Medivation/Astellas Seek Xtandi Approval in Japan - Analyst Blog
Medivation, Inc. ( MDVN ) and partner Astellas Pharma Inc. ( ALPMY ) recently submitted a marketing authorization application (MAA) in Japan for Xtandi (enzalutamide), their prostate cancer treatment.
The submission was based on results from the phase III AFFIRM study which showed statistically significant data compared to placebo.
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 Sanofi 's ( SNY ) Taxotere.
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 Taxotere.
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 I).
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. ( ANIK ) looks more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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