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Auxilium Pharmaceuticals, Inc. Announces 17 Month XIAFLEX® Safety Update
Date:9/6/2011

MALVERN, Pa., Sept. 6, 2011 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced a safety update following 17 months of post-approval use in the U.S. of XIAFLEX® for the treatment of adult Dupuytren's contracture patients with a palpable cord.  After approximately 11,000 injections administered to approximately 10,000 patients in the U.S., there was no clinically meaningful change in the nature of events expected relative to the clinical trial safety profile.  

From February 2, 2010 through June 30, 2011, approximately 560 adverse events have been reported to the Company. Of those events, local events such as skin laceration, swelling and bruising at the site of injection were the most commonly reported events representing 15%, 11.8% and 10.9% of the event reports, respectively.  Less commonly reported events included injection site hematoma and pain. Adverse event reporting requirements post-approval are different from requirements for reporting such events during a clinical trial.  See "About Voluntary Safety Reporting" below.

In the clinical trials, three (0.3%) subjects experienced a tendon rupture and one (0.1%) subject experienced ligament damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects in the safety database.    Approximately 60 clinical investigators injected XIAFLEX during the clinical trials.  In the post-approval period, five tendon ruptures (0.05%) and two ligament injuries (0.02%) were reported.  There have been no reports of complex regional pain syndrome or nerve injury to date.  Since launch, approximately 1,230 U.S. physicians have injected Dupuytren's contracture patients with XIAFLEX.

"Based on reported events, we believe that XIAFLEX has demonstrated a safety profile in post-approval use that is consistent w
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SOURCE Auxilium Pharmaceuticals, Inc.
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