Medivation, Inc., a biopharmaceutical company, focuses on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. The company has one commercial product, XTANDI (enzalutamide) capsules (XTANDI) through its collaboration with Astellas Pharma, Inc. (Astellas). 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, advanced breast cancer, and hepatocellular carcinoma. In 2015, the company acquired all worldwide rights to talazoparib (which the company refers to as MDV3800), an orally available poly-ADP ribose polymerase inhibitor, from BioMarin Pharmaceutical Inc. MDV3800 is in a Phase 3 clinical trial for the treatment of patients with germline BRCA (gBRCA) mutated advanced breast cancer (advanced breast cancer in patients whose BRCA genes contain germline mutations). The company is targeting various other indications in which to investigate MDV3800, including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung cancer, and ovarian cancer. In 2014, the company licensed worldwide rights to pidilizumab (which the company refers to as MDV9300), an antibody with immune-mediated anti-tumor effects for all indications from CureTech, Ltd. Under the license agreement, the company is responsible for all development, regulatory, manufacturing, and commercialization activities for MDV9300. The company initiated a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma in 2015, which is on partial clinical hold pending the company’s revision of certain investigator brochure, protocols and informed consent documents. The company submitted the revised documents to the U.S. Food and Drug Administration in early February 2016. The company also plans to develop MDV9300 in other hematologic malignancies, such as multiple myeloma. In addition, the company has various internal research and discovery efforts focused in oncology, neurology, and other areas. The company has three Phase 2 clinical trials evaluating enzalutamide in three subsets of breast cancer. Under an August 2005 license agreement with the Regents of the University of California (UCLA), the company’s subsidiary, Medivation Prostate Therapeutics, Inc. holds a worldwide license under various UCLA patents and patent applications covering XTANDI and related compounds. Under the Astellas collaboration agreement, the company granted Astellas a sublicense under the patent rights licensed to the company 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 have a base expiry in 2027 in the United States and in 2026 in Europe and Japan. The company has a license to multiple issued patents and pending patent applications covering MDV9300, including the antibody and methods of use of MDV9300. Government Regulation The company is subject to other state and federal privacy and security laws that are not specific to the healthcare industry, such as the Federal Trade Commission’s enforcement of Section 5 of the Federal Trade Commission Act and state security breach notification laws. The company and its business activities are also subject to the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value provided to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members. As a publicly-traded company, the company is also subject to regulations and laws, including the Sarbanes-Oxley Act of 2002. Research and Development For the year ended December 31, 2015, the company recorded $232.1 million of research and development expenses. Competition The company competes with Johnson & Johnson, Sanofi, and Bayer Pharma AG. History Medivation, Inc. was founded in Delaware in 1995.
medivation inc (WMD:Stuttgart)
525 Market Street
San Francisco, CA 94105
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