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Amicus Therapeutics Announces Fourth Quarter and Full Year 2007 Financial Results & Program Advancements
Date:1/29/2008

chaperone compounds for lysosomal storage disorders. Shire licensed the rights to commercialize these products outside of the United States and Amicus retained all rights to commercialize these products in the United States.

Program Advancements:

Fabry Disease:

In December 2007, Amicus announced positive results from its Phase 2 clinical trials of Amigal(TM) for Fabry disease. 26 patients completed the study, which was designed to evaluate safety and preliminary efficacy of multiple doses and regimens of Amigal in a broad range of Fabry disease patients. A majority of patients in these studies discontinued their enzyme replacement therapy (ERT) prior to enrollment in the Amigal protocols.
Key findings include the following:

-- Amigal was generally safe and well-tolerated at all doses evaluated and

no drug-related serious adverse events were reported

-- Amigal increased the level of the enzyme deficient in Fabry patients in

24 of 26 study subjects

-- Amigal was shown to reduce the accumulated substrate in a majority of

study subjects

-- Renal and cardiac function results were encouraging, including those

seen in patients treated for nearly two years

-- Responses in patients with different Fabry mutations were consistent

with the results of in vitro testing, thus confirming the ability to

use pharmacogenetics to select likely responders for future studies

-- 23 patients have elected to continue Amigal treatment in an extension

protocol

The Phase 2 Amigal study results will be presented to the scientific and medical community at the American College of Medical Genetics (ACMG) Annual Meeting on March 12-16, 2008, in Phoenix, Arizona.

Gaucher Disease:

Amicus also recently announced positive interim results from its first Phase 2 clinical trial for Gaucher disease in patients who switched from enzyme replacement therapy (
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SOURCE Amicus Therapeutics
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