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EU Nod for Medivation/Astellas' Xtandi

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Medivation, Inc. and partner, Astellas Pharma, Inc. , recently gained EU approval for their prostate cancer drug, Xtandi. Xtandi, a novel androgen receptor antagonist, was approved for treating metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after docetexal therapy.

Xtandi can also be marketed in Iceland, Liechtenstein and Norway, which come under the European Economic Area (EEA). Xtandi showed positive results from the phase III study, AFFIRM, which led to this approval. EU approval does not come as a surprise as Xtandi had received a positive opinion from the Committee for Medicinal Products for Human Use in Apr 2013.

Medivation has seen growing sales of Xtandi ever since it was launched in the US in Sep 2012. Medivation reported 1Q13 Xtandi net sales of $75.4 million, $18 million above the last quarter of 2012.

The prostate cancer market represents huge commercial potential. According to the American Cancer Society, 242,000 new cases of prostate cancer were diagnosed in the US in 2012, with 238,590 cases expected to be diagnosed this year. 

EU approval is a major positive for Medivation. The company is entitled to receive a $15 million milestone payment from Astellas based on the EU approval of Xtandi. Medivation’s collaboration agreement with Astellas for Xtandi was signed in 2009.

Medivation and Astellas are looking to get Xtandi approved in additional countries like Switzerland, South Korea, Brazil, Japan and Australia.

Moreover, the companies are working on expanding Xtandi’s label. Interim results from the phase III PREVAIL study on pre-chemo patients should be out later this year. The company also intends to start a phase III trial in patients with non-metastatic castration-resistant prostate cancer this year. Xtandi is being evaluated in other studies as well, including a breast cancer study.

Currently approved prostate cancer therapies include Zytiga and Jevtana.

Medivation currently carries a Zacks Rank #3 (Hold). At present, companies like Jazz Pharmaceuticals (JAZZ - Free Report) and Santarus, Inc. look well positioned with a Zacks Rank #1 (Strong Buy).

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