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