Sanofi and Regeneron purchase FDA priority voucher for alirocumab

French drug major Sanofi (Euronext: SAN) and USA-based biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) intend to use a US Food and Drug Administration rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab.

The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited six-month review from the filing date instead of the standard 10-month review. It was created by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) and is intended to encourage the development of treatments for rare pediatric diseases. Companies that receive a voucher may use it or transfer the voucher, including by sale, to other organizations.

Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, purchased the voucher from BioMarin GALNS, a direct, wholly-owned subsidiary of US drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) which had received it through the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) Program. Sanofi and Regeneron will equally share the purchase price of $67.5 million.