United Therapeutics (NASDAQ:UTHR), a biotechnology company, agreed to sell a voucher meant to speed approval for rare pediatric disease treatments to a unit of AbbVie (NYSE:ABBV) for $350mln.
The Rare Pediatric Disease Priority Review Voucher (PPRV) voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
The voucher entitles the holder to ask the FDA for priority review of a drug application that would otherwise get a standard review. That could shorten the review process to six months from the standard 10 months.
United Therapeutics received the PPRV when Unituxin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a rare pediatric disease.
"We are very pleased to monetize our PPRV, and hope that this transaction will encourage others to join us in focusing development efforts on rare pediatric diseases," Co-CEO of United Therapeutics Roger Jeffs said in the statement.
In July, Retrophin Inc. sold a priority-review voucher to French drug maker Sanofi SA for a total consideration of about $245mln.
Shares of the Silver Spring, Maryland-based company fluctuated on Wednesday morning and were trading down 0.4% at $166.,84 at 10.19 a.m. in New York.