Auxilium Presented New Analyses of XIAFLEX Peyronie's Disease Data at SMSNA Meeting

Auxilium Pharmaceuticals

has announced that new and updated data were presented from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the Phase 3 studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH) for the potential treatment of Peyronie's disease (PD).  The data were presented at the Sexual Medicine Society of North America (SMSNA) 19th Annual Fall Scientific Meeting held November 21-24, 2013 in New Orleans, LA. The Company's supplemental Biologics License Application (sBLA) for XIAFLEX, for the treatment of PD is currently under review at the Food and Drug Administration (FDA).  The Prescription Drug User Fee Act (PDUFA) review date is December 6, 2013. "We are pleased to share these results with the medical community and remain dedicated to an ongoing examination of XIAFLEX for the potential treatment of Peyronie's disease," said Dr. James Tursi, Chief Medical Officer of Auxilium.   Highlights of the data presented related to the use of XIAFLEX in PD include: An open-label baseline analysis from IMPRESS 3 showed a mean penile curvature deformity (PCD) of 53.0 degrees and a mean PD