Another Priority Review Voucher Sold

In August, AbbVie (NYSE: ABBV) paid a record-setting $350 million to United Therapeutics Corp. (NASDAQ: UTHR) for its Rare Pediatric Disease Priority Review Voucher. The fast-track voucher was awarded by the FDA as part of its approval of Unituxin™ (dintuximab), for the treatment of neuroblastoma. On Sept. 8, the FDA cleared Wellstat Therapeutics‘ Xuriden (uridine triacetate) for the treatment of hereditary orotic aciduria, a rare, potentially fatal genetic disorder. It also granted a Rare Pediatric Disease Priority Review Voucher to the privately held Wellstat. That voucher was immediately sold to AstraZeneca (NYSE: AZN) as part of an agreement made in September 2014. Financial terms were not disclosed. The main benefit of the voucher, which can be bought and sold an unlimited amount of times, is a six-month review clock. Also, the voucher owner only has to give the FDA a short 90-day notice of its intention to use it.

 

 

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