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Amicus Therapeutics Announces Issuance of New Plicera Composition of Matter Patent
Wednesday, March 25, 2009
Cranbury, NJ -- Amicus Therapeutics (Nasdaq: FOLD) today announced the issuance on March 10, 2009 of United States Patent No. 7,501,439, titled "Tartrate Salt of Isofagomine and Methods of Use." The patent covers the tartrate salt form of isofagomine, the active ingredient in the Company's investigational drug Plicera (afegostat tartrate), and its use for the treatment of Gaucher disease. The patent will expire in 2027.
John F. Crowley, President and CEO of Amicus, commented, "The issuance of this patent further strengthens our protection in the United States for Plicera in Gaucher and is one example of our ongoing efforts to establish a comprehensive intellectual property portfolio for our development programs and our pharmacological chaperone technology platform."
Plicera is currently being studied in an ongoing Phase 2 study in patients naive to enzyme replacement therapy. This six-month study is designed to evaluate safety and to demonstrate trends of efficacy, as measured by the standard endpoints in Gaucher disease. Amicus previously reported that enrollment has been completed for the study and the Company expects the results to be available in the third quarter of 2009.
Amicus is developing Plicera as part of a strategic collaboration with Shire Human Genetic Therapies (HGT), a business unit of Shire plc, to develop and commercialize Amicus' three lead pharmacological chaperone compounds for lysosomal storage disorders. Under the collaboration, Shire received commercial rights outside of the United States. Amicus retains all U.S. rights.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing and outcomes of the company's efforts to obtain intellectual property protection related to its development programs and technology platform and the potential goals, progress, timing and results of clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the inability to obtain and maintain protection for intellectual property relating to our programs and technology, the ability of competitors to design around our patents and other intellectual property protection, the potential that results of clinical or pre-clinical studies indicate that the product candidates are unsafe or ineffective; and, our dependence on third parties in the conduct of our clinical studies. Further, the results of earlier clinical trials may not be predictive of future results. Additionally, all forward looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2008, and our other public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Amicus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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