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Licensing In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer gains Schwarz urology agent fesoterodine: Pfizer has an estimated user fee date in January 2007 for incontinence therapy fesoterodine, acquired from Schwarz under a deal announced April 13. Schwarz' fesoterodine NDA, submitted in March for treatment of overactive bladder, is receiving a standard 10-month review at FDA. The firm also submitted an EU marketing authorization application in March. Under the terms of the licensing deal, Pfizer will make a $100 mil. up-front payment to Schwarz, up to $110 mil. in milestone payments, plus royalties on sales of the anti-muscarinic agent. Schwarz also will collect royalties on sales of Pfizer's established incontinence treatment Detrol (tolterodine), approved in 1998; the deal ends a patent dispute between Pfizer and Schwarz over fesoterodine. The NDA includes Phase III data comparing fesoterodine to placebo and to tolterodine. The study showed statistically significant improvement compared to placebo in the primary endpoints of change in micturition frequency, change in number of urge incontinence episodes and self-assessed treatment response. Schwarz notes that "improvements with the active comparator were below those achieved with fesoterodine"...

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