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Clinigen Group plc (CLIN)     

dreamcatcher - 25 Sep 2012 06:58






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/



Chart.aspx?Provider=EODIntra&Code=CLIN&SChart.aspx?Provider=EODIntra&Code=CLIN&S

dreamcatcher - 27 Feb 2013 17:56 - 15 of 300

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

dreamcatcher - 11 Mar 2013 08:22 - 16 of 300

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."

goldfinger - 11 Mar 2013 09:10 - 18 of 300

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

dreamcatcher - 11 Mar 2013 13:31 - 19 of 300

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

goldfinger - 12 Mar 2013 07:57 - 20 of 300

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.

dreamcatcher - 17 Mar 2013 13:55 - 21 of 300

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.

goldfinger - 26 Mar 2013 07:56 - 22 of 300

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

dreamcatcher - 26 Mar 2013 08:04 - 23 of 300

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

dreamcatcher - 26 Mar 2013 10:20 - 24 of 300

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

dreamcatcher - 29 Mar 2013 19:07 - 25 of 300

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

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

dreamcatcher - 20 Apr 2013 19:54 - 26 of 300

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.

dreamcatcher - 29 Apr 2013 15:56 - 27 of 300


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."

dreamcatcher - 01 May 2013 15:47 - 28 of 300

Investec starts buy on Clinigen Group, target 290p.

dreamcatcher - 03 May 2013 15:47 - 29 of 300

Chart.aspx?Provider=EODIntra&Code=CLIN&S

dreamcatcher - 07 May 2013 19:01 - 30 of 300

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%.

dreamcatcher - 08 May 2013 16:21 - 31 of 300

Good 5.5% rise today

dreamcatcher - 18 Jun 2013 17:49 - 32 of 300

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.
.

dreamcatcher - 20 Jun 2013 07:08 - 33 of 300


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 -

dreamcatcher - 20 Jun 2013 16:54 - 34 of 300

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%.
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