Acadia Sells Rare Pediatric Disease Priority Review Voucher for $150 Million

Rare Daily Staff

Acadia Pharmaceuticals said it agreed to sell its Rare Pediatric Disease Priority Review Voucher for $150 million.

The U.S. Food and Drug Administration granted Acadia the PRV in March 2023 following approval of Daybue, its treatment of the rare, neurodevelopmental condition Rett syndrome.

The Priority Review Voucher can be used to shorten FDA review time of a therapy seeking marketing approval to six months from the usual 10 months. These vouchers have typically sold for around $100 million, although Ipsen sold one in August for $158 million.

The sale comes as the future of the Rare Pediatric Priority Review Voucher program remains uncertain. The industry and rare disease community has lobbied to have the program renewed because it provides a needed incentive for the development of these therapies. It has also proved to be an important source of capital at a time when companies have faced challenges raising money.

The program was set to end on September 30, but it was extended until December 20. There is proposed legislation that would renew it through September 30, 2030.

Acadia licensed Daybue from Neuren Pharmaceuticals in August 2018. Under that license, Acadia is required to pay Neuren one-third of the net proceeds.

Acadia plans to invest proceeds from the sale of the PRV to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.