ABIVAX Enters into a Manufacturing Agreement with PCAS for ABX464, Thus Ensuring Drug Candidate Supply for Upcoming Clinical Trials

Regulatory News:

ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral therapies and therapeutic vaccines for infectious diseases like HIV/AIDS and chronic hepatitis B (CHB), today announced that it has signed a contract with PCAS Group, a global industrial manufacturer of pharmaceutical active ingredients, for the production and supply of ABX464, ABIVAX’s drug candidate for the treatment of HIV.

Under the contract signed by the two companies, PCAS will synthesize and manufacture the drug compound ABX464, and will ensure its availability for the completion of the Phase II and Phase III trials to be carried out by ABIVAX with ABX464, scheduled for 2016 and following years. ABIVAX has transferred the process for producing ABX464 to PCAS, which began manufacturing ABX464 on behalf of ABIVAX in March of this year while initiating a process optimization program. This collaboration is expected to be extended further for commercial supply once the clinical program has been completed and the required authorizations obtained.

ABIVAX’s CEO, Professor Hartmut Ehrlich, M.D., declared, "This contract with PCAS, a well-known and reliable custom manufacturer, is very important for the supply of ABX464. The agreement with PCAS ensures access to a reliable source of supply of raw materials for the medium and long-term, and will enable us to carry out the clinical phase II and III program we are envisioning to bring ABX464 to registration in Europe, the US and other geographies.”

Vincent Touraille, CEO of PCAS, further stated, "We are happy to collaborate with ABIVAX on the production of this promising compound. ABX464 could provide a great therapeutic solution for HIV, which remains a major global concern.” Mr. Touraille added, "By using its network of production facilities and its team of experts, PCAS is optimally positioned to support the drug substance portion of the ABX464 clinical program, from the late phase clinical trials up through a global launch.”

ABX464 is a first-in-class antiviral drug candidate for the treatment of patients with HIV-infection. It is an orally available small molecule that blocks HIV replication through an entirely novel mechanism, inhibition of Rev Activity. Preclinical data in humanized mice demonstrated that ABX464 monotherapy had an antiviral effect that was sustained following treatment interruption (Campos et al, Retrovirology 2015 12:30). A prior food-effect study demonstrated a three-fold increase in parent drug exposure when administered with food, without a significant impact on active glucuronide metabolite.

ABIVAX (www.ABIVAX.com) is an emerging global leader in the discovery, development and commercialization of anti-viral therapeutics and therapeutic vaccines to treat some of the world’s most life-threatening infectious diseases, including HIV/AIDS and chronic Hepatitis B. ABIVAX has 2 compounds in clinical stage research: ABX464 a novel first-in-class resistance-proof oral small molecule HIV/AIDS therapy; and, ABX203, a therapeutic vaccine recently approved in Cuba and in late-stage clinical development in other countries that could cure chronic Hepatitis B. ABIVAX also is advancing additional anti-viral compounds and therapeutic vaccines that may enter the clinical stage in the coming 18 months. A recently updated corporate presentation, which includes a timeline for the company’s anticipated news flow, is available at www.abivax.com.
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PCAS (www.pcas.com, Euronext Paris: PCA) specializes in the development and production of complex molecules for Life Sciences and Innovative Technologies. With 7% of its turnover dedicated to R&D and a wide international presence, PCAS is the preferred industrial partner of market-leading major global groups. The company offers a growing range of proprietary products and solutions in leading-edge segments, and also includes two subsidiaries with very strong potential: Protéus in biotechnology and Enersens in high-performance insulation. With a particularly high standard of performance, PCAS achieved net sales of €179,1 million in 2015 and employs nearly 900 people in six countries.
For more information about PCAS, please visit www.pcas.com

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