Print“An independent data monitoring committee recommended that the trial be stopped early and the men who had received the placebo be offered MDV-3100.”
Interim results from a late-stage trial of Medivation's and Astellas Pharma’s experimental prostate cancer drug showed that it could help the sickest patients live longer, rocketing Medivation’s shares up 140 percent to close at $39.75 on November 3.
Interim analysis of trial results found that the drug, called MDV-3100, helped men with advanced prostate cancer live a median of 18.4 months. That compares to men treated with a placebo who had a median survival rate of 13.6 months. The risk of dying of prostate cancer while being treated with MDV-3100, as compared to undergoing chemotherapy, was reduced by 37 percent. An independent data monitoring committee recommended that the trial be stopped early and the men who had received the placebo be offered MDV-3100.
The announcement was big news for Medivation, which just one and a half years earlier had flopped badly in a late-stage trial for its Alzheimer’s disease drug Dimebon. But good news for Medivation may spell trouble for its competitors.
MDV-3100 is now seen as a rival for Johnson & Johnson’s Zytiga, Dendreon’s Provenge, and Exelixis’ cabozantinib.
A day after reporting better-than-expected sales for Provenge in the third quarter, Dendreon plunged 37 percent, to $6.55, in part because of the positive news released by Medivation. Goldman Sachs downgraded its rating of Dendreon to “neutral” from “buy” following Medivation’s report.
Medivation, which hopes to meet with the U.S. Food and Drug Administration in early 2012 to discuss the submission of an application to market MDV-3100, says it plans to continue studying the compound in a broad array of earlier-stage prostate cancers.
November 04, 2011
http://www.burrillreport.com/article-encouraging_data_sends_medivation_soaring.html
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