Scientific/technical review for XIAFLEX' European MAA commences

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that its partner Auxilium Pharmaceuticals, Inc. announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application (MAA) for XIAFLEX™ for the treatment of Dupuytren's disease (a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers) has completed the validation phase successfully and that the scientific/technical review procedure commenced today. Pfizer has licensed rights from Auxilium to market XIAFLEX for Dupuytren's disease and Peyronie's disease in Europe and other territories. Based on this announcement, BioSpecifics will receive a $1.2 million milestone payment from Auxilium within 30 days, representing its 8.5% share of the $15 million payment that Auxilium will receive from Pfizer under the terms of their agreement in respect of this milestone.  

"We are happy to see Pfizer's commitment to advancing XIAFLEX to patients in need," commented Thomas L. Wegman, President of BioSpecifics. "We are enthusiastic about the potential of XIAFLEX for patients in Europe, and are looking forward to regulatory progress on the New Drug Application for XIAFLEX currently before the U.S. Food and Drug Administration."

Under the terms of the strategic alliance agreement between Pfizer and Auxilium, BioSpecifics receives 8.5% of any milestone payments received by Auxilium from Pfizer, in addition to milestones due to it under its separate agreement with Auxilium. BioSpecifics will also continue to receive a low double-digit royalty on sales of XIAFLEX, independent of indication, territory, sales volume and whether Auxilium or Pfizer sells the product. In addition BioSpecifics will receive a markup on the cost of goods sold for XIAFLEX.