Biohaven's Oral Zavegepant, A Third Generation CGRP Receptor Antagonist, Receives Authorization To Proceed From FDA And Achieves First In Human Dosing

NEW HAVEN, Conn., Sept. 10, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today reported that the U.S. Food and Drug Administration (FDA) has authorized the initiation of clinical trials for oral zavegepant (formerly BHV-3500) and that the company has achieved first in human dosing in a Phase 1 trial designed to assess the safety and pharmacokinetics of oral formulations of zavegepant.

Biohaven recently announced securing up to $250 million in funding to advance the company's CGRP receptor antagonist program through the development of zavegepant. The zavegepant program encompasses intranasal zavegepant as well as oral formulations of zavegepant for migraine and non-migraine indications. Intranasal zavegepant previously demonstrated superior efficacy to placebo in a Phase 2/3 study for the acute treatment of migraine and the investigational agent is also being studied in an ongoing double blind, randomized, placebo-controlled trial in COVID-19 infected hospitalized patients requiring supplemental oxygen.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "We are excited to advance the oral formulations of zavegepant into human studies and broaden our CGRP franchise into migraine adjacencies, non-migraine indications and new formulations across the globe. Our team has developed a deep knowledge of the receptor kinetics and pharmacology of the CGRP pathways, and our intention is to expand our CGRP targeting agents across a number of neuroimmune disorders."

Charles Conway, Ph.D., Chief Scientific Officer commented, "zavegepant has unique chemical properties and is a structurally distinct CGRP receptor antagonist that allows for administration in a variety of formulations.  Zavegepant provides an opportunity to expand our CGRP program with customization of our products to different disease states based on the distinct attributes of each agent and formulation."

About Zavegepant
Zavegepant 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. More information about zavegepant can be found on the Biohaven website: https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.

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 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 myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements
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", "continue", "may", "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 zavegepant as an acute treatment for patients with migraine. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively commercialize zavegepant, delays or problems in the supply or manufacture of zavegepant, 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 Biohaven's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission on August 10, 2020. 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.

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

NOJECTION and NURTEC are trademarks of Biohaven Pharmaceutical Ireland DAC.

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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