Medivation, Inc., a biopharmaceutical company, focuses on the development and commercialization of novel therapies to treat serious diseases for which there are limited treatment options. Xtandi (Enzalutamide) Capsules The company’s advanced program is XTANDI (enzalutamide) capsules (XTANDI), which it has partnered with Astellas Pharma Inc. (Astellas). In 2012, XTANDI received regulatory approval from the U.S. Food and Drug Administration (FDA) for the treatment of post-chemotherapy metastatic castration-resistant prostate cancer (mCRPC) patients. The company and Astellas began co-promoting XTANDI for that indication in the United States in 2012. Marketing applications for XTANDI for the treatment of post-chemotherapy mCRPC patients are also under review in Europe, South Korea, Canada, and Brazil. Enzalutamide in Pre-chemotherapy CRPC The company, together with Astellas, is also conducting multiple trials of enzalutamide in earlier prostate cancer disease states, including the Phase 3 PREVAIL trial in patients with mCRPC who have not received chemotherapy, or pre-chemotherapy mCRPC patients, and in patients with breast cancer. The company and Astellas are also conducting the TERRAIN trial and the STRIVE trial, two randomized, double-blind Phase 2 trials evaluating enzalutamide head-to-head versus bicalutamide in pre-chemotherapy CRPC patients. Enzalutamide in Earlier Prostate Cancer Disease States In 2012, the company initiated patient enrollment in an open-label clinical trial evaluating enzalutamide as neoadjuvant therapy in approximately 50 men who have been diagnosed with prostate cancer but not yet undergone prostatectomy. The primary endpoint in this trial is pathological response rate. Enzalutamide in Breast Cancer In 2012, the company and Astellas expanded the clinical development of enzalutamide to include a new indication, breast cancer. The company is enrolling patients in an open label Phase 1 study designed to evaluate the safety and tolerability of enzalutamide in approximately 60 breast cancer patients who have failed at least 2 prior hormonal therapies. Intellectual Property The company has an exclusive 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. The company also owns multiple pending patent applications covering its early stage technology programs. XTANDI is a registered trademark of Astellas. Research and Development For the years ended December 31, 2012, the company recorded $95.6 million of research and development expenses. History Medivation, Inc. was founded in 2003.
medivation inc (MDVN:NASDAQ GS)
525 Market Street
San Francisco, CA 94105
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