Medivation, Inc., a biopharmaceutical company, focuses on the rapid development and commercialization of novel therapies to treat serious diseases for which there are limited treatment options. XTANDI (enzalutamide) Program The company’s advanced program is XTANDI (enzalutamide) capsules, or XTANDI, which it has partnered with Astellas Pharma, Inc. (Astellas). The company received marketing approval from the U.S. Food and Drug Administration, or FDA, for the treatment of post-chemotherapy mCRPC. The company and Astellas began co-promoting XTANDI for that indication in the United States. In 2013, the company and Astellas announced that XTANDI was granted marketing authorization in the European Union, or EU, for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy. XTANDI is approved in approximately 35 countries for the post-docetaxel indication and marketing applications for this indication are under review in Japan and multiple other countries worldwide. Enzalutamide in Pre-chemotherapy CRPC The company, together with its collaboration partner, Astellas, has various ongoing clinical trials to evaluate the safety and efficacy of enzalutamide in pre-chemotherapy CRPC patients, including both metastatic and non-metastatic disease. In 2013, the company and Astellas initiated a Phase 4 clinical trial, known as PLATO. Enzalutamide in Hormone-Naive Prostate Cancer The company and Astellas are in the process of evaluating potential registration strategies that could support a label expansion of enzalutamide to treat hormone-naïve patients. Enzalutamide in Breast Cancer The company and Astellas expanded the clinical development of enzalutamide to include a new indication—breast cancer. It has established in a Phase 1 trial that enzalutamide dosed at 160 mg once daily, the same dose approved for men with post-chemotherapy mCRPC, is safe and well tolerated in women. In June 2013, the company and Astellas initiated patient enrollment in a Phase 2 clinical trial evaluating enzalutamide as a single agent for the treatment of advanced, androgen receptor positive (AR+), triple-negative breast cancer, or TNBC. In December 2013, the company and Astellas initiated a Phase 2 clinical trial evaluating enzalutamide in combination with exemestane in women with advanced breast cancer that is estrogen receptor positive (ER+) or progesterone receptor positive (PgR+) and HER2 normal. Strategy The company’s business strategy is to use current GMP compliant contract manufacturers for all of its manufacturing needs. Intellectual Property The company has a license to multiple issued patents and pending 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. It also owns multiple pending patent applications covering its early-stage programs. Research and Development Expense For the year ended December 31, 2013, the company recorded $119.0 million of research and development expenses. History Medivation, Inc. was founded in Delaware in 1995.
medivation inc (MDVN:NASDAQ GS)
525 Market Street
San Francisco, CA 94105
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