How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say
Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.
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Priority Review Voucher Crash: Spark's Sale To Jazz Lowest Price Since 2014
Only the first publicly disclosed sale of a priority review voucher was lower than what Jazz Pharmaceuticals paid Spark Therapeutics for its coupon.
PCSK9 Sponsors Looked For Regulatory Advantages In Race To Market
Both Sanofi/Regeneron and Amgen coveted priority review for their LDL-cholesterol-lowering agents, but the Praluent sponsors' purchase of a voucher gave them the definitive edge. Amgen found no help in the breakthrough program, with FDA twice denying designation requests for Repatha, review documents show.
Priority Review Voucher Not For Sale, Alexion Says After Strensiq Approval
Alexion plans to use voucher for one of its own products and might be targeting its next-generation version of blockbuster Soliris.