Medivation, Inc. (MDVN) and partner, Astellas Pharma Inc., recently submitted a new drug application (:NDA) with the U.S. Food and Drug Administration (:FDA) for their prostate cancer candidate, enzalutamide. The companies have evaluated enzalutamide in castration-resistant prostate cancer patients who have received docetaxel therapy.
Medivation and Astellas are seeking priority review for their candidate, which if granted, would mean the FDA will complete its review in six months. A response regarding the acceptance of the NDA should be out within 60 days. The E.U. filing is also scheduled to take place in 2012.
Enzalutamide is the lead pipeline candidate at Medivation. Earlier this year, Medivation and Astellas had presented positive results on enzalutamide from the phase III AFFIRM study that was conducted in prostate cancer patients previously treated with chemotherapy. The companies said that besides meeting the primary and secondary endpoints, enzalutamide’s safety profile was favorable.
Medivation and Astellas will be presenting data on enzalutamide at the June 2012 annual meeting of the American Society of Clinical Oncology (TATD).
Meanwhile, Medivation expects to finish enrolling patients for the phase III PREVAIL study, which is being conducted in chemotherapy naïve prostate cancer patients, later this month. Enzalutamide is also in a phase II study (:TERRAIN), which will compare enzalutamide with bicalutamide, in advanced prostate cancer patients who have progressed following medical castration with LHRH analog therapy or surgical castration. Another open-label phase II study is being conducted to evaluate enzalutamide in advanced prostate cancer patients who have not had any previous hormonal therapies. Enzalutamide is also being studied for breast cancer (phase I).
Neutral on Medivation
We currently have a Neutral recommendation on Medivation, which carries a Zacks #3 Rank (short-term ‘Hold’ rating). With the submission of the enzalutamide NDA, we expect investor focus to remain on the regulatory status of the candidate. Enzalutamide could very well be a game-changer for Medivation. Currently approved prostate cancer treatments include Sanofi’s (SNY) Jevtana and Johnson and Johnson’s (JNJ) Zytiga among others.
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