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Indevus Announces Submission of New Drug Application
Date:8/28/2007

une 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO.

"The submission of the NEBIDO NDA is a very important milestone for the Company," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "We strongly believe that NEBIDO can greatly improve the treatment options for men who suffer from hypogonadism."

Phase III Pharmacokinetic Trial

In June 2007, the Company announced positive results of its Phase III pharmacokinetic trial with NEBIDO. The purpose of the trial was to evaluate NEBIDO under U.S. Food and Drug Administration (FDA) pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism. The trial met its primary endpoints: a responder analysis based on the average testosterone concentrations during the steady-state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady-state dosing interval.

Phase III Study Design

The Phase III pharmacokinetic trial was a randomized open-label (unblinded) study that included the evaluation of the pharmacokinetics of NEBIDO dosed as either 1000 mg every 12 weeks or as 750 mg every 12 weeks, both via intramuscular injection. The primary endpoints included a responder analysis (based on guidelines provided from the FDA for average testosterone concentrations over the steady state dosing interval) and an outlier analysis (based on the maximum testosterone concentrations during the steady state dosing interval). Specifically, a responder was defined (per the FDA) as a patient who, at steady-state conditions, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary response endpoint was met if at least 75% of patients achieved a Cavg within this normal range. FDA also provided guidelines related to maximum testosterone (Cmax) levels, including thresholds that no patient should exceed a testosterone c
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SOURCE Indevus Pharmaceuticals, Inc.
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