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BioSpecifics Technologies Corp. Announces Initiation of Global Phase 3 Trial of XIAFLEX® for Treatment of Peyronie's Disease
Date:10/12/2010

LYNBROOK, N.Y., Oct. 12 /PRNewswire/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today 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.

"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," commented Thomas L. Wegman, President of BioSpecifics. "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.

Auxilium has announced that the late stage global development plan for XIAFLEX will consist of four clinical studies and will be known by the acronym IMPRESS - The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies. There will be two randomized, double-blind, placebo-controlled Phase 3 studies, which are expected to enroll at least 600 patients at approximately 70 sites in the U.S. and Australia, with a 2:1 ratio of XIAFLEX to plac
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SOURCE BioSpecifics Technologies Corp.
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