LEXINGTON, Mass., Aug. 13 IndevusPharmaceuticals, Inc. (Nasdaq: IDEV) announced today the issuance of U.S.Patent No. 7,410,978 (the "'978 patent"), entitled "Once Daily Dosage Forms ofTrospium," which is licensed exclusively to the Company by the patent'sassignee, Supernus Pharmaceuticals, Inc.
The '978 patent covers the Company's approved product, SANCTURA XR(TM), aonce-a-day formulation of trospium chloride which is indicated for thetreatment of symptoms of an overactive bladder. Based on calculations made bythe United States Patent and Trademark Office, the term of the '978 patent istwenty years plus 89 days from its filing date of November 4, 2004, orFebruary 1, 2025.
In September 2007, the Company entered into an agreement with Allergan,Inc. by which the Company granted Allergan an exclusive sublicense to marketSANCTURA XR in the United States. Allergan and Indevus launched SANCTURA XR inthe U.S. in January 2008. Indevus licensed to Rottapharm Madaus Group theright to market SANCTURA XR in certain territories outside the U.S., except inCanada, Japan, Korea and China, where the Company and Rottapharm Madaus havejoint rights. In May 2008, Indevus and Rottapharm Madaus licensed rights tomarket SANCTURA XR in Canada to Allergan.
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical companyengaged in the acquisition, development and commercialization of products totreat conditions in urology and endocrinology. The Company's approved productsinclude SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) foradvanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, andDELATESTRYL(R) to treat male hypogonadism. The Indevus development pipelinecontains multiple compounds within the Company's core therapeutic areas inaddition to several partnered or partnerable programs. The most advancedcompounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R)for male hypogonadism, PRO 2000 for the prevention of infection by HIV andother sexually-transmitted pathogens, and the octreotide implant foracromegaly.
About SANCTURA and SANCTURA XR
SANCTURA(R) and SANCTURA XR(TM) belong to a class of anticholinergiccompounds known as muscarinic receptor antagonists. These compounds relaxdetrusor smooth muscle tissue found in the bladder, thus decreasing bladdercontractions. Overactive or unstable detrusor muscle function is believed tobe the cause of overactive bladder.
SANCTURA and SANCTURA XR possess a quaternary ammonium structure that maybe instrumental in the low incidence of CNS side-effects. At therapeuticconcentrations in vitro, SANCTURA does not interact with drugs metabolized bythe Cytochrome P-450 system, a metabolic pathway commonly associated withdrug-drug interactions, and the majority of the absorbed dose is excretedlargely unchanged into the urine.
Patients who have urinary retention, gastric retention, uncontrollednarrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, thispress release contains forward-looking statements that involve risks anduncertainties that could cause the Company's actual results and financialcondition to differ materially from those anticipated by the forward-lookingstatements. These risks and uncertainties are set forth in the Company'sfilings under the Securities Act of 1933 and the Securities Exchange Act of1934 under "Risk Factors" and elsewhere, and include, but are not limited to:dependence on the success of SANCTURA, SANCTURA XR, NEBIDO, VANTAS andSUPPRELIN LA; need for additional funds and corporate partners, including forthe development of our products; effectiveness of our sales force; competitionand its effect on pricing, spending, third-party relationships and revenues;dependence