- Rimegepant, commercialized as Nurtec® ODT in the U.S., is the first and only oral CGRP (calcitonin gene- related peptide) receptor antagonist for the acute and preventive treatment of migraine
- Biohaven to receive tiered double-digit royalties on ex-U.S. net sales as well as upfront and milestone payments of up to $1.24 billion
- Biohaven and Pfizer global collaboration to be discussed on Biohaven 3Q Earnings Investor Call
Biohaven Pharmaceutical Holding CompanyLtd. and PfizerInc.moment blazoned a strategic commercialization arrangement for rimegepant in requests outside of the United States upon blessing. Rimegepant is capitalized as Nurtec ® ODT in theU.S., and is indicated for the acute treatment of migraine attacks with or without air and the preventative treatment of episodic migraine in grown-ups. An operation for the blessing of rimegepant is presently under review by the European Medicines Agency and several fresh nonsupervisory authorities outside of theU.S.
“ We believe this collaboration, which brings together the winning combination of Biohaven’s Neuroscience R&D with Pfizer’s assiduity- leading moxie and large global footmark will help accelerate access to rimegepant for cases around the world,” said Vlad Coric MD, Chief Executive Officer of Biohaven. “ With this alliance, Biohaven Pharmaceutical and Pfizer believe there’s an occasion to change the paradigm in migraine treatment and potentially establish a new standard of care.”
TERMS OF THE ARRANGEMENT
Biohaven and Pfizer are entering into a collaboration and license agreement and affiliated sublicense agreement pursuant to which Pfizer will acquire rights to manipulate rimegepant and zavegepant outside of theU.S. Biohaven will continue to lead exploration and development encyclopedically and Pfizer would execute commercialization encyclopedically, outside of theU.S. Under the fiscal terms of all sale agreements, Pfizer will make an outspoken payment of$ 500 million, conforming of$ 150 million cash and$ 350 million in the purchase of Biohaven equity at a 25 percent request decoration. Biohaven is also eligible to admit up to$ 740 million in mileposts. In addition to the tiered double- number royalties owed to Biohaven on net deals outside of theU.S., Pfizer will compensate Biohaven for the affiliated royalties on net deals outside of theU.S. owed under the Company’s license and backing agreements with Bristol-Myers Squibb Company and Royalty Pharma.
As noted over, in connection with the sale, Pfizer will make a$ 350 million investment in the common shares of Biohaven.
Ending 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 theU.S. and coequals outside theU.S., and other customary ending conditions.
Further 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 ails. Migraine is characterized by enervating headache attacks lasting four to 72 hours with multiple symptoms, including palpitating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/ or perceptivity to sound (phonophobia) and perceptivity to light (photophobia). There’s a large unmet need for new acute and preventative treatments, as a significant portion of migraine cases are unsatisfied with current standard of care migraine treatments due to a lack of efficacity or safety or tolerability burden.
Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the birth waterfall that results in a migraine attack. Rimegepant was approved by theU.S. Food and Drug Administration (FDA) under the trade name Nurtec ® ODT for the acute treatment of migraine in February 2020 and for the preventative treatment of episodic migraine in May 2021. Nurtec ODT is the# 1 specified migraine treatment in its class with a accretive launch to date ofU.S. net profit of roughly$ 336 million and with further than one million conventions. A single cure of 75 mg Nurtec ODT provides fast pain relief, significant pain reduction and return to normal function, and has a continuing effect of over to 48 hours in some cases. Nurtec ODT is taken orally as demanded, up to 18 boluses/ month to stop migraine attacks or taken every other day to help help migraine attacks and reduce the number of yearly migraine days. Nurtec ODT doesn’t have dependence eventuality and isn’t associated with drug overuse headache or rebound headache.
ABOUT PFIZER Improvements THAT CHANGE Cases’LIVES
At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. Harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 170 times, we’ve worked to make a difference for all who calculate on us.
Biohaven is a marketable- stage biopharmaceutical company with a portfolio of innovative, best- by- class curatives to ameliorate the lives of cases with enervating neurological and neuropsychiatric conditions, including rare diseases. Biohaven’s neuro- invention portfolio includes FDA-approved NURTEC ® ODT (rimegepant) for the acute and preventative treatment of migraine and a broad channel of late- stage product campaigners across three distinct mechanistic platforms CGRP receptor enmity for the acute and preventative treatment of migraine; glutamate modulation for compulsive-obsessive complaint, Alzheimer’s complaint, and spinocerebellar ataxia; and MPO inhibition for amyotrophic side sclerosis.
Source link: https://www.pfizer.com/