Medivation Seeks EU Approval - Analyst Blog


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Medivation, Inc. ( MDVN ) and partner Astellas Pharma Inc. recently submitted the second marketing application for their prostate cancer candidate, enzalutamide (formerly known as MDV3100). Astellas submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for the use of enzalutamide for the treatment of castration-resistant prostate cancer patients who have received docetaxel therapy.

The EU filing comes barely a month after Medivation and Astellas filed for approval in the US. Medivation and Astellas are seeking priority review for their candidate in the US which, if granted, would mean the FDA will complete its review in six months.

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.

Meanwhile, Medivation finished enrolling patients for the phase III PREVAIL study, which is being conducted in chemotherapy naïve prostate cancer patients. 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 marketing applications, 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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