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

Conference Call Scheduled for 10:00 a.m. today, Thursday, August 16, 2007

MALVERN, Pa., Aug. 16 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that the Company has received clearance from the U.S. Food and Drug Administration ("FDA") to resume its phase III clinical trials for XIAFLEX (clostridial collagenase for injection), formerly referred to as AA4500, in the treatment of Dupuytren's contracture. The Company will hold a conference call today, August 16, at 10:00 a.m. Eastern Time to discuss this news.

"We are delighted that we can resume our XIAFLEX phase III trials in Dupuytren's contracture earlier than anticipated. We expect to begin enrolling patients into our pivotal trial within the next 30 days," said Armando Anido, Chief Executive Officer and President of Auxilium. "I would like to give a special thanks to our employees for their tireless efforts in making this achievement possible."

The Company plans to initiate a pivotal double-blind trial in the U.S., a double-blind trial in Australia, and two open label trials that along with previously conducted trials will serve as the basis for the Biologics License Application ("BLA") for marketing approval from the FDA.

The U.S. pivotal trial is a double-blind, randomized, placebo-controlled study of XIAFLEX involving 216 patients in at least 15 sites throughout the U.S. Patients in the study will be randomized on a 2:1 basis in favor of treatment with XIAFLEX. The primary endpoint of the study is to determine if XIAFLEX can reduce the contracture angle in metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to within 0 to 5 degrees of normal.

Upon completion of the double-blind tria
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SOURCE Auxilium Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

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