News | January 7, 2019

Biohaven Announces Acceptance Of Investigational New Drug (IND) Filing For Rimegepant In China

  • Rimegepant is the first small molecule, orally administered, calcitonin gene-related peptide (CGRP) receptor antagonist potentially being developed for both the acute and preventive treatment of migraine in China
  • Biohaven's wholly-owned Asia-Pacific subsidiary, BioShin, is developing and potentially commercializing Biohaven's late-stage product portfolio in China

New Haven, CT and Shanghai /PRNewswire/ - Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and its wholly-owned Asia-Pacific subsidiary company, BioShin, announced today the National Medical Products Administration ("NMPA") (formerly, the China FDA) has accepted the investigational new drug (IND) application for rimegepant, Biohaven's lead oral calcitonin gene-related peptide (CGRP) receptor antagonist product candidate, for the treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class for the treatment of migraine in over 25 years. CGRP receptor antagonists potentially offer an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or those who have an inadequate response to standard therapies.

"We are pleased that the NMPA has accepted our first IND in China," said Donnie McGrath, M.D., CEO of BioShin. "There is a great need for novel, safe and effective acute treatments for migraine in China given the prevalence of this debilitating disease throughout the country. Our rimegepant program aims to demonstrate, in Chinese patients, efficacy and safety consistent with the results observed in the three successful Biohaven Phase 3 trials previously conducted in the United States."

The World Health Organization's (WHO) 2015 Global Burden of Disease Study ranks migraine as the third most prevalent disease in the world and the seventh highest specific cause of disability worldwide1. Migraine affects approximately 9-10% of the adult population in China2, comprising approximately 80 – 90 million adults. Approximately 90% of Chinese patients with migraines suffer from between one to fourteen headache days per month, and approximately 10% have more than fourteen headache days per month3. Approximately 24% of individual Chinese patients with migraines miss more than twenty days of work over a three month period as a result of migraine2. The total indirect cost to Chinese society from lost productivity each year due to migraine is estimated to be about USD$40 billion2.

"I am excited about the potential of rimegepant for the treatment of migraine in China," stated Professor Shengyuan Yu, Director of the Department of Neurology, Chinese PLA General Hospital, Beijing. "Our research has shown that migraine results in a considerable cost to Chinese society, and we need new, effective and safe treatment options to help improve the lives of our patients. I believe that rimegepant will be a welcome treatment option for patients and I am encouraged that we are moving one step closer to approval given the NMPA's acceptance of the IND."

Vlad Coric, CEO of Biohaven added, "The BioShin management team has the extensive experience in drug development and commercialization in markets within Asia-Pacific to efficiently advance our late stage migraine assets into the clinic in China. With this first IND for rimegepant accepted, the team will look to initiate our clinical trials with rimegepant in China in 2019 and will also be planning an IND with our third-generation, intranasal CGRP receptor antagonist BHV-3500."

About Rimegepant
Rimegepant is Biohaven's orally-dosed CGRP receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the U.S. Food and Drug Administration (FDA) and provide the basis for a planned submission of a new drug application (NDA) to the FDA in 2019.

About BioShin
BioShin is a Shanghai-based limited liability company established to develop and commercialize Biohaven's late-stage migraine and neurology portfolio in China and other Asia-Pacific markets. Biohaven's Chief of Corporate Strategy and Business Development, Donnie McGrath, M.D., is Chief Executive Officer of the subsidiary. Additional executive leaders of BioShin include: Karl Lintel, M.D., Chief Operating Officer; Zoey Wang, M.D., General Manager; and Elaine Hawkings, MSc, Head of Clinical Operations.

About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases. Biohaven combines internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase-inhibitor platforms. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. 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 that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release, including statements about the expected timing of initiation of clinical trials in China, the expected timing of regulatory submissions in China and the United States, BioShin's ability to develop and potentially commercialize product candidates in China and the Asia-Pacific region generally, potential advantages of applying for drug approval in China, the potential market in China for the Company's product candidates and the ability of BioShin to successfully operate, conduct preclinical studies and clinical programs, are forward-looking statements. The use of certain words, including "potential", "believe", "expects", "estimates" and "will" and similar expressions, is intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. 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, including those described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2018 and other filings Biohaven makes with the U.S. Securities and Exchange Commission from time to time. 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.

For further information, contact Dr. Vlad Coric, the Chief Executive Officer at Vlad.Coric@biohavenpharma.com

References:
1 Disease GBD, Injury I, Prevalence C. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet.2017;390(2017):1211–59.
2 Yu, S., et al., The prevalence and burden of primary headaches in China: a population-based door-to-door survey.Headache, 2012. 52(4): p. 582-91.
3 Liu, R., et al., Health-care utilization for primary headache disorders in China: a population-based door-to-door survey. J Headache Pain, 2013. 14: p. 47.

SOURCE: Biohaven Pharmaceutical Holding Company Ltd.

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