Auxilium Pharma Reports XIAFLEX Data from Multicord, Retreatment Studies at ASSH Annual Meeting

Auxilium Pharmaceuticals, Inc.

, a specialty biopharmaceutical company, today announced the first presentation of positive safety and efficacy data from the AUX-CC-867 MULTICORD (MULtiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytrens) Phase 3b study. This study evaluated collagenase clostridium histolyticum (CCH) for the treatment of two Dupuytren's cords concurrently in the same hand. In addition, the study examined expanded flexibility with timing of the finger extension procedure. Additional positive data were presented from the AUX-CC-862 retreatment study that evaluated the retreatment of recurrent contracture in joints that were previously treated with CCH. These data will be presented at the 69th Annual Meeting of the American Society for Surgery of the Hand (ASSH) being held in Boston, September 18-20, 2014. XIAFLEX® (CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. DC is a progressive hand disease that can present with multiple collagen "cords" that limit finger movement. It is estimated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time. "I believe these dual joint results are encouraging as they strongly suggest that XIAFLEX should provide a non-surgical option for treating appropriate DC patients with two affected joints concurrently in one office visit," said Gary M. Pess, M.D., an orthopedic surgeon with Central Jersey Hand Surgery. "Additionally, data supporting the ability to delay the finger manipulation procedure for up to 72 hours show that there should be a benefit to both patients and physician offices' scheduling flexibility." "In my opinion, the retreatment data support that XIAFLEX can provide expanded treatment options for physicians and appropriate DC patients," said James R. Verheyden, M.D. President of The Center for Orthopedic and Neurosurgical Care & Research. "The study provides data supporting that XIAFLEX retreatment may be an option for recurrent DC patients who were previously treated with XIAFLEX using the non-surgical, in-office injection procedure." "These data from the MULTICORD study formed the basis of our sBLA filing for a labeling expansion for the treatment of two cords concurrently and delayed finger extension" said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals. "We are looking forward to our PDUFA date in October and if approved, we believe that two concurrent XIAFLEX injections may allow more rapid overall treatment of multiple affected joints, without the need to wait approximately four weeks between treatments as required in the current labeling." Highlights of the data presented include: o Results were presented from the AUX-CC-867 MULTICORD Phase 3b study that provides data supporting that two concurrent CCH injections can be used in the treatment of hands with multiple affected joints, without the need to wait 30 days between single treatments, as required in the current approved product label for XIAFLEX. In the study, concurrent injections of CCH to treat two Dupuytren's contractures on the same hand reduced fixed flexion contractures (FFCs) and increased range of motion (ROM). These results support those of two previously conducted pivotal studies examining multiple concurrent injections, AUX-CC-861 and AUX-CC-864. o Delayed manipulation data from the MULTICORD study was selected for the ASSH Meeting's Best Paper Session. These data support the ability to vary the time between a CCH injection and the finger extension procedure from 24 hours, per the current product labeling, to 72 hours and may allow for greater flexibility for both physicians and patients. o Data presented from the AUX-CC-862 Retreatment study support retreatment of recurrent contractures in joints that were previously treated with CCH which may allow optionality for CCH patients. The investigator assessment of improvement and patient satisfaction showed that 85 percent of treated joints achieved positive outcomes. Study results also suggest an improvement in FFC and ROM in both metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints. o Following concurrent CCH injections to two affected joints (one injection per treated joint), FFCs reduction and clinical success rates were higher among joints with lower baseline severity compared to those with higher baseline severity. Lacerations were more common among patients with more severe pretreatment contractures. o A post-hoc analysis of the MULTICORD study examined concurrently treating two affected joints (one injection per treated hand) of the same hand using local anesthesia (LA) prior to finger extension, which may result in greater reduction in FFCs. Although the risk of skin laceration may be increased with LA, it was numerically lower when the finger extension was performed at 72 hours as opposed to 24 or 48 hours. All lacerations were treated with wound care or suture placement. The U.S. Food and Drug Administration is currently reviewing Auxilium's submission of a supplemental Biologics License Application (sBLA) requesting approval of XIAFLEX for the treatment of two Dupuytren's cords concurrently. The PDUFA date for the sBLA is October 20, 2014.