Mesoblast licensee files for marketing approval of TEMCELL
Mesoblast announced its licensee in Japan, JCR Pharmaceuticals Co., has filed to extend marketing approval of TEMCELL for use in patients with Epidermolysis Bullosa. TEMCELL is already approved for the treatment of acute graft versus host disease, and was the first allogeneic cellular medicine to receive full regulatory approval in Japan. The parties have amended their License Agreement in order for JCR to access Mesoblast's mesenchymal stem cell wound healing patents to enable it to develop and commercialize TEMCELL for EB. Mesoblast will receive royalties on TEMCELL product sales for EB. JCR has received Orphan Designation for TEMCELL in the treatment of EB based on promising results from an investigator-initiated trial at Osaka University Hospital where TEMCELL was subcutaneously administered. JCR also intends to seek a label extension for TEMCELL in Japan for intravenous delivery of TEMCELL. Mesoblast will have access to clinical data generated by JCR in Japan to support development and commercialization of its MSC product candidate remestemcel-L in markets outside Japan for EB and other wound healing applications. Mesoblast plans to file for United States FDA regulatory approval of remestemcel-L shortly for the treatment of aGVHD.