Biohaven Enrolls First Patient In Phase 3 Preventive Treatment Of Migraine Trial With Its Oral CGRP Receptor Antagonist Rimegepant

NEW HAVEN, Conn., Nov. 15, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases today reported enrolling its first patient in its Phase 3 preventive treatment of migraine trial with its lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate.

Vlad Coric, M.D., CEO of Biohaven commented, "We are excited to enroll the first patient in our Phase 3 trial evaluating rimegepant as a preventive therapy for migraine.  If successful, our plans will be to develop rimegepant for both the acute and preventive treatment of migraine. Oral small molecule CGRP receptor antagonists with high receptor affinity and long half-lives, such as rimegepant, may possess dual-therapy action with ability to provide both acute relief and preventive effects. Ongoing preliminary data from our long-term safety study suggests that rimegepant may have a role for both acute and preventive migraine treatment and has provided us with sufficient information to allow us to initiate this trial. Our intention is to develop convenient and easy to use CGRP-targeting formulations spanning from acute treatment to prevention."

This Phase 3 trial will examine the efficacy and safety of rimegepant for migraine prevention in adult subjects who have suffered from migraine for at least one year and who have a frequency of 4 to 14 migraine attacks of moderate to severe intensity per month over the three months prior to enrollment. The primary outcome measure is the change from baseline at week 12 in the mean number of migraine days per month. Secondary outcome measures include the achievement of at least a 50% reduction from baseline in mean monthly migraine days across the double-blind treatment phase, and the mean number of rescue medication days per month, each as measured over the course of the double-blind, treatment phase.

Robert Croop M.D., Chief Development Officer – Neurology at Biohaven, added, "Data from our Phase 3 rimegepant trials has shown durable effects up to 48 hours after a single dose and suggests rimegepant may be particularly suitable to studying in the prevention of migraine. Effectiveness in this application would further extend the potential clinical utility of rimegepant."

Rimegepant has now demonstrated efficacy and safety in three Phase 2/3 trials. In October, the Company also announced initiation of clinical dosing with its product candidate BHV-3500, the first small molecule CGRP receptor antagonist to be administered in an intranasal (IN) formulation in human testing. Biohaven's pipeline now includes product candidates across three novel mechanisms of action to target central nervous system disorders: 1) CGRP receptor antagonists for migraine and pain; 2) glutamate modulating agents for the treatment of neurological and neuropsychiatric disorders, and; 3) myeloperoxidase inhibition for neuroinflammatory disorders. The Company expects to reach significant pipeline milestones in the coming periods.

About Biohaven

Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. The Company's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. 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. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release, including statements regarding the expected commencement and completion of clinical trials, the anticipated timing of availability of data from those trials, the efficacy and safety profiles of the Company's product candidates and their expected benefits, and other statements regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "expect," "anticipate," "will," "potential," "plan," "might" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by the forward-looking statements including risks and uncertainties related to the timing of initiating, enrolling and completing clinical trials; the commencement or completion of enrollment in any clinical trial does not guarantee the continuation or successful outcome of the trial; and those factors described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed with the Securities and Exchange Commission on November 14, 2018. The forward-looking statements are made as of this date and the Company 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.

For further information, contact Dr. Vlad Coric, Chief Executive Officer, at [email protected]

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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