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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

tacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to < / = 5 degrees of normal. In CORD I, MP and PIP patients were stratified in a 2:1 ratio.

All patients receiving XIAFLEX in the double-blind portion of the study will be monitored for a minimum of 12 months following initial dosing. After finishing the double-blind portion, XIAFLEX and placebo patients are also eligible to receive additional XIAFLEX injections for either unsuccessfully treated joints or additional untreated joints during an open-label, extended treatment period. This open-label phase was designed to provide further data for the long-term safety and efficacy of XIAFLEX injections in the treatment of Dupuytren's contracture.

About CORD II

This Australian study is a supportive double-blind, randomized, placebo-controlled study with an open-label extension that enrolled 66 patients in five sites. The design of this study is similar to that of the pivotal U.S. phase III trial (CORD I) and its open-label extension. The primary endpoint was the reduction of contracture angle in MP or PIP joints to < / = 5 degrees of normal. In CORD II, MP and PIP patients were stratified in a 1:1 ratio.

After finishing this double-blind portion, patients from both XIAFLEX and placebo groups will be permitted to receive additional XIAFLEX injections for either unsuccessfully treated joints or additional untreated joints during an open-label, extended treatment period. This open-label phase was designed to provide further data for the long-term safety and efficacy of XIAFLEX injections in the treatment of Dupuytren's contracture.

About JOINT I and II

In addition to the open-label extensions of CORD I and II, the Company is concurrently conducting two phase III open-label studies in approximately 600 patients. These studies will provide additional safety and efficacy data and will contribute to the safety database that is required for the BLA.

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SOURCE Auxilium Pharmaceuticals, Inc.
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