Amicus drops 32.5% as it halts Ph II AT2220 trial

9 March 2009

Shares in Amicus Therapeutics dropped 32.5% to $6.42 on February 27,  after the US drug developer suspended enrollment into a Phase II trial  evaluating AT2220 (1-deoxynojirimycin HCI) for Pompe Disease on side  effect issues.

The Food and Drug Administration has placed the drug on clinical hold.  After evaluation of available data, the company says it plans to work  closely with the agency and, if appropriate, will amend the Phase II  protocol with the objective of restarting the trial as soon as possible.

Two patients enrolled in the trial experienced self-reported adverse  events and subsequently withdrew from the study. The events were  categorized by the site investigator as serious and probably related to  treatment with AT2220. After initial evaluation of the cases, Amicus  suspended patient enrollment and, in a subsequent discussion with the  FDA, the trial was placed on clinical hold status pending further  evaluation of the data.

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