- Biohaven Pharmaceuticals will pay $105 million to GW Pharmaceuticals for a priority review voucher, hoping to speed up the timeline to commercialization for its experimental migraine treatment.
- The clinical-stage pharma plans to use the voucher to cut four months off the review time for rimegepant, which now has the potential to leapfrog a rival therapy from Allergan to become the first oral CGRP antagonist to enter the acute migraine market.
- The companies reached the agreement on March 15 and announced the deal Monday. GW received the voucher last year when its cannabis-based drug, Epidiolex, won U.S. approval to treat seizures related to two rare, childhood-onset epilepsies.
The CGRP market rapidly emerged in 2018 with three major drug launches. While those medicines focused on preventing migraines, this year could see CGRP-focused therapies break into the acute treatment setting.
Biohaven’s decision to pay $105 million to cut a few months off a regulatory decision timeline suggests the competition with Allergan to be first to market. The Food and Drug Administration accepted Allergan’s drug application for ubrogepant on March 11, beginning a 10-month review period on a regulatory decision.
Now, with a priority review voucher attached to it, rimegepant could speed past ubrogepant — a “pleasant surprise,” as Piper Jaffray’s Tyler Van Buren called the news in a March 18 note to Biohaven investors.
Biohaven said it expects to file its application in the second quarter, which opens the possibility for approval by year’s end. That would potentially put the drug ahead of Allergan’s, depending on the exact filing time.
“An approval at the same time as or before ubrogepant could take away any first-mover advantage for Allergan, which we believe is important in the context of a promotion-sensitive and heavily contracted treatment setting,” Van Buren wrote.
Both companies’ treatments are oral CGRP antagonists. The three CGRP drugs currently approved as preventative treatments are all injectables. (A fourth preventative CGRP, from Alder BioPharmaceuticals, applied for U.S. approval in February, eyeing a commercial launch in early 2020 as a quarterly intravenous infusion.)
On the other side of this deal, GW will use the $105 million in cash to advance its pipeline and continue investing in the commercial launch of Epidiolex (cannabidiol), CEO Justin Gover said in a March 18 statement.
Priority review vouchers are a tradable commodity, awarded by the FDA beginning in 2007 to companies that develop drugs for certain rare or tropical diseases.
After AbbVie paid a record $350 million for such a voucher in 2015 from United Therapeutics, purchase prices have slid. For instance, Eli Lilly paid $80 million for one last November.
GW received one of the seven vouchers given out last year. So far, Novartis has been the only pharma to receive such a voucher in 2019, according to a Regulatory Affairs tracker.