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GW Pharmaceuticals to sell US FDA priority review voucher to Biohaven for $105M

GW Pharmaceuticals PLC will sell its U.S. Food and Drug Administration-granted rare pediatric disease priority review voucher to Biohaven Pharmaceutical Holding Co. Ltd. for $105 million.

Biohaven will use the priority review voucher for its new drug application for Zydis, or rimegepant, an oral treatment for migraines. The New Haven, Conn.-based company plans to submit the application in the second quarter of 2019, according to its March 18 press release.

The voucher, which can expedite a product candidate's review and time to approval, is transferable and can be sold without limitation.

GW Pharma will use the funds from the sale to advance its pipeline and further commercial development of Epidiolex, the first FDA-approved cannabis-derived therapy in the U.S., GW Pharma CEO Justin Gover said March 18. The U.K.-based pharmaceuticals company was awarded the priority review voucher when Epidiolex was approved in June 2018 for seizures associated with rare pediatric epileptic conditions.