Biohaven and BioShin Announce Positive Pivotal Trial Results of rimegepant (NURTEC® ODT) for the Acute Treatment of Migraine in China and Korea

Biohaven and BioShin Announce Positive Pivotal Trial Results of rimegepant (NURTEC® ODT) for the Acute Treatment of Migraine in China and Korea

- NURTEC® ODT is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist todemonstrate positive results in a pivotal trial in Asia-Pacific region where over 100 million patientsin China and Korea alone suffer from migraine

- The Study demonstrated statistical significance on both regulatory co-primary endpoints of painfreedom (p<0.0001) and freedom from most bothersome symptom (p<0.0001) at 2 hours

- A single oral dose of NURTEC ODT 75 mg provided both fast pain relief and freedom from most bothersome symptom within 45 minutes, return to normal functioning within 60 minutes, pain freedom within 90 minutes, and sustained efficacy that lasts up to 2 days for many patients

- This is the fourth NURTEC ODT positive pivotal trial to achieve significance on the regulatory coprimary endpoints and will be the basis for planned New Drug Application (NDA) submissions in China and Korea


NEW HAVEN, Conn. and NEW YORK, Feb. 10, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and its China-based subsidiary, BioShin Limited, today announced positive topline results from an Asia-Pacific Phase III clinical trial of rimegepant (NURTEC® ODT) for the acute treatment of migraine. Led by the BioShin, the Phase 3 regional multi-center study BHV3000-310 met the co-primary endpoints evaluating the efficacy and safety of orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist.


This is the fourth positive Phase 3 study of NURTEC ODT for the acute treatment of migraine and the first to be conducted in the Asia Pacific region. The study met its co-primary registrational endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2 hours using a single dose of Nurtec ODT. Approximately 1,431 subjects were randomized in the trial with 80% of the subjects enrolled in China and the remaining 20% in Korea. Nurtec ODT showed a favorable safety and tolerability profile among study participants that was consistent with prior clinical trial experience in the US trials.


Donnie McGrath, M.D., President and Executive Chairman of BioShin commented, "We are very grateful to the patients, sites and investigators in China and Korea who contributed to the success of this large trial. These pivotal trial results clearly show the consistent global performance of NURTEC ODT in the rapid and sustained relief of migraine symptoms and quickly returning patients to normal function. Through our partnership with Pfizer announced in November 2021, we are committed to rapidly expanding the availability of NURTEC ODT to patients in the Asia Pacific Region and around the world.”


Professor Shengyuan Yu, Principal Investigator of the BHV3000-310 study and Director of the Department of Neurology, Chinese PLA General Hospital, said, “According to the results of the World Health Organization (WHO) 2013 Global Burden of Disease Survey published in The Lancet, migraine is the third most common human disease and the first cause of disability in under 50s, and we need new, effective and safe treatment options to help improve the lives of our patients. The success of study BHV3000-310 demonstrates that rimegepant is a welcome treatment option for migraine patients in Asia, and I look forward to having rimegepant available for patients in China in the near future.”


Karl Lintel, M.D., CEO of BioShin, added, “The results from this study demonstrate the effectiveness of NURTEC ODT and highlight the important impact that it will likely have for patients in the Asia-Pacific region if approved. The successful completion of this study and high-quality results also highlight our global expertise in running complex neuroscience clinical trials -- I’m so proud of the BioShin R&D team who delivered these results and look forward to submitting our new drug applications to the regulatory agencies in China and Korea for approval.”


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 with or without aura and the preventive treatment of episodic 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 to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. 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 Migraine

More than one billion people worldwide suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.


CGRP Receptor Antagonism

Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine. CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. For acute treatment, this unique mode of action potentially offers an alternative to other agents, particularly for patients who have contraindications to the use of triptans or who have a poor response to triptans or are intolerant to them. CGRP signal-blocking therapies have not been associated with medication overuse headache (MOH) or rebound headaches which limits the clinical utility of other acute treatments due to increases in migraine attacks that result from frequent use.


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 and preventive 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 amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.


Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements regarding the future development, timing and potential marketing approval and commercialization of NURTEC ODT (rimegepant). Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forwardlooking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 1, 2021, and Biohaven's subsequent filings with the Securities and Exchange Commission. 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.

Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.


BioShin

Dr. Karl Lintel

Chief Executive Officer

Karl.lintel@bioshin.com


Media Contact:

Zoey Wang

Chief Operating Officer

Zoey.wang@bioshin.com