Raptor Pharmaceutical Corp Announces FDA Acceptance Of New Drug Application For RP103 For Potential Treatment Of Nephropathic Cystinosis

Raptor Pharmaceutical Corp announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. The FDA has granted Standard Review designation for RP103. Previously, Raptor announced that the European Medicines Agency (EMA) had validated its Marketing Authorization Application (MAA) for RP103 for the potential treatment of nephropathic cystinosis. Raptor's MAA is under review by the EMA, and the Company expects a decision in the first half of 2013. The NDA submission for marketing approval includes previously announced data from Raptor's Phase 3 cystinosis clinical trial of RP103. As reported, RP103 met the clinical trial's sole primary endpoint and there were no unexpected serious safety concerns attributable to RP103 experienced by patients in the trial. The clinical trial was conducted at three clinical sites in the U.S. and five clinical sites in Europe.