Astellas Pharma Inc.
) recently joined forces with Tecnofarma International Ltd. for
the distribution of Xtandi (enzalutamide) in Latin America,
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
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
) 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
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.
) looks more attractive in the pharma space with a Zacks Rank #1
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