BIOHAVEN ANNOUNCES NURTEC® ODT RECEIVES FIRST GLOBAL APPROVAL OUTSIDE THE U.S. FOR PREVENTION OF MIGRAINE

NEW HAVEN, Conn., Dec. 13, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") announced today that NURTEC ODT (rimegepant) 75 mg was approved by the Ministry of Health of Israel for the preventive treatment of episodic migraine in adults. NURTEC ODT is also approved in Israel for the acute treatment of migraine with and without aura in adults. Registration in Israel is the first approval for NURTEC ODT for the preventive treatment indication outside the United States.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "This first approval outside the United States of our dual-therapy NURTEC ODT for the acute and preventive treatment of migraine is an important milestone for patients. Regulatory approval of NURTEC ODT in Israel for the preventive treatment of episodic migraine will provide more patients with access to a novel, non-injectable treatment option for preventing migraine attacks and reducing monthly migraine days. NURTEC ODT can have a significant impact on improving patients' lives through a single medication to treat and prevent migraine attacks, helping them to gain better control of their disease."

NURTEC ODT is the first oral CGRP receptor antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment. A single dose of NURTEC ODT can deliver pain relief that's fast and lasts with onset within one hour and durable through 48 hours for many patients. NURTEC ODT can be taken up to once daily as needed to treat migraine attacks or taken every other day to help prevent migraines and reduce the number of monthly migraine days.

Strategic collaboration with Pfizer for global commercialization
Biohaven recently announced a strategic collaboration with Pfizer Inc. for the global commercialization of rimegepant (marketed in the United States and some ex-US regions as NURTEC ODT). Under the partnership, Pfizer gains rights to commercialize rimegepant in markets outside the U.S. upon approval. Biohaven will continue to commercialize NURTEC ODT in the U.S. and remain responsible for further clinical development of the rimegepant franchise. 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.

About NURTEC ODT
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. For more information about NURTEC ODT, visit www.nurtec.com.

Indication
NURTEC ODT orally disintegrating tablets 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.

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:

• 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, 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 www.fda.gov/medwatch or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4NURTEC.

See full Prescribing Information and Patient Information.

About Biohaven
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-looking Statement
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings,  the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021, and the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2021. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Contact:
Dr. Vlad Coric
Chief Executive Officer
[email protected]

Media Contact:
Mike Beyer
Sam Brown Inc.
[email protected]
312-961-2502

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

Related Links

http://biohavenpharma.com