ARIAD Pharmaceuticals, Inc. (ARIA) 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. “We are nearing completion of the Phase 1 portion of the Phase 1/2 clinical trial of AP26113 and are committed to advancing a dose and schedule for ‘113 that are optimal and provide the best opportunity for clinical success across each of the patient groups represented by the cohorts in the ongoing trial,” stated Harvey J. Berger, M.D., chairman and chief executive officer. “At the same time, we are very pleased with the progress being made in the U.S. commercial launch of Iclusig, and we are advancing the Phase 3 EPIC trial as planned. Each of these is a key value driver for our shareholders, and we are focused on nothing short of flawless execution.”
First Quarter 2013 Earnings Call Scheduled
ARIAD will host its first quarter 2013 webcast and investor conference call on Tuesday, May 7 at 8:30 a.m. ET. Additional details regarding the dial-in information for the call will be provided in the next few weeks.
Today’s Conference Call at 8:00 a.m. ET
We will hold a live webcast and conference call today at 8:00 a.m. ET. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 800-884-5695 (domestic) or 617-786-2960 (international) five minutes prior to the start time and providing the pass code 19013304. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.
About Iclusig™ (ponatinib) tablets
Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
Important Safety Information for Iclusig™ (ponatinib)
WARNING: ARTERIAL THROMBOSIS and HEPATOTOXICITY
Arterial Thrombosis: Cardiovascular, cerebrovascular, and peripheral vascular thrombosis, including fatal myocardial infarction and stroke have occurred in Iclusig-treated patients. In clinical trials, serious arterial thrombosis occurred in eight percent of Iclusig-treated patients. Interrupt and consider discontinuation of Iclusig in patients who develop arterial thrombotic events.
Hepatotoxicity: Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Iclusig for hepatotoxicity.
Please visit www.iclusig.com for full prescribing information, including boxed warning.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
This press release contains “forward-looking statements” including, but not limited to, updates on clinical, preclinical and regulatory developments and commercialization plans for our product candidates. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, our ability to successfully launch, commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our ability to obtain approval for Iclusig outside of the United States and in additional indications; our reliance on third-party manufacturers, and on specialty pharmacies for the distribution of Iclusig; preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the conduct and results of preclinical and clinical studies of our product candidates; difficulties or delays in obtaining regulatory approvals to market products; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; our failure to comply with extensive regulatory requirements; the occurrence of serious adverse events in patients being treated with Iclusig or our product candidates; risks related to
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