Pfizer and Biohaven Pharmaceutical, New Haven, Connecticut-based pharmaceutical company, have formed an ex-US commercialization arrangement for rimegepant, a drug to treat migraines, in a deal worth up to $1.24 billion, including a $350-million equity investment by Pfizer in Biohaven. 

Rimegepant is commercialized as Nurtec ODT in the US. Rimegepant was approved by the US Food and Drug Administration for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. An application for the approval of rimegepant is currently under review by the European Medicines Agency and several additional regulatory authorities outside of the US.

Under the arrangement, Biohaven would remain primarily responsible for further clinical development of rimegepant, and the parties will cooperate in regulatory activities to secure approval for the product. Biohaven will continue to solely commercialize Nurtec ODT in the US, and Pfizer would commercialize rimegepant, upon approval, in all regions outside the US. Additionally, per the arrangement, Pfizer gains rights outside of the US to zavegepant, a small-molecule drug in Phase III development to treat migraines in an intranasal delivery and a soft-gel formulation.

Under the financial terms of all transaction agreements, Pfizer will make an upfront payment of $500 million, consisting of $150 million cash and $350 million for an equity stake in Biohaven. Biohaven is also eligible to receive up to $740 million in milestones. In addition to 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 company’s license and funding agreements with Bristol-Myers Squibb Company and Royalty Pharma, a New York-based bio/pharmaceutical company.

Closing of the license agreements and equity purchase are contingent on completion of review under applicable antitrust laws in the US and equivalents outside the US and other customary closing conditions.

Source: Pfizer