Issue Date: August 4, 2014
Sanofi And Regeneron Buy Review Voucher
Sanofi and Regeneron Pharmaceuticals have paid BioMarin $67.5 million for a voucher that will speed up FDA review of alirocumab, a monoclonal antibody the two are developing as a cholesterol-lowering agent. Under a 2012 law, FDA issues such vouchers to firms that develop drugs for rare pediatric diseases. BioMarin obtained its voucher in February when it won approval of Vimizim, which treats Morquio A syndrome, a rare pediatric disease. With the voucher, Sanofi and Regeneron will enjoy a six-month review instead of the standard 10-month review. The sale is the first for the pediatric priority review voucher program.
- Chemical & Engineering News
- ISSN 0009-2347
- Copyright © American Chemical Society