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Astellas Launches Xtandi in the UK

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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 Sanofi’s (SNY - Free Report) 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 UK.

Medivation, Inc. 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 2012.

Astellas carries a Zacks Rank #4 (Sell) while Medivation carries a Zacks Rank #3 (Hold). Right now, Jazz Pharmaceuticals (JAZZ - Free Report) looks well positioned with a Zacks Rank #1 (Strong Buy).

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