BioSpecifics Technologies Corp, a biopharmaceutical company developing first in class collagenase-based products marketed as Xiaflex (collagenase clostridium histolyticum or CCH) in the US and Xiapex in the EU, announced that Swedish Orphan Biovitrum AB (Sobi) has received approval from the EU Commission to market Xiapex 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. Xiaflex has been approved in the US for Peyronie's disease since December 2013 and is marketed by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium), now a wholly-owned subsidiary of Endo International plc.
"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 US and are hopeful to see similar success in the EU," commented Thomas L. Wegman, President of BioSpecifics. "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."
Sobi is the Marketing Authorization Holder for Xiapex in 28 EU member countries, as well as Norway and Iceland, and holds the exclusive rights from Auxilium to commercialise Xiapex for Dupuytren's contracture and Peyronie's disease indications. Xiapex was approved in 2011 in the EU for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
Under the terms of BioSpecifics' agreement with Auxilium, BioSpecifics will receive a certain percentage of milestone payments that Sobi pays to Auxilium as well as royalties from net sales of Xiapex for Dupuytren's contracture and Peyronie's disease, and payments on costs of goods sold in Sobi territories from Auxilium, which will be a specified percentage of what Auxilium receives from Sobi.
Peyronie's disease is characterised by the presence of inelastic collagen on the shaft of the penis, which can cause the penis to curve during erection, and may make sexual intercourse difficult or impossible in advanced cases. Peyronie's disease typically affects males between 40-70 years of age. Frequent patient complaints include increased pain, painful erections, palpable plaque, penile deformity and erectile dysfunction. Significant psychological distress has also been noted in patients. The prevalence of Peyronie's disease in adult men has been reported to be approximately 5 per cent, but the disease is thought to be underdiagnosed and undertreated.