Mesoblast Limited (ASX:MSB) (Nasdaq:MESO) today announced that its licensee in Japan, JCR Pharmaceuticals Co. Ltd., has received notification that the Japanese Government’s National Health Insurance (NHI) body has formally set the price for the mesenchymal stem cell product TEMCELL® HS Inj., effective from today.
JCR announced that the launch of TEMCELL for the treatment of acute graft versus host disease (aGVHD) after an allogeneic bone marrow transplant (BMT) is anticipated in February 2016. Under its agreement with JCR, Mesoblast is entitled to receive royalties and other payments at pre-defined thresholds of cumulative net sales.
The approved and reimbursed dosing regimen in Japan for TEMCELL is as follows:
Reimbursement for TEMCELL has been authorized by NHI at ¥868,680 (A$9,767 / US$7,079) per bag of 72 million cells. In Japan, the average adult patient is expected to receive 16 or up to 24 bags of 72 million cells. On this basis, Mesoblast expects a treatment course of TEMCELL in an adult Japanese patient to be reimbursed at ¥13,898,880 (A$156,000 / US$113,000) or up to ¥20,848,320 (A$234,000 / US$170,000).
- For all patients, eight doses of 2 million cells/kilogram, delivered as an intravenous infusion.
- For patients with persistent symptoms beyond four weeks, a further weekly dose of 2 million cells/kilogram may be given for four additional weeks.
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