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Biohaven (BHVN) Enrolls First Patient In Pivotal Phase III Clinical Trial Of Oral Rimegepant For The Acute Treatment Of Migraine



7/24/2017 6:21:23 AM

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NEW HAVEN, Conn., July 24, 2017 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced enrollment in the first of its two registrational Phase 3 clinical trials to evaluate the safety and efficacy of orally-dosed rimegepant (BHV-3000) for the acute treatment of migraine. Biohaven expects to begin enrollment in the second Phase 3 clinical trial this summer and report topline results for both studies in the first half of 2018.

Biohaven traded on the NYSE (Photo Credit: NYSE)

"Large numbers of migraine patients, including those with cardiovascular disease or hypertension for whom existing treatment options such as triptans are contraindicated, may benefit from a safe and effective oral CGRP receptor antagonist medication that provides rapid and sustained relief from pain," said Vlad Coric, M.D., Chief Executive Officer at Biohaven.  "Based on the results of its Phase 2b clinical trial, we believe rimegepant has the potential to be a best-in-class treatment option, combining early, comprehensive, and durable efficacy with convenient oral dosing, so that patients are spared the need for any intravenous or subcutaneous administration."

Biohaven plans to conduct two double-blinded, 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 a demonstrated effect on the patient's most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing. Patients in the Phase 3 clinical trials will be eligible to participate in a long-term safety study.

In a previously completed Phase 2b clinical trial, the 75 mg dose of rimegepant was observed to have achieved 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 improvement 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.

Rimegepant is the most advanced candidate in Biohaven's CGRP receptor antagonist platform. Biohaven is also pursuing the development of BHV-3500 for the treatment of patients with chronic and episodic migraine. Biohaven's CGRP platform is focused on delivering oral or intranasal therapies for migraine that are easy to use for patients when and where a debilitating migraine attack hits.

"We are very pleased to begin the Phase 3 development of this important product candidate for migraine sufferers. We also plan to demonstrate, through our long-term safety study, a low risk of cardiovascular side effects and favorable safety profile in addition to comprehensive and durable treatment effects observed in the acute studies," said Elyse Stock, M.D., Chief of Portfolio Development and Strategy at Biohaven.

About Migraine 
Migraine is both widespread and disabling neurological disorder. 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 June 16, 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.

Biohaven Pharmaceuticals Logo

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.


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