Biohaven Pharmaceutical has announced a strategic commercialization arrangement for rimegepant in markets outside of the US upon its approval, in a deal worth an estimated $1.24b USD. The drug (commercialized as Nurtec ODT in the US) is intended for acute treatment of migraine attacks with or without aura, as well as preventing episodic migraine.
Currently, an application for approval of rimegepant is under review by the European Medicines Agency (EMA) and other additional regulatory authorities outside the States.
Vlad Coric, Biohaven CEO, said the partners believe the merging of his firm’s neuroscience R&D and Pfizer’s global reach and resources will help accelerate access to Rimegepant.
“With this alliance, Biohaven Pharmaceutical and Pfizer believe there is an opportunity to change the paradigm in migraine treatment and potentially establish a new standard of care,” Coric said.
According to the arrangement terms, Biohaven would remain primarily responsible for further clinical development of rimegepant, and the two organizations will cooperate in efforts to secure approval for the product. Also, Biohaven will continue to commercialize Nurtec ODT in the US and Pfizer would commercialize Rimegepant (upon approval) in all regions outside the US.
"We are excited to join forces with Biohaven in the fight against migraine and help those patients impacted by this debilitating neurological disease,” said Nick Lagunowich, global president for Pfizer Internal Medicine. “We believe our legacy in pain and women’s health combined with our experienced customer-facing colleagues, will enable us to maximize this opportunity with Biohaven, potentially bringing a valuable new treatment option to patients living with migraine pain.”
Additionally, the terms hold that Pfizer gains rights outside the US. to zavegepant, a third-generation, high-affinity, selective, and structurally unique, CGRP receptor antagonist. The treatment currently is being studied in an intranasal delivery and a soft-gel formulation in Phase III clinical trials for migraine indications.
According to the arrangement, Pfizer will make an upfront payment of $500m USD; this consists of $150m cash and $350m in the purchase of Biohaven equity at a 25% market premium. Further, Biohaven is eligible to receive up to $740m in milestones.
On top of the tiered double-digit royalties owed to Biohaven on net sales outside of the US, Pfizer will compensate Biohaven for the related royalties on net sales outside of the US (owed under the firm’s license and funding agreements with Bristol Myers Squibb and Royalty Pharma.