NEW HAVEN, Conn., and NEW YORK, November 9, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced a strategic commercialization arrangement for rimegepant in markets outside of the United States 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.
"We believe this collaboration, which brings together the winning combination of Biohaven's Neuroscience R&D with Pfizer's industry-leading expertise and large global footprint will help accelerate access to rimegepant for patients around the world," said Vlad Coric MD, Chief Executive Officer of Biohaven. "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."
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 and Pfizer would commercialize rimegepant, upon approval, in all regions outside the U.S. Additionally, per the arrangement, Pfizer gains 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.
"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, 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."
Terms of the Arrangement
Biohaven and Pfizer are entering into a collaboration and license agreement and related sublicense agreement pursuant to which Pfizer will acquire rights to commercialize rimegepant and zavegepant outside of the U.S. Biohaven will continue to lead research and development globally and Pfizer would execute commercialization globally, outside of the U.S. 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.
As noted above, in connection with the transaction, Pfizer will make a $350 million investment in the common shares of Biohaven.
Closing of the license agreements and equity purchase are contingent on completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. and equivalents outside the U.S., and other customary closing conditions.
Biohaven and Pfizer global collaboration will be discussed on Biohaven 3Q Earnings Investor Call 8:00AM ET on November 9, 2021. To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast and accompanying slide presentation can be accessed through the "Investors" section of Biohaven's website at www.biohavenpharma.com.
About Migraine
More than one billion people suffer from migraine worldwide, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating headache attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.
About Rimegepant
Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name Nurtec® ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. Nurtec ODT is the #1 prescribed migraine treatment in its class with a cumulative launch to date of U.S. net revenue of approximately $336 million and with more than one million prescriptions. A single dose of 75 mg Nurtec ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in some patients. Nurtec ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. Nurtec ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.
NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION
Nurtec® ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if Nurtec ODT is safe and effective in children.
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:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
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.
