Indevus Presents Successful Phase III NEBIDO(R) Data at American Urological Association94 Percent of Men Maintained Normal Testosterone Levels Throughout Treatment
LEXINGTON, Mass., May 20, 2008 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that data on NEBIDO(R) (testosterone undecanoate), an investigational, long-acting intramuscular injection for the treatment of hypogonadism, was presented in a late breaker presentation at the 2008 American Urological Association Annual Meeting held in Orlando. The data, which had been previously announced, are based on a Phase III study in which men with hypogonadism and low serum testosterone levels prior to entering the study were treated with NEBIDO for 24 weeks. This study demonstrated that 94 percent of the men had their testosterone levels restored and maintained to within normal levels; further, 92 percent of these men expressed satisfaction with their NEBIDO treatment. Sixty-two percent of men participating in the Phase III study had previously used other testosterone treatments.
"An estimated four to five million men in the U.S. suffer from a common but treatable condition called hypogonadism, or low testosterone. Men with this condition experience decreased libido, fatigue, depression, and muscle loss," said Abraham Morgentaler, MD, Associate Clinical Professor of Urology at . "Low testosterone is associated with other significant health issues including diabetes, obesity, cardiovascular disease, and osteoporosis. Low testosterone is under-recognized and under-treated. Results of a Phase III study on a long-acting testosterone injection called testosterone undecanoate (NEBIDO) revealed that a very high percentage of men who received this treatment maintained normal testosterone levels while receiving an injection every 10 weeks. This form of testosterone treatment would thus require only five injections per year. This would be an appealing alternative for many men, who may object to existing testosterone treatments such as twice-monthly injections or daily skin application of gels or patches."
About the Study
This Phase III study was a multi-center, open-label, randomized US trial designed to assess the pharmacokinetics, safety, and efficacy of NEBIDO in men with primary or secondary hypogonadism. The trial enrolled a total of 130 hypogonadal men (serum testosterone below 300 ng/dL, at least 18 years of age) that met the study inclusion criteria. Patients received injections of 750 mg of NEBIDO at baseline, week 4, and week 14 of the study, and were followed for an additional 10 weeks. Of the 130 men who participated in the trial, 117 patients were eligible for pharmacokinetics evaluations.
In the study, pharmacokinetic objectives were achieved, with 94 percent of patients reaching and maintaining normal serum testosterone levels. Additionally, secondary endpoints of mood and sexual function also improved. The most commonly reported possibly-related adverse events in the trial were acne (4.6 percent), fatigue (3.1 percent), and injection site pain (3.1 percent).
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed 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 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. 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(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) 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(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, the octreotide implant for acromegaly, and a biodegradable ureteral stent used in association with the adjunctive treatment of kidney stones.
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; effectiveness of our sales force; competition and its effect on pricing, spending, third-party relationships and revenues; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; risks associated with being a manufacturer of some of our products; 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; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, changes in reimbursement policies and/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by the healthcare community of our approved products and product candidates; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR; product liability and insurance uncertainties; risks relating to the Redux-related litigation; need for additional funds and corporate partners, including for the development of our products; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; difficulties in managing our growth; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; 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.
Michael W. Rogers Brooke D. Wagner Executive Vice President and CFO VP, Corp. Communications (781) 861-8444 (781) 402-3410
CONTACT: Michael W. Rogers, Executive Vice President and CFO,+1-781-861-8444, or Brooke D. Wagner, VP, Corp. Communications,+1-781-402-3410, both of Indevus Pharmaceuticals, Inc.
Web site: http://www.indevus.com/
Ticker Symbol: (NASDAQ-NMS:IDEV)
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Posted: May 2008