Melbourne, July 23, 2009 (ABN Newswire) - Australian regenerative medicine company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), today announced that it had commenced a formal process aimed at obtaining licenses from the Therapeutic Goods Administration (TGA) to commercially manufacture and distribute its adult stem cell products in Australia.
Mesoblast will seek to obtain TGA regulatory approval of its proprietary cell manufacturing process that will be provided and managed under a contractual agreement with a current TGA-licensed cell manufacturer, Cell Therapies Pty Ltd.
Mesoblast Executive Director, Professor Silviu Itescu, said TGA approval of its first product would result in earlier revenues by making a fracture repair product available to hospitals and clinicians throughout Australia.
Recently, Mesoblast successfully completed an Australian clinical trial of its proprietary autologous stem cell therapy for the repair of non-healing long bone fractures of the legs. The bone repair product for this trial was manufactured by Cell Therapies.
Non-healing long bone fractures affect millions of people worldwide, are usually a complication of road accident trauma, are very debilitating, and in some cases result in limb amputation.
"We are excited at the prospect of making our bone repair product available for those patients who have poorly-healing fractures of their long bones and for whom no satisfactory alternatives are available," Professor Itescu said.
The Managing Director of Cell Therapies, Mr Ray Wood, said that entering into this contractual agreement was in large part driven by Mesoblast's excellent clinical and manufacturing achievements to date, which he fully expects will meet the high standards of quality assurance and patient safety required by the TGA.
Professor Itescu added: "Australian regulatory approval will enable us to formulate a template that could be duplicated in other jurisdictions on a country by country basis," he said.
Mesoblast will seek to obtain TGA regulatory approval of its proprietary cell manufacturing process that will be provided and managed under a contractual agreement with a current TGA-licensed cell manufacturer, Cell Therapies Pty Ltd.
Mesoblast Executive Director, Professor Silviu Itescu, said TGA approval of its first product would result in earlier revenues by making a fracture repair product available to hospitals and clinicians throughout Australia.
Recently, Mesoblast successfully completed an Australian clinical trial of its proprietary autologous stem cell therapy for the repair of non-healing long bone fractures of the legs. The bone repair product for this trial was manufactured by Cell Therapies.
Non-healing long bone fractures affect millions of people worldwide, are usually a complication of road accident trauma, are very debilitating, and in some cases result in limb amputation.
"We are excited at the prospect of making our bone repair product available for those patients who have poorly-healing fractures of their long bones and for whom no satisfactory alternatives are available," Professor Itescu said.
The Managing Director of Cell Therapies, Mr Ray Wood, said that entering into this contractual agreement was in large part driven by Mesoblast's excellent clinical and manufacturing achievements to date, which he fully expects will meet the high standards of quality assurance and patient safety required by the TGA.
Professor Itescu added: "Australian regulatory approval will enable us to formulate a template that could be duplicated in other jurisdictions on a country by country basis," he said.
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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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