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FDA Accepts Medivation's NDA

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Medivation Inc. and its partner Astellas Pharma Inc. recently reported that the New Drug Application (NDA) for their prostate cancer candidate, enzalutamide, has been accepted by the US Food and Drug Administration (FDA).

The companies are looking to get enzalutamide approved for the treatment of castration-resistant prostate cancer patients who have received docetaxel-based chemotherapy.

The FDA granted priority review status to enzalutamide, which means a response from the FDA should be out by November 2012. With the FDA accepting the NDA, Medivation stands to receive a milestone payment of $10 million from Astellas, as per the terms and agreements of their collaboration.

Medivation has also submitted a Marketing Authorization Application (MAA) for enzalutamide to the European Medicines Agency (EMA) some time back.

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. Both companies stated that besides meeting the primary and secondary endpoints, enzalutamide’s safety profile was also favorable.

Meanwhile, Medivation and Astellas have 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 stage prostate cancer patients following medical castration with LHRH analog therapy or surgical castration.

Our Take

We currently have a Neutral recommendation on Medivation, which carries a Zacks #3 Rank (short-term Hold rating). With the acceptance of the enzalutamide NDA, we expect investor focus to shift to the candidate’s FDA approval.

Upon approval, enzalutamide could very well be a game-changer for Medivation. Currently approved prostate cancer treatments include Sanofi’s (SNY - Free Report) Jevtana and Johnson and Johnson’s (JNJ - Free Report) Zytiga among others.

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