) 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
Medivation and Astellas will be presenting data on enzalutamide
at the June 2012 annual meeting of the American Society of Clinical
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
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
) Jevtana and
Johnson and Johnson's
) Zytiga among others.
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