ARIAD provided an update on its progress over the past several weeks with both the commercial launch of Iclusig (ponatinib) in the U.S. and the clinical development programs for Iclusig and AP26113. In the first twelve weeks since commercial launch of Iclusig in the U.S., there now are more than 225 unique prescribers of Iclusig and nearly 200 unique accounts using Iclusig. More than 325 patients in the U.S. are now being treated with Iclusig. The company anticipates approval of Iclusig in the EU in Q2 and regulatory submissions in Canada, Switzerland, and Australia in Q3, and expects to be launch-ready in Europe by July 1. The global, Phase 3 EPIC trial of Iclusig, which compares Iclusig to imatinib in patients with newly diagnosed CML, is advancing with full patient enrollment on track for completion in Q4. Data from an interim analysis are anticipated in mid-2014. The EPIC trial continues as planned. The Phase 1 portion of the Phase 1/2 clinical trial of AP26113 is ongoing. The company will present clinical updates on AP26113 at meetings in June and September and apply for Breakthrough Designation status for AP26113 with the FDA.
- Pharmaceuticals & Drug Trials