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Japan Approves Medivation/Astellas' Xtandi

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Prostate cancer treatment, Xtandi, received approval in yet another country – Japan. Astellas and Medivation, Inc. said that Xtandi is now approved for the treatment of patients with castration-resistant prostate cancer in Japan.

Xtandi is already approved in more than 35 countries including the U.S. (Aug 2012) and the EU (Jun 2013) for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.

Medivation stands to receive a $15 million milestone payment on Xtandi’s approval in Japan.

Net sales of Xtandi in the U.S. in 2013, as reported by Astellas, were $392.4 million. Medivation and Astellas are currently looking to expand Xtandi’s label into the more lucrative chemo-naïve patient population. The companies recently filed a supplemental New Drug Application (sNDA) seeking FDA approval for Xtandi for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.

The sNDA is based on impressive data from the phase III PREVAIL study. Medivation and Astellas intend to apply for EU approval for the chemo-naïve indication later this year.

While expansion into additional countries like Japan should boost sales, we believe label expansion into the pre-chemo setting will be a major positive for Medivation. The 17-month delay in the time to initiation of chemotherapy should help Xtandi gain share once it is approved for the pre-chemo patient population.

Medivation is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include companies like Amgen (AMGN - Free Report) and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) . Both carry a Zacks Rank #1 (Strong Buy).

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