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.

Sanofi/Regeneron Pharmaceuticals Inc.’s $67.5 million purchase of a rare pediatric disease priority review voucher from BioMarin Pharmaceutical Inc. sets the first public price tag on what a four-month reduction in FDA review time is worth. However, it also renews questions about whether tropical disease vouchers can command as high a price as their pediatric voucher brethren.

The longer regulatory lead time needed for voucher redemption and limitations on the number of transfers have been seen as...

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