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December 6, 2013
16:12 EDTAUXL, BSTCBioSpecifics confirms FDA approval of XIAFLEX
BioSpecifics Technologies (BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S and XIAPEX in the EU, announced that the U.S. FDA has approved the supplemental Biologics License Application submitted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (AUXL) for XIAFLEX, an in-office, biologic for this treatment of Peyronie's disease. This is the first and only FDA-approved biologic therapy indicated for the treatment of Peyronie's disease in men with a palpable plaque and a curvature of 30 degrees or greater at the start of therapy. XIAFLEX is already approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord in the palm. Under the terms of BioSpecifics' agreement with Auxilium, BioSpecifics will receive a $2M milestone payment from Auxilium in connection with this approval. In addition, BioSpecifics will receive low double-digit royalties based on net sales by Auxilium of XIAFLEX for the treatment of Peyronie's disease.
News For BSTC;AUXL From The Last 14 Days
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April 14, 2014
08:16 EDTAUXLAuxilium management to meet with UBS
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April 11, 2014
07:06 EDTAUXLVIVUS announces avanafil clinical data presentation
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