Indevus Receives Approvable Letter from FDA for...(ct's eventual approval. We will work wit...)

Date:6/30/2008

ct's eventual approval. We will work with the FDA and our partner, Bayer Schering Pharma AG, to respond to the approvable letter and devise a plan to address the deficiencies. While the FDA has not specifically requested additional clinical studies, we believe that an additional study will likely be required to demonstrate that NEBIDO 750 mg (3 cc volume) administered with careful and proper intramuscular injection technique, has an acceptably low incidence of oil-based reactions to gain approval. In addition, we are pleased that FDA has provided guidance on how we can demonstrate that the product does not cause allergic reactions. We hope to be able to articulate a development plan to address FDA concerns within the next few months, and for now are maintaining our previous guidance that it may take the Company approximately 18 months to re-submit the revised NDA. We will communicate specific guidance on clinical plans and timelines when they are available."

Revised Operating Plan

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(R) and SUPPRELIN(R) LA, 2) aggressive support for the launch of VALSTAR(TM) for bladder cancer later this year, 3) continued co-promotion with Allergan of SANCTURA(R) 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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SOURCE Indevus Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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