Medivation and Astellas Pharma said today the Independent Data Monitoring Committee has informed the partners of positive results from an interim analysis of a phase 3 trial of a treatment for advanced prostate cancer previously treated with chemotherapy.
The treatment, MDV3100, successfully met the study's interim efficacy stopping criteria, which was to demonstrate a clinically meaningful and statistically significant improvement in overall survival compared to a placebo, with patients surviving 4.8 months longer with the treatment than with placebo.
The committee suggested the trial can be stopped early, and the men who were given a placebo can be given the drug.
MDV3100 is the first androgen receptor signaling inhibitor.
) and Astellas said they will meet with the US Food and Drug Administration in early 2012 prior to submitting a new drug application, and will provide an update on regulatory timelines following the meeting.
Keep an eye on shares of Dendreon
) today as well. The company reported earnings results late yesterday, and did not impress the markets with sales of its own prostate cancer treatment.
Dendreon said it lost $147.1 million, or $1 per share in the third quarter, compared to a loss of $79.3 million, or $0.56 per share, last year.
An adjusted loss of $0.56 per share was narrower than analysts expected.
Revenue more than tripled, to $64.3 million.
The company has said sales of its costly prostate cancer treatment Provenge were increasing more slowly than expected, even after Medicare agreed to cover the treatment.
Dendreon withdrew its earnings projections at the end of the summer, and did not offer new forecasts with its earnings report.
) said today it has agreed to pay $3 billion in settlements to put to rest US investigations into its sales and marketing practices.
An agreement is expected to be full hammered out in 2012.
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