Biohaven and Bioshin's Pivotal Trial of rimegepant (NURTEC® ODT) for Acute Treatment of Migraine Hits Primary Endpoint Press Release

- is the first oral calcitonin gene-related peptide NURTEC® ODT (CGRP) receptor antagonist to show positive results in a pivotal trial in Asia Pacific, with more than 100 million patients suffering from migraine in China and South Korea alone
.

- This study demonstrated statistically significant co-primary endpoints of pain relief (p<0.
0001) and most distressing symptoms relief (p<0.
0001) within 2 hours
.

- A single oral dose of NURTEC® ODT of 75 mg provides rapid pain relief and elimination of the most distressing symptoms in 45 minutes, normal function in 60 minutes, pain relief in 90 minutes; sustained efficacy for many patients Up to 2 days
.

- This is the fourth pivotal trial of NURTEC® ODT to achieve a significant co-primary endpoint and will form the basis for planned New Drug Applications (NDAs) in China and Korea
.

NEW HAVEN, Conn.
and New York, U.
S.
, Feb.
10, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd.
(NYSE: BHVN) and its China-based subsidiary Bioshin Limited announced that rimegepant (NURTEC® ODT) The results of the Asia-Pacific Phase III clinical trial for the acute treatment of migraine were positive
.

Led by BioShin, the Phase III regional multicenter study BHV3000-310 met the co-primary endpoints of evaluating the efficacy and safety of the oral calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant orally disintegrating tablet (ODT)
.

This is the fourth positive Phase III study of NURTEC® ODT for the acute treatment of migraine, and the first in the Asia-Pacific region
.

The study met the co-primary endpoints of pain relief and most distressing symptom (MBS) relief within 2 hours with a single dose of NURTEC® ODT
.

Approximately 1,431 subjects were randomized in this trial, with nearly 80% of the subjects enrolled in China and the remaining approximately 20% in South Korea
.

NURTEC® ODT demonstrated a favorable safety and tolerability profile among study participants, consistent with previous clinical trial experience in the U.
S.
trial
.

Donnie McGrath, MD, President and Executive Chairman of Bioshin, said: "We would like to express our sincere gratitude to the patients, institutions and investigators in China and South Korea who have contributed greatly to the success of this large study
.

These key trial results Clearly demonstrates the consistent global performance of NURTEC® ODT for rapid and durable migraine pain relief and rapid restoration of normal function in patients
.

Through the collaboration with Pfizer announced in November 2021, we are committed to rapidly expanding Asia Pacific and global Accessibility of NURTEC® ODT to NURTEC® ODT of patients
.

” said Prof.
Shengyuan Yu, the leader of the BHV3000-310 research project and Director of the Department of Neurology of the Chinese People’s Liberation Army General Hospital: “According to the results of the World Health Organization published in The Lancet in 2013 According to the Global Burden of Disease Survey on , migraine is the third most common disease in humans and the number one cause of disability in people under the age of 50.
We need new, effective and safe treatment options to help improve the lives of patients.
The results
of
our BHV3000-310 study show that rimegepant is a popular treatment option for migraine patients in Asia and I look forward to seeing rimegepant available in Chinese patients in the near future
.

Karl Lintel, MD, CEO of Bioshin, said: "The results of this study demonstrate the efficacy of NURTEC® ODT and underscore the importance of the impact it could have on patients in the Asia Pacific region once approved
.

The successful completion and high-quality results of this study also underscores our global expertise in running complex neuroscience clinical trials
.

I am proud of the BioShin R&D team that provided these results and look forward to submitting our NDA to the regulatory agencies in China and South Korea for approval
.

"About NURTEC® ODT NURTEC® ODT (Rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist with a rapidly dissolving orally disintegrating tablet form approved by the U.
S.
Food and Drug Administration ( FDA) approved for the acute treatment of migraine with and without aura in adults and for the prophylactic treatment of episodic migraine
.

The activity of the neuropeptide CGRP is thought to play a causal role in the pathophysiology of migraine
.

NURTEC® ODT is a CGRP receptor Antibody antagonists inhibit 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 every two days to help prevent bias Headache attack
.

For more information on NURTEC® ODT, visit NURTEC.
com
.

The most common adverse reactions of NURTEC® ODT are nausea and abdominal pain/dyspepsia
.

Avoid treatment with strong CYP3A4 inhibitors, strong or moderate CYP3A inducers, or P - gp or BCRP inhibitor concurrently administered
.

When NURTEC® ODT is used with a moderate CYP3A4 inhibitor, avoid another dose of NURTEC® ODT within 48 hours
.

Instructions for NURTEC® ODT are available at https://biohaven-nurtec-consumer-assets.
s3.
amazonaws.
com/nurtec-prescribing-information.
pdf and patient information at https://biohaven-nurtec-consumer-assets.
s3.
amazonaws .
com/nurtec-patient-prescribing-information.
pdf
.

About Migraine More than 1 billion people worldwide suffer from migraine, and the World Health Organization ranks migraine as one of the ten most serious disabling medical conditions
.

Migraines are characterized by debilitating attacks lasting 4 to 72 hours with a variety of symptoms, including moderate to severe throbbing headaches that can be accompanied by nausea or vomiting, and/or sensitivity to sounds (phonophobia) and sensitivity to light (photophobia)
.

With more than 90 percent of migraine sufferers unable to function or function properly during an attack, there is a significant need for new treatments
.

About CGRP receptor antagonism Small molecule CGRP receptor antagonists are a new class of drugs for the treatment of migraine
.

CGRP receptor antagonists work by reversibly blocking CGRP receptors, thereby inhibiting the biological activity of CGRP neuropeptides
.

For acute treatment, this unique mode of action may provide an alternative to other drugs, especially in patients with contraindications to triptan use or in patients with poor response or intolerance to triptans
.

CGRP signaling blockade therapy was not associated with medication overuse headache (MOH) or rebound headache, and other acute treatments have limited their clinical application due to frequent use leading to increased migraine attacks
.

About Biohaven Biohaven Biopharmaceutical Holdings, Inc.
(NYSE: BHVN) is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class products to improve the lives of patients with neurological and neuropsychiatric disorders, including rare diseases
.

Biohaven's Neuroinnovation™ product line includes the FDA-approved NURTEC® ODT (rimegepant) for the acute and prophylactic treatment of migraine and an extensive pipeline of late-stage product candidates based on three distinct mechanistic platforms: CGRP receptor antagonists - Acute and preventive treatment of migraine; glutamate modulation - obsessive compulsive disorder, Alzheimer's disease and spinocerebellar ataxia; spinal peroxidase inhibitors - amyotrophic lateral sclerosis
.

For more information on Biohaven, visit
.

BioshinKarl Lintel CEO Karl.
Lintel@bioshin.
com Media Contact Wang Zhiyao COO Zoey.
Wang@bioshin.
com