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/
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 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.
Vlad Coric, M.D.
Chief Executive Officer
SOURCE Biohaven Pharmaceutical Holding Company Ltd.