Regulatory Filings • Apr 12, 2011
Regulatory Filings
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Nantes, Lyon (France) – 12 April 2011 - VIVALIS (NYSE Euronext: VLS), a biopharmaceutical company, announced today that it has signed a research agreement with an undisclosed worldwide vaccine company, granting the rights to evaluate the EB66® cell line for the production of a human vaccine candidate.
Franck Grimaud, CEO and Majid Mehtali, CSO, co-managers of VIVALIS stated, "This second agreement signed since the beginning of 2011 is a continuing demonstration that our EB66® cell platform is attracting an increasing number of vaccine companies. In conjunction with developed upstream and downstream industrial production processes along with an increasing body of regulatory approvals, the EB66® cell line strengthens its position as a global standard for the replacement of the traditional egg-based process for the production of viral vaccines for human and veterinary applications."
Terms of the agreement were not disclosed.
The EB66® cell line, derived from avian embryonic stem cells, presents unique industrial and regulatory characteristics, such as long-term genetic stability, immortality and cell growth up to high cell densities in suspension using serum-free media (>40 million cells/mL).
EB66® cells replicate a wide range of human and animal viruses and are currently used for the production of investigational viral vaccines by many major vaccine developers.
A Biologics Master File (BMF) for the EB66® cell line with the U.S. Food and Drug Administration (FDA) was filed on June 27, 2008 and is updated annually.
EB66® cells are also easily engineered to express recombinant proteins of interest (> 1.0 g/l). Monoclonal antibodies produced in EB66® cells have a human-like glycosylation profile with the additional benefits of reduced fucose content, naturally. This latter characteristic provides increased cytotoxic activity (ADCC) to antibodies, which may be useful in the treatment of cancer and infectious disease.
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 exploited in three main areas:
VIVALIS offers research and commercial licenses for its EB66® cell line, derived from duck stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLPs and recombinant proteins, especially monoclonal antibodies with enhanced cytotoxic activity. VIVALIS receives upfront payments, clinical stage milestone payments and royalties on its licensees' net sales.
VIVALIS proposes customised solutions for the discovery, development and production of fully human monoclonal antibodies. VIVALIS receives upfront payments, clinical stage milestone payments and royalties on its licensees' net sales.
VIVALIS performs discovery and development, up to pre-clinical evaluation, of original small chemical molecules identified with its proprietary 3D-Screen platform. 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 currently building a portfolio of proprietary new chemical entities for the treatment of hepatitis-C virus infection.
Based in Nantes (France), VIVALIS was founded in 1999 by the Grimaud group (ca. 1,600 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, CSL, Kaketsuken, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters.
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 indices
This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given to any of the events anticipated by the forward-looking statements contained in this document, which are subject to inherent risks, including risk factors described in the company's 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]
NewCap Financial communications agency Steve Grobet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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