Auxilium and Actelion in partnership to develop Xiaflex
Xiaflex (collagenase clostridium histolyticum) is a novel, first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's disease.
Actelion will receive exclusive rights to commercialise Xiaflex in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals.
Actelion will be primarily responsible for the applicable regulatory and commercialisation activities for Xiaflex in these countries.
Xiaflex has been approved by the US Food and Drug Administration and the European Medicines Agency as a treatment for Dupuytren's contracture, and is also in development in Japan.
In addition, Xiaflex has been accepted for review by Health Canada for the treatment of Dupuytren's contracture and regulatory action is expected in the second half of the year.
Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico over the next 12 months.
Xiaflex is also being evaluated in a global phase III development program for Peyronie's disease with top-line data expected in late second quarter 2012.
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