Valneva SE announced that it has sold its Priority Review Voucher, granted by the U.S. Food and Drug Administration (FDA), for a sum of $103 million, equivalent to 95 million euros. The company acquired this voucher, linked with tropical diseases, in November 2023 after the FDA approved its single-dose, live-attenuated vaccine 'IXCHIQ'. IXCHIQ is used to prevent diseases brought about by the chikungunya virus (CHIKV), to aide individuals over the age of 18 who are at an elevated risk of CHIKV exposure.
The funds gained from the sale will be channelled into Valneva's research and development initiatives. These include its Phase 3 Lyme disease vaccine co-development, additional clinical trials of the chikungunya vaccine IXCHIQ, and the expansion of the company's clinical trials pipeline.
Through the tropical disease Priority Review Voucher Program, the FDA bestows priority review vouchers on applications for tropical disease-focused products that meet specific standards. The main objective of this program is to motivate the development of new drugs and biologics that prevent and treat tropical diseases. These PRVs can subsequently facilitate priority reviews for different product marketing applications, and can even be sold or transferred.
