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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

ith XIAFLEX. For placebo patients, the average percent improvement in primary joint contracture from baseline was 13.6% (50 degrees average contracture at baseline down to an average 44.3 degrees after placebo treatment) (p<0.001). A >/= 50% reduction from baseline in the affected joint's contracture was achieved in 77.8% of patients (35 of 45) of all primary joints treated with XIAFLEX compared to 14.3% of patients (3 of 21) for joints treated with placebo (p<0.001).

Top-line Efficacy Results of CORD I and CORD II

XIAFLEX arm Placebo arm p-value

CORD I:

Number of evaluable subjects 203 103

Percentage of contractures 64% 6.8% <0.001

achieving

Average percent improvement in 79.3% 8.6% <0.001

contracture from baseline (50.2 deg./ (49.1 deg./

12.2 deg.) 45.7 deg.)

Percentage of contractures 84.7% 11.7% <0.001

achieving >/= 50% reduction (172/203) (12/103)

CORD II:

Number of evaluable subjects 45 21

Percentage of contractures 44.4% 4.8% <0.001

achieving

Average percent improvement 70.5% 13.6% <0.001

in contracture from baseline (53.2 deg./ (50.0 deg./

16.7 deg.) 44.3 deg.)

Percentage of contractures 77.8% 14.3% <0.001

achieving >/= 50% reduction (35/45) (3/21)

Note: All data applies to primary joint 30 days after last injection

"As described in the available literature on surgery and as we have seen in previous XIAFLEX clinical studies, the CORD I and II trial
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SOURCE Auxilium Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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