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/

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.
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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%.