ARIAD Pharmaceuticals, Inc., an oncology company, discovers, develops and commercializes small-molecule drugs to treat cancer in patients. Pipeline of Products The company’s product pipeline consists of three product candidates – Iclusig, AP26113, and ridaforolimus. Iclusig (ponatinib) Iclusig is a tyrosine kinase inhibitor(TKI), which is approved in the United States and Europe for the treatment of adult patients with chronic myeloid leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In 2012, the company obtained accelerated approval from the U.S. Food and Drug Administration (FDA), to sell Iclusig. Iclusig was approved in the United States for the treatment of adult patients with chronic, accelerated or blast phase CML who are resistant or intolerant to prior TKI therapy, and the treatment of adult patients with Ph+ ALL who are resistant or intolerant to prior TKI therapy. International Markets: In 2013, the company announced the granting of its marketing authorization for Iclusig by the European Commission (EC), as an orphan medicinal product for two indications: 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 the treatment of adult patients with 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. AP26113 AP26113 is an investigational inhibitor of anaplastic lymphoma kinase (ALK). In non-clinical studies, AP26113 also demonstrated that it can inhibit epidermal growth factor receptor (EGFR), and c-ros oncogene-1 (ROS1). All of these kinases are clinically validated targets in non-small cell lung cancer. The company initiated patient enrollment in a Phase 1/2 clinical trial of AP26113 in 2011. In September 2013, the company announced updated clinical results from the ongoing Phase 1/2 clinical trial. The company focuses its development activities on ALK-positive NSCLC patients, both treatment naïve and resistant, and those with CNS activity. Ridaforolimus Ridaforolimus is an investigational inhibitor of the mammalian target of rapamycin (mTOR), that the company discovered and developed internally and later licensed in 2010 to Merck & Co., Inc. (Merck) for oncology applications. Strategy The company’s long-term strategy includes the commercialization of Iclusig and future products in the United States, Europe and other selected territories worldwide. Intellectual Property The company solely owns the following patents and patent applications for its product candidates: Iclusig, its pan BCR-ABL inhibitor, is protected by composition of matter claims of U.S. Patent No. 8,114,874, which expires on December 22, 2026, and corresponding international counterparts; AP26113, its dual ALK/EGFR kinase inhibitor, is covered by composition of matter claims of a pending U.S. patent application, which, if granted, is expected to expire in 2029, and corresponding international counterparts; and Ridaforolimus, its mTOR inhibitor licensed to Merck, is protected by composition of matter claims of U.S. Patent No. 7,091,213, which expires on February 3, 2023, and corresponding international counterparts. Research and Development As of December 31, 2013, the company spent approximately $162.9 million on its research and development activities. Government Regulation Governmental authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, marketing and export and import of products such as Iclusig and those the company is developing. The company’s product candidates must be approved by the U.S. Food and Drug Administration through the New Drug Application process before they may be legally marketed in the United States and by the European Medicines Agency through the marketing authorization application process before they may be legally marketed in Europe. History ARIAD Pharmaceuticals, Inc. was founded in 1991.
ariad pharmaceuticals inc
(APS:German Stock Exchange)
26 Landsdowne Street
Cambridge, MA 02139
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