Health Canada approves XIAFLEX for Dupuytren's contracture

Jul 9 2012

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."

"With the Canadian approval, Auxilium has now received regulatory approval of the first, effective nonsurgical treatment for Dupuytren's' contracture in thirty-three countries," said Adrian Adams, Chief Executive Officer and President of Auxilium.  "With the strength of Actelion's Canadian commercialization and development organization, we believe XIAFLEX has the potential to become a truly significant non-surgical treatment alternative to Canadian physicians and patients for Dupuytren's contracture."

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. 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 III trials of XIAFLEX for the potential treatment of Peyronie's disease and expects to file a sBLA for this second indication with the FDA by year-end 2012.