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Amicus shares fall after Fabry drug fails late-stage study

Thu, 20th Dec 2012 15:47

Dec 20 (Reuters) - Amicus Therapeutics Inc lostnearly half of its market value after the company said itsexperimental drug to treat a rare, inherited disorder failed tomeet the main goal of a late-stage study. The company's shares were down 43 percent at $3.28 in earlytrading on Thursday on the Nasdaq. The stock had gained about 85percent up to the close on Wednesday this year. Amicus said on Wednesday that six-month data from the studyshowed that the drug, Amigal, did not significantly cut down theamount of a kind of fat in kidney blood vessels in Fabry diseasepatients, compared to a placebo. Fabry disease is caused by the body's inability to producethe enzyme that helps breaks down fat. Amigal, being developed in partnership with Britishdrugmaker GlaxoSmithKline Plc, is Amicus's most advancedpipeline product. The news prompted at least three analysts to cut their pricetargets on the stock, and cast doubts on chances of the drugproving strong enough to be approved as a stand-alone therapy. Capstone Investments analyst Mayank Gandhi said Amigal data may not be sufficient to convince clinicians to use it as astand-alone therapy, compared to the strong efficacy proven byFabrazyme, the only enzyme replacement therapy for the diseasefrom Sanofi SA's unit Genzyme. Canaccord Genuity analyst Ritu Baral cut her price target onthe stock to $6 from $11. Leerink Swann analyst Joseph Schwartz said probability ofsuccess for Amigal as a stand-alone therapy was 25 percent nowfrom 75 percent earlier. Amicus also said the U.S. Food and Drug Administrationindicated that it will consider the 12-month efficacy and safetydata from the study. "Should we see extremely strong evidence of stabilization offunctional renal endpoints at 12 months, as well as supportiveGL-3 data, there may be a chance Amicus will file for andreceive approval," Canaccord Genuity's Baral said. The companies expect 12-month data from the study in thefirst half of 2013. (Reporting by Vidya P L Nathan; Editing by Sriraj Kalluvila)

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