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Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
Date:8/19/2007

l in the U.S., all patients are eligible to enter a separate open-label extension study in which they will receive XIAFLEX if they were initially given placebo or have other affected joints that need treatment. All patients in these studies will be monitored for a minimum of 12 months following initial dosing for efficacy and safety parameters.

The Australian study is a double-blind, randomized, placebo-controlled study with an open-label extension that will enroll 60 patients. The design of this study is similar to that of the U.S. pivotal phase III trial and its open-label extension.

In addition to the double-blind studies and their open-label extensions, the Company plans to concurrently conduct two phase III open-label studies in approximately 440 patients. These studies will provide additional safety and efficacy data and will contribute to the safety database that is required for the BLA.

"As XIAFLEX is ultimately targeted for worldwide markets, we believe that it is very important to perform well-controlled clinical trials at sites inside and outside of the U.S.," said Dr. Jyrki Mattila M.D., Ph.D., Executive Vice President of R&D, Business Development and Technical Operations. "The Company is eager to raise global physician and patient understanding of the potential benefits of XIAFLEX."

With respect to the clinical program for XIAFLEX for the treatment of Dupuytren's contracture, Auxilium expects to:

- complete enrollment in the pivotal U.S. trial and the Australian trial

by the end of 2007;

- release top-line results from the double-blind phase III clinical trials

in the second quarter of 2008; and

- file the BLA for approval of XIAFLEX by FDA in early 2009.

Conference Call

Auxilium will hold a conference call today, Thursday, August 16, 2007 at 10:00 a.m. Eastern Time. The conference call will be simultaneously web cast on Auxilium's web site and archived for future review until August
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SOURCE Auxilium Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

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