Valneva Announces Mutual Agreement with GSK to End Strategic Alliance Agreement; Regains Control of R&D

AINT HERBLAIN, France I June 20, 2019 I Valneva SE (“Valneva” or “the Company”), a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs, today announces that GSK and Valneva have decided, by mutual agreement, to end the Strategic Alliance Agreement (“SAA”), originally agreed between Novartis and Intercell (predecessor companies of GSK and Valneva, respectively). Valneva will pay €9 million to GSK immediately and up to a further €7 million in milestones relating to marketing approvals of its Lyme vaccine. As a result, Valneva is now fully in control of its main R&D assets including its Lyme vaccine candidate VLA15.

Valneva has the only clinical stage Lyme vaccine candidate worldwide and is fully committed to advancing this asset. The Company is driving the program forward and has recently reported progress of its Phase 2 studies. VLA15 has been awarded Fast Track status by the U.S. Food and Drug Administration (FDA) and is currently undergoing Phase 2 studies. The Lyme vaccine development program is fully funded through Phase 2.

Valneva is also developing a highly differentiated vaccine candidate for chikungunya – VLA1553. Recent positive data support an accelerated development strategy and the Company is also committed to advancing this vaccine candidate as expeditiously as possible. VLA1553 has also been awarded Fast Track status by the FDA.

Thomas Lingelbach, CEO of Valneva, commented, “We would like to thank GSK and, previously, Novartis, for the legacy partnership. I am delighted that Valneva is now solely able to determine its entire development strategy for all vaccine candidates, including Lyme and chikungunya whilst being in the position to capture their entire economic potential. I am confident that we can fully address these very serious threats to public health whilst simultaneously maximising value for our shareholders.”

Emmanuel Hanon, Senior Vice President, Head of R&D, GSK Vaccines, commented, “The partnership between Novartis and Intercell was established with positive intent and has benefited both parties. As part of GSK’s ongoing initiative to allocate capital to fewer, highest priority areas, we have elected to come to an early termination so that both parties can make clear plans for the future. We wish Valneva well and hope that the Lyme vaccine development will be successful.”

About Valneva SE

Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. 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 various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with approximately 480 employees. More information is available at www.valneva.com.

SOURCE: Valneva

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