Another first: Gilead spends $125M on priority review voucher for mystery drug
Will this move breathe new life into neglected tropical disease drug development?
- There are two types of FDA Priority Review Vouchers that allow companies to purchase vouchers and exercise those vouchers for a fee in exchange for an expedited review process (from 10 months down to 6 months).
- Gilead recently purchased a Neglected Tropical Disease Priority Review Voucher from Knight Therapeutics for $125 million, as RAPS' Alec Gaffney reports. This is the first time a tropical voucher has ever been sold.
- There is talk that Gilead has something big in the pipeline and that buying this voucher is intended to facilitate a faster review process. But so far, it's not clear what the drug is.
A faster review process for a promising drug can add hundreds of thousands of dollars, and potentially millions, to a company's bottom line and give it a competitive advantage over other companies seeking to compete in the same space.
Although there has been some activity surrounding the Voucher for Rare Pediatric Diseases, disease development for the 16 tropical diseases listed as priorities under the voucher system has not been a focus. Perhaps Gilead's latest move will shift that trend.
In related news, yesterday, the Senate considered adding Ebola onto the Tropical Disease priority list. If approved, it will be the 17th disease on the list and will provide an additional incentive for drug developers.
- Regulatory Affairs Professional Society Gilead Makes Record-Setting Purchase of Special FDA Voucher