(By Balaseshan) Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) said it has received Health Canada approval for Xiaflex (collagenase clostridium histolyticum or CCH), a biologic for the treatment of Dupuytren's contracture in adults with a palpable cord.
Xiaflex has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency as a treatment for Dupuytren's contracture in adults with a palpable cord, and is also in clinical development in Japan.
Collagenase clostridium histolyticum is used as a powder-and-solvent injection kit for the treatment for Dupuytren's contracture, a condition where the fingers bend towards the palm and cannot be fully straightened.
Under the terms of the Collaboration Agreement, Actelion Pharmaceuticals Canada Inc. received exclusive rights to commercialize Xiaflex for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals.
Auxilium plans to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for Xiaflex in Canada and, upon approval, in the remainder of these countries. Actelion expects to make Xiaflex available to patients in Canada in the first half of 2013.
Actelion expects to file for approval of Xiaflex for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico by the end of the 2012.
Auxilium recently announced positive top-line data from two pivotal, phase 3 trials of Xiaflex for the potential treatment of Peyronie's disease and expects to file a supplemental biologics license application for this second indication with the FDA by year-end 2012.
Actelion paid Auxilium an upfront payment of $10 million and would also make up to $16 million in potential regulatory, pricing and reimbursement milestone payments and $42.5 million in potential sales milestone payments.
Auxilium said it would also receive increasing tiered double-digit royalties based on sales of Xiaflex in Actelion's territories and would supply product to Actelion at a predetermined cost.
AUXL is trading up 0.37% at $26.90 on Monday. The stock has been trading between $13.59 and $27.89 for the past 52 weeks.