Regeneron Pharmaceuticals (REGN +5.8%) and partner Sanofi (SNY +1.4%) (OTCQB:SNYNF +0.3%) intend to use an FDA-issued rare pediatric disease review voucher for their alirocumab BLA. The voucher entitles the holder to designate a BLA for a six-month priority review instead of the standard 10-month review period.
Regeneron subsidiary Regeneron Ireland purchased the voucher from a subsidiary of BioMarin Pharmaceuticals who received it through the FDA's program. The companies will each pay half of the $67.5M price. They intend to submit the BLA before the end of the year.