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Amicus Therapeutics Announces Third Quarter 2009 Financial Results and Strategic Business Updates
Date:10/29/2009

ance to Amicus."

Amicus will continue to manage global clinical operations for Amigal Phase 3 development and expects to initiate more than thirty investigational sites worldwide. As previously announced, the first global Phase 3 Amigal study is a 60 patient randomized, double-blind placebo controlled six month study intended to support U.S. registration. The primary surrogate endpoint agreed to with the U.S. Food and Drug Administration (FDA) is a histological evaluation of the change in GL-3 levels in the interstitial capillary cells of the kidney. The first patient was randomized into this study in mid-October. The Company estimates it will complete enrollment for this trial by the end of 2010 and expects to have data available in mid-2011. A separate Phase 3 study for registration in the European Union comparing Amigal with Fabrazyme® is required by the European Medicines Agency (EMEA). Amicus expects to provide a further update on that proposed study for the EMEA in 2010 as the supply constraints with Fabrazyme become clearer.

Key Strategic Priorities and Workforce Reduction:

As part of its strategic business plan, Amicus will focus its resources in three key areas:

  • The Phase 3 development of Amigal for Fabry disease;
  • Advancement of its lead pre-clinical programs that utilize its pharmacological chaperone technology for the treatment of diseases of neurodegeneration. The Company has an advanced pre-clinical program in Parkinson's disease, as well as an earlier stage pre-clinical program in an as yet undisclosed neurodegenerative target disease; and
  • Advancement of pharmacological chaperones used in combination with enzyme replacement therapies (ERT) for the treatment of lysosomal storage diseases.

"By focusing our resources on these three value creating centers within Amicus, we will balance the execution of our global late stage clinical program in Fabry di
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SOURCE Amicus Therapeutics
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