Astellas Pharma Inc.
) recently announced that their prostate cancer treatment Xtandi,
gained approval in Canada following a priority review.
Xtandi gained approval in Canada for the treatment of patients
with metastatic castration-resistant prostate cancer in the
medical or surgical castration setting who have previously
We note that Xtandi is currently available in the US. Xtandi
delivered net sales of $75.4 million in the first quarter of
2013, $18 million above the last quarter of 2012. Revenues were
driven by higher volumes and a favorable gross to net adjustment
of about $4.4 million taken by Astellas.
Xtandi is currently under regulatory review in the EU
(positive opinion gained in Apr 2013) with a decision expected
shortly. EU approval would trigger a $15 million milestone
payment from Astellas. Medivation and Astellas are also looking
to get Xtandi approved in Japan.
We are encouraged by Xtandi's performance so far. Xtandi,
launched in the US in Sep 2012, could very well be a game-changer
for Medivation. The prostate cancer market represents huge
commercial potential and Xtandi is already off to a strong start.
Medivation has consistently presented impressive data on Xtandi.
Based on the data we have seen so far, we believe the product has
blockbuster potential. Xtandi is currently in several studies
including for the pre-chemo setting.
Interim results from the phase III PREVAIL study on pre-chemo
patients should be out later this year. Expansion into the
pre-chemo setting would be a major positive for Medivation. 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.
Medivation currently carries a Zacks Rank #3 (Hold). Stocks
that currently look well-positioned include companies like
). Both are Zacks Rank #1 (Strong Buy) stocks.
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