Healthcare Industry News: NEBIDO
News Release - December 13, 2006
FDA Accepts New Drug Application for SANCTURA XR(TM) Submitted by IndevusLEXINGTON, Mass., Dec. 13 (HSMN NewsFeed) -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for SANCTURA XR (trospium choloride), the once-daily formulation of SANCTURA®, for the treatment of overactive bladder (OAB). The FDA Prescription Drug User Fee Act (PDUFA) target action date for SANCTURA XR is August 13, 2007. The NDA was submitted to the FDA by the Company on October 12, 2006.
The NDA includes the results of the Company's Phase III clinical program as well as the results of additional Phase I and Phase II studies. The previous NDA for SANCTURA is also referenced for supportive data.
In addition to this clinical database, over 700,000 prescriptions for SANCTURA have been written since the launch of the product in August 2004. Indevus co-promotes SANCTURA with its partner, Esprit Pharma, which will also market SANCTURA XR upon approval in the United States. Indevus licensed trospium chloride from Madaus GmbH, which markets the product for overactive bladder in multiple countries outside the United States.
About SANCTURA and SANCTURA XR
SANCTURA® and SANCTURA XR(TM) belong to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax detrusor smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
SANCTURA and SANCTURA XR possess a quaternary ammonium structure that may be instrumental in the low incidence of CNS side-effects. At therapeutic concentrations in vitro, SANCTURA does not interact with drugs metabolized by the Cytochrome P-450 system, a metabolic pathway commonly associated with drug-drug interactions, and the majority of the absorbed dose is excreted largely unchanged into the urine.
Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.
Indevus is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological and men's health conditions. The Company's marketed products include SANCTURA® for overactive bladder and DELATESTRYL® to treat male hypogonadism. The compounds in development include SANCTURA XR(TM), the once-daily formulation of SANCTURA. NEBIDO®, for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, IP 751 is for interstitial cystitis, pagoclone for stuttering, and aminocandin, which the Company recently out-licensed to Novexel.
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, 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; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; our 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; and other risks.
Source: Indevus Pharmaceuticals
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