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Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture
Date:6/3/2008

rage percent improvement in contracture from baseline was 8.6% (49.1 degrees average contracture at baseline down to 45.7 degrees average contracture after placebo treatment) (p<0.001). Second, 84.7% of patients (172 of 203) treated with XIAFLEX achieved at least a 50% reduction in their primary joint contracture from baseline, compared with 11.7% of patients (12 of 103) treated with placebo (p<0.001).

Dr. Lawrence Hurst, M.D., Professor and Chair, Department of Hand Surgery, Department of Orthopaedics of the Health Science Center, State University of New York at Stony Brook, an investigator in the CORD I clinical trial, said, "I believe these clinical results are very encouraging for patients with Dupuytren's contracture. As a surgeon, I am pleased to get contracture improvement to < / = 5 degrees of normal in 50-60% of patients who undergo surgery. Based on the risk/benefit profile demonstrated in the data released today, I would anticipate that XIAFLEX will offer a strong therapeutic alternative to surgery and could potentially become the new first-line treatment option for Dupuytren's contracture."

CORD II Efficacy Results

CORD II enrolled a total of 66 Dupuytren's contracture patients in five clinical sites across Australia. Forty-five patients received XIAFLEX and 21 received placebo in the double-blind portion of the study. The joints were stratified 1:1 MP to PIP. The primary endpoint was met, with 44.4% (20 of 45) of patients' primary joints treated with XIAFLEX achieving

Within the CORD II study, average percent improvement in contracture from baseline was 70.5% (53.2 degrees average contracture at baseline down to 16.7 degrees average contracture after treatment) for primary joints treated w
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SOURCE Auxilium Pharmaceuticals, Inc.
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