BioSpecifics Technologies Corp. Reports Fourth Quarter and Full Year 2009 Financi... ( ...)

BioSpecifics Technologies Corp. Reports Fourth Quarter and Full Year 2009 Financial Results

Date:3/10/2010

On January 21, 2010, BioSpecifics' partner Auxilium announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application for XIAFLEX for the treatment of Dupuytren's contracture commenced. As a result, BioSpecifics will receive a $1.3 million milestone payment from Auxilium.

On December 16, 2009, the Company reported results from a Phase 2b clinical trial of XIAFLEX for the treatment of Peyronie's disease conducted by Auxilium. 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 for the PRO penile pain, intercourse discomfort or intercourse constraint domains between XIAFLEX and placebo. 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.

On September 3, 2009, The New England Journal of Medicine published data from the pivotal CORD I Phase III clinical trial of XIAFLEX for Dupuytren's contracture.

SOURCE BioSpecifics Technologies Corp.
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