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.