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Amicus Therapeutics Announces Third Quarter 2008 Financial Results
Date:11/3/2008

apies, Inc. ("Shire"), is engaged in ongoing discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) and will provide an update by the end of the year. A final decision on the global development strategy will follow the conclusion of the discussions with both agencies. Subject to the outcome of the discussions, the Company expects to initiate Phase 3 development of Amigal in the first half of 2009.

In addition, 23 of the original 26 patients continue to be treated in a voluntary Phase 2 extension study designed to monitor long-term safety and efficacy and to evaluate additional doses and dose regimens. Data from this extension study are expected in Q1 2009 prior to the start of the Phase 3 study.

Gaucher Disease:

Plicera(TM) (isofagomine tartrate) is an investigational, oral therapeutic in Phase 2 development for the treatment of Gaucher disease. As previously disclosed, a 6-month Phase 2 clinical trial of Plicera in patients naive to ERT is ongoing and Amicus expects the results of this study to be available in 2009.

Pompe Disease:

AT2220 (1-deoxynojirimycin HCl) is an investigational, oral therapeutic being developed for the treatment of Pompe disease. As previously disclosed, a Phase 2 clinical trial of AT2220 in adult Pompe patients is ongoing and includes an 11 week treatment period with an optional extension study.

In addition, Amicus is conducting preclinical animal studies to evaluate the effects of administering AT2220 in combination with enzyme replacement therapy. Based on the results of the preclinical work, Amicus will consider initiating a clinical trial of the AT2220-ERT combination treatment in Pompe patients.

Other Chaperone Programs:

Amicus continues to invest in research and development to assess the potential for using pharmacological chaperones to treat a broader range of human genetic diseases beyond lysosomal storage diseases. As part of this
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SOURCE Amicus Therapeutics
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