Updated on 21 July 2015
Tokyo: BioSpecifics Technologies Corp., a US-based biopharmaceutical company developing collagenase-based products, has indicated in a press release that Asahi Kasei Pharma Corporation has received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency (PMDA) for XIAFLEX (collagenase clostridium histolyticum) for the treatment of patients with Dupuytren's contracture in Japan.
Asahi has the rights to develop and market XIAFLEX in Japan through an agreement with BioSpecifics' partner Endo International plc (Endo). BioSpecifics will receive a milestone payment upon commercial launch in Japan.
"This approval in Japan marks another milestone in our globalization strategy for XIAFLEX and we look forward to the upcoming commercial launch. We believe Asahi Kasei's strong development and commercialization organizations will greatly enhance the sales potential of XIAFLEX in this region," commented Thomas L. Wegman, President of BioSpecifics. "We are very happy that these patients now have a minimally-invasive non-surgical treatment option available to them."
Dupuytren's contracture is caused by an abnormal accumulation of collagen in the palm of the hand characterized by the formation of nodules or lumps in the early stages. As the disease progresses, a cord is formed and the fingers may become progressively contracted.