New York, USA; and Melbourne, Australia; June 11, 2019: Mesoblast Limited (ASX:MSB;Nasdaq:MESO) today announced it has expanded its partnership with JCR Pharmaceuticals Co. Ltd. inJapan to the use of mesenchymal stem cells (MSCs) for the treatment of newborns who lack sufficientblood supply and oxygen to the brain, a condition termed neonatal hypoxic ischemic encephalopathy(HIE).HIE occurs in 2.5 per 1,000 live births1 and can cause seizures, delayed development of motor skillsand cognitive function, and cerebral palsy2. In preclinical studies, MSCs have been shown to have asignificant positive effect on neurobehavioral outcome following HIE injury3.JCR is marketing the allogeneic MSC product TEMCELL®4 HS Inj. for the treatment of steroidrefractory acute graft versus host disease (aGVHD) in children and adults in Japan. Under the terms ofthe partnership, Mesoblast receives royalties on TEMCELL product sales for all licensed indications. Thelicense agreement was previously expanded for use in wound healing in patients with EpidermolysisBullosa (EB), and JCR filed to extend marketing approval of TEMCELL in Japan for this indication inMarch 2019.The license agreement has now been further expanded to provide JCR with rights to sell TEMCELL forHIE and to access Mesoblast’s broad patent portfolio for this indication. JCR plans to initiate a clinicaltrial of TEMCELL in newborns with HIE in July 2019 in order to further extend the label in thisindication.Mesoblast has the right to use all safety and efficacy data generated by JCR in Japan to support itsdevelopment and commercialization plans for its MSC product candidate remestemcel-L in the UnitedStates and other major healthcare markets, including for GVHD, wound healing, and now HIE. In theUnited States there are approximately 6,000 new patients annually with moderate-severe HIE2 whocould potentially benefit from treatment with remestemcel-L.Mesoblast Chief Executive Dr Silviu Itescu stated: “We are pleased with the strategy by our partner toexpand TEMCELL marketing approval for indications beyond aGVHD. This supports our own strategicgrowth plans for our MSC product candidate remestemcel-L beyond aGVHD in children, including otherpediatric indications such as HIE and adult conditions such as aGVHD, chronic GVHD, biologicrefractory Crohn’s disease, and osteoarthritis.”Mesoblast recently initiated a rolling Biologics License Application to the U.S Food and DrugAdministration
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