- Subsidiary to develop and potentially commercialize late-stage migraine and neurological disorder product development portfolio in China and other Asia-Pacific markets
- BioShin senior leadership team appointed
NEW HAVEN, Conn. and SHANGHAI, Nov. 28, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN) announced today that it has advanced the formation of a wholly owned subsidiary, BioShin™, a Shanghai based limited liability company, to develop and commercialize its 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., has been appointed Chief Executive Officer of the new subsidiary which will be based in Shanghai. Previously, Dr. McGrath was Vice-President of Business Development and Head of Global Search and Evaluation at Bristol-Myers Squibb (BMS). His responsibilities involved overseeing BMS' venture fund investment program, including investments in Asia. Additional executive leaders appointed include Karl Lintel, M.D., Chief Operating Officer, Zoey Wang, M.D., General Manager, and Elaine Hawkings, MSc, Head of Clinical Operations. BioShin plans to submit its first Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA) before the end of 2018.
"Central nervous system disorders represent a major economic and health burden to all global societies. For example, it is estimated that almost 90 million individuals in China alone suffer from migraine and we believe that some of these individuals could benefit from new treatment options such as rimegepant and BHV-3500, if they are approved," said Vlad Coric, M.D., CEO of Biohaven. "I am very excited to have Donnie and the new team build BioShin to translate our late-stage development efforts in neurologic diseases to a clinical program that could benefit patients in Asia and throughout the region. Biohaven's newly formed Asia-Pacific subsidiary represents our commitment to addressing patient needs across the globe."
Neurologic and neuropsychiatric diseases in China remain a significant unmet medical need. Chinese patients may account for up to about 20% of all Alzheimer's disease cases worldwide, and the number of patients with Alzheimer's disease in China is estimated to reach approximately 16 million by 2030. Other degenerative neurologic diseases that may be increasingly diagnosed in the future include Parkinson's Disease, Amyotrophic Lateral Sclerosis, Spinocerebellar Ataxia and Multiple System Atrophy. About 2-3% of the general population may suffer from Obsessive-Compulsive Disorder, and up to 5% can have Generalized Anxiety Disorder. Major Depressive Disorder may affect 3-4% of the population, and more than 20% of those patients could progress to Treatment Resistant Depression when diagnosed and treated.
"I am very excited about the potential of Biohaven's product development portfolio in China, and Asia more broadly," stated Donnie McGrath, M.D., CEO of BioShin. "An abundance of recent developments in China, including changes in the regulatory landscape, a new rare-disease policy, and multiple alternatives available to finance the company makes forming an Asia-Pacific subsidiary an attractive option as we seek to rapidly advance our product candidates in the Asia-Pacific market. I believe that the positive data from Biohaven's Phase 3 program for rimegepant, and the potential of our other late-stage product candidates, has enabled BioShin to attract the top talent we need to execute on our strategy in Asia."
Other BioShin Management Team
Karl Lintel, Chief Operating Officer, was President and General Manager of BMS China from 2014 to 2018 and General Manager of BMS Middle East and Africa from 2010 to 2014. From 1989 to 2010, he worked in a variety of roles within Pfizer Inc. across Asia, the Middle East, Europe and Global headquarters. In 2018, Karl received the Siver Magnolia Award from the Shanghai Government for his contributions to the economic and social development of the city.
Zoey Wang, General Manager, is a physician entrepreneur with over a decade of pharmaceutical experience in China and Europe with Sanofi and Novartis in a variety of clinical operations roles, and is co-founder of MetroHealth, a life science artificial intelligence technology company. She is a board member of BayHelix, a Chinese non-profit professional organization geared to the life sciences and healthcare community.
Elaine Hawkings, Head of Clinical Operations, has over 25 years of leadership experience in clinical drug development. She led BMS clinical operations for Asia Pacific from 2009 to 2017 (based in Shanghai from 2012-2017) and led clinical operations for Japan from 2006 to 2010 (based in Tokyo from 2006-2009). From 1996 to 2006, she led BMS clinical operations teams in Europe and Asia.
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.
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 regulatory submissions in China, 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
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