LEXINGTON, MA, USA (Press Release) - September 26, 2008 -

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for NEBIDO^® in the first quarter of calendar 2009. The re-submission database will include experience from over 14,000 injections in more than 2,600 patients, all of which come from existing clinical trials conducted in the U.S. and post-marketing studies that have been conducted in Europe. FDA stated that the number of patients and the number of injections of testosterone undecanoate from these studies appear to provide an adequate size database to determine the precise incidence of serious post-injection, oil-based reactions.

Indevus and FDA also agreed on an education 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. Further, Indevus and FDA agreed to obtain skin-testing data to characterize an allergic component to the drug or any of its excipients in certain patients. Indevus has also agreed to conduct a large, simple post- marketing study of the safety of NEBIDO in approximately 10,000 patients.

"We are very pleased that we can provide to FDA additional data from existing clinical trials to satisfy FDA's desire to understand the incidence of these rare oil-based reactions, without the need to conduct new clinical trials prior to resubmission or approval," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "FDA also agreed with our outline of the proposed risk mitigation plans that included appropriate labeling description of intramuscular injection technique, adequate labeling information regarding allergic and oil-based reactions, and the commitment to conduct a large, simple post-marketing study. Risk mitigation plans are now commonly added to approval of new drugs and our agreed plans are consistent with FDA's new initiatives for the management of safety of new drugs. Given a six month FDA review time, assuming approval, we will be in a position to launch NEBIDO with our sales force in the fourth quarter of calendar 2009. We remain enthusiastic about the marketplace opportunity for a long-acting injectable testosterone therapy and we expect the introduction of NEBIDO to have a significant positive impact on the Company's business plan."

About NEBIDO^®

NEBIDO^® is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA^® and SANCTURA XR^™ for overactive bladder, VANTAS^® for advanced prostate cancer, SUPPRELIN^® LA for central precocious puberty, and DELATESTRYL^® to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR^™ for bladder cancer, NEBIDO^® for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and the octreotide implant for acromegaly and carcinoid syndrome.

Indevus Pharmaceuticals, Inc.

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