Indevus (IDEV) Receives Approvable Letter for NEBIDO Expressing Concerns; Co Revises Operating Plan

June 30, 2008 10:30 AM EDT

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) received an approvable letter from the FDA for NEBIDO.

The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product. The letter generally confirmed the Company's previously-announced indications from the FDA based on telephone discussions.

The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of NEBIDO 1000 mg, 4 cc injection volume, (versus the 750 mg, 3 cc injection volume used in the United States). The Company believes and the FDA concurs that the reaction is likely the result of a small amount of the oily solution immediately entering the vascular system from the injection site, a known, rare complication of oil-based depot injections.

The FDA has requested the Company address these clinical deficiencies by providing detailed safety information from clinical studies to determine the precise incidence of serious post-injection oil-based reactions and allergic reactions.

FDA has also requested the Company provide a plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil-based reactions and has requested certain in vitro and skin-testing data to exclude an allergic component to the drug or some of its excipients.

In view of the NEBIDO regulatory delay, the Company's Board of Directors has approved a revised operating plan that more appropriately aligns the cost structure to the Company's revenue projections and development opportunities. The new operating plan provides for 1) aggressive support and top-line growth of marketed products, VANTAS® and SUPPRELIN® LA, 2) aggressive support for the launch of VALSTAR(TM) for bladder cancer later this year, 3) continued co-promotion with Allergan of SANCTURA® and SANCTURA XR(TM) with the urology sales force through March 2009, 4) initiation of Phase III trials for the six-month octreotide implant for acromegaly, and 5) significant reduction in operating expenses through a combination of headcount reductions of approximately 12 percent of employees, primarily at the corporate and administrative levels at the Lexington, Massachusetts headquarters, and reduction of other operating expenses.

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