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Valneva SE

Regulatory Filings Jan 5, 2011

1739_iss_2011-01-05_c6060e24-1fe0-4215-a1a0-c8f83c3f408e.pdf

Regulatory Filings

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VIVALIS AND SANOFI PASTEUR INITIATE SECOND HUMAN MONOCLONAL ANTIBODY DISCOVERY PROGRAM AGAINST INFECTIOUS DISEASES IN THE FRAMEWORK OF THEIR COLLABORATION AGREEMENT

Nantes, Lyon (France) – January 5, 2011 − VIVALIS (NYSE Euronext: VLS) announced today the initiation of the second discovery program for human monoclonal antibody in the framework of the agreement signed with Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group (Euronext: SAN and NYSE: SNY), for the discovery and development of fully human monoclonal antibodies against several infectious diseases targets announced on June 8, 2010.

Sanofi Pasteur and its affiliates have exclusive access to the Humalex® platform for the discovery of several human monoclonal antibodies targeting several clinically significant infectious diseases, and will obtain worldwide exclusive development and commercialization rights for the discovered antibodies. The HUMALEX® platform is a potent technology for the discovery of fully human monoclonal antibodies produced by activated and immortalized B lymphocytes isolated from selected human donors. Humalex®was developed by Humalys SAS, a Lyon-based biotechnology company acquired by Vivalis in January 2010, and is used for the discovery and development of human monoclonal antibodies for both therapeutic and diagnostic applications.

VIVALIS may receive development milestone payments up to 35 million Euros per infectious disease, as well as royalty payments associated with product sales. In addition, Sanofi Pasteur finances collaborative research activities.

"We are very happy that, less than 6 months after the signature of this major collaboration agreement on the Humalex® platform and the initiation of the first discovery program, Sanofi Pasteur has decided to initiate the second discovery program within this collaboration. While we are working together for six months on the first project, it is a great sign of confidence from our partner that wants to progress quickly in this very competitive field. ", said Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS.

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Next Financial Press Release:

27January 2011, after NYSE Euronext market closing: Fourth quarter 2010 revenues

About VIVALIS (www.vivalis.com)

VIVALIS (Euronext code: 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 exploited in three main areas:

1. EB66® Cell Line:

VIVALIS offers research and commercial licenses for its EB66®cell line, derived from duck stem cells, to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLPs and recombinant proteins, especially monoclonal antibodies with enhanced cytotoxic activity. VIVALIS receives upfront payment, clinical stage milestone payments and royalties on its licensees' net sales.

2. Humalex® platform

VIVALIS proposes customized solutions for the discovery, development and production of fully Human

monoclonal antibodies. VIVALIS receives upfront payment, clinical stage milestone payments and royalties on its licensees' net sales.

  1. 3D-Screen platform

VIVALIS performs discovery and early stage development of small molecule compounds identified with its proprietary 3D-Screen platform. The 3D-Screen platform is designed to identify molecules that alter the three-dimensional structure of a target protein. With 3D-Screen, VIVALIS is building a portfolio of proprietary products for the treatment of hepatitis-C virus infection and other indications.

Based in Nantes and Lyon (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, Merck, CSL, Kaketsuken, Merial, Intervet, SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters.

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-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.

Contacts

VIVALIS

Franck Grimaud, CEO Email: [email protected]

NewCap

Financial communications agency Steve Grobet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email:[email protected]

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