Amicus Therapeutics Announces Second Quarter 2009 Financi...( ...)

CRANBURY, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) today announced financial results for the second quarter 2009.

On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Amicus announced a net loss attributable to common stockholders of $0.60 per share ($0.51 per share on a non-GAAP basis) for the three months ended June 30, 2009. As of June 30, 2009, cash, cash equivalents, and marketable securities totaled $100.4 million.

John F. Crowley, President and CEO of Amicus stated, "The second quarter was marked by a significant achievement for Amicus with our lead program, Amigal for Fabry disease, entering Phase 3 development." Crowley continued, "This is a major step for the Company as we have now transitioned to a late-stage biopharmaceutical company and are one step closer to bringing to market an important, novel treatment to patients who suffer with Fabry disease."

Clinical Program Updates

Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease

In the second quarter of 2009, Amicus announced that the Company reached agreement with the U.S. Food and Drug Administration (FDA) on the key protocol design elements of its pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations. Amicus has begun submitting the Phase 3 protocol to investigational sites worldwide and expects to begin the dosing of subjects in the second half of th
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