Medivation, Inc., a biopharmaceutical company, focuses on the development and commercialization of therapies to treat serious diseases for which there are limited treatment options. The company, through its collaboration with Astellas Pharma, Inc. (Astellas), has one commercial product, XTANDI (enzalutamide) capsules, or XTANDI. XTANDI has received marketing approval in the United States, Europe, and various other countries worldwide for the treatment of patients with metastatic castration-resistant prostate cancer and in Japan for the treatment of patients with castration-resistant prostate cancer. The company and Astellas are also conducting investigational studies of enzalutamide in prostate cancer and in advanced breast cancer. The company has three Phase 2 clinical trial evaluating enzalutamide in three subsets of breast cancer. In 2014, the company licensed exclusive worldwide rights to pidilizumab, an immune modulatory, anti-Programmed Death-1 (PD-1) monoclonal antibody for all potential indications from CureTech, Ltd. (CureTech). Under the license agreement, the company is responsible for all development, regulatory, manufacturing, and commercialization activities for pidilizumab. The company’s prostate cancer clinical trials include STRIVE, which is in Phase II clinical trial; PROSPER and EMBARK for which enrollment is ongoing for the Phase III clinical trial; PLATO, which is in the Phase IV clinical trial; AFFIRM and PREVAIL that have completed enrollment for the Phase III clinical trial; and TERRAIN for which enrollment is completed for the Phase II clinical trial. Its breast cancer clinical trials comprise AR+, TNBC, ER+ or PgR+ and HER2 Normal, and AR+ HER2 Amplified that are in Phase II clinical trials. License Agreement with The Regents of the University of California (UCLA) Under an August 2005 license agreement with UCLA, the company’s subsidiary Medivation Prostate Therapeutics, Inc. holds an exclusive worldwide license under various UCLA patents and patent applications covering XTANDI and related compounds. Under the collaboration agreement with Astellas, the company granted Astellas a sublicense under the patent rights licensed to it by UCLA. Intellectual Property The company has a license to multiple issued patents and pending patent applications covering XTANDI, related compounds and uses thereof, including issued composition of matter patents covering XTANDI in the United States, Europe, and Japan. The terms of these issued XTANDI composition of matter patents expire in 2027 in the United States and in 2026 in Europe and Japan. The company also has exclusive intellectual property rights with respect to pidilizumab and other research and drug discovery programs. XTANDI is a registered trademark of the company. Research and Development For the year ended December 31, 2014, the company recorded $189.6 million of research and development expense. Competition The company’s competitors include Johnson & Johnson, Sanofi, and Bayer Pharma AG. Government Regulation The company’s business activities, including research, sales, marketing, promotion, distribution, medical education and other activities are subject to regulation by various regulatory and enforcement authorities in the United States in addition to the U.S. Food and Drug Administration. The company is subject to the federal Physician Payments Sunshine Act. History Medivation, Inc. was founded in Delaware in 1995.
(MDVN:Consolidated Issue Listed on NASDAQ Global Select )
525 Market Street
San Francisco, CA 94105
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