Positive results from IMPRESS trial of Xiaflex (Auxilium Pharma) for Peyronie's Disease

The phase III IMPRESS studies of Xiaflex (clostridial collangase for injection), from Auxilium Pharma, for treatment of Peyronie's Disease (PD) annouce positive topline results. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for Xiaflex subjects and a 3.3 point improvement in the Peyronie's Disease Questionnaire bother domain. In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for Xiaflex subjects and a 2.4 point improvement in the PDQ bother domain. The drug was generally well-tolerated. Auxilium Pharma plans to file a supplemental Biologics License Application with the FDA seeking approval for the potential use of Xiaflex in the treatment of PD by the end of 2012. If approved, it is expected to be the first biologic therapy indicated for the treatment of PD.