ARIAD Issues Update on R&D, Commercial Initiatives

ARIAD Pharmaceuticals, Inc.

today provided an update on its progress over the past several weeks with both the commercial launch of Iclusig™ (ponatinib) in the United States and the clinical development programs for Iclusig and AP26113. We are providing this update to further clarify our recent news announcements and to respond to investor questions. Global Commercialization of Iclusig * In the first twelve weeks since commercial launch of Iclusig in the U.S. (through March 2013), 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 obtained commercially based on physicians' prescriptions. Importantly, this does not include any patients using the initial Quick Start 30-day supply. * Approximately 65 percent of prescribers are now community-based physicians, with the remainder based in the academic setting. We expect that adoption of Iclusig among community physicians will continue to increase as the ongoing launch progresses. * Nearly all of the patients enrolled in the U.S. expanded access program for Iclusig have now transitioned to commercial supply, with many still using the initial Quick Start supply. * In March 2013, the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for full approval of Iclusig for two indications. The positive recommendation by the CHMP of Iclusig for use in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL) provides a broad indication statement for Iclusig in resistant and intolerant patients, including many patients who have failed only one prior tyrosine kinase inhibitor. * When adopted by the European Commission, Iclusig will be indicated in the second-line setting in patients who are resistant to dasatinib or nilotinib, or who have the T315I mutation of BCR-ABL. Company and independent research shows that approximately 40 percent of chronic-phase patients and approximately 50 percent of advanced-phase patients with newly diagnosed CML are receiving dasatinib or nilotinib as their initial tyrosine kinase inhibitor treatment. We expect these percentages to continue to increase as the two second-generation therapies achieve greater adoption in Europe, as they have done in the U.S. * We anticipate approval of Iclusig in the EU in the second quarter of 2013 and regulatory submissions in Canada, Switzerland, and Australia in the third quarter of 2013. We are committed to being launch-ready in Europe by July 1, 2013. Broadening Iclusig Clinical Development * 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 the fourth quarter of 2013. Approximately 120 clinical sites in 20 countries are now participating in the trial, and data from an interim analysis are anticipated in mid-2014. * An experienced Data Monitoring Committee (DMC) that is chartered in the clinical protocol and is chaired by a well-known academic oncologist is overseeing the conduct of the EPIC trial. The DMC has met and reviewed the data from the study thus far, as stipulated in the protocol. The EPIC trial continues as planned. Advancing AP26113 * The Phase 1 portion of our Phase 1/2 clinical trial of AP26113 is ongoing, and we expect to transition into the four Phase 2 expansion cohorts, including the one designated for patients with EGFR-mutant non-small cell lung cancer (NSCLC), in the second quarter of 2013. * A fifth Phase 2 cohort in ALK-positive NSCLC patients with brain metastases is also being planned. * We will advance a dose and schedule for AP26113 in the Phase 2 cohorts that are appropriate based on safety, tolerability, and pharmacokinetics (i.e., circulating trough plasma levels of AP26113). * In parallel to the Phase 2 expansion cohorts, we plan to begin enrollment in a pivotal trial of AP26113 in ALK-positive NSCLC patients who are resistant to crizotinib in the third quarter of 2013. * We will present clinical updates on AP26113 at the 2013 annual meetings of the American Society of Clinical Oncology in June and the European Society of Medical Oncology in September. * We will also apply for Breakthrough Designation status for AP26113 with the U.S. Food and Drug Administration. This designation is not required in advance of the start of the pivotal trial of AP26113.