VIVALIS ANNOUNCES THE SUBMISSION OF THE FIRST NEW DRUG APPLICATION FOR AN H5N1 PANDEMIC INFLUENZA VACCINE PRODUCED IN THE EB66® CELL LINE
Nantes & Lyon (France) - April 2nd, VIVALIS (NYSE Euronext: VLS) announced today that The Chemo-Sero-Therapeutic Research Institute (Kaketsuken), a co-development partner with GlaxoSmithKline (GSK) Vaccines, submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for an H5N1 adjuvanted pandemic influenza vaccine produced in Vivalis's EB66® cell line.
The programme was funded by the MHLW with the objective of establishing a source of domestic production and supply of H5N1 pandemic influenza vaccine using "cell culture" technology in Japan.
Kaketsuken is currently performing validation of its brand new state of the art factory in Kumamoto for the manufacturing of the pandemic EB66® cell culture based influenza vaccine adjuvanted with GSK's proprietary adjuvant system, AS03, and will continue to develop seasonal influenza vaccines produced using EB66®.
This is a significant milestone for Vivalis as it is the first NDA submission filed for a human product using the EB66® cell line, in particular, one given to healthy individuals.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS said, "We are very impressed by the work done by Kaketsuken to run this program within the set timelines and achieve this milestone. This could potentially pave the way for the development of additional pandemic influenza strains on EB66® in the future. We hope the EB66® cell line will enable rapid and efficient viral vaccine production, such as the production of pandemic and seasonal flu vaccines."
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25 April 2013, after NYSE Euronext market closing
About VIVALIS (www.vivalis.com)
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and recombinant proteins, and develops monoclonal antibodies for the prevention and treatment of pathologies with unmet medical needs. Vivalis' expertise and intellectual property are leveraged in two main areas:
- EB66® Cell Line
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, VLPs and recombinant proteins, with a focus on monoclonal antibodies having enhanced cytotoxic activity. Clinical trials of EB66® produced vaccines are currently on-going in the USA and Japan. Through these programs, Vivalis receives upfront payments, clinical stage milestone payments and royalties on licensees' net sales.
- VIVA|Screen(TM) Human Antibody Discovery Platform
Customized solutions for the discovery, development and production of rare, fully human monoclonal antibodies are offered by Vivalis. Through these programs, Vivalis receives payments associated with the funding of discovery phase, upfront payments, clinical stage milestone payments, and royalties on net sales of licensed antibodies that are commercially developed and sold by our clients.
Based in Nantes and Lyon (France) and in Toyama (Japan), Vivalis was founded in 1999 by the Grimaud Group (ca. 1,700 employees), one of the worldwide leaders in animal genetic selection. Vivalis has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Transgene, Zoetis, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, Merck Animal Health and 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 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 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 E, changes in economic conditions, the financial markets or the markets in which the company operates.
Contacts
VIVALIS NewCap
Franck Grimaud, CEO Financial communications agency
Email: investors@vivalis.com Axelle Vuillermet / Pierre Laurent
Tel.: +33 (0) 1 44 71 94 91
Email: vivalis@newcap.fr
