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GSK and Amicus Therapeutics Enter Exclusive Worldwide Agreement to Develop and Commercialize Amigal™ for Fabry Disease
Date:10/29/2010

orate Executive Team.   "Our focus now is to continue to advance Amigal for Fabry disease and it is our hope to deliver a first-in-class, oral medicine to the thousands of people worldwide living with this devastating rare disease."

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics said, "The completion of this agreement with GSK is a transformational event for Amicus. It provides a strong validation of the potential for Amigal to become an important new treatment option for people living with Fabry disease and for our pharmacological chaperone technology broadly.  GSK has extremely impressive global clinical, regulatory and commercial expertise and a strong commitment to the development of treatments for rare diseases. We look forward to working in close partnership with them."  Crowley continued, "With this key strategic alliance with GSK and the added financial strength it provides, Amicus is now uniquely positioned to build shareholder value through our expertise in rare disease drug development."  

About Amigal™ (migalastat HCl) for the Treatment of Fabry DiseaseMigalastat HCl is an investigational treatment for Fabry disease and has the potential to be the first in a new class of oral, small molecule medicines called pharmacological chaperones.  It is designed to selectively bind to and stabilize the target enzyme alpha-galactosidase A (alpha-Gal A), which facilitates proper trafficking of the enzyme to the lysosomes, where it is needed to break down the target substrate globotriaosylceramide (GL-3).

Results from Phase 2 studies of migalastat HCl, which has orphan designation in both the US and EU, demonstrated that in subjects identified as responders to migalastat HCl treatment resulted in increased levels of alpha-Gal A, reduced levels of GL-3 as measured in renal interstitial capillary cells from kidney biopsies and in urine, and a potential positive impact on renal functio
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SOURCE Amicus Therapeutics
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