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Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
Date:1/22/2008

testosterone levels, minimal excursions outside of the normal range, and an extremely high percentage of patients maintaining a eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a responder analysis based on 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. As with the original dosing regimen, treatment with NEBIDO was well tolerated with this new dosing regimen.

"As we have previously stated, we have been evaluating dosing regimens that we believe optimize the replacement of testosterone in men with hypogonadism. I am extremely pleased that the dosing regimen evaluated in this study accomplishes this objective," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "The results of our trial demonstrate a rapid achievement of steady-state testosterone levels, the maintenance of levels within the eugonadal range, and reductions in excursions above the normal range. Steady state testosterone pharmacokinetics were achieved within just weeks under the new regimen, whereas the 1000 mg regimen, while successfully achieving all primary objectives, reached steady state pharmacokinetics after several months of treatment."

Dr. Cooper continued, "We intend to ask for approval of this new 750 mg regimen, rather than the 1000 mg regimen, as we believe this new regimen distinguishes itself by providing physicians with the optimal long-term dosing solution for treating their male patients with hypogonadism. Importantly, we are extremely pleased with the feedback we recently received from the FDA that the PDUFA target action date was likely to remain unchanged."

Study Design

The most recent Phase III pharmacokinetic trial was an open-label (unblinded) study that evaluated treatment with an initial 750 mg of NEBIDO given via intramuscular injection, followed 4-weeks lat
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SOURCE Indevus Pharmaceuticals, Inc.
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