) share price shot up 8.2% on Oct 22, 2013 to close the trading
session at $53.89. The stock was buoyed by the recommendation of
the Independent Data Monitoring Committee (IDMC) to stop a phase
III STUDY (PREVAIL; n>1700) on Xtandi (enzalutamide) following
the favourable benefit-risk exhibited by it in a planned interim
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The study is currently evaluating Xtandi in patients suffering
from metastatic prostate cancer that has progressed despite
androgen deprivation therapy. These patients have also not
received chemotherapy earlier. Based on the impressive results of
the interim analysis, the IDMC recommended patients taking
placebo to be treated with Xtandi.
Results from the study revealed that a 30% reduction in the risk
of death was observed in patients treated with Xtandi compared to
that of patients under placebo. A statistically significant
radiographic progression-free survival advantage was also
observed in Xtandi treated patients compared to the placebo
group. Overall survival and radiographic progression-free
survival were the two co-primary endpoints of the PREVAIL study.
The study also revealed that Xtandi had a favourable benefit-risk
ratio over the placebo arm.
Following the positive results, Medivation and partner,
Astellas Pharma Inc.
) are gearing up for regulatory submission for the drug's
potential label expansion. The companies intend to host meetings
with regulatory agencies early next year.
Xtandi is currently approved for the treatment of patients
suffering from metastatic castration-resistant prostate cancer
who have previously received
) Taxotere. Medivation is also exploring Xtandi for breast cancer
(phase II). Xtandi delivered net sales of $86.1 million in the
second quarter of 2013, $10.7 million above the first quarter of
We are encouraged by Xtandi's performance. Xtandi could very well
be a game-changer for Medivation. Successful label expansion of
the drug should boost sales further.
Medivation currently carries a Zacks Rank #3 (Hold). At present,
) look more attractive with a Zacks Rank #1 (Strong Buy).