Regulatory Filings • Nov 26, 2012
Regulatory Filings
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Nantes (France) – November 26th, 2012 − VIVALIS (NYSE Euronext: VLS) announced today that it has reached a new milestone with a global animal health vaccine company for the submission of a regulatory dossier for the approval of a veterinary vaccine produced in Vivalis' proprietary EB66® cell line. The approval is usually expected within 12 to 18 months after the initial filing.
This is the first vaccine submitted for approval in Europe.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS jointly stated, "Building on the success of a recent approval for a vaccine produced in EB66® cells, we are hopeful that this large international animal health firm will continue the momentum of market approvals of new products produced in EB66® cells into the veterinary field, a \$5 billion market where innovation continues to be rapidly recognized and rewarded. At the end of the procedure, this would be the second veterinary vaccine produced in EB66® cells to get market approval. We congratulate this company on this achievement and wish them success for a future approval."
Financial terms include a prenegotiated milestone payment to Vivalis.
January 15th, 2013, after NYSE Euronext market closing: 2013 Financial calendar
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the biotechnology and pharmaceutical industry for the manufacture of vaccines and recombinant proteins, and develops monoclonal antibodies for the prevention and treatment of diseases with 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, VLPs and recombinant proteins, including monoclonal antibodies. Clinical trials of EB66® produced vaccines are currently on EB66® cells received market approval in Japan for use in animal health. receives an upfront payment, clinical stage milestone payments along with royalties on licensees' net sal on-going in the USA and Japan and in 2012 a vaccine produced in Through these programs, Vivalis sales.
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 research, an upfront payment, clinical stage milestone payments along with royalties on net sales of licensed antibodies that are commercially developed from the use of the platform.
Based in Nantes and Lyon (France) and in Toyama (Ja Grimaud (approx. 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 biopharmaceutical industry, including Sanofi Pasteur, GlaxoSmithKline Biologicals, Transgene, Pfizer Animal Health, 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 INNOVATION CLUSTER FOR HEALTH SCIENCE based in Toyama. (Japan), Vivalis was founded in 1999 by the Group luding bio-clusters and a member of the Japanese HOKURIKU pan), clusters
VIVALIS Listed on Euronext Paris Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes – Compartment C of NYSE Euronext
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 contained in this document, which are subject to inheren company's Document de Référence in which the company operates. looking inherent risks, including risk factors described in the , changes in economic conditions, the financial markets or the markets forward-looking statements t
VIVALIS Franck Grimaud, CEO Email: [email protected] NewCap Financial communications Axelle Vuillermet / Pierre Laurent Tél.: +33 (0) 1 44 71 94 93 Email : [email protected] agency
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