AveedTreatment for Hypogonadism -- Male
FDA Accepts New Drug Application for Nebido Submitted by Indevus
LEXINGTON, Mass., November 01, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for Nebido, its long-acting injectable testosterone preparation for the treatment of male hypogonadism. The FDA Prescription Drug User Fee Act (PDUFA) target action date for Nebido is June 27, 2008. The NDA was submitted to the FDA by the Company on August 28, 2007.
The NDA contains data from six clinical studies in which over 400 patients received at least one dose of Nebido, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of Nebido have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of Nebido.
Nebido is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. Nebido is expected to be the first three-month testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to Nebido from Bayer Schering Pharma AG, Germany in July 2005.
Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving treatment with testosterone therapy.
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 XR and Sanctura 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, octreotide for acromegaly, and pagoclone for stuttering.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of Sanctura, Sanctura XR, Nebido, Vantas and Supprelin LA; the early state of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly Sanctura XR, Nebido, and Valstar; risks associated with contractual agreements, particularly for the manufacture and co-promotion of Sanctura and Sanctura XR and the manufacture of Nebido, Vantas, Supprelin LA and Valstar; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; changes in reimbursement policies and/or rates for Sanctura, Vantas, Supprelin LA, Delatestryl and any future products; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; the risk that the businesses of Indevus and Valera Pharmaceuticals, Inc. will not be integrated successfully during the period following the related merger; the risk that the cost savings and any other synergies from the merger may not be fully realized or may take longer to realize than expected; market acceptance for the merger and approved products; risks of regulatory review and clinical trials; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; the effect of changes in governmental regulations and other risks. Indevus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Posted: November 2007
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