§ Dexrazoxane portfolio revitalisation significantly enhanced by positive CHMP** opinion on Cardioxane and Totect US approval
§ New simplified operating and reporting structure comprising CTS, Unlicensed Medicines and Commercial Medicines
 
Shaun Chilton, Group Chief Executive Officer of Clinigen Group said:
 
"This has been another excellent year with all three operations, CTS, Unlicensed Medicines and Commercial Medicines, performing strongly.
 
"We have made significant progress in our strategy to build scale and capability in high growth geographies in Africa and Asia Pacific. Now that Link's earn-out period has been completed, we will be able to further integrate and develop our complementary portfolio of businesses worldwide.
 
"Our priorities in the current financial year remain unchanged. We will drive organic growth across all parts of the Group and search for selective acquisitions to complement our existing offering and capabilities."
 
Group performance
 
Overall the Group has traded in line with the Board's expectations and all operations are well positioned to drive good growth in the current financial year.
 
Following the completion of the Link earn-out and subsequent closer integration of Link into the Group, the performance of the business will be reported as three operations; CTS, Unlicensed Medicines, and Commercial Medicines. This structure reflects how Clinigen operates in practice and will allow the Group to better capitalise on our market leading positions and expanded geographical footprint.
 
Gross profit, viewed as the best measure of top line growth, is expected to increase by around 22% compared to last year, driven by organic growth across all operations, a full year's contribution from Link Healthcare ('Link') and currency benefits following the depreciation of Sterling.
 
Revenues increased around 7% excluding the effect of the change in mix in Managed Access towards programmes where the product is provided by the pharmaceutical client free of charge, and the termination of a large Global Access low margin commercial contract, which was inherited with the Idis acquisition. This revenue growth is lower than the growth in gross profit primarily due to the change in mix in CTS towards higher margin products and activity. Reported revenue decreased around 11%.
 
CTS
CTS, representing around 19% of Group gross profits, delivered another year of excellent growth. It continues to add complementary services to the core business to respond to the increased demand from clients requiring more global and complex solutions.
 
Unlicensed Medicines
Unlicensed Medicines, encompassing the Managed Access, Global Access and the unlicensed business within the Link division, represents around 42% of Group gross profit. This part of the business delivered strong growth with the highlight being outstanding growth in the Africa and Asia Pacific region.
 
Commercial Medicines
Commercial Medicines, encompassing the Specialty Pharma division and the commercial business of the Link division, representing around 39% of Group gross profits, delivered another excellent year of progress.
 
Foscavir was an important driver of growth and Ethyol stepped up in the second half benefiting from the strategic partnership with Cumberland in the US. The Group's dexrazoxane portfolio comprising Cardioxane, Savene and Totect, performed as expected, with Totect achieving FDA approval in the final quarter in the US.
 
As announced in May 2017, a key development was the positive CHMP** opinion to modify the current product information for Cardioxane. It is expected that the European Commission will accept the CHMP opinion and will issue its approval shortly. As a result of the approval, physicians will be able to consider use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The approval is expected to step up usage of Cardioxane in the medium term and further demonstrates Clinigen's ability to revitalise acquired products.
 
Excellent progress was made in the Africa and Asia Pacific region, building sales from Link's existing commercial portfolio and from the strategy of converting unlicensed medicines to licensed medicines.
 
Group overheads are expected to increase in line with budget as the Group continues to strengthen the infrastructure and management team to support its long term growth ambitions. The implementation of the Group's ERP system, which will make the business more efficient and scalable, is progressing to plan.
 
Cash flow performance was significantly stronger in the second half of the year.  As a result, net debt has decreased to around £35 million as at 30 June 2017 from £70.9 million as at 31 December 2016. It is estimated that the deferred cash consideration on the Link acquisition, payable in October 2017, will be in the region of £40m.
 
The Group expects to publish its final results for the year ended 30 June 2017 on Thursday 28 September 2017.
 
*Gross profit growth rate includes Clinigen's share of the South Africa Joint Venture and exclude the impact of the release of the fair valuation of inventory acquired with Idis and Link Healthcare. Under IFRS, the Joint Venture is excluded from revenue, gross profit and profit before tax and the Group's share of the Joint Venture's profit after tax is included in the Profit and Loss Account as 'other income'.  The release of the fair value element of inventories is included in the non-underlying costs of the Group.
 
**The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
 
- Ends -
 

Clinigen Group: A billion pound AIM company
Share
13:35 18 Jul 2017
Gross profit in the half year to December was up by 34%

INVESTMENT
OVERVIEW: CLIN
The Big
Picture
Clinigen saw strong growth across all divisions
There are not many £1bn market cap companies on AIM, but Clinigen PLC (LON:CLIN) is one and Shaun Chilton, chief executive, couldn’t be happier.
Speaking to Proactive Investors after a bumper year for the pharma services and drug group, he said business currently was very good.
Organic growth, a currency boost and full contribution from recent acquisition Link Healthcare helped gross profits rise by 22% in the year to June.
Chilton was especially pleased that all three of its divisions, clinical trial services, unlicensed medicines and commercial medicines, had made good progress.
Top stories

Carillion creeps higher as HSBC parachuted in ahead of possible £500mln fundraise

ITV shares gain after poaching easyJet boss Carolyn McCall as its new chief executive

Taxpayer's loss in government's RBS stake sale worse than thought, NAO reveals
WATCH: Clinigen's Shaun Chilton 'couldn't be happier' with full year performance
There was an outstanding performance in Africa and Asia Pacific from the unlicensed medicines business, he added, where with recent acquisition Link's infrastructure it started to distribute drugs for epilepsy and breast cancer in partnership with Japanese firm Eisai.
In the commercial division, Foscavir, for HIV sufferers with herpes, and chemotherapy relief Ethyol benefited from the strategic partnership with Cumberland in the US. 
Approval is also expected soon in Europe for a reformulated version of Cardioxane, a chemotherapy toxicity treatment for children based on Dexrazoxane, while Totect, another in the Dexrazoxane portfolio, has now received the green light in the US.
READ: Clinigen Group set for European approval for Cardioxane
Clinigen 'cash as usual'
Debts halved over the year to £35mln with strong cashflow in the second half of the year and Chilton says that the business is still generating £1 of cash for every £1 of underlying profit [EBITDA].
Clinigen estimates it will pay a further £40mln as the final consideration for Link in October and following that will be on the look-out for more acquisitions. 
These may be either through more products, adding to its geographic footprint or else pushing deeper into the unlicensed medicines to licensed arena, he said.
Deals were more likely to be bolt-ons such as Link rather than deals on the scale of its £200mln acquisition of Idis.
£1bn valuation
Even though Clinigen is now worth well over £1bn Chilton in insists the company is still happy to remain on AIM.
It’s [AIM] been very good for us, he said and a move to the main market is not something it’s been discussing.
At 923p, or just shy of its all-time high, Clinigen is worth £1.06bn.

Clinigen receives EC approval for Cardioxane
RNS
RNS Number : 3337N
Clinigen Group plc
08 August 2017
 
8 August 2017
Clinigen receives EC approval for updates to Cardioxane product information
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Commercial Medicines operation received a European Commission (EC) approval to update the current product information for Cardioxane.  
Cardioxane is an oncology support drug that prevents chronic cumulative cardiotoxicity caused by high dose anthracycline chemotherapy. In 1992, it was licensed for international markets but its label was revised in Europe as a result of an Article 31 referral in 2011. This restricted its indication and introduced a paediatric contraindication.
The EC approval follows a positive opinion issued by the EMA Committee for Medicinal Products for Human Use (CHMP) in May 2017, which was highlighted in the Group's trading update on 18 July, 2017.
Approval will enable physicians to consider the use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The product information will also be updated to reflect a more favourable safety profile for Cardioxane in adult populations at the same time.
Since Clinigen acquired Cardioxane three and a half years ago, a multi-disciplinary team at Clinigen has actively engaged with an extensive group of international paediatric oncologists and cardiologists. The aim was to achieve updates to the product information, especially concerning the paediatric population, to align with new data.
Clinigen will implement appropriate safety measures to ensure the continued safe use of the product and to expand the clinical understanding in the paediatric population and will submit amendments to the labelling in countries where Cardioxane licences are held.
Merav Edan, Head of Regulatory Specialty Pharmaceuticals of Clinigen said:
"EC approval is the final step to ensuring that the paediatric oncologists can effectively manage cardiotoxicity associated with anthracycline chemotherapy by using Cardioxane when needed. Not only that, the additional changes to the Cardioxane product information will extend its use in the adult population."
Shaun Chilton, Group Chief Executive Officer of Clinigen said:
"Final approval to enable Clinigen to implement the label change is a milestone achievement. This decision has been the work of many years, driven by a dedicated Clinigen team with the growing support of healthcare professionals. The impact for Cardioxane usage will not be immediate but this is a major regulatory achievement for us and demonstrates our ability to revitalise products so that they can benefit more patients over the long term."
- Ends-
 

Quantum leaps after receiving takeover proposal from Clinigen
Wed, 16 August 2017




(ShareCast News) - UK pharmaceutical developer Quantum Pharma announced it had received an indicative proposal of a possible offer for the company from Clinigen Group.
The proposal from Clinigen and would be satisfied through a combination of new ordinary shares in its fellow London-listed company and cash.

Quantum's board did emphasise that the proposal was non-binding and is subject to preconditions including the customary due diligence.

It noted a further announcement would be made in due course.

Shares in Quantum had advanced 16.71% to 76.15p as of 1245 BST, while Clinigen was up 1.4% to 1,024p.

Clinigen and Cumberland launch Totect
RNS
RNS Number : 7306R
Clinigen Group plc
25 September 2017
 
RNS Reach
 
25 September 2017
Clinigen and Cumberland launch Totect® in the U.S. for emergency oncology intervention
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company, announced today the promotional launch of Totect® (dexrazoxane hydrochloride), in the U.S.
Totect is an FDA-approved hospital based emergency oncology intervention drug, indicated to treat the toxic effects of anthracycline chemotherapy in case of extravasation. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body, causing severe damage and serious complications. Totect can limit such damage without the need for additional surgeries and procedures and enable patients to continue their essential anti-cancer treatment.
In preparation for Totect's launch, Cumberland has completed the training of its sales and medical organization, stocked the product at wholesalers serving hospitals nationwide, and recently introduced the product website. Totect will be supported by Cumberland's hospital sales force.
Totect is Cumberland's second oncology support product and complements its current portfolio of specialty pharmaceuticals. Cumberland entered into an exclusive agreement with Clinigen to commercialize Totect in the U.S. earlier this year. Cumberland is managing all marketing, promotion, and distribution of the product in the U.S. Clinigen is responsible for manufacturing, regulatory, and clinical management of the product.
Totect was acquired by Clinigen in March 2016 to expand its dexrazoxane portfolio and enter the U.S. market. Clinigen will continue to commercialize its existing dexrazoxane products, Savene® and Cardioxane®, in Europe and other territories outside of the U.S.
Simon Clayton, Commercial Director, Specialty Pharmaceuticals of Clinigen said:
"The commercial launch of Totect in the U.S. is an important milestone in the dexrazoxane revitalization strategy at Clinigen. It will ensure that patients in the U.S. can access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"This is a significant next step for Cumberland as we build our position in oncology supportive care while improving the quality of care for patients in the U.S."
 
-Ends-

Final results

HIGHLIGHTS
§ Adjusted gross profit up 22% - driven by organic growth, full year's contribution from Link Healthcare ('Link') and currency benefits
§ Adjusted EPS up 25% to 41.8p (2016: 33.4p)
§ Strong cash flow performance with cash generated from operations of £54.7m (2016: £49.4m)
§ Net debt substantially decreased by £33.1m to £35.0m (2016: £68.1m)
§ Full year dividend increased 25% to 5.0p (2016: 4.0p)
§ Strong growth across all operations
§ Outstanding performance in Africa and Asia Pacific
§ Dexrazoxane portfolio revitalisation significantly enhanced by EC approval to update product information for Cardioxane, and launch of Totect in US
§ New simplified reporting structure comprising Clinical Trial Services ('CTS'), Unlicensed Medicines and Commercial Medicines

Broker Forecast - Peel Hunt issues a broker note on Clinigen Group
BFN
Peel Hunt today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add) and raised its price target to 1350p (from 1200p).

Story provided by StockMarketWire.com

Clinigen acquires IMMC in Japan
RNS
RNS Number : 2527U
Clinigen Group plc
23 October 2017
 
RNS Reach
 
23 October 2017
  
Clinigen acquires Japan's largest supplier of unlicensed medicines
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has today acquired International Medical Management Corporation ('IMMC'), Japan's largest supplier of unlicensed medicines, for an undisclosed sum.
The acquisition will add to Clinigen's existing footprint in the country following the launch of its Japanese business in October 2016. The acquisition of IMMC is part of Clinigen's strategy to become the 'go to' global leader in ethical access to unlicensed medicines and will allow the Group to better address unmet patient needs.
IMMC, established in 2006, operates throughout Japan in sectors including niche vaccine, oncology and IVF. It currently has relationships with more than 850 hospitals and clinics, which will now be able to benefit from the broader access to medicines available as part of Clinigen.
Japan is the world's second largest pharmaceutical market. The unlicensed medicines market in Japan is underdeveloped, highly regulated and well controlled leading to a high unmet medical need. For instance, from the 154 new drugs launched globally between 2008 and 2012, two thirds still remained unavailable in Japan by 2013, illustrating the difficulties patients in Japan have in accessing approved medicines.
The threat of counterfeit medicines entering the supply chain in Japan, also remains an issue. Japan is the second-largest target of illegal online medicine sellers in the world behind the US.
IMMC was acquired for an upfront cash payment followed by certain potential milestone-based instalments over 12 months.
In the year ended 30 September 2017 the unaudited IMMC gross profit was ¥352m (£2.4m).
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This acquisition represents another strategic development, extending our geographical footprint and another step to becoming the global leader in ethical access to unlicensed medicines. The enlarged Japanese operation adds further capability in this high growth market which is crucial to our customers and a key part of Clinigen's global offering."
Yoshiyuki Kudo, President, IMMC, said:
"Clinigen's global expertise and our local knowledge will allow us to better address the unmet patient need in Japan, further benefiting our customers and increasing our offering in access to unlicensed medicines."
- Ends -

Ex-Dividend
09 Nov 17 Clinigen Group [CLIN] (3.4 p)

12:10 29/11/2017
Broker Forecast - N+1 Singer issues a broker note on Clinigen Group
N+1 Singer today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and set its price target at 1225p. Story provided by StockMarketWire.com

Wed 17th Jan - Trading statement

HY trading update
RNS
RNS Number : 0600C
Clinigen Group plc
17 January 2018

17 January 2018

HY trading update: good H1 performance with profits up over 10%

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the six months ended 31 December 2017.

The Group has traded well in the first half, in line with the Board's expectations.

Group revenues increased around 28%. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines.

Gross profit*, viewed by the Board as the best measure of top line growth, increased by around 10% compared to last year. Growth has been driven by a combination of a strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum').

Commercial Medicines, representing around 49% of Group gross profit and including the commercial business of Quantum, delivered excellent growth, with all products across the portfolio performing strongly.

Unlicensed Medicines, representing around 41% of Group gross profit, benefited from two months contribution from the related business within Quantum and IMMC. In early access, performance was affected by a number of larger programmes coming to the end of their lifecycle. There are a significant number of new programmes now starting that are expected to drive stronger second half performance.

Clinical Trial Services, representing around 10% of Group gross profits, was below last year following two years of double digit growth. Performance is expected to step up in the second half.

The Group acquired IMMC, Japan's largest supplier of unlicensed medicines, on 23 October 2017 and Quantum on 1 November 2017. Both businesses performed well in the two months following their acquisition.

Following a period of investment last year, underlying Group overheads are expected to grow at a slower pace than gross profit.

The Group has achieved another good cash flow performance. Following the acquisitions and the payment of the final scheduled deferred consideration on the Link acquisition, net debt increased to around £142m as at 31 December 2017 (31 December 2016: £70.9m).

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"We have delivered good growth and made strong progress against our strategic priorities, which have been enhanced by the acquisition of Quantum and IMMC.

"Our strategic priorities remain unchanged. We have and will continue to drive organic growth and search for selective acquisitions to complement our existing offering and capabilities.

"We are well positioned to deliver another good year of progress."


The Group expects to publish its interim results for the six months ended 31 December 2017 on Tuesday 27 February 2018.

*Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


- Ends -

17 Jan
N+1 Singer
1,225.00
Buy
17 Jan
Peel Hunt
1,350.00
Buy
17 Jan
Numis
1,208.00
Add

15:50 18/01/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from hold) and raised its price target to 1220p (from 1200p). Story provided by StockMarketWire.com

AIM company Clinigen enters the 1 billion + club

1 Feb
Peel Hunt
1,350.00
Buy

Interims Tues 27 Feb 18

Interims Tues 27 Feb 18

Half year results
HIGHLIGHTS
§ Adjusted gross profit up 10% driven by strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum')
§ Adjusted EPS up 13% to 21.2p (2016: 18.8p)
§ Strong cash flow performance with cash generated from operations of £34.3m (2016: £7.7m)
§ Interim dividend increased 10% to 1.76p (2016: 1.6p)
§ All products across Commercial Medicines portfolio performing strongly
§ Good growth in Africa and Asia Pacific region
§ Acquisition of Quantum adds complementary capability in Unlicensed Medicines and provides pipeline of products and in-house development capabilities
§ Unlicensed Medicines capability and geographical footprint further enhanced by acquisition of IMMC in Japan

28 Feb
Peel Hunt
1,350.00
Buy

Clinigen and Jazz Pharma initiate MA programme
RNS
RNS Number : 0522I
Clinigen Group plc
19 March 2018

RNS Reach
19 March 2018


Clinigen appointed by Jazz Pharmaceuticals to manage Managed Access Program for Vyxeos® (CPX-351) outside the United States
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been appointed by Jazz Pharmaceuticals plc (NASDAQ: JAZZ, 'Jazz') to distribute Vyxeos® (daunorubicin and cytarabine) liposome for injection via a Managed Access Program ('MAP') outside the United States.
This MAP is for the treatment of adults aged 60-75 with newly-diagnosed, therapy-related, acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos® is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio respectively.
Initially, the program is being launched in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
In August 2017, the U.S. Food and Drug Administration ('FDA') approved Vyxeos® liposome for injection for the treatment of adults with newly-diagnosed t-AML or AML-MRC. Vyxeos® is not approved for use outside of the U.S.
AML is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made. It is relatively rare with approximately 21,000 people in the United States and 19,000 in the European Union diagnosed each year.1 However, it is the most common type of acute (aggressive) leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient. It has one of the lowest survival rates of all types of leukemia.
John Lagus, Head of Managed Access, Clinigen, said:
"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos® provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."

09:20 23/05/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and cut its price target to 1160p (from 1220p). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Extended partnership agreement signed with BMS
RNS
RNS Number : 7396P
Clinigen Group plc
31 May 2018

RNS Reach
31 May 2018

Clinigen and Bristol-Myers Squibb sign extended partnership agreement in South Africa
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has signed a commercial agreement with Bristol-Myers Squibb ('BMS') in South Africa. The agreement covers BMS' South African portfolio of products for an initial period of five years.
Clinigen's Commercial Medicines business operation will provide access for patients in South Africa for the BMS products. Clinigen will provide local regulatory expertise, supply and distribution infrastructure and experience in managing licensed medicines in the region. The agreement will lead to the transfer of Marketing Authorisations (product registration certificates) from BMS to Clinigen, which will likely be completed in the first half of 2019.
In the Africa and Asia Pacific region, Clinigen has 192 actively marketed specialist pharmaceutical and medical technology licensed products, including both branded and generic products. This agreement with Bristol-Myers Squibb will complement the Group's growing basket of essential medicine on offer to healthcare providers and their patients in the region.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This agreement demonstrates the long and successful relationship we have built with BMS, which began with providing access to BMS' unlicensed products globally, and has grown with Clinigen's expansion into important future growth markets.

"Clinigen is increasingly becoming the partner of choice for pharmaceutical companies to license and distribute their products. This agreement shows that our strategy for Commercial Medicines of adding regional commercial agreements to our existing portfolio of global products, a key strategic priority for the Group, is working."

- Ends -

10:20 31/05/2018
Broker Forecast - Numis issues a broker note on Clinigen Group
Numis today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Year end trading update
RNS
RNS Number : 7933U
Clinigen Group plc
17 July 2018

17 July 2018

Year end trading update

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides an unaudited trading update for the year ended 30 June 2018.

The Group has had a strong year, combining a good financial performance with excellent progress on delivering the Group's strategy. The Board expects results to be in line with current market expectations and the Group is well positioned to drive further growth across all parts of the business in the year ahead.

Revenues increased by around 26% on a reported basis and by around 27% on a constant currency basis* compared to last year. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines. Gross profit** increased by around 14% on a reported basis and by around 16% on a constant currency basis*. Following tight cost control and benefits obtained from the integration of the acquisitions, EBITDA growth is expected to increase at a higher rate than gross profit.

Commercial Medicines continued to deliver excellent growth with the Group continuing to realise the benefits of its expanding geographical presence. The performance in Clinical Trial Services ('CTS') and Unlicensed Medicines strengthened in the second half with the latter benefiting from a number of new early access programs starting. Integration of Quantum is going to plan with the unlicensed to licensed portfolio performing well.

In addition, today the Group announced it has acquired from Novartis the global rights outside the United States to Proleukin®. Proleukin® is indicated for use in metastatic renal cell carcinoma, as well as for metastatic melanoma in certain markets and is a good fit with the Group's current Commercial Medicines portfolio of products in the oncology and infectious disease therapy areas - see separate press release.

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"This year has demonstrated the strength and diversity of the Group's portfolio. Our largest business operation, Commercial Medicines, has had an excellent year more than offsetting weakness in CTS.

"I am particularly pleased with the performance from our acquisitions in the year, Quantum and IMMC, and the performance in the Africa and Asia Pacific region.

"With a strong balance sheet and cash generative business model, our strategy remains to drive growth across our portfolio organically, by making acquisitions and through geographic expansion."

* Constant currency is growth applying prior period's actual exchange rate to this period's result.
** Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


- Ends -

Clinigen acquires global rights to Imukin
RNS
RNS Number : 6382V
Clinigen Group plc
25 July 2018

RNS Reach
25 July 2018

Clinigen acquires global rights to Imukin®
from Horizon Pharma
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has acquired the global rights to Imukin® (recombinant human interferon gamma-1b) from Horizon Pharma plc ('Horizon'). Horizon will retain the rights to Actimmune® (recombinant human interferon gamma-1b) in the US, Canada and Japan.
Imukin® is licensed in 19 countries globally to reduce the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD) and for the treatment of Severe Malignant Osteopetrosis (SMO), both considered rare conditions.
Clinigen will revitalise Imukin® by working with healthcare professionals to ensure its benefits to patients are well understood. The Group will also make the medicine available to those who need it through the Group's global distribution network for both licensed and unlicensed supply.
Imukin® is the second global acquisition of a biologic by Clinigen following the acquisition of the global rights (outside the US) of Proleukin® from Novartis on 17 July 2018.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"Imukin® strengthens our commercial offering and represents a good strategic fit with our medicines portfolio growth strategy focused on products in oncology and rare diseases."
David Bryant, Chief Business Officer, Clinigen, said:
"Our second acquisition in recent weeks delivers on our long term strategy of acquiring global rights to assets with the aim of revitalising and returning them back to the broadest possible access."

1 Aug
Peel Hunt
N/A
Buy

Clinigen acquires iQone Healthcare Holding
RNS
RNS Number : 0824C
Clinigen Group plc
26 September 2018

27 September 2018

Clinigen acquires Swiss based iQone Healthcare Holding
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has agreed to acquire iQone Healthcare Holding ('iQone'), a privately owned Swiss based speciality pharmaceutical business for an initial consideration of €7.5 million (£6.7 million) on a cash free, debt free basis.
iQone is based near Geneva with operations across Europe. It has medical and commercial operations in France, Germany, Italy, Spain and Switzerland. Its team has extensive experience in the set up and delivery of both Managed Access Programs and commercial solutions across Europe.
iQone adds capability to Clinigen's Unlicensed and Commercial divisions, whilst also offering the Group a platform to support and expand its activities in mainland Europe. It also provides iQone with resources and access to an extensive customer and product base to accelerate its growth.
Clinigen is acquiring iQone on a cash free, debt free basis for a total initial consideration of €7.5 million, made up of €5.0m in cash and €2.5m in new Clinigen shares, with an additional potential deferred consideration based on the achievement of certain future EBITDA targets.
The Group has also published today its year end results and announced that it is acquiring CSM - see separate announcements.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"Expanding our geographical footprint to support our activities in mainland Europe is a key benefit of this acquisition, along with the additional services it will offer our customers in Unlicensed Medicines. It also has the potential to drive growth in our owned Commercial Medicines portfolio.
"This acquisition coincides with our Full Year Results and the strategic acquisition of CSM, both announced earlier this morning. Today sees a significant strengthening in the Clinigen offering both through an increased global footprint, particularly in Europe, and across each of our three business divisions."
Laurent Massuyeau, Chief Executive Officer, iQone, said:
"We explored multiple strategic options which would allow iQone to grow and fulfil its potential. Clinigen is a recognised industry leader across the unlicensed and licensed medicine sectors. As both our companies share a common vision, we believe that being part of the Clinigen Group provides a compelling strategic fit and a strong growth potential."

Consideration detail
The €2.5m of initial share consideration will be satisfied through the issuance of 241,744 new Ordinary Shares in Clinigen (the "New Ordinary Shares") at an issue price of 925.13 pence per share. Application will be made to the London Stock Exchange for the New Ordinary Shares to be admitted to trading on AIM ("Admission"). It is expected that Admission will occur at 8:00 a.m. on 9 October 2018. Completion of the acquisition is expected to take place on or about 9 October 2018. The Ordinary Shares will rank pari passu with the Group's existing ordinary shares in issue.
- Ends -

Proactive investor - Clinigen Group set for 77% upside according to RBC Capital
Share
15:21 15 Oct 2018
The company's prospects are boosted by recent acquisitions, and, according to RBC,more deals may follow.


Capital Network report here
RBC has a 1,470p price target
Clinigen Group PLC (LON:CLIN) shares could see some 77% upside to the current price, that’s according to RBC Capital, which rates the London listed life science company as a ‘top pick’.
RBC has a 1,470p price target, compared to the current price of around 830.3p.







“We believe acquisitions have positioned Clinigen as the No. 1 player in the ‘ethical’ supply of medications and, alongside existing products, this should lead to strong cash flow generation over the coming 5 years,” RBC analyst Nick Keher said in a note.
“With management aiming to double the number of products under its control and with the business model enhancing its product acquisition pipeline, we see this goal as likely.
READ: Clinigen raises £80mln to fund two new acquisitions
“We see further product acquisitions enhancing margins and promoting even faster earnings growth.”
Keher highlighted that further acquisitions are likely due to the company’s growing cash position and its desire to build a portfolio of ten products – and, such deals would represent a potential value catalyst for Clinigen shares.
Other possible catalysts identified by RBC include programme wins in the group’s Unlicensed Medicines division and/or upgrades created by the Quantum Pharma and CSM acquisitions.
“Clinigen trades at a material discount to its peer group but we think this discount will unwind as organic growth rates improve in FY19E,” the analyst said.
He added: “Our upside scenario values Clinigen at 1740p per share and is based upon the successful integration of recent acquisitions plus a return to growth of the CST and Unlicensed Medicines business, leading to forecast certainty and potential earnings upgrades.
“In such a scenario, we think Clinigen would hold a premium rating (c25x EPS) which we would apply to our FY20E estimates.”

In the Sunday Mail today -

THE SUNDAY TIMES
AIM-listed Clinigen specialises in supplying drugs to patients who cannot get access to them through normal channels, says Sarah Meddings in The Sunday Times Inside the City column.
Acting as a middleman, it can send a medicine that has been approved for use somewhere in the world to somewhere it has yet to get the green light — and add a mark-up for its trouble.
Demand for its services is set to surge in the next decade as patients, often in emerging markets, become more aware of the availability of life-saving treatments in different parts of the world and demand their doctor supplies them.
Since it listed on AIM in 2012, it has bought rival Idis in 2015 for £225million and Link Healthcare in the same year for £100million. In recent weeks, it returned to the acquisition trail, agreeing in September to buy CSM, a European specialist in packaging, labelling, warehousing and distribution. A second smaller deal to buy iQone, which specialises in oncology, for €7.5million (£6.6million), brought with it scientific expertise.
With increasing fears that a no-deal Brexit could cause chaos among medicine makers, Clinigen has been extremely smart. Shares have been volatile since the CSM deal was announced on September 26, falling 11.1 per cent the first day to 830p.
However, they have recovered to 902.5p, valuing the company at £1.2billion. And at 13 times expected full-year earnings, Clinigen is viewed as undervalued by analysts.
Verdict: Buy

Half Year trading update
RNS
RNS Number : 0648N
Clinigen Group plc
15 January 2019

15 January 2019

Half Year trading update

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides an unaudited trading update for the six months ended 31 December 2018.

Revenues increased by around 24% on a reported basis and by around 25% on a constant currency basis* compared to last year. Gross profit** increased by around 25% on a reported basis and by around 27% on a constant currency basis* in line with the Board's expectations.

The Group completed two corporate acquisitions, CSM and iQone, in October 2018 and two product acquisitions, Proleukin® and Imukin®, in July 2018. Both of the acquired businesses have performed well.

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"The Unlicensed Medicines portfolio performed well as anticipated, starting a number of new programs, and we have diversified our Commercial Medicines portfolio with the purchase of two specialty medicines. We are already seeing the operational benefit of combining CTS with the clinical trial capabilities of the recently acquired CSM, which when combined with iQone, also acquired in October 2018, enhance our European and US infrastructure for the benefit of all our businesses.

"We are well positioned to deliver another good year of progress."

The Group expects to publish its interim results for the six months ended 31 December 2018 on Wednesday 27 February 2019.

* Constant currency is growth applying prior period's actual exchange rate to this period's result.
** Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.

- Ends -