Mesoblast and JCR Pharmaceuticals Expand Japan License Agreement

Mesoblast (NASDAQ:MESO, ASX:MSB) has announced it has expanded its partnership with JCR Pharmaceuticals for its use of mesenchymal stem cells (MSCs) for treating newborns who lack sufficient blood supply and oxygen to the brain, a condition called neonatal hypoxic ischemic encephalopathy (HIE).

As quoted in the press release:

HIE occurs in 2.5 per 1,000 live births¹ and can cause seizures, delayed development of motor skills and cognitive function, and cerebral palsy².  In preclinical studies, MSCs have been shown to have a significant positive effect on neurobehavioral outcome following HIE injury³.

JCR is marketing the allogeneic MSC product TEMCELL®⁴ HS Inj. for the treatment of steroid-refractory acute graft versus host disease (aGVHD) in children and adults in Japan. Under the terms of the partnership, Mesoblast receives royalties on TEMCELL product sales for all licensed indications. The license agreement was previously expanded for use in wound healing in patients with Epidermolysis Bullosa (EB), and JCR filed to extend marketing approval of TEMCELL in Japan for this indication in March 2019.

The license agreement has now been further expanded to provide JCR with rights to sell TEMCELL for HIE and to access Mesoblast’s broad patent portfolio for this indication.  JCR plans to initiate a clinical trial of TEMCELL in newborns with HIE in July 2019 in order to further extend the label in this indication.

Mesoblast has the right to use all safety and efficacy data generated by JCR in Japan to support its development and commercialization plans for its MSC product candidate remestemcel-L in the United States and other major healthcare markets, including for GVHD, wound healing, and now HIE.  In the United States there are approximately 6,000 new patients annually with moderate-severe HIE² who could potentially benefit from treatment with remestemcel-L.

Mesoblast Chief Executive Dr Silviu Itescu stated: “We are pleased with the strategy by our partner to expand TEMCELL marketing approval for indications beyond aGVHD. This supports our own strategic growth plans for our MSC product candidate remestemcel-L beyond aGVHD in children, including other pediatric indications such as HIE and adult conditions such as aGVHD, chronic GVHD, biologic-refractory Crohn’s disease, and osteoarthritis.”

Click here to read the full press release.