) 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
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
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
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
) Jevtana and
Johnson and Johnson's
) Zytiga among others.
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