NEW HAVEN, Conn., July 10, 2019 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN), announced today
that positive results from a Phase 3 pivotal clinical trial of
rimegepant, Biohaven's small molecule calcitonin gene-related
peptide (CGRP) receptor antagonist, for the acute treatment of
migraine, are published in the July 12,
2019 issue of the New England Journal of Medicine
(NEJM). These data show that, compared to placebo, patients treated
with a single dose of oral rimegepant 75mg experienced superior,
rapid pain freedom and freedom from the most bothersome
migraine-associated symptom.
"The results from this study demonstrate rimegepant's potential
as an effective treatment for migraine, a widespread, disabling
disease that has seen only minimal improvements in acute treatment
since the 1990s," said Richard B.
Lipton, M.D., Lead Author, Professor and Vice Chair of
Neurology at the Albert Einstein College of Medicine and Montefiore
Health System, Director of the Montefiore Headache Center, and
Chair of Biohaven's CGRP Scientific Advisory Board. "I hope the
publication of these data in the New England Journal of
Medicine, a journal with worldwide reach and significance, will
bring attention to this complex neurological condition and the need
for new treatment options."
In this pivotal Phase 3 trial of rimegepant, 1,186 patients were
randomized to receive a single dose of either rimegepant or
placebo. A broad spectrum of clinically meaningful benefit compared
to placebo was seen across multiple outcome measures, including the
co-primary endpoints of pain freedom and freedom from the most
bothersome symptom at two hours post-dosing.
A single dose of rimegepant 75mg was demonstrated to have
significant superiority on pain freedom and pain relief at 2 hours,
freedom from the most bothersome symptom at 2 hours as well as
photophobia and phonophobia at 2 hours. Additionally, rimegepant
was numerically superior in terms of sustained pain freedom and
pain relief through 48 hours and the ability to return to function
at 2 hours.
Rimegepant was generally well tolerated with a low incidence of
side effects. The most frequent adverse events were nausea,
occurring in 1.8% of rimegepant patients, as compared to 1.1% of
patients on placebo and urinary tract infection (UTI), occurring in
1.5% of rimegepant patients, as compared to 1.1% of patients on
placebo. Serious adverse events were observed in one patient in the
rimegepant group (back pain) and two patients in the placebo group
(Chest Pain and UTI). Additionally, rimegepant demonstrated a liver
safety profile similar to placebo in this acute treatment
trial.
"Publication in this prestigious journal allows us to share the
positive data from this pivotal Phase 3 trial of rimegepant with
the broader scientific community. These results are representative
of the consistent benefit of rimegepant in migraine we have seen
across our entire clinical program," said Vlad Coric, M.D., CEO of Biohaven. "As we
previously guided, we submitted a New Drug Application with the
U.S. Food and Drug Administration in the second quarter of this
year and are looking forward to working with the Agency to advance
this new candidate drug for acute treatment to the millions of
people suffering from migraine in the U.S."
About Rimegepant
Rimegepant is Biohaven's orally-dosed calcitonin gene-related
peptide (CGRP) receptor antagonist, which the Company is developing
as a treatment for migraine. Rimegepant represents a novel
mechanism that targets the underlying pathophysiology of migraine
without causing vasoconstriction. The efficacy and safety profile
of rimegepant for the acute treatment of migraine has now been
established across four randomized controlled trials to date: the
three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in
all three Phase 3 trials are consistent with regulatory guidance
from the FDA and provide the basis for the NDA submission to the
FDA.
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, ALS Biopharma LLC and
Massachusetts General Hospital. Currently, Biohaven's lead
development programs include multiple compounds across its CGRP
receptor antagonist, glutamate modulation and myeloperoxidase
inhibition platforms. 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.
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 rimegepant, 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 28, 2019 and the Company's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and
Exchange Commission on May 8, 2019.
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
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
For Media:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.