NEW HAVEN, Conn., March 11, 2021 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and
Genpharm announced today that NURTEC® ODT (rimegepant) was approved
by the United Arab Emirates Ministry of Health and
Prevention for the acute treatment of migraine with and
without aura in adults. NURTEC ODT is the first and only
calcitonin gene-related peptide (CGRP) receptor antagonist
available in a fast-acting orally disintegrating tablet (ODT)
approved for the acute treatment of migraine.
Vlad Coric, M.D., Chief Executive
Officer of Biohaven commented, "We are enthusiastic about joining
forces with Genpharm to expand access of NURTEC ODT to patients
with migraine in the UAE. The expansion of NURTEC ODT into
countries beyond the US is an important step to help patients
suffering from migraines and continues our strategy of global brand
expansion through key distribution agreements."
A single quick-dissolving tablet of NURTEC ODT can provide fast
pain relief and return patients to normal function within one hour,
and deliver sustained efficacy that lasts up to 2 days after a
single dose for many patients. NURTEC ODT disperses almost
instantly in a person's mouth without the need for water, offering
people with migraine a convenient, discreet way to take their
medication anytime and anywhere they need it. NURTEC ODT is not
indicated for the preventive treatment of migraine. Biohaven
partnered with Genpharm to pursue regulatory approval of
the NURTEC ODT dossier in the UAE.
Kamel Ghammachi, Co-Founder and
Chairman of Genpharm commented, "We are proud to announce the UAE
has issued the marketing approval of NURTEC ODT. This is in line
with Genpharm's mission of speeding up the availability of
innovative and ground-breaking medicines for patients in the
region."
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 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. The recommended dose of NURTEC ODT is 75 mg,
taken as needed, up to once daily. For more information about
NURTEC ODT, visit www.nurtec.com.
The most common adverse reaction was nausea (2% in patients who
received NURTEC ODT compared to 0.4% in patients who received
placebo). Avoid concomitant administration of NURTEC ODT with
strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A
or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT
within 48 hours when it is administered with moderate inhibitors of
CYP3A4.
Indication
NURTEC ODT is indicated for the acute
treatment of migraine with or without aura in adults.
Limitations of Use
NURTEC ODT is not indicated for the
preventive treatment of migraine.
Important Safety Information
Contraindications:
Hypersensitivity to NURTEC ODT or any of its components.
Warnings and Precautions: If a serious
hypersensitivity reaction occurs, discontinue NURTEC ODT and
initiate appropriate therapy. Serious hypersensitivity
reactions have included dyspnea and rash, and can occur days after
administration.
Adverse Reactions: The most common adverse reaction
was nausea (2% in patients who received NURTEC ODT compared to 0.4%
in patients who received placebo). Hypersensitivity,
including dyspnea and rash, occurred in less than 1% of patients
treated with NURTEC ODT.
Drug Interactions: Avoid concomitant administration
of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate
inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid
another dose of NURTEC ODT within 48 hours when it is administered
with moderate inhibitors of CYP3A4.
Use in Specific Populations:
- Pregnant/breast feeding: It is not known if NURTEC ODT can harm
an unborn baby or if it passes into breast milk.
- Hepatic impairment: Avoid use of NURTEC ODT in persons with
severe hepatic impairment.
- Renal impairment: Avoid use in patients with end-stage renal
disease.
Please click here for full Prescribing
Information.
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.
Please click here for full Prescribing
Information and Patient Information.
About Genpharm Services
Genpharm Services is a
regional pharmaceutical company, based in the Dubai Science Park
(DSP), UAE, with operations across the Middle East and North Africa (MENA) region. Genpharm is the
leading partner in the region for multinational companies with
innovative therapeutics, in specialty care and rare diseases.
Working with evidence-based medicine and thanks to an established
expert team, Genpharm provides its partners with market access
strategies and sustainable commercial solutions for MENA. For more
information, visit https://www.genpharmservices.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 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;
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 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. 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.
Biohaven Contact
Dr. Vlad
Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.