BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX® in Europe and Eurasia, today announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (Auxilium). Results from the two randomized, double-blind, placebo-controlled studies at 52 weeks demonstrated statistically significant improvements in both co-primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium's Peyronie's Disease Questionnaire (PDQ) compared to placebo. Auxilium expects to submit a supplemental Biologics License Application (sBLA) filing to the U.S. Food and Drug Administration (FDA) by the end of 2012.
"We are very pleased with these positive top-line Phase III results and are enthusiastic about the potential availability of XIAFLEX as the first FDA-approved prescription product labeled for treatment of Peyronie's disease that could be administered in a physician's office. Peyronie's disease can be psychologically devastating for patients and the only proven therapy available today is penile surgery," stated Thomas L. Wegman, President of BioSpecifics. "We look forward to Auxilium's sBLA filing with the FDA by the end of this year, as well as to announcing the initiation of our Phase II human lipoma trial by the end of this month."
Data from Auxilium's IMPRESS I trial met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjectss disease and penile pain.
Safety measurements included adverse event monitoring and clinical labs. Immunogenicity testing was also performed. XIAFLEX was generally well-tolerated. The most common treatment related adverse events reported in the Phase III studies were local to the treatment site and consistent with adverse events reported in previous Peyronie's disease trials with XIAFLEX, which included injection site hematoma, pain and swelling. These adverse events were comparable to the previous trials and most resolved within 14 days. There were three serious adverse events of corporal rupture (penile fracture) and three serious adverse events of hematomas related to XIAFLEX reported in IMPRESS I and II. There were no systemic hypersensitivity events reported in the Phase III trials or any of the previous XIAFLEX Peyronie's disease clinical studies to date.
BioSpecifics Technologies Corp.