ARIAD Provides Update on Important Progress Being Made in R&D and Commercial Initiatives
ARIAD Pharmaceuticals, Inc.Kendra Adams, 617-503-7028orLiza Heapes, 617-621-2315
(NASDAQ: 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.
“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.”
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.
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 . 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.
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.
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 for full , including boxed warning.
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 or follow ARIAD on Twitter ().
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 key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.