Medivation Inc was formed in Delaware in October 1995. The Company is a biopharmaceutical company engaged in the rapid development of novel small molecule drugs to treat diseases for which there are limited treatment options. Together with its collaboration partner Astellas Pharma Inc., or Astellas, the Company is developing XTANDI enzalutamide capsules. Together with Astellas, it 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. Based on the positive results of the AFFIRM trial, the Company has exercised its right under its collaboration agreement with Astellas to co-promote XTANDI in the U.S., should it receive marketing approval. Their subsidiaries are Medivation Prostate Therapeutics Inc or MPT, Medivation Neurology Inc or MNI, Medivation Technologies Inc, or MTI, Medivation Field Solutions, Inc., or MFSI, and Medivation Services, Inc., or MSI. MPT holds the intellectual property rights covering XTANDI. MNI holds the intellectual property rights covering dimebon, which was in development for Alzheimer's disease and Huntington disease under its former collaboration with Pfizer. MTI holds the intellectual property rights covering its early-stage technologies. MFSI provides commercialization services to the Company, and MSI provides research and development services. It has received "Fast Track" designation from the U.S. Food and Drug Administration for the post-docetaxel indication. The Company is conducting this program in collaboration with Astellas. The Company is subject to extensive regulation by the Federal Food, Drug, and Cosmetic Act, or the FDC Act, and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
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