Healthcare Industry News: NEBIDO
News Release - March 9, 2006
Indevus Announces FDA Acceptance of IND for NEBIDO(R)Company to Commence Pharmacokinetic Trial in Men with Hypogonadism
LEXINGTON, Mass.--(HSMN NewsFeed)--March 9, 2006--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV ) today announced that the U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug ("IND") application for NEBIDO, its long-acting injectable testosterone preparation for the treatment of male hypogonadism. The Company intends to begin its pharmacokinetic study by the end of March.
"We are pleased that the FDA, upon review of the clinical and non-clinical data package from the work of our partner Schering AG, has agreed with the design of our proposed pharmacokinetic study. The primary endpoint will require assessment of the average serum testosterone levels (Cavg) at steady state, measured in hypogonadal men receiving NEBIDO via intramuscular injection every 12 weeks," stated Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "While our assessment of the available European data indicates steady state levels are achieved by the third injection of NEBIDO, the FDA advised us that it would be preferable to measure our endpoint at the fourth injection to confirm steady state levels. We have agreed with this approach and assuming positive results, we anticipate submitting an NDA in the second quarter of calendar 2007. As part of this trial, we will also study other unique attributes of the drug to support the future commercialization of NEBIDO."
"We have recently entered the hypogonadism market with our acquisition of DELATESTRYL®, a short-acting injectable testosterone product," stated John H. Tucker, executive vice president and chief marketing officer. "The experience we are gaining in this therapeutic area with urologists and endocrinologists will be invaluable in planning the launch of NEBIDO. Our market research and early market development indicates that a long-acting 3-month injectable testosterone product would have a significant role in the treatment of hypogonadal men."
NEBIDO is a novel, investigational, long-acting injectable testosterone preparation for the treatment of male hypogonadism. Recently approved and launched in Europe, NEBIDO is expected to be the first 3-month testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Schering AG, Germany in July 2005.
DELATESTRYL is a well established, marketed injectable testosterone preparation for the treatment of male hypogonadism. DELATESTRYL provides testosterone enanthate, a derivative of the primary endogenous androgen testosterone, via intramuscular injection. Suggested dosing of DELATESTRYL is once every 2 to 4 weeks. Dosage and duration of therapy will depend on age, sex, diagnosis and patient's response to treatment. DELATESTRYL is contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men's health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.
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® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
Source: Indevus Pharmaceuticals
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