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

Company Files Additional Data to the NEBIDO NDA

PDUFA Date Expected to Remain June 27, 2008

LEXINGTON, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced additional positive results from its Phase III program for NEBIDO (testosterone undecanoate), a long-acting injectable testosterone therapy under development for the treatment of male hypogonadism. The trial data announced today has been filed with the U.S. Food and Drug Administration (FDA) as an addition to data contained in the Company's existing New Drug Application (NDA) that was originally filed on August 28, 2007. Based on recent conversations with the FDA, the Company anticipates that the FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO will remain June 27, 2008.

The dosing regimen for NEBIDO submitted in the original NDA was 1000 mg given every 12 weeks, and as announced previously, achieved all of the primary endpoints according to the FDA criteria for approvability. The Company has been exploring additional dosage regimens to determine if it is possible to achieve a more rapid onset of steady state testosterone pharmacokinetics and still satisfy each of the FDA pre-specified criteria for approvability. This recently completed Phase III trial, announced today, studied a new treatment regimen in which hypogonadal men were given an initial injection of 750 mg of NEBIDO, followed 4-weeks later by an additional 750 mg loading injection and then 750 mg injections every 10-weeks thereafter.

The data from this recently completed Phase III trial demonstrated a highly effective treatment regimen. In the trial, NEBIDO demonstrated a rapid achievement of steady state
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SOURCE Indevus Pharmaceuticals, Inc.
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