NEW HAVEN, Conn. and
SHANGHAI, Jan. 7, 2019 /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.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.