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Amicus Therapeutics Appoints Former FDA Division Deputy Director Andrew Mulberg as Vice President, Regulatory Strategy

     Former Deputy Director of FDA Division of Gastroenterology 
and Inborn Errors Products

Brings Significant Drug Development and Pharmaceutical Industry Experience

CRANBURY, N.J., July 12, 2016 (GLOBE NEWSWIRE) -- Amicus Therapeutics, Inc. (Nasdaq:FOLD), a global biotechnology company at the forefront of rare and orphan diseases, has appointed Andrew E. Mulberg, MD, FAAP, CPI as Vice President, Regulatory Strategy, effective today. He will be responsible for directing global regulatory strategies for all Amicus programs to bring multiple therapies to patients with rare and devastating diseases. Dr. Mulberg is a pediatric gastroenterologist who has spent the past 6 years working at the U.S. Food and Drug Administration (FDA), most recently as Deputy Director of the Division of Gastroenterology and Inborn Errors Products. Dr. Mulberg will serve as a member of the executive team reporting to Jay A. Barth, M.D., Chief Medical Officer.

“I am very pleased to welcome Andrew to our team,” stated Dr. Barth. “As we advance several programs through global clinical development, his direct experience at the FDA within the gastroenterology and inborn errors division, as well as his successful track record in drug development and regulatory approvals within industry, will be very valuable for Amicus. Andrew will be instrumental in shaping our regulatory strategies from investigational new drug, or IND, applications and first-in-man studies through regulatory approvals.”

In addition to Dr. Mulberg’s FDA experience, he previously held various roles of increasing responsibility within global drug development and medical affairs at leading pharmaceutical companies, including Johnson & Johnson, where he successfully led multiple products through clinical development to regulatory approvals. 

Dr. Mulberg received his B.A. from Columbia University and his M.D. from the Mount Sinai School of Medicine. From 1993-2010, Andrew served as Attending Physician in Gastroenterology and Hepatology at Children’s Hospital of Philadelphia. He currently serves as Adjunct Professor of Pediatrics at the University of Maryland School of Medicine, Adjunct Associate Professor of Pediatrics in the University of Pennsylvania School of Medicine and Associate Professor of Pharmacy at the University of the Sciences in Philadelphia. He is also a member of numerous medical organizations including Alpha Omega Alpha Honor Medical Society, American Gastroenterological Association and the North American Society for Pediatric Gastroenterology and Nutrition.

About Amicus Therapeutics
Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases.

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, financing plans, and the projected cash position for the Company. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that we may not be successful in commercializing Galafold in Europe or our other product candidates if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; and the potential that we will need additional funding to complete all of our studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. With respect to statements regarding projections of the Company's cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2015. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.


CONTACTS:Investors/Media:Amicus TherapeuticsSara PellegrinoSenior Director, Investor 662-5044Media:MWW PRSid 381-9017

Source:Amicus Therapeutics, Inc