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BioSpecifics Technologies Corp. Announces Top-Line Phase 2b Results for XIAFLEX(TM) for Treatment of Peyronie's Disease
Date:12/16/2009

LYNBROOK, N.Y., Dec. 16 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced top-line efficacy and safety results from a Phase 2b clinical trial of XIAFLEX(TM) for the treatment of Peyronie's disease. Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can distort an erection and make sexual intercourse difficult or impossible in advanced cases. The Phase 2b study, conducted by the Company's partner, Auxilium Pharmaceuticals, Inc., was designed to measure efficacy endpoints of improvement in penile curvature and improvement in patients' sexual quality of life using the 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 curvature (p=0.001) and the PRO Peyronie's disease bother domain (p=0.046). There was no statistically significant change in mean scores between XIAFLEX and placebo in the PRO penile pain, intercourse discomfort or intercourse constraint domains. XIAFLEX was well-tolerated and the most common treatment related adverse events in the Phase 2b study were consistent with adverse events reported in previous Peyronie's disease trials with XIAFLEX, which included injection site bruising, edema and pain.

"Peyronie's disease can be psychologically devastating and patients have very limited and undesirable treatment options today," commented Thomas L. Wegman, President of BioSpecifics. "We look forward to progress in the clinical program for XIAFLEX in Peyronie's disease in 2010."

In patients who received XIAFLEX, a mean improvement of 29.7% in penile curvature from baseline to 36 weeks was seen (54.4 to 38.
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SOURCE BioSpecifics Technologies Corp.
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