) and partner, Astellas Pharma Inc., received a major boost with
the US Food and Drug Administration (FDA) granting approval for
their prostate cancer candidate, Xtandi (enzalutamide).
The FDA approved Xtandi for the treatment of patients with
metastatic castration-resistant prostate cancer who have previously
received docetaxel. Approval came well ahead of the Prescription
Drug User Fee Act (PDUFA) action date of November 22, 2012.
Per the requirements of the FDA, Medivation and Astellas have
agreed to conduct an open label safety study of Xtandi at the
approved dose of 160 mg per day in patients who are at high risk
for seizure. The companies have agreed to provide results from this
study, which will involve about 350 patients, in 2019. We note that
the "warnings and precautions" section of the product label
mentions that about 0.9% of patients in the Xtandi arm experienced
a seizure compared to none in the placebo arm of a randomized
Meanwhile, Medivation also announced that its marketing
application for Xtandi in the EU has been accepted for review. With
the FDA approval of Xtandi and the acceptance of the EU filing,
Medivation stands to receive total milestone payments of $35
million from Astellas. About 10% of these milestone payments will
be paid to UCLA as per the terms of Medivation's licensing
agreement with UCLA.
Xtandi could very well be a game-changer for Medivation. The
prostate cancer market represents huge commercial potential.
According to the American Cancer Society, prostate cancer is the
most commonly diagnosed cancer among men in the US, other than skin
cancer. It is estimated by the American Cancer Society that about
241,740 new cases of prostate cancer will be diagnosed in the US in
2012 with 28,170 men expected to die from the disease.
Medivation and Astellas expect to launch Xtandi in mid-September
at a wholesale acquisition cost of $7,450 for a 30-day supply.
While Medivation has a 60-person sales force in place for promoting
Xtandi, Astellas will be using a 90-person sales force to promote
Currently approved prostate cancer treatments include
) Jevtana and
Johnson and Johnson
) Zytiga among others.
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