Indevus Pharmaceuticals, Inc will provide FDA with additional data and a risk management strategy in order to determine the risk of oil-based reactions to NEBIDO(R).

The complete response resubmission of their New Drug Application (NDA) for NEBIDO(R) will include a database of over 14,000 injections to over 2,600 patients, from existing trials in the U.S. as well as post-marketing studies made in Europe. The size of the data base is large enough to evaluate the frequency of the incidence of post-injection, oil-based reactions. Additionally, the company and the Food and Drug Administration (FDA) agreed on an education strategy to minimize the incidence and/or severity of the oil- based reactions due to the clinical use of intramuscular injections of testosterone undecanoate.

The company further agreed to collect skin-testing data to determine any allergy causing components in the drug or its excipients, as well as to conduct a simple post-marketing study of the safety of NEBIDO(R) in approximately 10,000 patients.

The company expects to launch their product at the end of 2009, assuming FDA approval. Indevus acquired U.S. rights to NEBIDO(R), a long-acting depot of testosterone undecanoate, from Bayer Schering Pharma AG, Germany in July 2005. Other company products include VALSTAR(TM) for bladder cancer, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and the octreotide implant for acromegaly and carcinoid syndrome.

Source: Indevus Pharmaceuticals, Inc.