On August 6, 2007, Indevus announced that SANCTURA XR (trospium chloride extended release capsules) was approved by the U.S. Food and Drug Administration (FDA). SANCTURA XR is indicated for the once-daily treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Following the approval, the Company received a $49.9 million milestone payment from Esprit Pharma, the Company's partner in the U.S. for SANCTURA and SANCTURA XR. The milestone payment was based on the total costs to develop SANCTURA XR, including clinical development, as well as manufacturing development costs.
Under the terms of the amended and restated license, commercialization and supply agreement, Allergan will be responsible for all marketing and sales activities. Indevus will be responsible for supply of SANCTURA XR through June 30, 2008. Beginning in July 2008, Allergan will assume manufacturing responsibilities for SANCTURA XR. Upon closing of this agreement, Allergan will pay Indevus an upfront license fee of $25 million, a portion of which will begin to be creditable by Allergan in 2010, against certain future payments owed to Indevus. Allergan will also pay Indevus royalties on net sales of SANCTURA and SANCTURA XR of 12.5% and will reimburse Indevus for required royalty payments to Indevus' licensors. For a period of seven years, the royalties payable to Indevus will be subject to a guaranteed minimum level, except under specified conditions. The guaranteed minimum royalties will be as follows: 2008 - $8.1 million, 2009 - $10.6 million, 2010 - $15.6 million, 2011 - $18.1 million, 2012 - $20.6 million, 2013 - $23.5 million, 2014 - $26.3 million. Indevus will also receive a milestone payment of $20 million in December 2013 based on certain market exclusivity conditions.
Additionally, Indevus will continue to co-promote SANCTURA XR through
September 2008 an
|SOURCE Indevus Pharmaceuticals, Inc.|
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