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 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."

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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