Rare Daily Staff
GW Pharmaceuticals said it has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review voucher to Biohaven Pharmaceuticals for $105 million.
The U.S. Food and Drug Administration awarded GW the voucher under a program intended to encourage the development of treatments for rare pediatric diseases. GW Research received the PRV when it won approval for Epidiolex for the treatment of seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome, two rare, severe childhood-onset epilepsies.
The transaction remains subject to customary closing conditions, including anti-trust review.
“Having successfully developed and launched Epidiolex as the first plant-derived cannabinod medicine approved by the FDA, GW is advancing a pipeline of additional cannabinoid products to address patient needs across a range of therapeutic areas,” stated Justin Gover, GW’s CEO. “The sale of the PRV provides an important source of non-dilutive capital to help advance our pipeline and to continue to invest in the Epidiolex commercial launch in both the U.S. and Europe.”
A priority review voucher entitles the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PRV upon approval of the rare pediatric disease product application and it can be sold without limitation, subject to applicable FDA requirements for filing and use.
The value of the vouchers has fallen as the FDA has issued more of them. Though the record sale for a priority review voucher reached $350 million, in November, one sold for just $80 million.
Photo: Justin Gover, CEO of GW Pharmaceuticals