FDA backs Medivation and Astellas' prostate cancer drug Xtandi

USA-based Medivation (Nasdaq: MDVN and Japanese drug major Astellas Pharma (TYO: 4503) say that the US Food and Drug Administration has granted approval for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Medivation shares leapt 7.6% to $104.86 on Friday after the FDA announcement. Analysts at Credit Suisse have a net present value for Xtandi in the USA for post-chemo prostate cancer of $17.64/share (31% of total) for Medivation. For Astellas, their NPV is 85.89 yen per share (2% of total).

The FDA accepted the Xtandi New Drug Application on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012, meaning the approval has come three months ahead of schedule. Medivation and Astellas expect to make Xtandi, which will cost $7,450 for a month’s treatment, available to patients in the USA in mid-September. Separately, a Marketing Authorization Application for the drug has been accepted for review by the European Medicines Agency, the companies stated.