NEW HAVEN, Conn., Dec. 13, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven")
announced today that NURTEC ODT (rimegepant) 75 mg was approved by
the Ministry of Health of Israel
for the preventive treatment of episodic migraine in adults. NURTEC
ODT is also approved in Israel for
the acute treatment of migraine with and without aura in adults.
Registration in Israel is the
first approval for NURTEC ODT for the preventive treatment
indication outside the United
States.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "This first approval outside
the United States of our
dual-therapy NURTEC ODT for the acute and preventive treatment of
migraine is an important milestone for patients. Regulatory
approval of NURTEC ODT in Israel
for the preventive treatment of episodic migraine will provide more
patients with access to a novel, non-injectable treatment option
for preventing migraine attacks and reducing monthly migraine days.
NURTEC ODT can have a significant impact on improving patients'
lives through a single medication to treat and prevent migraine
attacks, helping them to gain better control of their disease."
NURTEC ODT is the first oral CGRP receptor antagonist approved
for the preventive treatment of migraine, and the only migraine
medication approved as a dual therapy for both the acute and
preventive treatment. A single dose of NURTEC ODT can deliver pain
relief that's fast and lasts with onset within one hour and durable
through 48 hours for many patients. NURTEC ODT can be taken up to
once daily as needed to treat migraine attacks or taken every other
day to help prevent migraines and reduce the number of monthly
migraine days.
Strategic collaboration with Pfizer for global
commercialization
Biohaven recently announced a strategic
collaboration with Pfizer Inc. for the global commercialization of
rimegepant (marketed in the United
States and some ex-US regions as NURTEC ODT). Under the
partnership, Pfizer gains rights to commercialize rimegepant in
markets outside the U.S. upon approval. Biohaven will continue to
commercialize NURTEC ODT in the U.S. and remain responsible for
further clinical development of the rimegepant franchise. Closing
of the license agreements and equity purchase are contingent on
completion of review under applicable antitrust laws, including the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the
U.S. and equivalents outside the U.S., and other customary closing
conditions.
About NURTEC ODT
NURTEC ODT (rimegepant) is the first
and only calcitonin gene-related peptide (CGRP) receptor antagonist
available in a quick-dissolve ODT formulation that is approved by
the U.S. Food and Drug Administration (FDA) for the acute treatment
of migraine with or without aura and the preventive treatment of
episodic migraine in adults. The activity of the neuropeptide CGRP
is thought to play a causal role in migraine pathophysiology.
NURTEC ODT is a CGRP receptor antagonist that works by reversibly
blocking CGRP receptors, thereby inhibiting the biologic activity
of the CGRP neuropeptide. For more information about NURTEC ODT,
visit www.nurtec.com.
Indication
NURTEC ODT orally disintegrating tablets is
a prescription medicine that is used to treat migraine in adults.
It is for the acute treatment of migraine attacks with or without
aura and the preventive treatment of episodic migraine. It is not
known if NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT if
you are allergic to NURTEC ODT (rimegepant) or any of its
ingredients. Before you take NURTEC ODT, tell your healthcare
provider (HCP) about all your medical conditions, including if
you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
NURTEC ODT may cause serious side effects including allergic
reactions, trouble breathing and rash. This can happen days after
you take NURTEC ODT. Call your HCP or get emergency help right away
if you have swelling of the face, mouth, tongue, or throat or
trouble breathing. This occurred in less than 1% of patients
treated with NURTEC ODT.
The most common side effects of NURTEC ODT were nausea (2.7%)
and stomach pain/indigestion (2.4%). These are not the only
possible side effects of NURTEC ODT. Tell your HCP if you have any
side effects.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088
or report side effects to Biohaven at 1–833–4NURTEC.
See full Prescribing Information and Patient Information.
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 ODT (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,
Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition
for amyotrophic lateral sclerosis. More information about Biohaven
is available at www.biohavenpharma.com.
Forward-looking Statement
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", "may" and "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 NURTEC
ODT as an acute treatment for patients with migraine.
Forward-looking statements include those related to: Biohaven's
ability to effectively commercialize NURTEC ODT, delays or problems
in the supply or manufacture of NURTEC ODT, 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 the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 1, 2021, and the
Company's Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission on November 9,
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.
NURTEC and NURTEC ODT are registered trademarks of Biohaven
Pharmaceutical Ireland DAC.
Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding
Company Ltd.
Biohaven Contact:
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
Media Contact:
Mike
Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.