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Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2a Cellulite Study of Collegenase Clostridium Histolyticum
Date:10/23/2013

lude doses both lower and higher than the dose used in Dupuytren's contracture with a palpable cord.

This study will be conducted in two stages.  If the safety and local tolerability profile from the first stage has been found to be acceptable, subjects will be enrolled in stage 2.  Topline results from the study are expected in the first quarter of 2015.

CCH is currently approved in the United States under the trade name XIAFLEX® for the treatment of adult Dupuytren's contracture patients with a palpable cord and is awaiting a decision from the FDA for use in Peyronie's disease.  A sBLA for XIAFLEX for the potential treatment of Peyronie's disease has been submitted to the FDA.  The PDUFA goal date for action on the application for Peyronie's disease is December 6, 2013.

"Our growing clinical research and development program for CCH is designed to examine the compound's effectiveness in a wide-range of collagen-related conditions, including cellulite and Frozen Shoulder syndrome," said Adrian Adams, Chief Executive Officer and President of Auxilium.  "We believe that advancing the evaluation of CCH for cellulite represents another important milestone for the product and underscores our commitment to developing treatments for unmet medical needs."

More information on the study will be posted at www.clinicaltrials.gov.

About CelluliteIn the normal subcutaneous fat layer directly under the skin, there are both perpendicular columnar and net-like fibrous connective tissue called septae. These fibrous septae, made of collagen, connect the skin to the muscle layers below and create a network of compartmentalized adipose deposits. Women tend to have a higher proportion of columnar septae that are perpendicular to the epidermis, while men tend to have more of the net-like system.  In cellulite
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SOURCE Auxilium Pharmaceuticals, Inc.
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