Amicus Therapeutics Announces Second Quarter 2008 Financi...(lyAmicus announced that it had successfu...),Health

Date:8/7/2008

ly, Amicus announced that it had successfully completed an End of Phase 2 meeting for Amigal with the U.S. Food and Drug Administration (FDA). The FDA indicated that the data from the completed Phase 2 clinical studies of Amigal support the start of Phase 3 development and agreed that Amigal meets the criteria to be considered for accelerated approval. The Agency further indicated that it is not opposed to the use of a surrogate primary endpoint, pending further discussion and final agreement on the Phase 3 trial design.

Amicus, along with its partner Shire Human Genetic Therapies, Inc. ("Shire"), is engaged in ongoing discussions with FDA and the European Medicines Agency (EMEA) regarding plans for a global Phase 3 clinical development program for Amigal. In line with previous guidance, Amicus expects to complete these interactions in the second half of 2008, and subject to the outcome of the discussions, the Company plans to initiate Phase 3 development of Amigal in the first half of 2009.

In parallel with the regulatory process, 23 of the original 26 patients will continue to be treated with Amigal in a voluntary Phase 2 extension study to monitor long term safety and efficacy and to evaluate additional doses and dose regimens. Data from this extension study are expected to be available by Q1 2009. In addition, Amicus expects to conduct clinical pharmacology studies to support the Phase 3 program.

Gaucher Disease:

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

The Company has modified its development plan for Plicera to include a study of the pharmacokinetics of Plicera in Gaucher patients. In addit
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SOURCE Amicus Therapeutics Copyright©2008 PR Newswire. All rights reserved

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