MDWD - MediWound partner seeks approval of burn therapy in Japan
Siriporn Lin/iStock via Getty Images MediWound (MDWD) rose sharply in the pre-market after its partner Kaken Pharmaceutical (SKKAF) announced that it submitted a new drug application for approval of topical burn therapy KMW-1 in Japan. The new drug application to the Ministry of Health, Labour, and Welfare in Japan is intended to secure manufacturing and marketing approval of KMW-1 in the removal of burn eschar (dead or damaged tissues due to burns). In 2016, MediWound inked an exclusive licensing agreement with Kaken for KMW-1 available as NexoBrid in several other markets. A Phase 3 trial conducted in Japan has shown a favorable efficacy and safety profile for the therapy Kaken said, adding that the approval will allow a” new treatment option for burn patients by enabling non-invasive removal of eschar.” MediWound sales rose ~32% YoY in Q1 2021 Mainly due to the purchase of NexoBrid by the Biomedical Advanced Research and Development Authority
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MediWound partner seeks approval of burn therapy in Japan