Valneva SE

Regulatory Filings • Nov 24, 2010

VIVALIS ACHIEVES A SIGNIFICANT MILESTONE WITH THE ACCEPTANCE OF AN INVESTIGATIONAL NEW DRUG FILING (IND) FOR A CANDIDATE INFLUENZA VACCINE USING EB66® CELL-BASED TECHNOLOGY

Nantes, Lyon (France) – November 24th, 2010. VIVALIS (NYSE Euronext: VLS) announced today that the company achieved a significant milestone under its agreement with GlaxoSmithKline (GSK) following the U.S. Food and Drug Administration's acceptance of an Investigational New Drug (IND) application for an investigational influenza vaccine produced in EB66® cells. The corresponding Phase I clinical trial will be the first human trial of clinical material produced using the EB66® cell line. The IND is held by GSK.

VIVALIS' EB66® platform, which was used to develop the EB66® cell line, uses a revolutionary technology to derive avian-based stem cells for vaccine production. EB66® cells are non-genetically modified and represent the closest cell-based substrate for chicken egg substitution. Unlike many other cell lines, the EB66® cell line does not require the use of viral genes to enable continuous and stable growth. This is the first IND ever successfully filed and accepted using the EB66® cell line and for the first vaccine produced in an avian cell line.

The VIVALIS – GSK worldwide collaboration and license agreement is focused on developing cell-based manufacturing of seasonal and pandemic human influenza vaccines.

"This achievement supports the regulatory review of the EB66® cell line by the US FDA and the corresponding Biologics Master File submitted to the agency in 2008. Evaluation or development programs for EB66® cells are being conducted by over 75% of the world's leading vaccine developers in human and animal health, with over 25 license and commercial agreements in place to date. Influenza is the largest and fastest growth sector in the vaccine field, having sales of \$2.8 billion in seven major markets. This milestone is shared not only by VIVALIS but also our dedicated partners and shareholders. We continue in our commitment to advancing innovative technologies in markets where commercial success is defined by safety, efficacy, and efficiency," said Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of VIVALIS.

Terms of the milestone were not disclosed.

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Next Financial Press Release: 27 January 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.

1. 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 (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: investors@vivalis.com

NewCap

Financial communications agency Steve Grobet / Pierre Laurent Tel.: +33 (0) 1 44 71 94 91 Email: vivalis@newcap.fr