Regulatory Filings • Sep 6, 2011
Regulatory Filings
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Nantes, Lyon (France) – 6th September 2011 - VIVALIS (NYSE Euronext: VLS) announces the creation of the EB66® cell line Regulatory Forum.
VIVALIS proprietary expertise in avian embryonic stem cells has led to the successful development of the duck EB66® cell line which displays remarkable industrial and biological features and constitutes an innovative and cost-effective production platform for the manufacture of human and animal vaccines. In addition, EB66® cells which are amenable to easy genetic modification are an attractive substrate for the production of monoclonal antibodies having enhanced antibody dependent cell-mediated cytotoxicity (ADCC) activity against malignant cells.
The EB66® cell line is currently used by major pharmaceutical and biotechnologies companies for research, development and production of clinical batches of vaccines and monoclonal antibodies. With around 30 EB66® licence agreements worldwide, EB66® cell line is rapidly evolving as an industry standard. Two EB66® based vaccines are currently in clinical trial in United States and in Japan.
To comply with the requirements of health regulation authorities and to guarantee the highest levels of safety standards, VIVALIS has undertaken an extensive characterization program of the sanitary status of the EB66® cell line. The characterization results are included in a Biologic Master File (BMF) that was filed with the U.S. Food and Drug Administration (FDA) on June 2008 and that is regularly updated.
Today, VIVALIS and its commercial licensees have established a Forum to promote and facilitate the exchange of information on the EB66® sanitary and regulatory characteristics; the objective is to optimize and accelerate the generation of the EB66® cell line data required for regulatory authorities to evaluate the use of the EB66® Cell Line as a new technology to manufacture biopharmaceutical products.
The Forum is open to pharmaceutical and biotechnology companies that have commercially licensed the EB66® cell technology and are developing biological products produced using the EB66® cell line, including human vaccines, animal vaccines and therapeutic proteins. The Forum will include 13 members at the beginning. Future EB66® commercial licensees may also become members of the Forum.
Franck Grimaud, C.E.O. and Majid Mehtali, C.S.O., co-managers of VIVALIS, declare: "The launch of the Forum is an important step in the process aiming at accelerating regulatory approval of the EB66® based biological product. We are very pleased that most of our commercial partners have decided to join the Forum. This will allow all members to mutually benefit from the huge amount of characterization data that has been compiled so far by each member. We consider the launch of the Forum as a major milestone in our efforts to establish the EB66® cell line as a worldwide industrial standard for the production of vaccines and therapeutic proteins".
Next financial press release: 2011 third-quarter sales October 20, 2011, after NYSE Euronext market closing
VIVALIS (NYSE- Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of unmet medical needs. VIVALIS' expertise and intellectual property are leveraged in three main areas:
VIVALIS offers research and commercial licenses for its EB66® cell line, derived from duck embryonic stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLP's, and recombinant proteins (with a focus on monoclonal antibodies having enhanced cytotoxic activity). EB66® cell line based vaccines are currently in clinical trials in USA and in Japan. Through these programs VIVALIS receives upfront, clinical stage milestone payments along with royalties on licensees' net sales.
Customized solutions for the discovery, development, and production of fully human monoclonal antibodies are now offered by VIVALIS. Through these programs VIVALIS receives upfront, clinical stage milestone payments along with royalties on licensees' net sales.
VIVALIS performs discovery and development, up to pre-clinical evaluation, of original small chemical molecules identified with its proprietary platform, 3D-SCREEN. This unique screening platform is designed to identify original molecules that alter the three-dimensional structure of a target protein, thus modulating its biological function through an innovative mode of action. VIVALIS is building a portfolio of proprietary new chemical entities for the treatment of hepatitis-C virus infection. VIVALIS also proposes, on a fee for service basis, to develop ready to use customized 3D-Screen HTS assays directed against client's target protein of interest.
Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS was founded in 1999 by the Grimaud Group (ca. 1,500 employees), a worldwide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Pfizer Animal Health, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bioclusters and a member of the Japanese OKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama.
VIVALIS
Listed on Euronext Paris – Compartment B of NYSE Euronext Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including the risk factors described in the company's registration document (document de référence), changes in economic conditions, the financial markets or the markets in which the company operates.
VIVALIS Franck Grimaud, CEO Email: [email protected]
Financial communications agency Axelle Vuillermet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email : [email protected]
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