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Biohaven Completes Randomization In Phase 2/3 Trial In Spinocerebellar Ataxia: Expected Topline Data Advanced To Fourth Quarter Of 2017

NEW HAVEN, Conn., Aug. 7, 2017 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has commenced dosing of all 141 randomized patients with spinocerebellar ataxia (SCA) in its Phase 2/3 trial of trigriluzole (previously known as BHV-4157). As a result, Biohaven now expects to receive topline results in the fourth quarter of 2017, earlier than previously expected. Trigriluzole, a novel glutamate modulator, is a drug candidate being developed by Biohaven as a potential treatment for patients with SCA, a rare, debilitating, genetic neurodegenerative disorder that affects approximately 22,000 people in the United States. No medications are currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of this devastating condition or any other cerebellar ataxias. Trigriluzole has received both Orphan Drug Designation and Fast Track Designation for the treatment of SCA from the FDA.

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"We are pleased to reach this important milestone in our efforts to advance trigriluzole for treatment of patients with SCA, and we are likewise happy to accelerate our expectation for receiving topline data to Q4 of this year rather than Q1 of next year," said Vlad Coric, M.D., Chief Executive Officer at Biohaven. "Patients with SCA are a highly underserved population who are currently suffering without approved medications, and our goal is to continue to move as rapidly as possible to try to bring this new treatment to market. We would like to thank and acknowledge all of those who are working with us, including the patients who enrolled in this trial, their families and caregivers, the National Ataxia Foundation, and the many academic clinicians, investigators and trial sites who have helped us to advance trigriluzole."

"The rapid progress of enrollment, randomization and dosing in this study reflects the high unmet medical needs and determination of the SCA community," said Robert Berman, M.D., Chief Medical Officer at Biohaven. "Our goal is to achieve a long-awaited breakthrough in the treatment of patients with SCA and we believe that if the topline data is positive, the Phase 2/3 trial may be sufficient to support our application for regulatory approval of trigriluzole."