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May 19, 2014
07:01 EDTAUXLAuxilium announces analyses of Xiaflex from Phase 3 studies
Highlights of the information presented include: 75% of men with PD treated with XIAFLEX in the IMPRESS pivotal studies had a clinically meaningful improvement in their penile curvature deformity by the end of the trials. These subjects reported an improvement of 25% or greater in penile curvature deformity. Peyronie's plaque tissue was excised and exposed to XIAFLEX in vitro. XIAFLEX preferentially degraded type I and type III collagen, predominant collagen types in PD plaques, while sparing type IV collagen present within connective tissues that surround arteries, large veins and nerves. There was no detectable effect of XIAFLEX on the structure of blood vessels, nerves, and fibroblasts at any dose evaluated.
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July 31, 2014
06:41 EDTAUXLAuxilium reports XIAFLEX milestone, triggers $10M payment
Auxilium Pharmaceuticals announced that the company will receive a $10M regulatory milestone payment from its partner Asahi Kasei Pharma Corporation. The payment is due because of the successful submission of a regulatory application to the Japanese Pharmaceutical and Medical Device Agency, or PMDA, for XIAFLEX for the treatment of Dupuytren's contracture, or DC. The review by PMDA is expected to be completed by mid-2015. XIAFLEX is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the U.S. for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

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