Regulatory Filings • Apr 19, 2011
Regulatory Filings
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Nantes, Lyon (France) – April 19th, 2011 VIVALIS (NYSE Euronext: VLS) today announced that the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) initiated the first human injection of an investigational influenza vaccine produced in EB66® cells in Japan. This program is part of the codevelopment and license agreement signed between GlaxoSmithKline (GSK) Biologicals and Kaketsuken, to co-develop seasonal and pandemic influenza vaccines produced using Vivalis' EB66® cell line.
Many influenza vaccine manufacturing processes, based on chicken eggs, have remained unchanged for over 70 years. Annual production of worldwide influenza vaccine requires the processing of over 500 million chicken eggs and is viewed by leaders of the vaccine field as outdated. The development of cell-based technologies for use in industrial scale bioreactors has been a goal to quickly satisfy worldwide demands for rapid and efficient vaccine production.
This follows the first 2010 Investigational New Drug application (IND) granted to GSK Biologicals for human clinical studies by the U.S. FDA using the EB66® cell line for influenza vaccine production. The Kaketsuken trial is the second human clinical study in the world for EB66® produced materials.
"With this new clinical trial, we now have two clinical trials on-going with an influenza vaccine produced on our EB66 cell line in two of the world largest markets, the USA and Japan. These represent a major step in the development of the EB66 cell line franchise and more than ever we are convinced that EB66 cells will be the cell line of choice as the new production platform for human and animal vaccines. We will continue to promote the EB66 cell line both for the production of vaccines and therapeutic proteins with the objective to expand our worldwide partnering activities," said Franck Grimaud, CEO, and Majid Mehtali, CSO, comanagers of VIVALIS.
VIVALIS will not receive any payment related to the initiation of this clinical trial.
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 stage 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 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 (France), 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 Co., LTD, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters.
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 document de référence, changes in economic conditions, the financial markets or the markets in which the company operates.
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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