Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Actelion Pharmaceuticals Canada Inc. announced today that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, first-in-class biologic for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.
Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion 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. Pursuant to the Collaboration Agreement, Auxilium intends 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.
Jacques Archambault, General Manager of Actelion Pharmaceuticals Canada commented: "The approval of XIAFLEX in Canada is excellent news for Canadian patients and for Actelion. This milestone is the signal to Actelion's organization to move quickly and diligently to make XIAFLEX available to Canadian patients as soon as possible."