Orphan status for Mesoblast
Wednesday, 17 September, 2008
The US FDA has granted orphan drug designation for the use of adult stem cells developed by Mesoblast [ASX: MSB] in patients undergoing bone marrow transplantation.
Mesoblast's sister company Angioblast Systems has been granted the right to use its allogeneic mesenchymal precursor cells in patients with haematologic malignancies which have proven unresponsive to conventional chemotherapy.
The orphan drug designation is reserved for diseases affecting fewer than 200,000 patients annually.
It allows for an accelerated review process by the FDA, seven year exclusivity in the market and various tax benefits.
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