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Melbourne, July 21, 2010 (ABN Newswire) - Australian regenerative medicine company, Mesoblast Limited (
ASX:MSB) (PINK:MBLTY), today announced that the Australian Therapeutic Goods Administration (TGA) has issued a licence to Mesoblast to manufacture and supply its proprietary Mesenchymal Precursor Cells (MPC) products.
Under this licence, Mesoblast will now make commercially available to doctors and hospitals across Australia manufactured MPC products for a patient's own, or autologous, use in the repair and regeneration of their damaged tissues. The cells will be manufactured under an agreement between Mesoblast and the TGA licensed contractor Cell Therapies Pty Ltd.
Mesoblast will initially target major bone repair markets, including long bone fractures after trauma, stress fractures following sporting injury, and vertebral fractures due to osteoporosis.
"Gaining a licence from the TGA, one of the world's foremost regulatory bodies, to manufacture our adult stem cell products for supply to Australian patients is a major validating step in Mesoblast's history," said Mesoblast Chief Executive Professor Silviu Itescu. "It underscores the robustness of our manufacturing process and the excellent safety profile of our products in patients.
"To our knowledge, this is the first culture-expanded adult stem cell product that has received manufacturing approval anywhere in the world," he added.
Professor Itescu said that Australian TGA approval will mean early revenue generation for Mesoblast, faster product adoption and branding, and accrual of clinical outcome data for use by the Company in subsequent local and international filings for product registrations.
In addition, it will position Australia as a global leader in the use of regulated stem cell therapies.
ASX:MSB) (PINK:MBLTY), today announced that the Australian Therapeutic Goods Administration (TGA) has issued a licence to Mesoblast to manufacture and supply its proprietary Mesenchymal Precursor Cells (MPC) products.Under this licence, Mesoblast will now make commercially available to doctors and hospitals across Australia manufactured MPC products for a patient's own, or autologous, use in the repair and regeneration of their damaged tissues. The cells will be manufactured under an agreement between Mesoblast and the TGA licensed contractor Cell Therapies Pty Ltd.
Mesoblast will initially target major bone repair markets, including long bone fractures after trauma, stress fractures following sporting injury, and vertebral fractures due to osteoporosis.
"Gaining a licence from the TGA, one of the world's foremost regulatory bodies, to manufacture our adult stem cell products for supply to Australian patients is a major validating step in Mesoblast's history," said Mesoblast Chief Executive Professor Silviu Itescu. "It underscores the robustness of our manufacturing process and the excellent safety profile of our products in patients.
"To our knowledge, this is the first culture-expanded adult stem cell product that has received manufacturing approval anywhere in the world," he added.
Professor Itescu said that Australian TGA approval will mean early revenue generation for Mesoblast, faster product adoption and branding, and accrual of clinical outcome data for use by the Company in subsequent local and international filings for product registrations.
In addition, it will position Australia as a global leader in the use of regulated stem cell therapies.
About Mesoblast Limited
Mesoblast Limited (ASX:MSB) (OTC ADR: MBLTY) is the world's leading developer of innovative biological products for the broad field of regenerative medicine.
Mesoblast's commercial strategy is based on its unique proprietary adult mesenchymal precursor cells.
The company's lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions.
Mesoblast and global biopharmaceutical company Cephalon Inc. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.
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