A treatment owned by Mesoblast Pharmaceutical is set to become the first stem cell treatment to be available in Japan, following an application by its local partner, JCR Pharmaceutical, to launch the product in that market.
According to Japanese reports, JCR Pharmaceutical will lodge its application to market a treatment for so-called graft versus host disease (GVHD), which is a side effect of bone marrow or umbilical cord blood transplant surgery, by the end of December.
Recently, the Japanese government changed the law to fast-track approvals for stem cell treatments, an area where some other countries in the region, such as South Korea, have made similar changes, spawning a great deal of end-market activity.
Earlier this year, Mesoblast agreed to pay up to $US100 million to buy a suite of stem cell patents and products from US drug company Osiris Therapeutic, which brought with it entry into the Japanese drugs market.
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According to the reports, the Japan Society of Hematopoietic Cell Transplantation estimates about 1200 people annually develop acute GVHD in that country.
In recent research, broker Bell Potter estimated this could be a $US59 million-a-year market and, with the number of transplants growing, this should see a rise in demand for the treatment. If approved, this would be the first allogeneic stem cell product to be launched in Japan, according to the broker.
JCR could obtain approval within a year from filing to launch the treatment, which would rank it as one of the first of Mesoblast's products to be launched.
Instead of phased clinical trials, the law changes enable regenerative medicines to demonstrate efficacy in pilot studies of as few as 10 patients if the change is dramatic enough, or a few hundred with more marginal treatments.
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Stem cell treatment set for Japan