Astellas Pharma Inc. (ALPMY) recently joined forces with Tecnofarma International Ltd. for the distribution of Xtandi (enzalutamide) in Latin America, excluding Brazil.
We note that Xtandi (160 mg once daily) is already available in the US since Sep 2012 for the treatment of castration-resistant prostate cancer (:CRPC) that has spread to other parts of the body in patients who previously received 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.
In May 2013, Astellas and partner Medivation, Inc. (MDVN) submitted a marketing authorization application (MAA) in Japan for Xtandi. 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 CRPC and phase II enrolled patients with advanced CRPC who received treatment with Taxotere.
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 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.
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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