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Biohaven Completes Enrollment In Pivotal Phase 2/3 Alzheimer's Disease Clinical Trial Of Troriluzole

- Over 700 patients enrolled in the T2 Protect AD Study evaluating troriluzole in symptomatic treatment of mild-to-moderate Alzheimer's disease

- Secondary and exploratory measures to assess if troriluzole can protect against, slow down, and potentially improve memory and thinking problems of Alzheimer's disease

- Interim futility analysis results expected in the fourth quarter of 2019

NEW HAVEN, Conn., Nov. 5, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN) a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that it has completed enrollment in the T2 Protect AD Study, a Phase 2/3 clinical trial of troriluzole in Alzheimer's disease. An interim futility analysis examining standard cognitive assessments and volumetric magnetic resonance imaging (MRI) is expected before the end of 2019.

Howard Feldman, MD, FRCP, director of the Alzheimer's Disease Cooperative Study (ADCS) and professor of neurosciences at University of California San Diego.

"We are hopeful this study will demonstrate that troriluzole can ameliorate the symptoms of Alzheimer's disease, by reducing synaptic glutamate through a novel mechanism of action," said Howard Feldman, MD, FRCP(C), Director of the Alzheimer's Disease Cooperative Study (ADCS) and Professor of Neurosciences at the University of California San Diego School of Medicine, who is Principal Investigator of the T2 Protect AD Study. "Glutamate is one of the only clinically validated therapeutic targets for Alzheimer's disease."

The T2 Protect AD Study (clinicaltrials.gov identifier NCT03605667) is a Phase 2/3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of troriluzole in patients diagnosed with Alzheimer's disease of mild-to-moderate severity (Mini-Mental State Examination scores of 14-24). Patients are randomized on a 1:1 basis to receive 280 mg of troriluzole or placebo once daily for 48 weeks. The trial is being conducted in collaboration with the ADCS at UC San Diego School of Medicine. More information about the trial can be found at the website: http://www.t2protect.org/

Vlad Coric, M.D., CEO of Biohaven commented, "Given the devastating impact of Alzheimer's disease on patients, their families and the healthcare system, we need to urgently assess novel treatment interventions targeting the underlying pathophysiology of this illness. We are grateful to the ADCS and patients participating in our trial to assess the potential efficacy of our glutamate modulator, troriluzole, in this illness."

Alzheimer's disease is a progressive, fatal neurodegenerative dementia that accounts for 60 to 80 percent of dementia cases. Alzheimer's disease currently has no cure. Although there are FDA-approved medications for symptomatic treatment, their clinical benefits are generally limited.

"We are extremely grateful to all the trial participants and their families, as well as our trial sites, for helping us achieve this milestone," commented Irfan Qureshi, MD, Vice President of Neurology at Biohaven. "We believe that troriluzole is a promising potential therapy for people suffering from Alzheimer's disease and look forward to the study results, including the interim analysis by the end of this year."

About Troriluzole

Troriluzole is a third-generation prodrug and new chemical entity that modulates glutamate, the most abundant excitatory neurotransmitter in the human body. The primary mode of action of troriluzole is reducing synaptic levels of glutamate. Troriluzole increases glutamate uptake from the synapse, by augmenting the expression and function of excitatory amino acid transporters (i.e., EAAT2) located on glial cells that play a key role in clearing glutamate from the synapse. More information about trorilzuole can be found at the Company's website: https://www.biohavenpharma.com/science-pipeline/glutamate/troriluzole

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, and ALS Biopharma LLC. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven'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.

About ADCS

The Alzheimer's Disease Cooperative Study (ADCS) at the University of California San Diego is an academic research organization that promotes the discovery and testing of new drugs for the treatment of Alzheimer's disease. ADCS was developed in response to an urgent need to advance research in the development of drugs that might be useful for treating patients across the spectrum of Alzheimer's disease.

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 expected enrollment for the Company's Phase 2/3 trial of troriluzole in AD, the potential results of the Company's Phase 2/3 trial of troriluzole in AD, the potential role of glutamate in AD, the possible benefits of troriluzole for AD patients, as well as the size of the potential market for troriluzole in AD, 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 troriluzole. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2018, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. 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.

Biohaven Contact

Dr. Vlad Coric
Chief Executive Officer

Biohaven Pharmaceuticals Logo (PRNewsfoto/Biohaven Pharmaceutical Holding)

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