Auxilium and Actelion get Xiaflex approval in Canada

US company Auxilium Pharmaceuticals (Nasdaq: AUXL) and the Canadian subsidiary of Actelion (SIX: ATLN), Europe’s largest biotech firm, have received marketing approval from 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.

Under the terms of the collaboration deal between the two companies (The Pharma Letter February 24), 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. The accord is worth a potential $68.5 million to the US firm. Auxilium receives a $500,000 milestone on the Canadian approval.

Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion, which 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.