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Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009
Date:1/12/2009

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A Phase 2 clinical trial of Plicera in Gaucher patients is ongoing. This 6 month study is designed to evaluate safety as well as to demonstrate trends of efficacy as measured by the standard endpoints in Gaucher disease. Target enrollment of 16 patients for this study is expected to be surpassed and the results are expected to be available in the third quarter of 2009.

In addition, Amicus is working closely with its partner Shire HGT to prepare for Phase 3 development of Plicera pending the results of the ongoing Phase 2 trial.

AT2220 (1-deoxynojirimycin HCl) for the treatment of Pompe Disease

A Phase 2 clinical trial of AT2220 in adult Pompe patients is ongoing. The trial includes an 11 week treatment period with an optional extension study. The objectives of the trial include the evaluation of the safety and pharmacodynamics of multiple doses and regimens of AT2220. The results of this study are expected to be available in the second half of 2009.

In addition, Amicus is continuing to conduct preclinical animal studies to evaluate the effects of administering AT2220 in combination with ERT. Encouraging preliminary results were announced at the American Society of Human Genetics conference in November 2008. These results indicated that AT2220 in combination with ERT significantly increases the stability and tissue uptake of ERT. Amicus is conducting additional preclinical proof-of-concept studies to determine the feasibility of a combination that may be appropriate for Pompe patients who are not amenable to chaperone monotherapy. Amicus expects to announce additional results in the first quarter of 2009.

2009 FINANCIAL GUIDANCE

Amicus expects to spend a total of approximately $70 million on 2009 cash operating expenses, to be offset by $50 million in program cost-sharing reimbursements and clinical milestone payments from Shire. Amicus
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SOURCE Amicus Therapeutics
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