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6-Month (Stage 1) Results from Ongoing Phase 3 Fabry Disease Monotherapy Study at Lysosomal Storage Disease Network WORLD Symposium (LDN WORLD) in February 2013; 12-Month Results Expected in 2Q13
Pompe, Fabry and Other New Chaperone-Enzyme Replacement Therapy (ERT) Programs Advancing in 2013FY13 Cash Spend Guidance Range of $52-$58 Million — Current Cash Expected to Fund Operations into at Least 2H14
CRANBURY, N.J., Jan. 7, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today provided its full-year 2013 strategic outlook and financial guidance. John F. Crowley, Chairman and CEO of Amicus, will discuss Amicus' corporate objectives and key milestones in a presentation at the 31st Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2013 at 3 p.m. PT (6 p.m. ET). A live webcast of the presentation can be accessed through the Investors section of the Amicus Therapeutics corporate web site at
http://ir.amicustherapeutics.com/events.cfm , and will be archived for 90 days.
Mr. Crowley stated, "We have a great 2013 ahead of us. The Stage 1 data from our Fabry monotherapy Study 011 are certainly encouraging. We look forward to presenting additional detail about this 6-month data from Study 011 at the WORLD Symposium in February. We also look forward to receiving and analyzing the 12-month efficacy and safety data from Stage 2 of Study 011 in the second quarter of this year. With these data, we expect to engage in constructive discussions with the FDA regarding a U.S. approval pathway for migalastat HCl as the first orally available pharmacological chaperone monotherapy for Fabry disease. Additionally, our Pompe program continues to provide excellent data demonstrating positive effects of AT2220-ERT co-administration, especially regarding the potential to mitigate the immune response to ERT as shown in preclinical studies. Finally, we continue to advance our chaperone-ERT co-formulated products. We believe that these next-generation ERTs have the potential to transform the treatment paradigm for many lysosomal storage diseases."