NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ -- Biohaven
Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and
Medison Pharma, Israel's leading
partner for innovative pharmaceuticals, announced today an
agreement to distribute NURTEC™ ODT (rimegepant) in Israel. 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 commented, "Migraine is a common
global disease, and our partnership with Medison marks an important
step in our plan to bring the innovation that is
NURTEC ODT to patients suffering from migraine,
regardless of location. Medison has strong distribution, medical
and access capabilities with a proven track record of delivering
innovative products successfully to patients in Israel. We are excited to partner with Medison
to bring what we believe is the best-in-class oral small molecule
CGRP-antagonist NURTEC ODT to migraine patients in
Israel."
Meir Jakobsohn, Founder and CEO, Medison Pharma commented, "We
are proud to partner and collaborate with Biohaven Pharmaceuticals
to bring the benefits of the best-in-class new CGRP-antagonist
NURTEC ODT for the acute treatment of migraine to patients in
Israel. NURTEC ODT is fully
in keeping with Medison's vision to provide innovative treatments
to patients. Migraine is a serious and often underappreciated
burden for patients and Israeli society, and we will do everything
in our capabilities to secure migraine patients access to
NURTEC ODT."
The agreement between Biohaven and Medison 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 Medison
Medison is one of the world's largest
commercial partners of leading global biotech companies, providing
the complete spectrum of integrated services for international
companies looking to enter or expand their presence in Israel, Canada and CEE markets. Medison operates a
corporate venture arm with a dedicated research and evaluation team
boasting deep scientific and commercial backgrounds. Medison also
operates a scouting program to cater its partners and is an active
investor in life science projects around drug development and
digital health.
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 Company's management
about NURTEC™ ODT as an acute treatment for patients with migraine.
Forward-looking statements include those related to: the Company'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 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, the potential for the Company's product
candidates to be first in class or best in class therapies and the
effectiveness and safety of the Company'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 February 26, 2020. 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.
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.