LYNBROOK, N.Y., Sept. 3 BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products today announced results of the pivotal CORD I Phase III clinical trial of XIAFLEX(TM) (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of Dupuytren's disease, was published in today's edition of the New England Journal of Medicine (N. Engl. J. Med. 2009;361:968-79.). The article, entitled "Injectable Collagenase Clostridium Histolyticum for Dupuytren's Contracture" describes the positive results observed in a Phase III trial conducted by BioSpecific's licensee Auxilium Pharmaceuticals, Inc. Dupuytren's disease is a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers. The first Phase III study of XIAFLEX in Dupuytren's disease was sponsored and monitored by BioSpecifics, with follow-up and data analysis conducted by Auxilium.
"We are very pleased that the results of the successful CORD 1 study were published in this premier medical journal," stated Thomas L. Wegman, President of BioSpecifics. "The details of the study provided in the article further support our view and enthusiasm for the potential benefits of XIAFLEX as a treatment for Dupuytren's disease, and we look forward to the upcoming review by the Arthritis Advisory Committee to the Food and Drug Administration on September 16."
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. has announced the acceptance of the Biologic License Application (BLA) and Priority Review by the U.S. Food and Drug Administration for injectable collagenase XIAFLEX(TM) in the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX(TM) product in Europe.
SOURCE BioSpecifics Technologies Corp.