09.11.2021 14:02:27
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Pfizer Inks Deal With Biohaven To Commercialize Rimegepant, Zavegepant, Outside The U.S.
(RTTNews) - Biohaven Pharmaceutical Holding Co. Ltd. (BHVN) and Pfizer Inc. (PFE) announced Tuesday a strategic commercialization arrangement for rimegepant in markets outside of the U.S., upon approval.
Rimegepant is commercialized as Nurtec ODT in the U.S., and is indicated for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency and several additional regulatory authorities outside of the U.S.
Under the terms of 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 U.S.
Additionally, Pfizer will gais rights outside of the U.S. to zavegepant, a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, currently being studied in an intranasal delivery and a soft-gel formulation in Phase 3 clinical trials for migraine indications.
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 in the purchase of Biohaven equity at a 25 percent market premium.
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 U.S., Pfizer will compensate Biohaven for the related royalties on net sales outside of the U.S. owed under the Company's license and funding agreements with Bristol-Myers Squibb Company and Royalty Pharma.
Closing of the license agreements and equity purchase are contingent on completion of review under applicable antitrust laws.
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