Indevus Pharmaceuticals Provides Update on NEBIDO(R) ...( Company Expects FDA to Request Addi...),Health

Company Expects FDA to Request Additional Safety Study Prior to Approval

LEXINGTON, Mass., June 4 /PRNewswire/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA filing for NEBIDO(R), the Company expects the FDA to formally request that the Company provide additional safety data prior to approving NEBIDO. The Company currently believes that an additional study will be required in order to supply the necessary data. The Company expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the Company expects to receive by the original June 27, 2008 PDUFA date.

The Company believes the requirement for additional data relates to a reaction immediately following the injection and is a known rare complication of oil-based depot injections. The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and may be due to improper injection technique. The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting.

The Company believes that the FDA's safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml) dose. In the Indevus U.S. clinical trials, which included a total of approximately 500 patients, there was a si
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