Medivation, Inc.’s (MDVN) 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 analysis.
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. (ALPMY) 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 Sanofi’s (SNY) 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 2013.
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, companies like Actelion Ltd. (ALIOF) look more attractive with a Zacks Rank #1 (Strong Buy).
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