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Biopharmaceuticals Neurology

 News Release - November 16, 2017

Biohaven Completes Enrollment In The First Of Two Pivotal Phase 3 Clinical Trials Of Rimegepant, A Second Generation Oral CGRP-Receptor Antagonist, For The Acute Treatment Of Migraine

NEW HAVEN, Conn., Nov. 16, 2017 -- (Healthcare Sales & Marketing Network) -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced that it is completing enrollment today in the first of its two registrational Phase 3 clinical trials, Study BHV3000-301, to establish the safety and efficacy of orally-dosed rimegepant. Study BHV3000-301 has enrolled over 1,400 subjects since July 2017. Rimegepant is a second generation, oral, calcitonin gene related peptide (CGRP) receptor antagonist being developed for the acute treatment of migraine. Rimegepant has composition of matter protection until 2030, not including patent term adjustment or any potential patent term extension. Rimegepant is one of only two small molecule CGRP-receptor antagonists in late stage clinical development.

CGRP-receptor antagonists represent a novel class of drug candidates designed to block the molecules in the body responsible for pain and associated symptoms that occur during a migraine attack. Additionally, large numbers of migraine patients, especially those with cardiovascular disease or hypertension for whom existing treatment options such as triptans are contraindicated, may benefit from safe and effective oral CGRP-receptor antagonists since this class of drugs is not associated with vasoconstriction.

Vlad Coric, M.D., Chief Executive Officer at Biohaven, commented, "Completing enrollment in this large Phase 3 pivotal trial in four months reflects the high unmet need of people with migraine and dissatisfaction with current treatment approaches. Our team has focused on advancing small molecule CGRP-receptor antagonists in convenient and easy to use oral or intranasal formulations for patients to control migraines when and where a debilitating attack hits. We want to give patients the means to control their migraines in their own hands—tablets comprise the vast majority of migraine therapy prescriptions reflecting patient preference while nasal formulations provide rapid, non-invasive treatment. Based upon our Phase 2 data, we believe our lead candidate, rimegepant, has the potential to be a best-in-class and first-in-class treatment option for the acute treatment of migraine."

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. To the Company's knowledge, rimegepant is the only oral, small molecule CGRP-receptor antagonist currently in development that has achieved statistically significant improvements on all four of these key migraine symptoms within a single study. 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.

"We are very pleased to accomplish this important step in the development of rimegepant and continue our work to bring this important product candidate forward for migraine sufferers. The rimegepant development program is designed to demonstrate comprehensive and durable treatment benefits and a favorable safety profile. Rimegepant may provide a new approach to treating migraine without the cardiovascular risks associated with other drugs," said Robert Croop, M.D., Chief Development Officer – Neurology, at Biohaven.

Biohaven is conducting two double-blind, placebo-controlled Phase 3 clinical trials to evaluate the efficacy and safety of 75 mg of rimegepant, Biohaven's innovative, orally-dosed small molecule CGRP-receptor antagonist, for the acute treatment of migraine. 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. Patients who have participated in the Phase 3 clinical trials may be eligible to participate in a long-term safety study. In addition to rimegepant, Biohaven is also pursuing the development of its third generation CGRP-receptor antagonist, BHV-3500, for the acute and preventive treatment of migraine.

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 36 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 and its potential to be a best-in-class treatment option for the acute treatment of migraine, as well as the size of the potential market for rimegepant, are forward-looking statements. The use of certain words, including the "believe" 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 Vlad.Coric@biohavenpharma.com.


Source: Biohaven Pharmaceutical

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