Biohaven Showcases CGRP-Antagonist Franchise Data including Nurtec ODT (rimegepant), Now Approved to Treat and Prevent Migraine Attacks, and…

NEW HAVEN, Conn., June 3, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 19 abstracts, including one late-breaking presentation and two oral presentations, will be presented at the virtual 63rd Annual Scientific Meeting of the American Headache Society (AHS) being held June 3-6. The presentations will be available to view on the AHS website from June 3, 2021 for one year.

Biohaven will be presenting new and encore data presentations for Nurtec ODT (rimegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the FDA for the acute and preventive treatment of migraine in adults. Nurtec ODT received FDA approval for the preventive treatment of episodic migraine in adults on May 27. Efficacy and safety results from the pivotal Phase 2/3 clinical trial of rimegepant for the preventive treatment for migraine will be presented including data showing a rapid reduction in migraine days. Additionally, posters feature data from the Phase 3 trials and the long-term safety study of rimegepant as an acute treatment for migraine, including in people who have a history of treatment failure with triptans. Health economics and outcomes research analyses shed light on the impact of redosing on cost utility outcomes and demonstrate that the use of rimegepant taken as an acute treatment on an as needed basis over one year was associated with a reduction in monthly migraine days and tablet utilization as well as improved quality of life outcomes. An oral presentation for the Phase 2/3 dose-ranging study of intranasal zavegepant, the only intranasal CGRP receptor antagonist currently in late-stage clinical trials for the acute treatment of migraine, will also be presented.

Elyse Stock, MD, Chief Medical Officer of Biohaven commented, "We continue to build on our deep body of research that demonstrates Nurtec ODT's clinical efficacy and safety for the acute and preventive treatment of migraine. We are energized by the recent FDA approval for Nurtec ODT as a preventive treatment for episodic migraine and are excited to bring forward this oral dual therapy indication to physicians and patients alike. The clinical and health economics data presented at AHS emphasize this paradigm changing treatment approach as the first and only medication that can treat and prevent migraine attacks."

Notable highlights include:

The complete list of accepted abstract titles is below and full presentations will be available on the 2021 AHS virtual annual meeting website beginning June 3, 2021.

Oral Presentations:

Late-Breaking Poster Presentation:

Poster Presentations:

About NURTEC ODTNURTEC 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. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit http://www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

IndicationNURTEC 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 InformationDo not take NURTEC ODT if youare 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/medwatchor call1800FDA1088or report side effects to Biohaven at18334NURTEC.

Please click here for fullPrescribing InformationandPatient Information.

About ZavegepantZavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2 hour freedom from pain and freedom from a patients' most bothersome symptom (either nausea, photophobia or phonophobia). Following successful end of Phase 2 interactions with FDA (clinical and nonclinical), zavegepant is advancing to Phase 3 for the acute treatment of migraine in adults. For more information, visithttps://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.

About BiohavenBiohaven 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 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 multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available atwww.biohavenpharma.com.

Forward-looking StatementThis 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 or preventative 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 applicableU.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. 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 and NOJECTION are trademarks of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven ContactDr. Vlad CoricChief Executive Officer[emailprotected]

Media ContactMike BeyerSam Brown Inc.[emailprotected] 312-961-2502

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

http://biohavenpharma.com

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Biohaven Showcases CGRP-Antagonist Franchise Data including Nurtec ODT (rimegepant), Now Approved to Treat and Prevent Migraine Attacks, and...