) and partner
Astellas Pharma Inc.
) recently submitted a marketing authorization application (MAA)
in Japan for Xtandi (enzalutamide), their prostate cancer
The submission was based on results from the phase III AFFIRM
study which showed statistically significant data compared to
This filing was also based on phase I-II trials, of which
phase I enrolled patients with advanced castration-resistant
prostate cancer (CRPC) and phase II enrolled patients with
advanced CRPC had received treatment with
As per the American Cancer Society, about 242,000 new cases of
prostate cancer were diagnosed in the US in 2012 with 28,000 men
dying of prostate cancer.
Medivation entered into a deal with Astellas, for the
development and commercialization of Xtandi for the treatment of
prostate cancer, in late Oct 2009. While all US development and
commercialization costs and profits will be shared equally,
Astellas will be responsible for the ex-US development and
commercialization of Xtandi.
In Apr 2013, Xtandi received a positive opinion from the
European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) for the treatment of adult men with
metastatic CRPC whose disease has progressed on or after Taxotere
therapy. A final decision should be out shortly.
We note that Xtandi (160 mg once daily)is already available in
the US since Sep 2012 for the treatment of CRPC that has spread
to other parts of the body in patients who previously received
Medivation is currently working on expanding Xtandi's label.
Xtandi is in several studies including the phase III PREVAIL
study which is being conducted in chemotherapy-naive advanced
prostate cancer patients with data read-outs expected this year.
Medivation is also exploring Xtandi for breast cancer (phase
The company has consistently presented impressive data on
Xtandi. We believe Xtandi has the potential to differentiate
itself from other prostate cancer treatments. Xtandi delivered
net sales of $75.4 million in the first quarter of 2013, $18
million above the last quarter of 2012.
Medivation carries a Zacks Rank #3 (Hold) while Astellas
carries a Zacks Rank #4 (Sell). Currently,
Anika Therapeutics Inc.
) looks more attractive in the pharma space with a Zacks Rank #1
ASTELLAS PHARMA (ALPMY): Get Free Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.