NEW HAVEN, Conn., Nov. 20, 2017 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today
that the Company has received agreement from the U.S. Food and Drug
Administration (FDA) on the initial pediatric study plan (iPSP) for
orally-dosed rimegepant. Rimegepant is a second-generation, small
molecule, calcitonin gene-related peptide (CGRP) receptor
antagonist being developed for the acute treatment of migraine.
Agreement on an iPSP is one of the regulatory requirements
that must be met prior to submitting a new drug application
(NDA).
"We are pleased to have the FDA's agreement on an iPSP, which
marks another key milestone in our CGRP development program," said
Vlad Coric, M.D., Chief Executive
Officer of Biohaven. "Millions of Americans who suffer from
migraine are not being helped by the current approved therapies,
and we believe rimegepant has the potential to provide them with a
safe and effective migraine treatment with the ease of oral
dosing. We are now another step closer toward preparing our
regulatory package and eagerly await topline data from our two
Phase 3 trials in the first quarter of 2018."
Biohaven recently reported completion of enrollment in the first
of the Company's two pivotal Phase 3 studies evaluating the
efficacy and safety of rimegepant in the acute treatment of
migraine. Patients who have participated in the Phase 3 clinical
trials are eligible to participate in an ongoing long-term safety
study. In addition to rimegepant, Biohaven is also pursuing the
development of its third generation CGRP-receptor antagonist,
BHV-3500, for acute and preventative treatment for migraine.
"Our regulatory team has been working since May of 2017 to gain
alignment with the FDA on the iPSP, and we are very pleased to have
now accomplished this important step toward an NDA filing.
Our development program for rimegepant is designed to demonstrate
comprehensive and durable treatment benefits and a favorable safety
profile for migraine sufferers," said Marianne Frost, Head of Regulatory Affairs at
Biohaven.
About Migraine
Migraine is both a widespread and disabling neurological
disease. The Migraine Research Foundation ranks migraine as the
world's third most prevalent illness, affecting approximately 36
million people in the United
States. Current treatment approaches, such as triptans, can
be limited by headache recurrence within 24 hours after taking
migraine medication, as well as cardiovascular contraindications
and warnings.
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, 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.
Rimegepant is one of only two small molecule CGRP-receptor
antagonists in late stage clinical development.
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 Company's timing of the expected
data readouts from the Company's registrational trials of
rimegepant, the potential for rimegepant to provide a safe
and effective treatment option for the acute treatment of migraine,
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
rimegepant, and whether the results observed in the Phase 2b
clinical trial will be observed in the Phase 3 pivotal trials.
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 November 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.
For further information, contact Dr. Vlad Coric, the Chief Executive
Officer at Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.