BioSpecifics Tech Says FDA Approved XIAFLEX For Treatment Of Peyronie's Disease

(RTTNews) - BioSpecifics Technologies Corp. (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 it has received approval from the U.S. Food & Drug Administration or FDA for the supplemental Biologics License Application or sBLA submitted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (AUXL) for XIAFLEX, an in-office, biologic for this treatment of Peyronie's disease.

The company noted that 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, BioSpecifics said.

Under the terms of BioSpecifics' agreement with Auxilium, BioSpecifics will receive a $2 million 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.

The company stated that the approval by the FDA of Auxilium's sBLA for XIAFLEX for the treatment of Peyronie's disease is based on safety and efficacy data from Auxilium's Phase III clinical trials and other controlled and open label clinical studies in which over 1,000 patients with Peyronie's disease were enrolled and received over 7,400 injections of XIAFLEX.