Partner: Astellas Pharma
Lead indication: Prostate cancer
Key date: NDA planned for this year
Medivation ($MDVN) has endured the failure of its late-stage trial for an Alzheimer's drug and loss of its partnership with Pfizer ($PFE) in January. Despite the major setbacks, its stock price has risen more than 65% so far this year. How is this possible? The simple answer: Enzalutamide, the drug formerly known as MDV3100 that has wowed investors with data from trials as a weapon against prostate cancer.
The San Francisco-based drug developer plans to file for FDA approval of the drug, which targets androgen receptor signaling, later this year, after revealing details this year from its Phase III Affirm trial that addressed some of the seizure risk and safety concerns about the drug. The efficacy figures from the study revealed initially last year are certainly impressive: Patients on the drug had median overall survival that was 4.8 months better than those on a placebo, for instance.
As FierceBiotech's John Carroll wrote last year, Medivation's drug stacks up nicely with the recently approved prostate cancer drug Zytiga on the efficacy front without some of the safety issues associated with the latter drug. Unlike patients on Zytiga, patients on enzalutamide don't have to take prednisone and deal with the risk of elevated blood pressure from the corticosteroid.
Expect Medivation to ask the FDA to give enzalutamide a priority review for treating patients with advanced prostate cancer after they've received chemotherapy. The FDA has already granted the program fast-track status, and if that is any indication of the agency's decision on a priority request, count on a speedy evaluation of the drug. A priority review would also be good news for Astellas Pharma, which has co-marketing rights to the drug in the U.S. under its partnership deal with Medivation.