BioMarin sells Priority Review voucher

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said it sold a Priority Review voucher to Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) for $67.5 million late Wednesday and separately reported 2Q14 financial results. BioMarin gained the voucher earlier this year following FDA's approval of the company's Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). BioMarin was the first company to receive a voucher under the agency's Rare Pediatric Disease Priority Review Voucher program, which was created by PDUFA V to encourage the development of new drugs and biologics to prevent and treat rare pediatric diseases (see BioCentury Extra, Feb. 7).

Sanofi and Regeneron are equally splitting the cost of the voucher and said they plan to use it to obtain Priority Review for a BLA for alirocumab to treat primary hypercholesterolemia. The partners plan to submit the application for the human mAb targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) to FDA by year end. ...