ARIAD Pharmaceuticals, Inc., an oncology company, engages in the discovery, development, and commercialization of small-molecule drugs to treat cancer in patients with the unmet medical need. Iclusig (ponatinib) is the company’s primary approved cancer medicine, which it is commercializing in the United States, Europe and other territories for the treatment of certain patients with rare forms of leukemia. The company is conducting additional randomized clinical trials to evaluate Iclusig at lower starting doses and in earlier lines of therapy. Iclusig is a tyrosine kinase inhibitor (TKI) that is approved in the United States, the European Union, Australia, Switzerland, Israel and Canada for the treatment of adult patients with chronic myeloid leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig is approved in the United States for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL; and chronic phase, accelerated phase, or blast phase CML or Ph+ ALL for whom no other tyrosine-kinase inhibitor therapy is indicated. The company obtained accelerated approval from the U.S. Food and Drug Administration (FDA) to sell Iclusig in the United States in 2012. In the United States, the company is distributing Iclusig through a single specialty pharmacy. Iclusig has also received approval in the European Union and in various other countries throughout the world. The company and its distributors are selling Iclusig in Europe and various other countries throughout the world where it has received marketing authorization. In the European Union, the company obtained marketing authorization for Iclusig in 2013 from the European Commission (EC), as an orphan medicinal product for the treatment of adult patients with chronic phase, accelerated phase or blast phase CML who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, and Ph+ ALL who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. In 2015, the company announced the initiation of a dose-ranging trial of ponatinib called the OPTIC (Optimizing Ponatinib Treatment In CML) trial, which is designed to provide important data regarding the efficacy and safety of ponatinib at doses lower than the currently approved dose. Brigatinib is the company’s next most advanced drug candidate, which it is developing for the treatment of certain patients with a form of non-small cell lung cancer (NSCLC). Brigatinib (AP26113) is an investigational inhibitor of anaplastic lymphoma kinase (ALK). In 2014, brigatinib received a Breakthrough Therapy designation from the FDA, for the treatment of patients with ALK+ NSCLC who are resistant to crizotinib, and it initiated a pivotal Phase 2 trial in these patients. Brigatinib has received a Breakthrough Therapy designation by the FDA for the treatment of patients with ALK+ metastatic NSCLC whose tumors are resistant to crizotinib. In the second quarter of 2016, the company also plans to initiate a randomized Phase 3 clinical trial of brigatinib vs. crizotinib in first-line patients, which, if successful, would significantly expand the potential commercial opportunity of the drug candidate. The company’s development of brigatinib also includes key product and process development activities to support its clinical trials, as well as the anticipated filing of the new drug application and potential commercial launch of the product. In addition, the company is continuing to conduct its fully enrolled Phase 1/2 clinical trial of brigatinib. AP32788 is the company’s internally discovered drug candidate, which it is developing for the treatment of patients with NSCLC with specific mutations in the epidermal growth factor receptor or human epidermal growth factor receptor 2 kinases. The company submitted an investigational new drug application, to the FDA in 20
ariad pharmaceuticals inc
26 Landsdowne Street
Cambridge, MA 02139
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