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 C... (to offer a safe and effective non-surgic...)

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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

to offer a safe and effective, non-surgical treatment for Dupuytren's contracture," said Armando Anido, Auxilium's Chief Executive Officer and President. "We expect the results of these trials, together with all previous clinical and pre-clinical data, will enable us to submit a Biologics License Application for XIAFLEX in Dupuytren's contracture in early 2009. I wish to thank all the patients, investigators and Auxilium employees who contributed to these trials."

CORD I Efficacy Results

CORD I is the largest placebo-controlled study ever conducted in Dupuytren's contracture patients and the second U.S. pivotal phase III study for XIAFLEX in Dupuytren's contracture. A total of 306 patients evaluable for efficacy enrolled in 16 clinical sites across the U.S., with 203 patients receiving XIAFLEX and 103 receiving placebo in the double-blind portion of the study. The joints were stratified 2:1 Metacarpal Phalangeal Joint, or MP joint, to Proximal Intra-Phalangeal, or PIP joint. The primary endpoint was met with 64% (130 of 203) of patients' primary joints treated with XIAFLEX achieving

In addition to the primary endpoint, there were 26 secondary endpoints that were measured, each of which was met with statistical significance. The Company believes two important secondary endpoints are the difference between the pre- and post-treatment contracture angles and whether patients achieved at least a 50% reduction in their contracture compared to baseline. First, the average percent improvement in contracture from baseline was 79.3% (50.2 degrees average contracture at baseline down to 12.2 degrees average contracture after treatment) for primary joints treated with XIAFLEX, compared to placebo patients, where the ave
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SOURCE Auxilium Pharmaceuticals, Inc.
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