SOBI granted marketing authorization for Xiapex in Peyronie's disease in the EU

Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI) has received approval from the European Commission to market Xiapex (collagenase clostridium histolyticum) for the treatment of adult men with Peyronie’s disease.

The drug, marketed as Xiaflex in the USA and Xiapex in the European Union, is targeted at Peyronie’s disease sufferers with a palpable plaque and curvature of at least 30 degrees at the start of therapy. It has been approved in the USA for the indication since December 2013, and is developed by BioSpecifics Technologies Corp (Nasdaq: BSTC) and marketed by Auxilium Pharmaceuticals and SOBI.

Thomas Wegman, president of BioSpecifics, said: "The EU approval of Xiapex to treat Peyronie's Disease marks an important milestone for patients with this disease, as they now have access to a minimally-invasive treatment. We have been very pleased by the commercial success to date for this indication in the USA and are hopeful to see similar success in the EU. In addition to the anticipated commercial growth from the launch in Europe, we look forward to broadening our presence internationally with the potential approval of Xiaflex in Japan for Dupuytren's contracture."