Regulatory Filings • Mar 22, 2011
Regulatory Filings
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Nantes, Lyon (France) – March 22, 2011 − Vivalis, (NYSE Euronext: VLS) announced today that Okairos S.r.l, has executed a research license agreement to access Vivalis's EB66® cell line to evaluate the production of a candidate human vaccine.
"Okairos's interest in the evaluation of the EB66® cell line results from its regulatory status and its industrial capabilities for vaccine development," states Dr. Riccardo Cortese, CEO of Okairos. "We look forward to working with Vivalis in this program as we continue to build our vaccine franchise for unmet medical needs."
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS stated, "Working with Okairos in their assessment of the EB66® cell line continues to validate the strength of the technology. In conjunction with our process development and GMP manufacturing capabilities, Vivalis brings further value to our partners and licensees, of whom benefit the most through the use of a highly qualified and scalable cell substrate for vaccine production. Industry advancement, along with an increasing body of regulatory approvals utilizing the EB66 cell substrate for clinical trials, continues to grow with Vivalis providing a path for their overall adoption."
Terms of the agreement were not disclosed.
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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 (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). Through these programs VIVALIS receives upfront, clinical, and milestone payments along with royalties on licensees net sales.
Customized solutions for the discovery, development, and production of fully human monoclonal antibodies is now offered by VIVALIS. Through these programs VIVALIS receives upfront, clinical, and 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.
Based in Nantes (France), VIVALIS was founded in 1999 by the Grimaud Group (ca. 1,600 employees), a world-wide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Merck, CSL, Kaketsuken, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of both the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters.
OKAIROS SRL is a clinical stage biopharmaceutical company and a fully owned subsidiary of Okairos AG, which is dedicated to the development of genetic vaccines against infectious diseases and cancer.
VIVALIS Listed on Euronext Paris – Compartment C 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]
Financial communications agency Steve Grobet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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