LEXINGTON, Mass., Aug. 13 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today the issuance of U.S. Patent No. 7,410,978 (the "'978 patent"), entitled "Once Daily Dosage Forms of Trospium," which is licensed exclusively to the Company by the patent's assignee, Supernus Pharmaceuticals, Inc.
The '978 patent covers the Company's approved product, SANCTURA XR(TM), a once-a-day formulation of trospium chloride which is indicated for the treatment of symptoms of an overactive bladder. Based on calculations made by the United States Patent and Trademark Office, the term of the '978 patent is twenty years plus 89 days from its filing date of November 4, 2004, or February 1, 2025.
In September 2007, the Company entered into an agreement with Allergan, Inc. by which the Company granted Allergan an exclusive sublicense to market SANCTURA XR in the United States. Allergan and Indevus launched SANCTURA XR in the U.S. in January 2008. Indevus licensed to Rottapharm Madaus Group the right to market SANCTURA XR in certain territories outside the U.S., except in Canada, Japan, Korea and China, where the Company and Rottapharm Madaus have joint rights. In May 2008, Indevus and Rottapharm Madaus licensed rights to market SANCTURA XR in Canada to Allergan.
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, and the octreotide implant for acromegaly.
About SANCTURA and SANCTURA XR
SANCTURA(R) 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.
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; need for additional funds and corporate
partners, including for the development of our products; 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; history of
operating losses and expectation of future losses; uncertainties relating
to controls over financial reporting; 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
Michael W. Rogers Robin L. DeCarlo
EVP and CFO Director, Corporate Communications
(781) 861-8444 (781) 402-3405
|SOURCE Indevus Pharmaceuticals, Inc.|
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