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

CHESTERBROOK, Pa., Oct. 23, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully-integrated specialty biopharmaceutical company, today announced the first patient dosed in its Phase 2a study of collagenase clostridium histolyticum (or "CCH") for the treatment of edematous fibrosclerotic panniculopathy ("EFP"), commonly known as cellulite.  As previously reported, Phase 1b open label dose-ranging study results demonstrated that some doses of CCH provided potential improvement in the cellulite target dimple volume following a single injection into that dimple.  The most common adverse events (>10%) in this study included injection site bruising and pain.

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Cellulite occurs mainly on the pelvic region, lower limbs, and abdomen and has been reported to occur in 85-98 percent of post-pubertal females and rarely in men.
The condition is prevalent in women of all races.[i],[ii]  Cellulite is described as a localized metabolic disorder of tissue under the skin, which can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to the muscle layers below.  When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite.[iii]  CCH is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.  There is no definitive medical explanation for the presentation and prevalence of cellulite and, despite multiple therapeutic approaches for the attempted treatment of cellulite, there are no FDA approved treatments and little scientific evidence that any current
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