GEN Exclusives

More »

GEN News Highlights

More »
Mar 1, 2011

Pfizer Wins EMA Approval to Market Dupuytren Contracture Therapy

  • 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.




Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content


GEN Jobs powered by connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
More »

Be sure to take the GEN Poll

Easing Restrictions for Terminal Patients

Should the Federal Government Pass a “Right to Try” Bill Allowing Terminally Ill Patients Access to Experimental Medicines?

More »