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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
Date:6/22/2009

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European Phase 3 Registration Trial Update

Amicus and its partner, Shire Human Genetic Therapies, Inc. (Shire HGT), have completed a series of discussions with the European Medicines Agency (EMEA). Based on feedback from the EMEA, the Companies expect a separate clinical study will be required for Amigal registration in Europe.

The EMEA has recommended a registration trial evaluating the safety and efficacy of Amigal in males and females with Fabry disease as compared to enzyme replacement therapy (ERT). The Agency agrees that the trial may enroll subjects currently receiving ERT. The recommended primary endpoint is renal function as measured by glomerular filtration rate (GFR) and the recommended primary analysis is a comparison of outcomes between the Amigal and ERT groups using descriptive statistics.

Amicus and Shire HGT are reviewing the final EMEA feedback and will provide an update regarding plans for registration in Europe in the second half of 2009.

About Amigal

Amigal has undergone clinical testing in a series of Phase 2 studies. Twenty-six male and female subjects were included in these studies and studied initially for either 12 or 24 weeks. Twenty-three of the 26 subjects continue to receive treatment in an ongoing extension study designed to evaluate the long-term safety and efficacy of Amigal. Fifteen of the 23 subjects have been on treatment for at least two years and five subjects have been on treatment for more than three years.

Results from the Phase 2 and the extension study were presented in March 2009 at the American College of Medical Genetics (ACMG) Annual Meeting in Tampa, FL. Specifically, Amicus reported that treatment with Amigal was generally well-tolerated, with no drug-related serious adverse events. The most common adverse events were headache, arthralgia and diarrhea. In s
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SOURCE Amicus Therapeutics
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