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12-Month Results From Ongoing Phase 3 Fabry Disease Monotherapy Study Anticipated 3Q13
Phase 2b Pompe Co-Administration Study on Track to Begin 3Q13
CRANBURY, N.J., May 9, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the first quarter ended March 31, 2013. The Company also summarized recent and upcoming milestones and reiterated full-year 2013 operating expense guidance.
Key Highlights and Upcoming Milestones:
12-month results from first ongoing Phase 3 Fabry monotherapy study ( Study 011) anticipated 3Q13. FDA will consider entirety of 6- and 12-month data for potential U.S. approval of migalastat HCl monotherapy.
Phase 2b repeat-dose clinical study of AT2220 (duvoglustat HCl) co-administered with ERT (Myozyme®/Lumizyme®) for Pompe disease expected to begin 3Q13.
IND submission for Fabry chaperone-ERT co-formulated product planned by year-end 2013 for potential entry into clinic in early 2014.
Next-generation ERTs for Pompe disease and other LSDs advancing in preclinical studies.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics stated, "Amicus had a productive first quarter that was largely focused on the execution of clinical and regulatory activities for migalastat HCl monotherapy for Fabry disease, our upcoming clinical studies in Fabry and Pompe, and the build out of our CHART platform. A Type C meeting with the FDA will take place during the second quarter to discuss the statistical analysis plan for Study 011 while the 12-month data are still blinded. We remain on track to unblind and announce these 12-month results in the third quarter. We are also finalizing the design of our repeat-dose Phase 2b co-administration study for Pompe disease, which we expect to begin in the third quarter. Our strong financial position will continue to support the advancement of these programs as we approach several key milestones throughout the remainder of 2013."