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June 25, 2014
16:02 EDTBSTC, AUXLBioSpecifics announces filing by Sobi for EU approval of XIAPEX
BioSpecifics Technologies (BSTC) announced today that Swedish Orphan Biovitrum AB, or Sobi, has filed for an extension of the label for XIAPEX with the European Medicines Agency to include the indication of Peyronie's disease. XIAPEX is currently approved for the treatment of Dupuytren's contracture in adult patients with a palpable cord. BioSpecifics' partner, Auxilium Pharmaceuticals (AUXL), is partnered with Sobi for the marketing of XIAPEX in 71 Eurasian and African countries for the treatment of Dupuytren's contracture, and Peyronie's disease pending applicable regulatory approvals.
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