Biohaven Completes Enrollment In Pivotal Phase 3 Migraine Prevention Trial

NEW HAVEN, Conn., Aug. 7, 2019 /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 completion of enrollment in its pivotal Phase 3 preventive treatment of migraine trial with rimegepant, its lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate.

Vlad Coric, M.D., CEO of Biohaven commented, "Given rimegepant's high affinity for the CGRP receptor and its relatively long half-life, we believe rimegepant may possess unique "dual-therapy" action with a potential ability to provide acute treatment of migraine attacks and preventive effects. We are excited to complete enrollment in this Phase 3 preventive trial. To our knowledge, rimegepant is currently the only small molecule CGRP antagonist being developed for both the acute and preventive indications in the treatment of migraine."

The Phase 3 trial of rimegepant in the preventive treatment of migraine examines the efficacy and safety of rimegepant 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, commented, "Migraine is the 6th most disabling illness in the world, where more than 90% of sufferers are unable to work or function normally during an attack. Our hope is to bring forward a new oral therapy that is convenient for patients to administer, fulfills their needs for acute and preventive therapies, and has the potential to give back to these migraine sufferers significant portions of their lives otherwise lost to disability caused by migraine."

Rimegepant has demonstrated efficacy and safety in four Phase 2/3 trials in the acute treatment of migraine and Biohaven submitted New Drug Applications (NDAs) to the FDA for the Zydis ODT and tablet formulations of rimegepant in 2Q2019. Biohaven is also developing 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 Migraine
Approximately 40 million Americans suffer from migraine. Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling. More than 90 percent of migraine sufferers are unable to work or function normally during an attack. In the Global Burden of Disease Study, updated in 2015, migraine was ranked as the seventh highest cause worldwide of years lost due to disability. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class specific to the acute treatment of migraine in over 25 years. This unique and specific mode of action potentially offers an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or who either do not respond or have inadequate or inconsistent response to triptans or are intolerant to them.

About Rimegepant
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine and refractory trigeminal neuralgia. The efficacy and safety profile of rimegepant for the acute treatment of migraine, as compared to placebo, has now been established across four randomized controlled trials to date: three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA and provided the basis for Biohaven's NDA submission to the FDA in the second quarter of 2019. More information about rimegepant can be found at the Company's website: https://www.biohavenpharma.com/science-pipeline/cgrp/rimegepant

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, and ALS Biopharma LLC. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven'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 regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the effectiveness and safety of rimegepant, the expected timing, commencement and outcomes of the Company'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 the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify forward-looking statements. 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 February 28, 2019 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. 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.

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

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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