Auxilium Pharmaceuticals reports interim data from XIAFLEX Phase 4 study in patients with DC

Jan 9 2014

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced that interim data from its Phase 4 retreatment study (AUX-CC-862) evaluating XIAFLEX® (collagenase clostridium histolyticum or CCH) in adult patients with Dupuytren's contracture (DC) and a recurrent contracture with a palpable cord will be presented for the first time at the American Association for Hand Surgery (AASH) 2014 Annual Meeting being held January 8-11, 2014 in Kauai, Hawaii. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug Designation in the U.S. by the FDA for DC and PD.

This open-label Phase 4 study is evaluating 51 patients who had recurrence of a contracture (an increase of >20 degrees as well as a palpable cord) in a joint that had been previously effectively treated with XIAFLEX (resulting in contracture of <5 degrees). Patients were treated with up to three injections of XIAFLEX (28 days apart) to the recurrent cord and were then evaluated for clinical outcome, changes in contracture and range of motion, physician assessment of improvement, patient satisfaction and safety. This interim analysis was conducted after all patients had completed their 30-day follow up assessments.

Key Data Highlights:

• 87 percent of recurrent contractures of metacarpophalangeal or "MP" joints (large joints in the hand at the base of each finger) were successfully retreated:
  • 65 percent of patients were treated with up to three injections to clinical success – defined as contracture reduced to <5 degrees
  • 3 percent of patients had no palpable cord remaining to treat after one or two injections and thus were considered successfully treated
  • 19 percent of patients electively declined further injections as they were treated successfully with < three injections and were satisfied with treatment prior to a second or third injection
  • Patients showed an average 83 percent improvement in fixed flexion
• 85 percent of recurrent contractures of proximal interphalangeal or "PIP" joints (middle joint in the finger) were successfully retreated:
  • 45 percent of patients were treated with up to three injections to clinical success – contracture reduced to <5 degrees
  • 30 percent of patients had no palpable cord remaining to treat after one or two injections and thus were considered successfully treated
  • 10 percent of patients electively declined further injections as they were treated successfully with < three injections and were satisfied with treatment prior to a second or third injection
• Retreatment with CCH was well tolerated:
  • Adverse events were consistent with previous clinical studies of XIAFLEX and included swelling, bruising and pain – all were mild or moderate
  • There was one report of partial ligament injury which resolved in six months without intervention

"This study is important as it is helping us to understand more about XIAFLEX, specifically how it could be used following a recurrence that was initially treated with this modality," stated James P. Tursi, M.D., Chief Medical Officer of Auxilium. "Dupuytren's contracture is a chronically progressive disorder in which as many as one half of patients previously treated eventually suffer recurrence of disease. This study provides preliminary information regarding the use of XIAFLEX in these patients."