LEXINGTON, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today announced that it has licensed the rights to sell SANCTURA XR, the once-daily formulation of trospium chloride, in certain territories outside the U.S., to Madaus GmbH. Madaus has successfully marketed trospium chloride throughout Europe for over 20 years and has a strong, well established position within the European overactive bladder market. Under the terms of the agreement, Madaus has the right to sell SANCTURA XR outside the U.S. except in Canada, Japan, Korea and China, where Indevus and Madaus will share equally in the economics. Madaus will pay Indevus a royalty on net sales and will purchase SANCTURA XR from Indevus at cost plus a manufacturing margin based on units sold in the Madaus territories. In addition, Madaus will be responsible for all payments to Supernus Pharmaceuticals, Inc., Indevus' drug delivery partner, in the Madaus territories.
"We believe the position Madaus holds in the European market offers us the best opportunity to successfully commercialize SANCTURA XR outside the United States," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "This agreement increases the economic opportunity for Indevus as Madaus currently markets trospium chloride through much of the world either directly or through co-promotion or distribution partners. We are very pleased to be continuing our mutually beneficial relationship."
Dr. Kurt N. Gebhart, Member of the Board of Madaus stated, "Madaus will leverage this unique opportunity to build on its own trospium chloride success story in Europe. SANCTURA XR will start a new lifecycle in one of Madaus' strong competence areas -- Urology -- in the important European markets. Since external sources project a doubling of the European overactive bladder / incontinence market in the next 3-year-period, it is the right time to bring out this patent protected innovation. We will immediately begin working with the SANCTURA XR NDA to prepare for our regulatory submission and we are looking forward to significant incremental turnover with the launch of SANCTURA XR."
Separately, the Company announced that Madaus has agreed to waive its rights under the original licensing agreement with Indevus to manufacture SANCTURA XR in the United States. In return, Madaus will receive a manufacturing margin, based on SANCTURA XR units sold in the United States, which will be included in the manufacturing cost of SANCTURA XR. Indevus will sell SANCTURA XR to its partner Esprit Pharma for the U.S. market.
In June and July 2006, the Company announced positive results from the two Phase III trials for SANCTURA XR in overactive bladder. Both trials met their primary endpoints and key secondary endpoints. In addition, the Company believes that SANCTURA XR has set a new tolerability benchmark for oral drugs in the treatment of overactive bladder with an overall dry mouth incidence of 10.7% from the Phase III trials. The Company filed a New Drug Application with the U.S. Food and Drug Administration on Thursday, October 12, 2006.
About SANCTURA(R) and SANCTURA XR
SANCTURA and SANCTURA XR belong to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax 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. In animal studies, SANCTURA does not appear to cross the blood-brain barrier. 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 it is excreted largely unchanged in the urine.
SANCTURA is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for SANCTURA vs. 5.8 percent for placebo) and constipation (9.6 percent for SANCTURA vs. 4.6 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to SANCTURA should not use SANCTURA.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological and men's health conditions. The Company currently co-promotes SANCTURA(R) for overactive bladder and markets DELATESTRYL(R) to treat male hypogonadism and currently has six compounds in clinical development. The compounds in clinical development include SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO(R) for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.
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(R) 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(R); 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.
Michael W. Rogers Brooke D. Wagner
Executive Vice President and CFO VP, Corp. Communications
(781) 861-8444 (781) 402-3410
Indevus Pharmaceuticals, Inc.