LEXINGTON, Mass., Sept. 26 IndevusPharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reachedagreement with the U.S. Food and Drug Administration (FDA) with regard to theadditional data and risk management strategy that will lead to re-submission(complete response) of the New Drug Application (NDA) for NEBIDO(R) in thefirst quarter of calendar 2009. The re-submission database will includeexperience from over 14,000 injections in more than 2,600 patients, all ofwhich come from existing clinical trials conducted in the U.S. andpost-marketing studies that have been conducted in Europe. FDA stated thatthe number of patients and the number of injections of testosteroneundecanoate from these studies appear to provide an adequate size database todetermine the precise incidence of serious post-injection, oil-basedreactions.
Indevus and FDA also agreed on an education plan to minimize the risksassociated with the clinical use of testosterone undecanoate intramuscularinjection, namely, to reduce the incidence and/or severity of the serious oil-based reactions. Further, Indevus and FDA agreed to obtain skin-testing datato characterize an allergic component to the drug or any of its excipients incertain 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 fromexisting clinical trials to satisfy FDA's desire to understand the incidenceof these rare oil-based reactions, without the need to conduct new clinicaltrials prior to resubmission or approval," stated Glenn L. Cooper, M.D.,chairman and chief executive officer of Indevus. "FDA also agreed with ouroutline of the proposed risk mitigation plans that included appropriatelabeling description of intramuscular injection technique, adequate labelinginformation regarding allergic and oil-based reactions, and the commitment toconduct a large, simple post-marketing study. Risk mitigation plans are nowcommonly added to approval of new drugs and our agreed plans are consistentwith FDA's new initiatives for the management of safety of new drugs. Given asix month FDA review time, assuming approval, we will be in a position tolaunch NEBIDO with our sales force in the fourth quarter of calendar 2009. Weremain enthusiastic about the marketplace opportunity for a long-actinginjectable testosterone therapy and we expect the introduction of NEBIDO tohave a significant positive impact on the Company's business plan."
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoateunder development for the treatment of male hypogonadism. NEBIDO is expectedto be the first long-acting testosterone preparation available in the U.S. inthe growing market for testosterone replacement therapies. Indevus acquiredU.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical companyengaged in the acquisition, development, and commercialization of products totreat conditions in urology and endocrinology. The Company's approved productsinclude SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) foradvanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, andDELATESTRYL(R) to treat male hypogonadism. The Indevus development pipelinecontains multiple compounds within the Company's core therapeutic areas inaddition to several partnered or partnerable programs. The most advancedcompounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R)for male hypogonadism, PRO 2000 for the prevention of infection by HIV andother sexually-transmitted pathogens, and the octreotide implant foracromegaly and carcinoid syndrome.
Forward Looking Statements
Except for the descriptions of histori