Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

Dec 16 2009

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced top-line efficacy and safety results for the phase IIb clinical trial for XIAFLEX™ (collagenase clostridium histolyticum) in the treatment of Peyronie's disease. The phase IIb study was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using the Company's Peyronie's disease Patient Reported Outcome (PRO) questionnaire. Overall, XIAFLEX demonstrated a statistically significant change compared to placebo at 36 weeks in both improvement in penile curvatures disease bother domains disease trials with XIAFLEX, which included injection site bruising, edema and pain.

"We believe the results from this trial provide a meaningful step forward to a better understanding of the treatment of Peyronie's disease with XIAFLEX," said Armando Anido, Auxilium's Chief Executive Officer and President. "We expect to meet with the FDA in the second quarter of 2010 to discuss a proposed phase III plan that potentially could be started in the second half of 2010."