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

S. Food and Drug Administration (FDA). At that time, the FDA indicated that the data from the completed Phase 2 clinical studies of Amigal support the initiation of Phase 3 development and that Amigal was eligible for Accelerated Approval under Subpart H regulations. The FDA further indicated at that time that it was not opposed to the use of a surrogate primary endpoint, pending further discussions with the company.

Following this End of Phase 2 meeting, Amicus continued discussions with the FDA in the second half of 2008. The Agency has indicated that it supports a Phase 3 clinical trial comparing Amigal to placebo based on a surrogate primary endpoint of the change in the amount of kidney GL-3, the substrate that accumulates in the cells of Fabry patients. Amicus plans to continue discussions with the FDA through a Special Protocol Assessment (SPA) procedure that it commenced in the fourth quarter of 2008 to finalize how the primary endpoint will be measured. Amicus expects the SPA process to be complete in the second quarter of this year.

Based on discussions with the European Medicines Agency (EMEA), Amicus expects to initiate a separate clinical study designed to evaluate the safety and efficacy of Amigal versus ERT in Fabry patients. Amicus and its partner Shire HGT plan additional discussions with the EMEA in the first half of 2009 to finalize the design of this study.

In parallel with the Phase 3 regulatory discussions, 23 of the original 26 patients from the Phase 2 studies continue to be treated in a voluntary extension study to characterize the long-term safety and efficacy of Amigal and to evaluate additional doses and dose regimens. Data from this extension study are expected to be available in the first quarter of 2009 and the results will be used to finalize the dose and regimen for the Phase 3 studies.

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