BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications. Injectable collagenase is marketed as XIAFLEX® in the United States for the treatment of adult Dupuytren's contracture patients with a palpable cord in the palm by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. and is approved for Dupuytren's contracture in the European Union and Canada.
XIAFLEX is also in clinical development for the treatment of several additional promising indications. The U.S. Food & Drug Administration (FDA) has accepted for filing Auxilium's supplemental Biologic License Application (sBLA) 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 would be the first and only FDA-approved biologic treatment for Peyronie's disease.
BioSpecifics is currently managing the clinical development of XIAFLEX for the treatment of human and canine lipomas. We are conducting a Phase II placebo-controlled randomized clinical trial for the treatment of canine lipoma and a Phase II dose escalation clinical trial for human lipoma. We anticipate that we will complete enrollment for both trials in the first half of 2013. Auxilium is also testing XIAFLEX for cellulite and frozen shoulder syndrome (adhesive capsulitis) in Phase Ib and IIa clinical trials, respectively. Auxilium has reported top-line 30-day data from the Phase Ib cellulite trial, which support progression into Phase IIa in the second half of 2013, and Auxilium expects to report top-line data from the Phase IIa frozen shoulder trial in the first quarter of 2013.
is currently partnered with Asahi Kasei Pharma Corporation for the development
and commercialization of injectable collagenase for Dupuytren's contracture and
Peyronie's disease in Japan and with Actelion Pharmaceuticals Ltd. for these
same indications in Canada, Australia, Brazil and Mexico. Pfizer Inc. has
marketing rights to XIAPEX® (the EU trade name for XIAFLEX) for Dupuytren's
contracture in 46 countries in Eurasia through April 24, 2013.