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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

s demonstrate that MP joints generally respond better to treatment than PIP joints, and joints of lesser severity generally respond better than joints of higher severity," said Dr. Tony DelConte, Chief Medical Officer for Auxilium. "We believe these findings will be well-received by the physician and patient community who have expressed a desire to treat affected joints earlier than current surgical practice."

Pharmacokinetic Study Results

An open label study was conducted to assess the pharmacokinetics of a single injection of XIAFLEX in 16 subjects with Dupuytren's contracture. Nine patients with MP contractures and seven patients with PIP contractures were enrolled in the study. No measurable levels of XIAFLEX were detected in plasma from 5 minutes to 30 days post injection.

Although the study was not designed to measure efficacy in comparison to placebo, 12 of the 16 patients achieved < / = 5 degrees of normal contracture after their only injection of XIAFLEX.

Adverse Events

The most common adverse events reported in the CORD I and II and PK studies were pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling and pain. These adverse events were consistent with previous trials. No systemic allergic reactions were noted.

In data from the CORD I and II studies, the open label JOINT I and II studies and the PK study, over 2,000 XIAFLEX injections have been administered to approximately 850 patients through the end of May 2008. There have been seven SAEs possibly related to drug (rate per injection = 0.33%). There have been a total of three confirmed tendon ruptures (rate per injection =0.14%), one reported tendon rupture remains unconfirmed (rate per injection = 0.05%), and one pulley ligament injury (rate per injection = 0.05%). Additionally, one complex regional pain syndrome (rate per injection = 0.05%) and one deep vein thrombosis ("DVT") (rate per injection = 0.05%) occurred. Three
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SOURCE Auxilium Pharmaceuticals, Inc.
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