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Description of Business
6 Months Ended
Jun. 30, 2014
Accounting Policies [Abstract]  
Description of Business

NOTE 1 — DESCRIPTION OF BUSINESS

Medivation, Inc. (the “Company” or “Medivation”) is a biopharmaceutical company focused on the rapid development and commercialization of novel therapies to treat serious diseases for which there are limited treatment options.

The Company’s most advanced program is XTANDI® (enzalutamide) capsules, or XTANDI, which is partnered with Astellas Pharma Inc., or Astellas. On August 31, 2012, XTANDI received marketing approval from the U.S. Food and Drug Administration, or FDA, for the treatment of metastatic castration-resistant prostate cancer, or mCRPC, patients who previously received docetaxel, or post-chemotherapy mCRPC patients. The Company and Astellas began co-promoting XTANDI for that indication in the United States on September 13, 2012. On June 24, 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. On March 24, 2014, the Company’s partner, Astellas, announced that it received approval to market XTANDI in Japan for the treatment of patients with castration-resistant prostate cancer, or CRPC, with the precaution that the efficacy and safety of XTANDI have not been established in patients with prostate cancer who have not received chemotherapy. XTANDI is approved in more than 40 countries for the post-docetaxel indication and marketing applications for this indication are under review in multiple countries worldwide.

On March 18, 2014, the Company and Astellas announced the submission of a supplemental New Drug Application, or sNDA, filing to the FDA to extend the indication for XTANDI for the treatment of men with mCRPC who have not received chemotherapy. On May 6, 2014, the Company announced that the FDA accepted the sNDA filing and granted priority review designation. The Prescription Drug User Fee Act (PDUFA) date for the completion of the FDA’s review of the sNDA is September 18, 2014. On April 3, 2014, the Company and Astellas announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI for the treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. The European Medicines Agency validated Astellas’ application for an amended European Marketing Authorization Application and accepted the filing.

Together with Astellas, the Company is also conducting multiple trials of enzalutamide to further develop enzalutamide in the prostate cancer disease continuum, and also in breast cancer.

In addition, the Company is investing in multiple early-stage research and drug discovery projects. The Company’s early-stage research and drug discovery projects focus primarily on cancer and central nervous system diseases for which it believes new therapies can substantially improve the current standard of care. These early-stage projects include technologies that are being developed through the Company’s own internal research activities as well as through in-license agreements with third parties.