Regulatory Filings • Aug 28, 2012
Regulatory Filings
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Press Release
Nantes & Lyon (France) – 28 August 2012 VIVALIS (NYSE Euronext: VLS) announced today that it has signed a non-exclusive research license agreement with BioFactura, Inc. (Rockville, MD) for the development of a novel human vaccine platform and candidate vaccine in the EB66® cell line.
Under this agreement, Vivalis will transfer the EB66® cell line and associated know-how to BioFactura to complete the program. Earlier this year, BioFactura was awarded a two-year \$1.8 million grant from the Department of Defense (DoD) for studies directed at the development of an improved scalable cell culture bioprocess for the production of virus-like replicon particle (VRP) vaccines. BioFactura's proposed production methods, which include the EB66® cell line, have the ability to speed up the advanced development process leading to FDA approval for a broad range of VRP vaccines against high-threat pathogens with the potential to offer a significant reduction in costs and production time over current manufacturing processes. This will be the first time the EB66® cell line will have been used in this manner.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS jointly stated, "The use of EB66® cells in a new vaccine development platform continues to show the versatility of the EB66® cell line in areas outside of traditional viral-based vaccines and recombinant proteins. We are excited that BioFactura will be using the EB66® platform, along with a combination of Vivalis know-how in both viral vaccine and recombinant protein technologies, to assess the challenge of producing novel vaccines in systems that have, to date, been determined insufficient for these applications."
Darryl Sampey, CEO of BioFactura, said, "Vivalis's EB66® cell line was an immediate consideration for our vaccine development program funded by the DoD. The regulatory history and clinical success of products derived from the cell line made it an obvious choice for evaluating this new vaccine manufacturing opportunity. BioFactura looks forward to advancing the program with Vivalis's EB66® technology to support critical requirements for US national defense."
Financial terms of the agreement were not disclosed.
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BioFactura offers companies and government agencies developing biological drugs, such as monoclonal antibodies, vaccines, and biosimilars, shorter time-to-market, reduced costs, and high potency/fidelity candidates through the application of its proprietary technologies, including its StableFastTM
Biomanufacturing Platform. BioFactura's team has extensive biopharmaceutical industry experience in bioprocess development, scale-up, and cGMP manufacturing. The Company's service capabilities range from mammalian and microbial cell line generation to upstream and downstream bioprocesses and analytical assay development.
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 two 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 rare, 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.
Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS, VIVALIS was founded in 1999 by the Grimaud group (ca. 1,700 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 bio-clusters and a member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama.
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 NewCap
Franck Grimaud, CEO Financial communications agency Email: [email protected] Axelle Vuillermet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: [email protected]
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