Indevus Announces Licensing and Manufacturing Pact for SANCTURA XR(TM) With Madaus GmbH
Monday November 6, 8:00 am ET
LEXINGTON, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV - News) 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.
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