Biohaven Completes Enrollment In Second Pivotal Phase 3 Clinical Trial Of Oral CGRP-Receptor Antagonist Rimegepant

NEW HAVEN, Conn., Nov. 27, 2017 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company") announced today completion of enrollment in Study BHV3000-302, the Company's second pivotal Phase 3 clinical trial examining the efficacy and safety of rimegepant in the acute treatment of migraine. The trial began shortly after the commencement of rimegepant's first efficacy trial, Study BHV3000-301, and the two trials enrolled simultaneously with the objective of announcing topline results for the migraine program in the first quarter of 2018.  Together the two pivotal trials enrolled approximately 3,000 subjects, which is expected to support a robust assessment of the efficacy of rimegepant in the acute treatment of migraine as required by the FDA for registration. Biohaven continues to evaluate the long-term safety of rimegepant in a third trial, Study BHV3000-201.

Rimegepant is a second generation, oral, calcitonin gene related peptide (CGRP) receptor antagonist being developed for the acute treatment of migraine. Rimegepant is, to the Company's knowledge, only one of two small molecule CGRP-receptor antagonists in late stage clinical development. Biohaven is conducting two double-blind, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant. The co-primary endpoints of the studies are freedom from pain at two hours post-dosing and freedom from the patient's most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. The Company is also pursuing development of its third generation CGRP-receptor antagonist, BHV-3500, for the acute and preventative treatment of migraine.

Vlad Coric, M.D., Chief Executive Officer at Biohaven, commented, "Completion of enrollment in this second migraine trial in only about four months underscores both the priority of the CGRP program within Biohaven and the very high unmet need for innovative therapies to better treat migraine attacks. Rimegepant was designed to be highly potent at the CGRP receptor and administered orally to allow convenient dosing by migraine sufferers when and where a migraine attack hits. We continue to efficiently advance our CGRP-receptor antagonist program as we strive to bring patients more therapeutic options in treating disabling migraines. I am pleased to report that we remain on track to receive topline results in these two Phase 3 trials in the first quarter of next year."

Acute attacks of migraine can differ in intensity and frequency, with many being highly disabling.  More than 90% of migraine sufferers are unable to work or function normally during an attack.  CGRP-receptor antagonists represent a novel class of drug candidates for the treatment of migraine and 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.  In addition, CGRP-receptor antagonists could be appropriate for those who have contraindications to the frequently used triptans, such as patients with underlying cardiovascular diseases.

"Migraine is the third most prevalent and the sixth most disabling disease in the world. We are focused on bringing relief to the millions of migraine patients who are not adequately helped by current treatments, and who suffer through countless days with their families and at their jobs each year.  With the goal of providing patients a convenient, safe and effective oral therapy, which they can take anywhere and at any time, our hope is that rimegepant will enable people with migraine to take back control of their lives. I am proud of the work our team has accomplished to date, and we look forward to completing the necessary steps to provide this new approach to treating migraine," said Elyse Stock, M.D., Chief of Portfolio Strategy and Development at Biohaven.

In a previously completed Phase 2b clinical trial, the 75 mg dose of rimegepant was observed to have achieved a statistically significant improvement compared to placebo at two hours post-dosing on all four key migraine symptoms: pain, nausea, photophobia and phonophobia. Rimegepant-treated patients also experienced durable efficacy, achieving statistically higher rates of pain freedom at 24 and 48 hours post-dosing compared to placebo. Durability of treatment response is an important unmet need not fulfilled by current treatment options associated with headache recurrence.

About Migraine 

Migraine is both a widespread and disabling neurological disease. The Migraine Research Foundation ranks migraine as the world's third most prevalent illness, affecting approximately 39 million people in the United States. Current treatment approaches, such as triptans, can be limited by headache recurrence within 24 hours after taking migraine medication, as well as cardiovascular contraindications and warnings.

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 and glutamate modulation 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 the Company's timing of the expected data readouts from the Company's registrational trials of rimegepant, the potential results of the trials and the Company's planned long-term safety study of rimegepant, the adequacy of the enrollment size of the trials for purposes of FDA registration, rimegepant's potential to be a best-in-class treatment option for the acute treatment of migraine and its advantages over current migraine treatment options, as well as the size of the potential market for rimegepant, are forward-looking statements. The use of certain words, including the "believe", "could", "expect" and "will" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives 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 our forward-looking statements, including uncertainties relating to the future clinical success of rimegepant, and whether the results observed in the Phase 2b clinical trial will be observed in the Phase 3 pivotal trials. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2017. 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, the Chief Executive Officer at [email protected]

SOURCE Biohaven Pharmaceutical Holding Company Ltd.