Biohaven to Present Key and Expanded Data from Phase 3 Clinical Trials of Rimegepant, its Oral CGRP Receptor Antagonist, During Four Late-Breaking Sessions at American Headache Society (AHS) Annual Scientific Meeting 2018

Published: Jun 05, 2018

NEW HAVEN, Conn., June 5, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that expanded data from two randomized, pivotal Phase 3 clinical trials of rimegepant, along with other important preclinical and clinical results, will be presented at the American Headache Society (AHS) 60th Annual Scientific Meeting in San Francisco, CA, June 28-July 1, 2018.

Biohaven is presenting further results from its two pivotal Phase 3 clinical trials with rimegepant in the acute treatment of migraine. Researchers will present data on the durability and consistency of clinical effect seen with a single oral dose across multiple outcome measures from both trials. Biohaven will also present results from a preclinical study in which its CGRP receptor antagonists were not observed to have vasoconstrictive properties in human coronary or cerebral arteries. Expanded data from a Phase 1 trial evaluating the bioequivalence of oral tablet and orally dissolving tablet formulations of rimegepant also will be discussed.

Vlad Coric, M.D., CEO of Biohaven commented, "We are grateful to the AHS for accepting four late-breaking presentations regarding rimegepant. Biohaven is pleased to be able to present the full breadth of our Phase 3 trials that demonstrate the clinical benefit of rimegepant on multiple outcome measures important to migraine patients, including sustained pain freedom and pain relief, and improvement on measures of functional disability. We are also excited to present in vitro human artery data supporting the potentially favorable cardiovascular profile of rimegepant. The Biohaven team looks forward to sharing our clinical and preclinical results with the patients and medical community at AHS."

The schedule of Biohaven presentations at AHS includes:

  • Late-breaking oral presentation IOR-02LB
    Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg, an Oral CGRP Receptor Antagonist, for the Acute Treatment of Migraine: Results from a Double-Blind, Randomized, Placebo-Controlled Trial, Study 302
    Date and Time: Saturday, June 30, 10:00-10:10 a.m.
    Presenter: Richard B. Lipton, MD, Albert Einstein College Of Medicine
  • Late-breaking poster presentation PS123LB
    Title: Efficacy, Safety, and Tolerability of Rimegepant 75 mg, an Oral CGRP Receptor Antagonist, for the Acute Treatment of Migraine: Results from a Double-Blind, Randomized, Placebo-Controlled Trial, Study 301
    Date and Time: Saturday, June 30 (all day with presenter Q&A 1:00-2:15 p.m.)
    Presenter: Richard B. Lipton, MD, Albert Einstein College Of Medicine
  • Late-breaking poster presentation PF116LB
    Title: A Phase 1 Study to Evaluate the Bioequivalence of Oral Tablet and Orally Dissolving Tablet Formulations of Rimegepant in Healthy Adult Subjects Under Fasting Conditions
    Date and Time: Friday, June 29 (all day with presenter Q&A 1:15-2:15 p.m.)
    Presenter: Robert Croop, MD, Biohaven
  • Late-breaking oral presentation LBOR-08
    Title: Rimegepant and BHV-3500, Small Molecule CGRP Receptor Antagonists, Exhibit No Active Vasoconstrictive Properties in Ex Vivo Human Coronary or Cerebral Arteries
    Date and Time: Saturday, June 30, 3:05 PM - 3:15 p.m.
    Presenter: Charles M. Conway, PhD, Biohaven

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 statements about rimegepant's potentially favorable cardiovascular profile and its potential to be an improved and effective treatment option for the acute treatment of migraine, are forward-looking statements. The use of certain words, including "potential" and "will" and similar expressions, is 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 those described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2018 and other filings Biohaven makes with the U.S. Securities and Exchange Commission from time to time. 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

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.


Company Codes: NYSE:BHVN

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