Thursday, October 25, 2018
Mesoblast Limited today announced it has expanded its partnership with JCR Pharmaceuticals Co. Ltd. in Japan for wound healing in patients with Epidermolysis Bullosa (EB).
JCR has received Orphan Designation for the allogeneic mesenchymal stem cell (MSC) product TEMCELL HS Inj1 in the treatment of EB. Based on promising results from an investigator-initiated trial in Japan, JCR intends to seek label extension for TEMCELL in Japan beyond its existing approval for the treatment of acute graft versus host disease.
Under the expanded License Agreement covering EB, Mesoblast has provided JCR with access to its broad patent portfolio for the use of mesenchymal stem cells in wound healing. Mesoblast will receive royalties on TEMCELL product sales for EB. Additionally, Mesoblast has the right to use safety and efficacy data generated by JCR in Japan in support of development and commercialization of its MSC product candidate remestemcel-L for EB and other non-healing wound indications in the United States and other major healthcare markets.
There are many genetic and symptomatic variants of EB, with all sharing the prominent symptom of extremely fragile skin that blisters and tears from minor friction or trauma. Internal organs and bodily systems can also be seriously affected by the disease. EB is always painful, often pervasive and debilitating, and is in some cases lethal before the age of 30. The international branch of the Dystrophic Epidermolysis Bullosa Research Association (DEBRA International) reports that there were approximately 25,000 cases within the United States as of April 2011. Currently, there are no effective treatments available.