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Biopharmaceuticals FDA

 News Release - March 18, 2020

Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy

NEW HAVEN, Conn., Mar. 18, 2020 -- (Healthcare Sales & Marketing Network) -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, announced today that the Company's myeloperoxidase (MPO) inhibitor, verdiperstat, received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of multiple system atrophy (MSA).

Irfan Qureshi, MD, Vice President of Neurology at Biohaven, commented, "We are extremely pleased that the FDA has granted Fast Track designation for verdiperstat, acknowledging the high unmet medical need for people suffering with MSA. The Fast Track designation may help accelerate the development of verdiperstat as the first treatment aimed at slowing progression of this devastating disease."

The FDA's Fast Track designation provides for an expedited review of potential new drugs intended to treat serious conditions with high unmet need, allowing important new drugs to become available more quickly to patients suffering from serious conditions. Benefits of Fast Track designation include enhanced interaction with the FDA as well as the eligibility to obtain accelerated approval and priority review at the time of a New Drug Application (NDA) filing if relevant criteria are met. More information about FDA Fast Track designation can be found at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

"We are grateful to the FDA for recognizing the serious and urgent need to accelerate the development of a potential new treatment for people living with MSA," commented Pamela Bower, Secretary of the MSA Coalition. "Each day that is saved through the Fast Track process brings us one day closer to providing hope to the MSA community," added Philip Fortier, Executive Director of the Defeat MSA Alliance. More information about the MSA Coalition and Defeat MSA Alliance is available at www.multiplesystematrophy.org and www.defeatmsa.org.

Verdiperstat is a potential first-in-class, oral, brain-penetrant, irreversible inhibitor of myeloperoxidase, an enzyme that acts as a key driver of pathological oxidative stress and inflammation in the brain. A phase 3, multinational clinical trial is currently ongoing to evaluate the efficacy of verdiperstat in MSA across approximately 50 sites in the United States and Europe. Additional details about the Study of Verdiperstat in Subjects with Multiple SysTem AtRophy (referred to as "M-STAR") can be found at clinicaltrials.gov/ct2/show/NCT03952806 and www.msaresearchstudy.com.

About Multiple System Atrophy

MSA is a rare, rapidly progressive, and fatal neurodegenerative disease. Only symptomatic and palliative therapies are currently available. MSA causes Parkinson's disease-like movement problems (slow movement, rigid muscles, tremor, and poor balance), cerebellar ataxia, as well as problems with involuntary (autonomic) functions, including blood pressure control, bladder function, and digestion. MSA usually leads to death after an average of 6 to 10 years from the onset of symptoms.

About Verdiperstat

Biohaven licensed verdiperstat (BHV-3241) from AstraZeneca AB in September 2018, where it was known as AZD3241. The M-STAR study is a currently ongoing phase 3 clinical trial designed to evaluate the efficacy of verdiperstat in MSA. Verdiperstat received Orphan Drug designation from the US FDA as well as the European Medicines Agency due to the unmet medical need in MSA. Verdiperstat also has the potential to be developed in a number of other diseases associated with oxidative stress, inflammation, and neurodegeneration. A clinical trial designed to evaluate the efficacy of verdiperstat in amyotrophic lateral sclerosis (ALS) is being planned in collaboration with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. More information about the HEALEY ALS Platform Trial can be found at www.massgeneral.org/als.

About Biohaven

Biohaven is a biopharmaceutical company focused on the development and commercialization of innovative best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: calcitonin gene-related peptide (CGRP) receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. For more information, visit 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 effectiveness and safety of verdiperstat, the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2020. 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.

NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.


Source: Biohaven Pharmaceutical

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