Key Trials of NURTEC(R) ODT for acute migraine treatment in the Asia-Pacific region reached primary endpoints

NURTECODT®is the first oral calcitonin gene-associated peptide (CGRP) receptor antagonist to show positive results in a key trial in the Asia-Pacific region, with more than 100 million patients suffering from migraines in China and South Korea alone

- This study shows that pain is eliminated within 2 hours (p

- NURTEC ODT with a single oral dose of 75 mg provides rapid pain relief and elimination of the most disturbing symptoms in 45 minutes, returns to normal function within 60 minutes, eliminates pain within 90 minutes, and for many patients, its sustained efficacy can reach 2 days

This is the fourth key trial of NURTEC ODT to achieve a significant common primary endpoint and will form the basis for planned Chinese and Korean new drug applications (NDAs).

NEW HAVEN, CONNECT AND NEW YORK, FEB 15, 2022 /PRNEWS/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and its China-based subsidiary BioShin Limited today announced positive results in the Asia-Pacific Phase III clinical trial of rimegepant (NURTECODT®) for the acute treatment of migraines. Led by BioShin, the Phase III regional multicentre study of BHV3000-310 achieved a common primary endpoint evaluating the efficacy and safety of oral calcitonin gene-associated peptide (CGRP) receptor antagonist rimegepant oral disintegration tablets (ODT).

This is the fourth positive Phase 3 study of NURTEC ODT for acute treatment of migraine and the first in the Asia-Pacific region. The study achieved a common primary endpoint of pain elimination and most troublesome symptom (MBS) elimination within 2 hours of using a single dose of NURTEC ODT. About 1431 subjects were randomized in the trial, with nearly 80 percent enrolled in China and about 20 percent in South Korea. NURTEC ODT has shown good safety and tolerability among study participants, which is consistent with previous clinical trial experience in U.S. trials.

BioShin President and Executive Chairman Donnie McGrath, M.D.

"We would like to express our heartfelt gratitude to the patients, research institutions and researchers in China and South Korea who have contributed greatly to the success of this large-scale study," he said. These key trial results clearly show a consistent global performance of NURTEC ODT in terms of rapid and lasting migraine pain relief and rapid return to normal functioning in patients. Through our partnership with Pfizer announced in November 2021, we are committed to rapidly expanding patient access to NURTEC ODTs in the Asia-Pacific region and globally. ”

BHV3000-310 The research project leader is Professor Yu Shengyuan, director of the Department of Neurology of the General Hospital of the Chinese People's Liberation Army

"According to the Results of the World Health Organization (WHO) published in The Lancet in 2013, migraine is the third most common disease in humans and the first major cause of disability for people under 50 years of age, and we need new, effective and safe treatments to help improve the lives of patients," he said. Our BHV3000-310 study shows that rimegepant is a popular treatment option for migraine sufferers in Asia, and I look forward to using rimegepant in Chinese patients in the near future." ”

chief executive officer Karl Lintel, M.D.

"The results of this study demonstrate the effectiveness of NURTEC ODT and highlight its importance in the impact that, once approved, it will have on patients in the Asia-Pacific region," he said. The successful completion of this study and the high-quality results also highlight our global expertise in running complex neuroscience clinical trials. I am proud of the BioShin R&D team that delivered these results and look forward to submitting our new drug applications to regulatory agencies in China and South Korea for approval." ”

concerning NURTEC ODT NURTEC

ODT (Rimegepant) is the first and only calcitonin gene-associated peptide (CGRP) receptor antagonist with a rapidly dissolving oral disintegration tablet form approved by the U.S. Food and Drug Administration (FDA) for acute treatment of migraines with aura and preventive treatment of episodic migraines in adults. The activity of the neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine. NURTEC ODT is a CGRP receptor antagonist that inhibits the biological activity of CGRP neuropeptides by reversibly blocking CGRP receptors. The recommended dose of NURTEC ODT is 75 mg as needed, up to once a day for treatment or once every two days to help prevent migraine attacks. For more information on NURTEC ODTs, please visit the NURTEC.com. The most common adverse reactions are nausea and abdominal pain/dyspepsia. Avoid taking NURTEC ODT concurrently with strong CYP3A4 inhibitors, strong or moderate CYP3A inducers, or P-gp or BCRP inhibitors. When NURTEC ODT is used with a moderate CYP3A4 inhibitor, avoid another dose of NURTEC ODT within 48 hours. Please click here for the full instruction manual and patient information of nurTEC ODT.

About migraines

More than 1 billion people worldwide suffer from migraines, and the World Health Organization lists migraines as one of the ten most serious disabling medical conditions. Migraines are characterized by debilitating episodes lasting 4 to 72 hours and are accompanied by a variety of symptoms, including moderate to severe pulsatile headache, which can be accompanied by nausea or vomiting, and/or sensitivity to sound (voicephobia) and sensitivity to light (photophobia). Since more than 90% of migraine sufferers do not function properly or function during an episode, there is a significant need for new therapies.

CGRP

Receptor antagonism

Small molecule CGRP receptor antagonists are a new class of drugs for the treatment of migraines. CGRP receptor antagonists inhibit the biological activity of CGRP neuropeptides by reversibly blocking the CGRP receptor. For acute treatment, this unique mode of action may provide an alternative to other drugs, especially in patients with contraindications to the use of triptans or adverse or intolerant responses to triputams. CGRP signal-blocking therapy is not associated with drug overuse headache (MOH) or rebound headache, and other acute treatments have increased migraine attacks due to frequent use, limiting the clinical use of other acute treatments.

Biohaven

Biohaven Biopharmaceutical Holdings Limited (NYSE: BHVN) is a commercial stage biopharmaceutical company with a range of innovative, best-in-class products to enhance the lives of people with neurological and neuropsychiatric disorders, including rare diseases. The Biohaven Neuroinnovation™ product line includes the FDA-approved NURTEC ODT (rimegepant) for the acute and preventive treatment of migraines and a rich product line based on three different mechanism platforms that includes multiple late product candidates: CGRP receptor antagonists - acute and preventive treatments for migraine; glutamate regulation-obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia Spinal peroxidase inhibitor - amyotrophic lateral sclerosis of the spinal cord. For more information about Biohaven, visit .

Forward-Looking Statements

This version includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements contain a number of risks and uncertainties, including statements regarding the future development, planning and potential listing approval and commercialization of NURTEC ODT (rimegepant). A variety of important factors may cause actual results or events to differ materially from those expressed or implied by our forward-looking statements. Other material factors to consider in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report for the year ended December 31, 2020, the SEC filings on March 1, 2021, and subsequent filings. This forward-looking statement is made on the date of this statement. Except as required by law, Biohaven assumes no responsibility to update any forward-looking statements, whether due to new information, future events or other circumstances.

NURTEC and NURTEC ODT are trademarks held by Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a trademark of Biohaven Pharmaceutical Holding Company Ltd.