Indevus Pharmaceuticals, Inc. announced the signing of a license agreement with Allergan Inc., a Canadian affiliate of Allergan, Inc., based in Irvine, California, granting Allergan the right to market Sanctura XR (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 US Food and Drug Administration (FDA) in August 2007, but has not yet been approved in Canada. In October 2007, Allergan, Inc. obtained the US rights to Sanctura and Sanctura XR through its acquisition of Esprit Pharmaceuticals and began selling Sanctura XR in the US 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 US rights to Sanctura from Rottapharm Madaus in late 1999.
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.
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology.