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June 25, 2014
08:09 EDTAUXLAuxilium files for EU approval of Xiapex for Peyronies disease
Auxilium and Swedish Orphan Biovitrum AB announced that Sobi has filed for an extension of the label for Xiapex - collagenase clostridium histolyticum - with the EMA to include the indication of Peyronie's disease. The filing is based on positive safety and efficacy outcome data from two double-blind placebo-controlled studies. Sobi is Marketing Authorisation Holder for Xiapex in 28 EU member countries as well as Norway and Iceland.
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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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