VALNEVA Announces Signing of a New EB66® Commercial License with Bavarian Nordic

  • Valneva Announces Signing of a New EB66® Commercial License with Bavarian Nordic
  • Valneva's EB66® cell-line licensed to Bavarian Nordic for MVA-BN® based product candidates
  • Valneva to support process development

LYON, France I April 18, 2017 I Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced that it has entered into a commercial agreement with Danish biotech company Bavarian Nordic (OMX:  BAVA, OTC:BVNRY), for the production of poxvirus-based vaccines using Valneva's EB66® cell-line technology.

The agreement grants Bavarian Nordic the rights to develop and commercialize multiple poxvirus-based vaccines on the EB66® cell-line.

Bavarian Nordic's vaccine candidates are currently produced on chicken embryonic fibroblast (CEF) and the company will explore the potential of switching to Valneva's EB66® technology.

Valneva will support Bavarian Nordic in establishing and optimizing the manufacturing process on EB66® for future large scale industrialization under a dedicated service agreement.

Thomas Lingelbach, CEO, and Franck Grimaud, Deputy CEO of Valneva, commented, "This new partnership is of significant strategic importance for Valneva as it could be the first time that a late stage clinical vaccine development program is transferred to our EB66®cell line and could therefore set a precedent. We look forward to Bavarian Nordic's clinical results and are pleased to support them on their development route."

In a recent scientific article published by Elsevier, one of the world's major providers of scientific information, the EB66® cell line demonstrated to be a valuable cell substrate for Modified Vaccinia Ankara ("MVA")-based vaccine production showing that EB66® cells are highly permissive to recombinant MVA viruses and that it is possible to manufacture and purify a recombinant MVA virus at the clinical production scale (100 L) in a three-week timeframe[1].

Financial terms of the agreements were not disclosed but do include upfront payments, milestones and future royalties on sales.

About the EB66® Cell Line

Valneva's EB66® cell line is a highly efficient platform for vaccine production. It is derived from duck embryonic stem cells and today represents a compelling alternative to the use of chicken eggs for large scale manufacturing of human and veterinary vaccines. EB66® is one of the most extensively studied and characterized cell line available for use in human vaccine development. More than 20 different families of viruses have been shown to efficiently propagate in EB66® cells. To date, Valneva has more than 35 license agreements with some of the world's largest pharmaceutical companies for the use of its EB66® cell line technology in both human and animal health vaccines. The first human vaccine produced using the EB66® technology received marketing approval in 2014 and the first veterinary vaccine in 2012.

About Valneva SE

Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.

The Company seeks financial returns through focused R&D investments in promising product candidates and growing financial contributions from commercial products, striving towards financial self-sustainability.

Valneva's portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including candidates against Clostridium difficile and Lyme disease. A variety of partnerships with leading pharmaceutical companies complement the Company's value proposition and include vaccines being developed using Valneva's innovative and validated technology platforms (EB66® vaccine production cell line, IC31® adjuvant).

Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in France, Austria, Great Britain, Sweden, Canada and the US with over 400 employees. More information is available at www.valneva.com.

[1] Arnaud et al. "The EB66® cell line as a valuable cell substrate for MVA-based vaccines production", Elsevier, Vaccine Volume 34, Issue 48, 21 November 2016, Pages 5878-5885, http://www.sciencedirect.com/science/article/pii/S0264410X16309781

SOURCE: Valneva

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