BioSpecifics Technologies' XIAFLEX receives FDA approval

Feb 3 2010

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX™, a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. Dupuytren's contracture is a debilitating disease resulting from excessive collagen deposition that causes contractures of the fingers. The Company's partner, Auxilium Pharmaceuticals Inc., expects to launch XIAFLEX in late March, 2010.  

"We believe that patients afflicted with Dupuytren's contracture will greatly benefit from XIAFLEX, the first pharmaceutical treatment for this disabling disease. We would like to acknowledge the efforts of the scientists and clinicians who have worked with XIAFLEX over many years to usher in a new era of hope for millions of patients that suffer from this condition," stated Thomas L. Wegman, President of BioSpecifics. "We look forward to its commercial launch and to the results of clinical trials of XIAFLEX in other indications."

Auxilium estimates that there are 240,000 annual candidates for XIAFLEX for Dupuytren's contracture in the US and Europe. It has stated that it expects to sell XIAFLEX in the United States through a team of approximately 100 field sales managers and representatives, reimbursement specialists and managed market account directors. In addition, a staff of 11 highly trained medical science liaisons will provide medical support for XIAFLEX. Auxilium has established a distribution network that will allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.

Auxilium plans to market XIAFLEX to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren's contracture and will only provide access to XIAFLEX after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of XIAFLEX, as well as an overview of both identified and potential risks with XIAFLEX. The FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS program is designed (1) to evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and, (3) to inform patients about the serious risks associated with XIAFLEX.

Pfizer, Inc., Auxilium's marketing partner for XIAFLEX in Europe, has stated that the scientific/technical review procedure for the Marketing Authorization Approval (MAA) for XIAFLEX in Europe began in January 2010. Pfizer is responsible for marketing XIAFLEX for Dupuytren's contracture and Peyronie's disease in 27 member countries of European Union and 19 other European and Eurasian countries.