Auxilium Pharmaceuticals and Actelion Pharmaceuticals Canada have announced Health Canada notice of compliance (approval) for Xiaflex (collagenase clostridium histolyticum or CCH) to treat Dupuytren's contracture in adults with a palpable cord in Canada.
Under the collaboration agreement between Auxilium and Actelion, 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.
According to the collaboration agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion, which will then 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 launch Xiaflex in Canada in the first half of 2013.
Actelion Pharmaceuticals Canada general manager Jacques Archambault said, "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."
The FDA and the European Medicines Agency approved Xiaflex as a treatment for Dupuytren's contracture in adults with a palpable cord, and is also in clinical development in Japan.
