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GEN News Highlights : Mar 1, 2011

Pfizer Wins EMA Approval to Market Dupuytren Contracture Therapy

Company obtained European rights to Xiapex from Auxilium, which developed the treatment with BioSpecific Technologies.

EMA granted Pfizer approval to market Xiapex® (collagenase clostridium histolyticum) for the treatment of Dupuytren contracture. The treatment is expected to be available for use in some European markets later this year.

Pfizer holds rights to market Xiapex for Dupuytren contracture and Peyronie disease in the EU and 19 other European and Eurasian countries under a sublicense from Auxilium Pharmaceuticals. Auxilium  markets the injectable treatment in the U.S. for Dupuytren contracture under the trade name Xiaflex and is conducting Phase III trials in Peyronie disease. The therapy was originally developed by Auxilium and BioSpecific Technologies under a collaboration to develop collagenase clostridium histolyticum, a combination of two purified collagenases derived from the bacterium Clostridium histolyticum.

Under the agreement between Pfizer and Auxilium, BioSpecifics receives 8.5% of any milestone payments received by Auxilium from Pfizer in addition to milestone payments under a separate arrangement with Auxilium. BioSpecifics will receive its first milestone fee from Auxilium based on the first commercial sale in the U.K., France, Germany, and Spain.

BioSpecifics will also continue to receive low double-digit royalties on sales, independent of indication, territory, sales volume, and whether Auxilium or Pfizer sells the product. In addition, BioSpecifics will receive a markup on the cost of goods sold.

Xiaflex was approved in the U.S. for Dupuytren contracture in February 2010 and launched a month later. Auxilium reported worldwide revenues for Xiaflex was $18.4 million for the year ending December 31, 2010, versus $3.6 million in 2009. Most of the increase reflected the March 2010 launch of Xiaflex in the U.S., where the treatment generated $14.1 million in sales last year, representing approximately 4,500 vials.