Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced that the parties have completed the collaboration transaction between the two companies.
| NEW HAVEN, Conn. and NEW YORK, Jan. 5, 2022 /PRNewswire/ -- Biohaven Pharma (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced that the parties have completed the collaboration transaction between the two companies. The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of required regulatory approvals and the satisfaction of other customary conditions, and BHVN shares have been issued to Pfizer. Biohaven will continue to lead research and development globally and retain rights to the U.S. market.
In connection with the closing of the equity purchase and effectiveness of the strategic transaction, Pfizer made an upfront payment to Biohaven of $500 million, consisting of $150 million cash and $350 million in the purchase of Biohaven equity. At close, Pfizer will own 3% of Biohaven. Biohaven is also eligible to receive up to $740 million in future 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 a pro-rata share of certain of its sales-based milestone obligations owed to Bristol-Myers Squibb Company (“BMS”), and for the related royalties on net sales outside of the U.S. owed under Biohaven’s license and funding agreements with BMS and Royalty Pharma. “The successful closing of our collaboration agreements represent an important and exciting step in expanding the impact of rimegepant to people outside the U.S. with migraine,” said Nick Lagunowich, Global President, Pfizer Internal Medicine. “We are enthusiastic about working with the Biohaven team to bring this valuable new treatment option to the millions of people across the globe suffering from migraine.” Rimegepant is commercialized as Nurtec® ODT in the U.S. and is the only oral CGRP (calcitonin gene-related peptide) receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022. Rimegepant is already approved for the acute treatment of migraine in Kuwait and the United Arab Emirates, and for the acute and preventive treatment of migraine in Israel. Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist delivered in an intranasal spray which recently achieved positive Phase 3 topline data in its second pivotal clinical trial for the acute treatment of migraine in adults. Zavegepant, if approved, would be the first intranasal CGRP receptor antagonist for the acute treatment of migraine in adults. Intranasal treatments like zavegepant offer additional potential benefits including ultra-rapid speed of onset and a non-oral delivery for patients who experience significant nausea or vomiting. Vlad Coric M.D., Chairman and CEO of Biohaven commented, “Together we hope to establish a world-class migraine business that can deliver on our promise of providing new treatment options for people living with this debilitating disease.” Dr. Coric added, “We are excited to collaborate with Pfizer given their global footprint and experience in the treatment of pain and in Women’s Health, which we believe may help establish rimegepant as a leading novel treatment of migraine.” About Migraine About Rimegepant NURTEC ODT U.S. Important Safety Information Do not take Nurtec ODT if you are allergic to Nurtec ODT (rimegepant) or any of its ingredients. Before you take Nurtec ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Nurtec ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take Nurtec ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with Nurtec ODT. The most common side effects of Nurtec ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of Nurtec ODT. Tell your HCP if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4Nurtec. Please click here for full Prescribing Information and Patient Information. About Zavegepant About Pfizer: Breakthroughs That Change Patients’ Lives Pfizer Disclosure Notice This release contains forward-looking information about rimegepant, zavegepant, and a collaboration agreement between Pfizer and Biohaven for commercialization of rimegepant and zavegepant outside the U.S., including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when any applications may be filed for rimegepant or zavegepant in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be pending or filed for rimegepant or zavegepant in any jurisdictions (including the application for rimegepant pending with the European Medicines Agency), which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether rimegepant and/or zavegepant will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of rimegepant and/or zavegepant; whether the collaboration between Pfizer and Biohaven will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About Biohaven Biohaven Forward-looking Statement Nurtec,Nurtec ODT and NOJECTION are registered trademarks of Biohaven Pharmaceutical Ireland DAC. Biohaven Media Contact: Pfizer Investor Relations
SOURCE Biohaven Pharmaceutical Holding Company Ltd. | ||
Company Codes: NYSE:BHVN, NYSE:PFE, NEO:PFE |
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