Biohaven Enrolls First Patient In Pivotal Trial Of Trigriluzole In Patients With Obsessive-Compulsive Disorder

NEW HAVEN, Conn., Dec. 21, 2017 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, today announced that it has commenced enrollment in its Phase 2/3 clinical trial assessing the efficacy and safety of trigriluzole in patients with obsessive-compulsive disorder (OCD).

Biohaven's glutamate modulating prodrug product candidates, including trigriluzole, are being studied in clinical trials and preclinical studies for the treatment of patients with a number of severe neurologic diseases, including forms of ataxia.

"Existing medications for OCD target the neurotransmitters serotonin or dopamine, but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may be a contributing factor in some cases of OCD. We are hopeful that trigriluzole could be a promising alternative to current standards of care due to its potential to moderate excessive glutamate, and we are pleased to have taken this important first step in further exploring its potential," said Vlad Coric M.D., Chief Executive Officer at Biohaven.

Biohaven expects to enroll approximately 226 patients in this randomized, double-blind, placebo-controlled trial across approximately 35 sites in the United States. Researchers will evaluate acute symptomatic treatment with trigiluzole as adjunctive treatment in patients who are experiencing an inadequate response to their current standard of care medication for OCD. The primary outcome measure is the change in a patient's score on the Yale-Brown Obsessive Compulsive Scale, a scale designed to assess the severity and type of symptoms in patients with OCD. The trial will also assess the safety, tolerability and pharmacokinetics of trigriluzole. Additional details about the trial can be found at www.clinicaltrials.gov.

"We are pleased to begin this trial of trigriluzole, a glutamate modulator, for the treatment of OCD.  OCD is often linked with crippling fear, anxiety, discomfort, depression and a host of other serious maladies, and new avenues of treatment are urgently needed. We believe trigriluzole could offer a promising alternative for OCD sufferers who are not adequately responding to currently available therapies," said Loren Aguiar, M.D., Vice President, Research and Development, at Biohaven.

About Obsessive-Compulsive Disorder

OCD affects approximately 1-2% of the population in the United States. The current standards of care include behavioral therapy and selective serotonin reuptake inhibitors. It is estimated that 20-30% of OCD sufferers derive minimal benefit from current treatment options. OCD is a chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that he or she feels the urge to repeat over and over.

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 potential results of the Company's Phase 2/3 trial of trigriluzole in OCD, the potential for the Phase 2/3 trial to be a pivotal trial, the role of glutamate in OCD and the possible benefits of trigriluzole compared to current standard of care for OCD patients, as well as the size of the potential market for trigriluzole in OCD, 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 trigriluzole. 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, Biohaven's Chief Executive Officer at [email protected]

SOURCE Biohaven Pharmaceutical Holding Company Ltd.

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