NEW HAVEN, Conn., March 29, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a
commercial-stage biopharmaceutical company with a marketed drug for
the acute treatment of migraine and a portfolio of innovative,
late-stage product candidates targeting neurological diseases
including rare disorders, today announced that it has enrolled the
first patient in a Phase 2/3 clinical trial of oral zavegepant for
the preventive treatment of migraine.
In August 2020, Biohaven entered
into a funding agreement with Royalty Pharma to secure up
to $250 million to advance the development of zavegepant
in migraine and other CGRP-mediated diseases. Biohaven
previously received $150 million in
funding and will now receive $100
million with the enrollment of this first patient in the
oral zavegepant Phase 3 clinical trial.
Elyse Stock, M.D., Chief Medical
Officer of Biohaven commented, "We are excited to advance the oral
formulation of zavegepant into this late-stage, clinical trial and
broaden our CGRP franchise. We plan on following the science of
CGRP receptor antagonism into pain related disorders and
non-migraine indications. By expanding beyond our migraine
franchise, we are hoping to meet the needs of people impacted by
the debilitating aspects of multiple CGRP-mediated diseases."
The randomized, double-blind, placebo-controlled trial will
enroll approximately 2,900 people with migraine and will evaluate
the efficacy and safety of 100 mg and 200 mg doses of oral
zavegepant. For more information about the trial, visit
clinicaltrials.gov.
"We are pleased to see Biohaven progress oral zavegepent into
Phase 3 for the prevention of migraine, as people suffering from
frequent migraines continue to need additional treatment options,"
said Jim Reddoch, PhD, Royalty Pharma's Co-Head of Research
& Investments and Chief Scientific Officer. "Our successful,
multi-year partnership with Biohaven to support both the regulatory
approval and commercialization of Nurtec as well as pipeline
development is an excellent example of how Royalty Pharma can be a
collaborative partner to innovative biopharma companies."
The zavegepant program encompasses intranasal and oral
formulations for migraine and non-migraine indications. Intranasal
zavegepant previously demonstrated superior efficacy to placebo in
a Phase 2/3 study for the acute treatment of migraine and the
investigational agent is also being studied in an ongoing double
blind, randomized, placebo-controlled trial in COVID-19 infected
hospitalized patients requiring supplemental oxygen.
About Biohaven
Biohaven is a commercial-stage
biopharmaceutical company with a portfolio of innovative,
best-in-class therapies to improve the lives of patients with
debilitating neurological and neuropsychiatric diseases, including
rare disorders. Biohaven's neuroinnovation portfolio includes
FDA-approved NURTECĀ® ODT (rimegepant) for the acute treatment of
migraine and a broad pipeline of late-stage product candidates
across three distinct mechanistic platforms: CGRP receptor
antagonism for the acute and preventive treatment of migraine and
non-migraine CGRP-mediated diseases; glutamate modulation for
obsessive-compulsive disorder, Alzheimer's disease, and
spinocerebellar ataxia; and MPO inhibition for multiple system
atrophy and amyotrophic lateral sclerosis. 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. The use of certain words,
including "believe", "continue", "may", "will" and similar
expressions, are intended to identify forward-looking statements.
These forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Biohaven's management about
zavegepant as an acute and preventive treatment for patients with
migraine and non-migraine CGRP-mediated diseases. Factors that
could affect these forward-looking statements include those related
to: Biohaven's ability to effectively commercialize zavegepant,
delays or problems in the supply or manufacture of zavegepant,
complying with applicable U.S. regulatory requirements, the
expected timing, commencement and outcomes of Biohaven'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 Biohaven's product
candidates, the potential for Biohaven's product candidates to be
first in class or best in class therapies and the effectiveness and
safety of Biohaven's product candidates. 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 Biohaven's Annual Report on Form 10-K for
the year ended December 31, 2020, filed with the Securities
and Exchange Commission on March 1, 2021. The forward-looking
statements are made as of this date and Biohaven 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.
NOJECTION and NURTEC are trademarks of Biohaven Pharmaceutical
Ireland DAC.
Contact:
Dr. Vlad
Coric
Chief Executive Officer
Phone: (203) 404-0410
Email: vlad.coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.