NEW HAVEN, Conn., April 27, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and
Genpharm Services, a leading partner for innovative pharmaceuticals
in Dubai, announced today an
agreement to distribute NURTEC™ ODT (rimegepant) in the
Middle East and Gulf countries.
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.
Donnie McGrath, Head of Corporate
Strategy and Business Development of Biohaven commented, "Our
agreement with Genpharm is further evidence of our commitment to
make NURTEC ODT as widely available as possible to
patients suffering from migraine, and as quickly as possible,
regardless of location. We are excited to partner with the team at
Genpharm to bring what we believe is the best-in-class oral small
molecule CGRP-antagonist NURTEC ODT to migraine patients in
the Middle East region".
Karim Smaira and Kamel Ghammachi,
Co-Founders of Genpharm Services commented, "Migraine represents a
significant and underappreciated burden for both patients and
society in the Middle East, and
our mission is to bring innovative medicines that can address unmet
needs in this region. We are proud to work with Biohaven
Pharmaceuticals to bring the benefits of the new CGRP-antagonist
NURTEC ODT for the acute treatment of migraine to patients in
the region."
Dr. Mohammed Al Jumah, Professor
of Neurology, Saudi Arabia
commented, "Migraine is very common in the Middle East, possibly more common than in
other parts of the world. Practices across the region see many
patients who fear every day that their life will be disrupted by a
migraine attack. Many are unsure if their current treatment will
work and if they can manage the many side effects of their current
treatments. Fortunately, there has been innovation in migraine
treatments recently, and now patients have the option of
NURTEC ODT, a new oral tablet that is effective, well
tolerated and easy to use for the acute treatment of migraine. It
brings hope for people living with migraine that they can quickly
treat their migraine and get back to living their lives without
fear of the next attack."
The agreement between Biohaven and Genpharm includes NURTEC ODT,
approved in the USA on
February 27, 2020 for the acute
treatment of migraine.
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.
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 biopharmaceutical
company focused on the development and commercialization of
innovative best-in-class therapies to improve the lives of patients
with debilitating neurological and neuropsychiatric diseases.
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 myeloperoxidase (MPO) inhibition for
multiple system atrophy and amyotrophic lateral sclerosis. For more
information, visit http://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 the Biohaven's management about
NURTEC™ ODT as an acute treatment for patients with migraine.
Forward-looking statements include those related to: the 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 the 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 the Biohaven's
product candidates, the potential for the Biohaven's product
candidates to be first in class or best in class therapies and the
effectiveness and safety of the 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 Biohaven's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on February 26, 2020. The
forward-looking statements are made as of this date and the
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 is a trademark of Biohaven Pharmaceutical Holding Company
Ltd.
Biohaven Contact
Vlad
Coric, M.D.
Chief Executive Officer
Vlad.Coric@biohavenpharma.com
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.