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Bio Technology  News  Story
Mesoblast sees strong clinical, regulatory progress in FY'10

Singapore, Aug 26, 2010: Australia’s regenerative medicine company, Mesoblast, has reported its results for the year ended June 30, 2010. With cash reserves of $32.05 million compared to $16.5 million for the 2009 financial year, Mesoblast has strengthened its capacity to commercialize a broadening portfolio of its allogeneic, or off-the-shelf, stem cell products.

The company's operating cash use for the year was $9.7 million and net loss for the year was $14.8 million.

The low-cost, high margin business model associated with these products is similar to pharmaceutical drugs, and is said to underscore the company’s significant commercial advantages over competitive technologies.

Mesoblast Chairman, Mr Brian Jamieson, said that it has been an extremely rewarding year for Mesoblast, which was highlighted by the timely achievements of a number of key clinical and commercial milestones. “A stand-out accomplishment was Mesoblast’s success in obtaining a license from the Therapeutic Goods Administration (TGA) to manufacture and distribute our first generation autologous, or patient’s own, adult stem cell products throughout Australia.

“This represents the first culture-expanded adult stem cell therapy that has received manufacturing approval anywhere in the world and is a strong validation of the company’s science, manufacturing, preclinical and clinical strategies and results,” Mr Jamieson added. “Early adoption of our first generation products will establish a clear path for our second generation allogeneic products that are derived from a universal or unrelated donor.”

Key highlights from clinical trials
  • Safe and robust lumbar fusion demonstrated over 12 months in Mesoblast's first spinal fusion trial of NeoFuse at New York’s Hospital for Special Surgery which employed an invasive surgical approach
  • Phase II trials for lumbar and cervical spinal fusion products used in minimally invasive surgical procedures continue to recruit well in US and Australia
  • Phase II trial of RepliCart for prevention of knee cartilage loss and osteoarthritis after anterior cruciate ligament damage continues recruitment in Australia
  • Phase II trial of Revascor, the cardiac repair stem cell product, being developed by Mesoblast’s US associated company Angioblast Systems for congestive heart failure, has completed 60-patient recruitment; interim results indicate positive three and six month efficacy in the lowest-dose treatment group
  • Angioblast’s bone marrow repair product, being developed under a US Food and Drug Administration (FDA) Orphan Drug Designation, has demonstrated successful bone marrow engraftment in 25 patients
Proposed acquisition of angioblast
In order to maximize shareholder benefits across the entire technology platform, the board of directors of the company has recommended to shareholders to consider a strategic acquisition of Angioblast. According to the company, this would transform Mesoblast from a biologics company focused on orthopedic applications to a global leader in the regenerative medicine industry.

Commenting on this, Mr Jamieson said, “Bringing the technology platform and assets into one company would enable us to streamline corporate operations, strengthen the global leadership team, rationally allocate resources based on maximal return, and facilitate commercial partnering discussions.”

© BioSpectrum Bureau
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