Regulatory Filings • May 24, 2012
Regulatory Filings
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Nantes, Lyon (France) – May 24th, 2012, VIVALIS (NYSE Euronext: VLS) today announced that Kaketsuken has commenced a phase 2 clinical trial in Japan in April 2012, for the cell culture based pandemic flu vaccine being co-developed with GlaxoSmithKline (GSK) and using Vivalis' EB66® cell line.
In the "Program for preparing pandemic influenza vaccine development and production system" (hereinafter referred to as the "Program"), the Japanese Ministry of Health, Labour and Welfare is taking the lead in establishing domestic production and supply of pandemic influenza vaccine using "cell-culture technology" . It is anticipated that cell-culture technology has the potential to enable a vaccine to be available for use in advance of an imminent pandemic.
In order to contribute to the Program, Kaketsuken is aiming to early establish in Japan a domestic production and supply system for influenza vaccines co-developed with GSK, which vaccines are produced in Vivalis proprietary EB66® cell line in combination with GSK antigen-sparing adjuvant technology.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS jointly stated, "We have now two clinical trials on-going, including one in phase II, with an influenza vaccine produced on our EB66® cell line in two of the world largest markets, the USA and Japan. 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."
July 19, 2012, after NYSE Euronext market closing: Second Quarter 2012 Revenues
Based in Kumamoto, Japan, Kaketsuken has pursued the preventive medicine fields of microbiology, immunology and serology, towards the improvement of health and hygiene, and is a leading company in the fields of human vaccines, animal vaccines, and blood plasma derivatives respectively in Japan. In the field of human vaccines, Kaketsuken is currently manufacturing more than 10 kinds of vaccines for humans, such as Influenza vaccine, DTaP vaccine, recombinant Hepatitis B vaccine and Hepatitis A vaccine.
Kaketsuken is also developing a therapeutic monoclonal antibody for HIV, a cell-cultured Japanese encephalitis vaccine and Influenza vaccine.
VIVALIS (NYSE Euronext: VLS) is a biopharmaceutical company that provides innovative cell pharmaceutical industry for the manufacture of vaccines and proteins, and treatment of unmet medical needs. VIVALIS' expertise and intellectual property are leveraged in three main areas: develops drugs for the prevention and cell-based solutions to the areas:
VIVALIS offers research and commercial licenses for its EB66 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 en EB66® cell line based vaccines are currently in clinical trials in the USA and Japan. receives upfront, clinical stage milestone payments along with royalties on licensees net sales. ® cell line, derived from duck embryonic stem cells, to Through these programs VIVALIS enhanced cytotoxic activity).
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 alon royalties on licensees net sales. along with
VIVALIS performs discovery and development, up to pre identified with its proprietary platform, 3D 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 ne hepatitis-C virus infection. VIVALIS also offers on a service basis to develop ready assays directed against target proteins of interest. pre-clinical evaluation, of original small chemical molecules 3D-ScreenTM. This unique screening platform is designed to identify original dimensional new chemical entities for the treatment of ready-to-use customized 3D clinical ue w use 3D-ScreenTM HTS
Based in Nantes & Lyon (France) and in Toy 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, Transgene, Pfizer Animal Health, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, a member of the French ATLANPOLE BIOTHERAPIES and LYON BIOPOLE bioclusters and a member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama. Toyama (Japan) VIVALIS was founded in 1999 by the Grimaud Group (ca. 00 o Merck Animal Health, and SAFC Biosciences. VIVALIS is OKURIKU ama ,
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 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 inherent risks, including the risk factors described in the company's conditions, the financial markets or the markets in which the company operates. looking forward-looking statements, which are subject to isk document de référence looking , changes in economic
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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