Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding
Company Ltd. (NYSE: BHVN) today announced that the European
Commission (EC) has granted marketing authorization for VYDURA®
(rimegepant), a calcitonin gene-related peptide (CGRP) receptor
antagonist for both the acute treatment of migraine with or without
aura, and prophylaxis of episodic migraine in adults who have at
least four migraine attacks per month. VYDURA®, an orally
disintegrating tablet, is the first medicine approved for both
acute and prophylactic treatment of migraine in the European Union
(EU). Migraine is a leading cause of disability worldwide with
approximately one in ten people living with the condition in Europe
alone. Globally, migraine disproportionately affects women by three
to four times compared to men.
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“There is a significant unmet need for people in the European
Union living with the pain and disability caused by frequent
migraines,” said Nick Lagunowich, Global President, Pfizer Internal
Medicine. “The comprehensive clinical program has established
VYDURA’s efficacy and safety as both an acute and preventive
treatment of migraine. Studies in acute migraine demonstrated a
rapid and long-lasting relief of migraine headache and other
symptoms with a single dose, while the prevention study found a
significant reduction in migraine attacks with every other day
dosing. We have great confidence in the positive impact VYDURA
could have on people living with this debilitating condition in the
EU.”
Results from the Phase 3 study published in Lancet demonstrated
that a single dose of rimegepant provided superior pain reduction
and associated symptoms of migraine at two hours compared to
placebo. The prevention study, also published in Lancet,
demonstrated that rimegepant taken every other day provided
superior reduction in the number of days per month with migraine in
Weeks 9 –12 of the 12-week treatment period compared to placebo,
that was maintained with continued dosing during the 12-month
open-label extension period.
“Today’s approval marks a huge step forward for patients in
Europe who are living with migraine. Migraine is often overlooked
and undertreated, resulting in substantial disability with
suboptimal care for patients,” commented Professor Peter Goadsby,
Director of the National Institute for Health and Care Research
(NIHR) Clinical Research Facility and Professor of Neurology at
King’s College London. “VYDURA’s promising efficacy and favorable
benefit-risk profile spark hope for people in need of new migraine
treatment options. This approval has the potential to advance the
standard of care for migraine in the EU and I am hopeful it will
improve the quality of life for many people living with the burden
of this prevalent neurological disease.”
The Marketing Authorization follows the recommendation for
approval by the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) in February. The EC
approval will be valid for all 27 EU member states as well as
Iceland, Liechtenstein, and Norway and local reimbursement approval
will follow. Assessment of the marketing authorization application
by the Medicines & Healthcare products Regulatory Agency (MHRA)
is underway and approval is expected to shortly follow in the
United Kingdom.
About VYDURA® (rimegepant) VYDURA® targets a key
component of migraine by reversibly blocking CGRP receptors. CGRP
is increased during a migraine attack, dilates blood vessels and is
involved in nociceptor signaling. CGRP receptor antagonists work by
reversibly blocking CGRP receptors, thereby inhibiting the biologic
activity of the endogenous CGRP neuropeptide.
The Marketing Authorization for VYDURA® was based, in part, on
the review of the results from three Phase 3 studies for acute
treatment, a long-term, open-label safety study in acute treatment
of migraine and a Phase 3 study with a 1-year open-label extension
in the preventive treatment of migraine. VYDURA® is taken orally as
needed, up to once daily, to stop migraine attacks or taken every
other day to help prevent migraine attacks.
The most frequent adverse event in clinical trials with VYDURA®
was nausea, occurring in 3% of patients compared to 1% with
placebo, while hypersensitivity reactions including rash occurred
in less than 1% of patients. Less than 2% of patients discontinued
from VYDURA® due to adverse events. VYDURA® does not have addiction
potential and was not associated with medication overuse headache
or rebound headache in clinical trials, although overuse of any
type of medicinal products for headache can make them worse.
VYDURA® is commercialized as Nurtec® and Nurtec® ODT outside
Europe. It is commercialized in the U.S. for the acute treatment of
migraine and for the preventive treatment of episodic migraine in
adults, and ex-U.S. is approved for the acute treatment of migraine
in Kuwait and the United Arab Emirates, and for acute treatment of
migraine and preventive treatment of episodic migraine in
Israel.
Earlier this year, Pfizer and Biohaven entered into an agreement
for the commercialization of VYDURA®. Under the terms of the
agreement, Pfizer has commercialization rights to rimegepant in
markets outside the U.S. Biohaven continues to lead research and
development globally and retains the U.S. market.
About Migraine More than one billion people worldwide
suffer from migraine. Migraine is characterized by debilitating
attacks lasting four to 72 hours with multiple symptoms, including
pulsating headaches of moderate to severe pain intensity that can
be associated with nausea or vomiting, and/or sensitivity to sound
(phonophobia) and sensitivity to light (photophobia). There is a
significant unmet need for new treatments as more than 90 per cent
of people with migraine are unable to work or function normally
during an attack.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us.
We routinely post information that may be important to investors
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Pfizer Disclosure Notice The information contained in
this release is as of April 27, 2022. Pfizer assumes no obligation
to update forward-looking statements contained in this release as
the result of new information or future events or developments.
This release contains forward-looking information about VYDURA®
(rimegepant) including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; the risk that clinical trial
data are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from the clinical studies;
whether and when any applications may be filed for rimegepant in
any other jurisdictions; whether and when regulatory authorities
may approve any applications that may be pending or filed for
rimegepant in any jurisdictions, which will depend on a myriad
factors, including making a determination as to whether the
product’s benefits outweigh its known risks and determination of
the product’s efficacy and, if approved, whether rimegepant will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of rimegepant; whether the collaboration between Pfizer and
Biohaven will be successful; uncertainties regarding the impact of
COVID-19 on Pfizer’s business, operations and financial results;
and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2021 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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 Nurtec® (rimegepant) for the acute and preventive
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; glutamate modulation for obsessive-compulsive disorder,
and spinocerebellar ataxia; MPO inhibition for amyotrophic lateral
sclerosis; and Kv7 Ion Channel Activators (Kv7), and myostatin.
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 regarding the future development, timing and potential
marketing approval and commercialization of VYDURA® (rimegepant).
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 February 25, 2022, and
Biohaven's subsequent filings with the Securities and Exchange
Commission. 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.
VYDURA® is a registered trademark of Biohaven Pharmaceutical
Ireland DAC. Nurtec® and Nurtec® ODT are registered trademarks of
Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark
of Biohaven Pharmaceutical Holding Company Ltd.
Category: Medicines
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Pfizer Media Relations EU AfME +44 (0) 1737 332 335
EUPress@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
Biohaven Media Relations Counselor Mike Beyer Sam Brown
Inc. mikebeyer@sambrown.com +1 (312) 961-2502
Investor Relations Jen Porcelli, VP, Investor Relations
jennifer.porcelli@biohavenpharma.com +1 (201) 248-0741
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