Forging New Pathways for Cancer Patients

The American Cancer Society estimates approximately 1.4 million new cases of cancer will be diagnosed in 2008 in the United States alone, with over 500,000 Americans expected to die from the disease this year. The National Institutes of Health estimates that the overall cost of cancer in the U.S. during 2007 was $219.2 billion.* To address this dire healthcare challenge, new and more effective cancer treatments are urgently needed.

At ARIAD, we are leading a pathway to improved cancer therapies. Through our collaboration with Merck & Co., Inc. (see Merck collaboration) for the global development of our lead product candidate, deforolimus, a novel, potent mTOR inhibitor, we are making significant clinical progress toward the commercialization of the drug in oncology. In collaboration with Merck, our global development plan for deforolimus includes clinical initiatives in five oncology indications (sarcomas, endometrial, prostate, breast and non-small cell lung cancers).

Our initial registration path for deforolimus is in metastatic sarcomas. In this indication, a Phase 3 registration trial referred to as SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Deforolimus) is currently open and enrolling patients (www.succeedtrial.com). The U.S. Food and Drug Administration (FDA) has granted fast track status and orphan drug designation to deforolimus for the treatment of soft-tissue sarcomas and bone sarcomas.

Our second product candidate, oral AP24534, is an internally discovered novel multi-targeted kinase inhibitor that has broad potential applications in cancer. We plan to initiate two Phase 1 trials in 2008; the first in patients with drug-resistant and refractory chronic myeloid leukemia and other hematologic cancers, and the second in patients with solid tumors.

Our team at ARIAD continues to focus on advancing novel targeted cancer therapies from discovery into development. Our extensive research builds on ARIAD’s long-standing success in applying our expertise in cell signaling, cancer biology and computational drug-discovery to the design and characterization of small-molecule drugs, such as deforolimus and AP24534.