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PCAS : Clinigen and PCAS sign long-term supply agreement

01/06/2012 | 03:53am US/Eastern
PRESS RELEASE Clinigen and PCAS sign long?term supply agreement for the production of Foscavir Active Pharmaceutical Ingredient (API) 5th January 2012 Burton?on?Trent, UK, and Longjumeau, France ?? Clinigen Healthcare, the products division of Clinigen Group, has signed a long?term global supply agreement with PCAS, a leading active pharmaceutical ingredient (API) manufacturer, for the production of the Foscavir drug substance.

Under the agreement, PCAS will be responsible for manufacturing foscarnet sodium hexahydrate, the API contained in Clinigen's Foscavir, while Clinigen will leverage its own infrastructure and global network of partners to supply the medicine to hospitals worldwide.
Clinigen holds marketing authorizations to sell Foscavir as a treatment for HIV/AIDS?related cytomegalovirus (CMV) infections and herpes in 16 markets, as well as in bone marrow transplantation in Japan. Clinigen is working with medicines regulatory agencies to secure licenses to market Foscavir in additional markets, including the US in Q1 2012.
Anton Jenkins, Chief Operating Officer of Clinigen Healthcare, commented: "PCAS has an impeccable track record in the area of API manufacturing, with strong technical capabilities and robust compliance systems, making the company an ideal partner for Clinigen. We are confident that PCAS and Clinigen will together ensure the continued availability of Foscavir wherever it is needed. Our agreement underlines Clinigen Group's mission to get the right drug to the right patient at the right time."
Didier Combis, Head of the Exclusive Synthesis business unit at PCAS, said:
"We are delighted to be working with Clinigen and its team of experienced managers. The company's streamlined structure allows for very short response times, a key requirement in the low?volume, specialist?supply drugs business. This agreement makes a perfect fit for PCAS. We will rely on our dedicated site in France for the production of starting material and our world?class facilities in Finland for the manufacture of injectable APIs."

About Clinigen Healthcare

Clinigen Healthcare is part of Clinigen Group, a fast?growing specialty pharmaceutical and pharma services business formed by merger in 2010. Clinigen Healthcare acquires or in?licenses mature or end?of?lifecycle products for development and commercialization in hospitals. Clinigen Healthcare's core therapeutic areas include oncology, leukemia, hematology, transplantation, virology, pain management and critical care. The company also looks to acquire products that it can develop and commercialize in orphan indications.

Clinigen Group is headquartered in Burton?on?Trent, UK, with offices in Philadelphia, US, and Tokyo, Japan. For more information visit: www.clinigengroup.com.

About PCAS

PCAS is a Euronext compartiment C?listed company specializing in the production of specialty chemicals and active pharmaceutical ingredients for life sciences customers. It develops, manufactures and markets complex molecules and competitive industrial
solutions for the global healthcare, cosmetic and material science industries, with a focus on
quality, innovation, safety and sustainability. For more information visit: www.pcas.com.

About Foscavir

Foscavir (foscarnet sodium) is licensed to treat cytomegalovirus (CMV) retinitis in HIV patients and acyclovir?resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromized patients in: Australia, Belgium, France, Germany, Hungary, Israel, Italy, Japan, Luxembourg, Mexico, the Netherlands, New Zealand, Singapore, Spain, Switzerland and the UK. In July 2011, the Japanese Ministry of Health Labor and Welfare (MHLW) approved Foscavir for the treatment of CMV in hematopoietic stem cell transplant patients.
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