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Osiris Therapeutics rallies as stem cell therapy gets marketing approval in New Zealand

Published: 16:50 14 Jun 2012 BST

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Osiris Therapeutics (NASDAQ: OSIR) said Thursday that it can now market in New Zealand its stem cell therapy Prochymal for the treatment of acute graft-vs-host disease (GvHD) in children, marking the company's second approval for the drug following Canada.

The company reported that it has received approval from Medsafe, NewZealand’s medical regulatory agency. Prochymal is the world’s first approved drug to treat GvHD, Osiris said.

The drug is expected to be commercially available in New Zealand later this year.

GvHD is a complication of bone marrow transplantation that is the leading cause of transplant-related mortality, killing 80 per cent of children affected.

With GvHD, the immune cells contained within the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. If it is severe, blistering of the skin occurs, as well as intestinal hemorrhage and liver failure.

Severe GvHD is fatal often within just weeks of diagnosis.

Steroids are currently used as first-line therapy, with a low success rate of 30 to 50 percent, the company noted. When steroids fail, treatment options are limited to immunosuppressive agents - which show little benefit and significant toxicities.

GvHD had no approved treatment until Prochymal, which is the world’s first approved drug with a stem cell as its active ingredient.

"With each of our approvals it becomes clearer that the time for life-saving stem cell therapies in the practice of medicine has arrived, and we are humbled to have a leading role," said Osiris’ president and CEO, C. Randal Mills.

Clinical trials showed that Prochymal is able to induce an "objective, clinically meaningful" response in 61 to 64 per cent of children with GvHD that are otherwise refractory to treatment.

Osiris submitted the application to Medsafe in May of 2011, and was granted priority review status in June of 2011. Priority review provides accelerated review for new drugs that offer a considerable clinical advantage over treatment options currently available.

Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs), which are taken from the bone marrow of healthy adult donors between the ages of 18 to 30 years.

The MSCs are grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor.

Prochymal is currently in phase 3 trials for refractory Crohn’s disease, and is also being evaluated in clinical trials for the treatment of myocardial infarction (heart attack), and type 1 diabetes.

Osiris is a stem cell therapeutics company that is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets.

Shares increased 12.45 percent to $7.95 Thursday morning.

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