Healthcare Industry News: NEBIDO
News Release - May 22, 2008
Indevus Pharmaceuticals Licenses Canadian Rights for SANCTURA XR(TM) to Allergan, Inc.LEXINGTON, Mass., May 22 (HSMN NewsFeed) -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV ) today announced the signing of a License Agreement with Allergan Inc., a Canadian affiliate of Allergan, Inc., based in Irvine, CA, granting Allergan the right to market SANCTURA XR(TM) (trospium chloride extended release preparation) throughout Canada. Indevus jointly granted the rights along with Rottapharm Madaus Group, an Italian pharmaceutical group, as required by a prior agreement between Indevus and Rottapharm Madaus. Indevus and Rottapharm Madaus will share equally in the proceeds from the license transaction. Under the terms of the agreement, Allergan will pay up to $9 million to each of Indevus and Rottapharm Madaus, including a $7 million up-front license fee and up to $2 million in sales threshold milestone payments. Allergan will be responsible for all regulatory and marketing activities in Canada.
"We are pleased to have licensed the Canadian rights for SANCTURA XR to Allergan," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "This agreement further consolidates the rights for SANCTURA XR within one highly competent organization. We continue to pursue opportunities to obtain marketing partners in Japan, Korea and China, where we agreed to jointly license rights with Rottapharm Madaus."
SANCTURA XR is indicated for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. SANCTURA XR was approved by the U.S. Food and Drug Administration (FDA) in August 2007, but has not yet been approved in Canada. In October 2007, Allergan, Inc. obtained the U.S. rights to SANCTURA® and SANCTURA XR through its acquisition of Esprit Pharmaceuticals and began selling SANCTURA XR in the U.S. in January 2008. Indevus previously licensed rights to SANCTURA XR throughout the rest of the world to Rottapharm Madaus , except for Canada, Japan, Korea and China, where Indevus and Rottapharm Madaus agreed to jointly license rights to SANCTURA XR to third party partners.
SANCTURA (trospium chloride 20 mg tablets) was originally developed by Rottapharm Madaus and is currently marketed by Rottapharm Madaus and several Rottapharm Madaus licensees as a prescription drug product in Europe and other territories, with different trade marks, where it is one of the leading products for OAB / urinary incontinence. Indevus licensed exclusive U.S. rights to SANCTURA® from Rottapharm Madaus in late 1999.
About SANCTURA XR(TM)
SANCTURA XR belongs 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 XR possesses a quaternary ammonium structure that may be instrumental in the low incidence of CNS side-effects. At therapeutic concentrations in vitro, SANCTURA XR 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 XR should not use SANCTURA XR.
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® and SANCTURA XR(TM) 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(TM) for bladder cancer, NEBIDO® 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.
Source: Indevus Pharmaceuticals
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