BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, announced that its partner Auxilium Pharmaceuticals, Inc. (Auxilium) has dosed the first subject in the global Phase 3 program of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of Peyronie’s disease. Peyronie’s disease is the development of scar tissue on the shaft of the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient. XIAFLEX is currently approved and marketed in the U.S. for the treatment of Dupuytren’s contracture.
Thomas L. Wegman, President of BioSpecifics commented, The initiation of this Phase 3 trial is an important advance for XIAFLEX, moving it one step further as a treatment for Peyronie’s disease. Currently, patients have only limited and undesirable treatment options available to them. We are very happy that XIAFLEX is progressing through the clinic as a second potential indication for the patients who could benefit immensely from a new treatment option. We look forward to these trial results next year.
Auxilium anticipates that it will complete enrollment for the double-blind studies in the first quarter of 2011 and will report top-line results in first half of 2012.