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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) (USOTC:MBLTY) is committed to the development of novel treatments for orthopaedic conditions, including the rapid commercialisation of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Our focus is to progress through clinical trials and international regulatory processes necessary to commercialise the technology in as short a timeframe as possible. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction and culture of adult Mesenchymal Precursor Cells (MPCs). The Company has acquired 38.4% of Angioblast Systems Inc., an American company developing the platform MPC technology for the treatment of cardiac, vascular and eye diseases including repair and regeneration of blood vessels and heart muscle. Mesoblast and Angioblast are jointly funding and progressing the core technology. Mesoblast's strategy is to maximise shareholder value through both corporate partnerships and the rapid and successful completion of clinical milestones.
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