Biohaven Receives FDA May Proceed Letter for Phase 2/3 Clinical Trial of Trigriluzole in Patients with Obsessive-Compulsive Disorder

NEW HAVEN, Conn., Oct. 24, 2017 /PRNewswire/ -- (NYSE: BHVN) Biohaven Pharmaceutical Holding Company Ltd. (Biohaven or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its clinical investigation of trigriluzole, a novel glutamate modulator, as a potential treatment for patients with obsessive-compulsive disorder (OCD). The FDA "May Proceed Letter" was received following Biohaven's filing of an investigational new drug (IND) application for this program, and the Company expects to commence a Phase 2/3 clinical trial of trigriluzole in OCD in the current quarter.

"OCD is a serious neuropsychiatric disorder for which many patients do not have effective or tolerable therapy, and in which glutamate dysregulation may play a significant role.  We are very pleased to explore the potential of trigriluzole as a safe and effective therapy for these patients as part of our mission to develop best-in-class and first-in-class therapies for patients with severe neurologic and neuropsychiatric diseases," said Vlad Coric, M.D., Chief Executive Officer of Biohaven.

OCD is a chronic and disabling condition characterized by symptoms of obsessions (intrusive thoughts) and compulsions (repetitive behaviors) that can interfere with patients' functional abilities.  Current first-line drug treatment options include pharmaceutical agents which may be ineffective or produce significant side effects in many patients.  Clinical evidence suggests that dysregulation of glutamate, which plays an essential role in normal brain functioning and is present in over 90% of brain synapses, may contribute to the underlying cause of OCD. Trigriluzole is a novel third-generation prodrug glutamate modulator representing more than six years of chemistry research and development involving over 300 drug candidates.  Trigriluzole has been observed to have a favorable safety and tolerability profile in clinical trials. Exposure data from recent clinical experience with trigriluzole has helped inform the dosing of trigriluzole in the planned OCD Phase 2/3 trial.

Development Across Two Technology Platforms

Beyond its planned Phase 2/3 trial in OCD, Biohaven is making progress across its oral, small molecule calcitonin gene-related peptide (CGRP) receptor antagonist and glutamate modulation technology platforms.

In its CGRP antagonist platform, the Company anticipates a number of important upcoming milestones. Enrollment and randomization continue to proceed rapidly in both of Biohaven's Phase 3 clinical trials of rimegepant for the acute treatment of migraine, and the Company expects to report topline results in the first quarter of 2018. Data from the long-term safety study is expected to support a potential NDA submission in the first half of 2019. Biohaven also expects to file an IND with the FDA by the end of this year for BHV-3500 for the treatment of migraine.

In its glutamate modulation platform, Biohaven anticipates commencing a bioequivalence study for BHV-0223 for the treatment of patients with amyotrophic lateral sclerosis (ALS) in the fourth quarter of 2017. With regard to BHV-5000, a low trapping NMDA receptor antagonist in-licensed from AstraZeneca AB, the company continues to optimize its formulation to support a Phase 1 pharmacokinetic trial in Rett syndrome, as well as other neuropsychiatric indications. Biohaven is also continuing a long-term (48-week) extension study of trigriluzole in patients with SCA.

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, 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 regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the role that glutamate may play in the causes, symptoms and treatment of OCD, the safety and efficacy of trigriluzole, and the timing and outcome of expected regulatory filings. The use of certain words, including "believe", "may", "expects" 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. 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 August 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.

Contact

Dr. Vlad Coric
Chief Executive Officer
Biohaven Pharmaceutical Holding Company Ltd.
Phone: (203) 404-0410
Email: vlad.coric@biohavenpharma.com

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