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.
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.