BioMarin Pharmaceutical Has Announced That it is Selling its FDA Priority Review Voucher to Regeneron Ireland
BioMarin received the rare pediatric disease priority review voucher In February 2014 for its drug Vimizim, the first FDA approved drug for the treatment of Mucopolysaccharidosis (Morquio A syndrome.)
The coveted priority review voucher allows for a prospective drug to be reviewed by the FDA more rapidly, with the FDA stating that it aims to review a drug with priority review status within six months of submission. For other drugs under standard review, the turn over time for review is normally at least 10 months.
Jean-Jacques Bienaimé, the CEO of BioMarin, has said of the transaction that ‘leveraging the sale of the Priority Review Voucher to reinvest in products to treat rare and ultra-rare diseases makes the most sense for BioMarin given our stage of growth. We are very pleased that a patient population beyond BioMarin’s will potentially be able to benefit from a faster drug application review process.’
The priority review voucher was sold to Regeneron Ireland, a wholly-owned subsidiary of Regeneron Pharmaceuticals.
The FDA Pediatric Disease Priority Review Voucher is normally issued to a sponsor of a drug that has a rare pediatric disease application. It entitles the holder of the voucher to priority review of a single new drug application. The voucher is received once the application of the drug has been approved. These vouchers can be sold or transferred as many times as the holder wishes.
Read more about it here: BioMarin Sells Priority Review Voucher for $67.5 Million