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Amicus Therapeutics Announces Successful Completion of End of Phase 2 Meeting With FDA for Amigal in Fabry Disease
Date:8/4/2008

Agency Supports Amigal Move to Phase 3; Eligible for Accelerated Approval;

Final Global Regulatory Plan Expected by Year End

CRANBURY, N.J., Aug. 4 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD), a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of human genetic diseases, announced today that it has successfully completed an End of Phase 2 meeting for Amigal(TM) 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 the 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.

"We are very pleased with the outcome of the End of Phase 2 meeting with the FDA," said John F. Crowley, President and CEO of Amicus Therapeutics. "We look forward to continuing our work with the FDA and EMEA to design a global Phase 3 program for Amigal in Fabry disease."

The meeting followed the successful conduct of Phase 2 clinical studies in patients wit
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SOURCE Amicus Therapeutics
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