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news.Asahi Kasei Pharma has received approval for its regulatory application from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for Xiaflex (collagenase clostridium histolyticum) to treat patients with Dupuytren's contracture in Japan.
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Asahi has the rights to develop and market Xiaflex in Japan through an agreement with BioSpecifics’ partner Endo International (Endo).
In return, BioSpecifics will be eligible for receiving a milestone payment upon commercial launch in Japan.
BioSpecifics president Thomas Wegman said: "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.
"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.