|Exchange:||NASDAQ national market|
|Stock:||Amicus Therapeutics, Inc.|
|Amicus Therapeutics, Inc. was incorporated on February 4, 2002 in Delaware. The Company is a Biopharmaceutical Company focused on the discovery, development and commercialization of orally-administered, small molecule drugs known as pharmacological chaperones, a novel, first-in-class approach to treating a broad range of diseases including lysosomal storage disorders and diseases of neurodegeneration. The Company is focused on the development of pharmacological chaperones as monotherapies and in combination with enzyme replacement therapy (ERT), the current standard of treatment for Fabry and other lysosomal storage diseases. In 2012, it is advancing two monotherapy programs for genetic diseases: Migalastat HCl for patients with Fabry disease identified as having alpha-galactosidase A (alpha-Gal A) mutations amenable to chaperone therapy, and AT3375 for Parkinson’s disease in Gaucher disease carriers and potentially the broader Parkinson’s population. Its pharmacological chaperone-ERT combination programs for 2012 include: Migalastat HCl co-administered with ERT for patients with Fabry disease receiving ERT treatment with any genetic mutation, AT2220 (duvoglustat HCl) co-administered with ERT for Pompe disease, AT3375 and afegostat tartrate co-administered with ERT for Gaucher disease, and Several new, undisclosed pharmacological chaperone programs focused on the combination of chaperones with ERTs for additional lysosomal storage diseases. The Company’s novel approach to the treatment of human genetic diseases consists of using pharmacological chaperones that selectively bind to the target protein; increasing the stability of the protein and helping it fold into the correct three-dimensional shape. Its product candidate, migalastat HCl for Fabry disease, is in late Phase 3 development. It is developing and commercializing migalastat HCl with an affiliate of GlaxoSmithKline PLC (GSK) pursuant to a License and Collaboration Agreement entered into in October 2010. Its partnership with GSK allows it to utilize GSK’s significant expertise in clinical, regulatory, commercial and manufacturing matters in the development of migalastat HCl. In addition, it is conducting another Phase 2 co-administration study evaluating its pharmacological chaperone AT2220 (duvoglustat HCl) co-administered with ERT in Pompe patients. Unlike migalastat HCl, it owns rights to the development of AT2220. In addition to its patents and trade secrets, The Company owns certain trademarks in the U.S. and/or abroad, including A AMICUS THERAPEUTICS® & design and AMICUS THERAPEUTICS®. Its competitors include Sanofi Aventis, Shire, Actelion, Ltd. and Protalix Biotherapeutics. The Company’s product candidates, including migalastat HCl, and the activities associated with their development and commercialization, including their testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other regulatory agencies in the U.S. and by comparable authorities in other countries.|
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