) and Astellas Pharma Inc. recently launched their prostate cancer
treatment, Xtandi (enzalutamide) which gained US Food and Drug
Administration (FDA) approval in late August 2012.
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.
Besides making Xtandi available through specialty pharmacies and
specialty distributors, Medivation and Astellas have also launched
a comprehensive patient access support program so that patients
requiring Xtandi have timely access to the drug.
Meanwhile, Xtandi is currently under review in the EU. 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.
Medivation and Astellas have priced Xtandi at $7,450 (wholesale
acquisition cost) 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 the product.
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
Currently approved prostate cancer treatments include
) Jevtana and
Johnson and Johnson
) Zytiga among others.
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