Exelixis Inc incorporated in November, 1994. It is a biotechnology company which develops small molecule therapies to treat cancer. Its two advanced assets, COMETRIQ "cabozantinib", its wholly-owned inhibitor of multiple receptor tyrosine kinases, and cobimetinib "GDC-0973/XL518", a potent, highly selective inhibitor of MEK, which it out-licensed to Genentech, Inc. a wholly-owned member of the Roche Group, or Genentech, are currently the subject of six ongoing phase 3 pivotal trials. Cabozantinib is being evaluated in a development program, including two ongoing phase 3 pivotal trials in metastatic castration-resistant prostate cancer or CRPC, an ongoing phase 3 pivotal trial in metastatic renal cell cancer or RCC, and an ongoing phase 3 pivotal trial in advanced hepatocellular cancer, or HCC. The programs that the Company runs are Cabozantinib Development Program, CRPC, COMET Pivotal Trials, Combination trials. The Company has development programs in collaboration with Genentech, GlaxoSmithKline, Bristol-Myers Squibb Company, Sanofi, Merck, Daiichi Sankyo Company Limited. It contracts third parties to manufacture raw materials, the active pharmaceutical ingredient, or API, and finished solid dose COMETRIQ products for clinical and commercial uses. The Company follows regulations set forth by FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries. Federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, are applicable to the Company.
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