) 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
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
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.
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Currently approved prostate cancer therapies include Zytiga and
Medivation currently carries a Zacks Rank #3 (Hold). At present,
) look well positioned with a Zacks Rank #1 (Strong Buy).