ARIAD Pharmaceuticals, Inc. (ARIAD) is biopharmaceutical company. As of December 31, 2011, the Company’s pipeline contains three product candidates: ponatinib, AP26113 and ridaforolimus. It is building a pipeline of product candidates that expand upon treatment options for patients with cancer. Each of its product candidates were discovered internally. It is building a commercial organization to market, distribute and sell its products upon regulatory approval in the United States, Europe and other select markets, worldwide. It has commenced preparations for the commercial launch of ponatinib in the United States and Europe.Ponatinib is an investigational, pan BCR-ABL inhibitor. Ponatinib was internally discovered and is wholly owned by the Company. Results from preclinical studies showed that ponatinib inhibits BCR-ABL, a target protein associated with drug-resistant CML, as well as various mutants of BCR-ABL. Preclinical studies also showed that ponatinib demonstrated efficacy and oral dosing in animal models of CML, including forms of CML caused by clinically relevant mutants of BCR-ABL. Ponatinib potently inhibited a specific mutant, T315I, which is resistant to all marketed drugs. Additional preclinical studies demonstrated that ponatinib also inhibits Flt3, a target associated with acute myeloid leukemia (AML).
In preclinical studies ponatinib has demonstrated potent inhibition of additional targets implicated in the initiation and progression of multiple cancers, including the receptors for vascular endothelial growth factors (VEGFRs), fibroblast growth factors (FGFRs), and angiopoietin, or Tie2. It has completed enrollment in its pivotal Phase 2 clinical trial in patients with resistant or intolerant chronic myeloid leukemia (CML), and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). This trial is designed to provide definitive clinical data for regulatory approval of ponatinib for the treatment of patients with this disease.
AP26113 is an investigational dual inhibitor of anaplastic lymphoma kinase (ALK), and epidermal growth factor receptor (EGFR), two clinically validated targets in non-small cell lung cancer, or NSCLC. The Company initiated patient enrollment and dosing in a Phase 1/2 clinical trial of AP26113 in the third quarter of 2011. The initial Phase 1 dose-escalation portion of the trial includes patients with advanced solid tumors, particularly those with NSCLC.
Ridaforolimus is an investigational mTOR inhibitor that it discovered internally and later licensed to Merck, Sharpe & Dohme Corp. (Merck). Under the license agreement, Merck is responsible for all activities and has agreed to fund 100% of the costs related to the development, manufacturing and commercialization of ridaforolimus in oncology. TOR acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival. Blocking mTOR creates a starvation-like effect in cancer cells by interfering with cell growth, division, metabolism and angiogenesis. In addition to its development programs, it has a focused drug discovery program centered on small-molecule therapies that are molecularly targeted to cell-signaling pathways implicated in cancer.
The Company competes with Amgen Inc., AstraZeneca PLC, Bristol-Myers Squibb Company, Eli Lilly and Company, the Roche Group, GlaxoSmithKline plc, Johnson & Johnson, Merck, Merck KGaA, Novartis AG, Sanofi-Aventis, Takeda Pharmaceutical Co., Ltd., Celgene Corporation, Pfizer, Inc., Chugai Pharmaceutical Co., Tesaro, Xcovery, Astella, Boehringer Ingleheim, Avila Therapeutics and Clovis Oncology, PharmaMar and Ziopharm Oncology, Inc.
