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Description of Business
9 Months Ended
Sep. 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 medically innovative 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 the drug have not been established in patients with prostate cancer who have not received chemotherapy. XTANDI is approved in more than 45 countries for the post-docetaxel indication and marketing applications for this indication are under review in multiple countries worldwide.

On September 10, 2014, the FDA approved a new indication for the use of XTANDI to treat patients with mCRPC who have not received chemotherapy. This new approved use follows a priority review of the supplemental New Drug Application, or sNDA, submission to the FDA that was based on the results of the Company’s Phase 3 PREVAIL trial. In October 2014, in Japan, the item “Precautions relating to indications” of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, “The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy,” has been deleted. The revision of this item of the XTANDI package insert in Japan triggers a $45.0 million milestone payment to the Company, which will be recognized as collaboration revenue in the fourth quarter of 2014. Then, on October 24, 2014, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a variation to amend the European Marketing Authorisation for XTANDI. The positive opinion relates to the use of enzalutamide 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. If the European Medicines Agency amends the European Marketing Authorisation for XTANDI, the Company will earn the final development milestone payment from Astellas under the Astellas Collaboration Agreement, totaling $45.0 million.

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 programs where there is an unmet medical need. The Company’s research and drug discovery projects focus on diseases, including cancer for which it believes new therapies can substantially improve the current standard of care.

On October 23, 2014, the Company announced that it licensed exclusive worldwide rights to CureTech, Ltd.’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti PD-1 monoclonal antibody, for potential applications, including in oncology. Additional information regarding the agreement with CureTech, Ltd. is included in Note 13, “Subsequent Event.”