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 that The Journal of Urology has electronically published the uncorrected proof of the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials on its website at www.jurology.com. These Phase III studies were conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) and assessed XIAFLEX for the treatment of Peyronie's disease, an excess of inelastic collagen causing penile curvature deformity. The full article may be found at http://www.jurology.com/article/S0022-5347(13)00227-9/abstract. The manuscript is currently scheduled to appear in print in the July 2013 print version of The Journal of Urology.
"These results are quite positive and demonstrate the significant therapeutic opportunity of XIAFLEX for the treatment of Peyronie's disease patients, who currently have no FDA-approved pharmaceutical treatment options available for this devastating condition," commented Thomas L. Wegman , President of BioSpecifics. "We look forward to receiving the potential FDA approval of XIAFLEX for Peyronie's disease this year and we also plan to announce several near-term milestones for the broader XIAFLEX pipeline in the coming months."
Auxilium has previously announced positive top-line efficacy and safety results of the IMPRESS studies' co-primary endpoints. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent improvement in penile curvature deformity and mean improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects vs. placebo patients. Additionally, XIAFLEX was generally well-tolerated.
The publication includes details of the co-primary and secondary families of endpoints. Statistical significance for the co-primary endpoints and two families of secondary endpoints was determined by a multiple comparison algorithm based on gate keeping strategies designed to control the overall family-wise type 1 error rate to be less than or equal to 0.05. In IMPRESS I and II individually, the two co-primary endpoints each required a p-value less than or equal to 0.05, while the algorithm for the first family of secondary endpoints was equivalent to requiring a p-value less than or equal to 0.0167 and the algorithm for the second family required a p-value less than or equal to 0.0042. In both IMPRESS I and II, first family secondary endpoints (improvement from baseline in percentage of global responders, PDQ psychological and physical symptoms, and IIEF (International Index for Erectile Function) overall satisfaction) and second family secondary endpoints (percentage of composite responders, improvement in penile length, plaque consistency, and penile pain) were measured in XIAFLEX-treated men compared with placebo.
Based on results from the IMPRESS Phase III program, Auxilium has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for XIAFLEX for the potential treatment of Peyronie's disease and, under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to take action on the application by September 6, 2013. If approved, XIAFLEX is expected to be the first and only biologic therapy indicated for the treatment of Peyronie's disease.
BioSpecifics Technologies Corp.