NEW HAVEN, Conn., Mar. 18, 2020 /PRNewswire/ -- 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 NURTECâ„¢
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.
Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
NURTEC is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.