Valneva SE announced it sold the Priority Review Voucher (PRV) it received from the U.S. Food and Drug Administration (FDA) for $103 million (€95 million).
The Company was awarded a tropical disease PRV in November 2023 following U.S. FDA approval of IXCHIQ, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. With this approval, IXCHIQ became the world’s first licensed chikungunya vaccine available to address this unmet medical need.
Valneva will invest proceeds from the sale of the PRV into its R&D projects, including the co-development of its Phase 3 vaccine candidate against Lyme disease, additional clinical trials for its chikungunya vaccine IXCHIQ and the expansion of the Company’s clinical pipeline.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “This non-dilutive capital provides an important source of additional funding to advance the continued development of our clinical pipeline. As shown with the recent approval of our chikungunya vaccine, we remain committed to growing our portfolio of vaccines addressing unmet medical needs which have the potential to transform people’s lives.”
Under the tropical Disease Priority Review Voucher Program, FDA awards priority review vouchers to sponsors of tropical disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of tropical diseases. PRVs can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.