Astellas Pharma, Inc.
) recently announced the launch of its prostate cancer drug,
Xtandi, in the UK.
Xtandi had gained EU approval in late Jun 2013 for the
treatment of adult men with metastatic castration-resistant
prostate cancer (CRPC) whose disease has progressed on or after
) Taxotere (docetaxel) therapy. Approval was based on encouraging
results from a randomized, placebo-controlled, multicenter, phase
III study (AFFIRM) which evaluated the safety and efficacy of the
drug versus placebo.
The study not only met the primary and secondary endpoints but
Xtandi's safety profile was also found to be favorable. Xtandi
was also approved in Japan and the US for the same indication in
Jun 2013 and Aug 2012, respectively.
According to Cancer Research UK, prostate cancer is estimated
to be the second most common cause of cancer death in men in the
) entered into a deal with Astellas, for the development and
commercialization of Xtandi, for the treatment of prostate
cancer, in 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.
Medivation is currently working on expanding Xtandi's label. A
phase III study (PREVAIL) in chemotherapy-naïve advanced prostate
cancer patients is currently ongoing with data read-outs expected
later this year. Medivation is also exploring Xtandi for breast
cancer (phase II). Xtandi delivered net sales of $75.4 million in
the first quarter of 2013, $18 million above the last quarter of
Astellas carries a Zacks Rank #4 (Sell) while Medivation
carries a Zacks Rank #3 (Hold). Right now,
) looks well positioned with a Zacks Rank #1 (Strong Buy).
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