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Amicus Therapeutics Announces First Quarter 2008 Financial Results
Date:5/13/2008

tors presented positive results from Phase 2 clinical trials of Amigal at the American College of Medical Genetics (ACMG) meeting. The data showed that Amigal was generally safe and well-tolerated at all doses evaluated and no drug-related serious adverse events were reported. In addition, Amigal increased the level of the enzyme deficient in Fabry patients in 24 of 26 study subjects, and in a majority of study subjects the treatment resulted in a reduction of kidney GL-3 as measured in urine.

Amicus, along with its partner Shire, has initiated discussions with the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) regarding its plans for Phase 3 clinical evaluation of Amigal. Amicus expects to complete these interactions and provide an update in the second half of 2008, and subject to the outcome of the discussions, the Company plans to initiate the Phase 3 clinical trial in the first half of 2009.

In parallel with the regulatory process, 23 of the original 26 patients continue to be treated with Amigal in the voluntary Phase 2 extension study to monitor long term safety and efficacy. In addition, the Company will evaluate modified doses and dose regimens in these 23 patients. Data from this extension study are expected to be available by Q1 2009, prior to finalization of the Phase 3 protocol.

Gaucher Disease:

Plicera(TM) (isofagomine tartrate) is an investigational, oral therapeutic being developed for the treatment of Gaucher disease. At the ACMG meeting in March, clinical investigators presented full data from a 4 week Phase 2 study in Gaucher patients who switched from enzyme replacement therapy (ERT) with imiglucerase to the pharmacological chaperone Plicera. Results showed that Plicera was generally safe and well tolerated at all doses and increased target enzyme activity levels in a majority of patients. In the trial, GCase activity, as measured in white blood cells, was increased in 20 of the 26 pat
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SOURCE Amicus Therapeutics
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