MESOBLAST ACQUIRES OSIRIS' CULTURE EXPANDED STEM CELL THERAPEUTIC BUSINESS

MELBOURNE, Australia and NEW YORK, Oct. 10, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced the acquisition of the entire culture-expanded mesenchymal stem cell (MSC) business of Osiris Therapeutics (OSIR) by the Mesoblast Group.

"The many commercial and strategic benefits of this transaction firm Mesoblast's leadership position in the global regenerative medicine industry," said Mesoblast Chief Executive Officer Professor Silviu Itescu.

The benefits derived from acquiring the approved and late-phase MSC products include:

"Importantly, in 2014 we plan to have active products in Phase 3 clinical trials in all four core major therapeutic areas of focus: cardiovascular medicine (congestive heart failure), inflammatory/immune diseases (Crohn's disease), orthopedics (spinal fusion and intervertebral disc repair) and oncology (acute Graft versus Host Disease, and cord blood expansion in bone marrow transplantation)."

Existing cash reserves are sufficient to meet current and new product development plans. Cost savings and other synergies are expected across personnel, capital expenditure, and manufacturing, and as a result there will only be a modest increase in operating cash burn.

Strategic and Financial Benefits of the Transaction

Significant new and early potential revenue stream with the acquisition of Prochymal(R), the world's first approved stem cell therapeutic and the only stem cell therapeutic designated by the United States Food and Drug Administration (FDA) as both an Orphan Drug and Fast Track product. Prochymal(R) has already received conditional approval in Canada and New Zealand for the treatment of children with acute GvHD, and is available in the United States under an Expanded Access Program for treatment of acute GvHD in both children and adults.

A broadening of Mesoblast's Phase 3-ready products in two new indications:

Crohn's disease - a major driver for the transaction was Mesoblast's evaluation of the ongoing, 330-patient, Phase 3 trial in patients with Crohn's disease who have failed other biologic agents. Following an interim analysis for futility after 207 patients were enrolled, the best performing Prochymal dose (based on the primary endpoint of disease remission) was selected to complete the study.

Acute GvHD - the promising Phase 3 data in adults with GvHD at high risk of death due to liver or gut complications was another major driver for the transaction, and Mesoblast intends to seek approval from the FDA for this indication.

Excerpt from:
MESOBLAST ACQUIRES OSIRIS' CULTURE EXPANDED STEM CELL THERAPEUTIC BUSINESS

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