‘Biological Legos’ Could Become a Blockbuster For Osiris Therapeutics

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By: John Persinos

Applying stem cells to regenerate healthy human tissue has been the dream of scientists for more than a century. Osiris Therapeutics (OSIR), based in Columbia, Maryland, is not only succeeding in this goal but it’s the first company to commercialize the process.

Osiris develops and brings to mar­ket compound drugs that incorporate stem cells. The company focuses on “living skin equivalents” and thera­pies for diseases that have histori­cally resisted all other types of treat­ment. Osiris takes its name from the ancient Egyptian god of the Afterlife, which is appropriate for a company that gives once hopeless patients new leases on life.

A stem cell is one of the body’s unspecialized master cells, with the ability to grow into other specific cell types. Stem cell therapy applica­tions are wide, from treating chronic wounds and burns to bone tissue re­pair and providing living skin grafts.

Chronic wounds that fail to heal, such as diabetic foot ulcers, are resis­tant to conventional drugs and typi­cally result in severe infection, ampu­tation or even death. According to the National Institutes of Health (NIH), chronic wounds in the US alone affect 6.5 million patients.

NIH estimates that more than $25 billion is spent annually on the treat­ment of chronic wounds and the problem is growing because of an ag­ing population and a sharp rise in the incidence of diabetes and obesity.

Biological Legos

Osiris uses adult “mesenchymal” stem cells, which are especially re­sourceful for chronic wound treat­ment and creating living skin.

This category of stem cell is akin to biological Legos, with the flexibility to differentiate into a particularly broad range of functioning cells. Since it was founded in 1992, Osiris has treated more patients with mesenchymal stem cells than the entire stem cell industry combined.

Most stem cell companies are en­meshed in laboratory-based research and clinical trials, with the develop­ment of a product still years away, if at all. However, Osiris already is bring­ing mesenchymal stem cell products to market.

In May, Osiris announced that it had received authorization from Health Canada, that country’s equiva­lent of the US Food and Drug Ad­ministration, to sell its new stem cell therapy Prochymal for the treatment of acute graft-vs-host disease (GvHD) in children. Prochymal is an intrave­nous formulation of mesenchymal stem cells.

The watershed decision marks the world’s first regulatory approval of a stem cell treatment for GvHD, a complication of bone marrow transplanta­tion that kills up to 80 percent of chil­dren affected, often within weeks of diagnosis. Prochymal has the potential to be a blockbuster; Osiris could then use that revenue to develop its other products in the pipeline.

Osiris’ other clinical development ef­forts for mesenchymal stem cells include treatments for Crohn’s disease, Type I diabetes and cardiac complications.

Science Fact

Osiris produces another potential blockbuster called Grafix, a living skin equivalent that’s the stuff of science fiction. Doctors can peel it off a roll, as if it were Scotch tape, and put it to immediate use on the human body.

Grafix is a membrane, comprised of mesenchymal stem cells, growth factors and living skin cells, all of which work in concert for tissue repair in chronic wounds, limb salvage procedures, and the repair of tendons and burns.

As with Prochymal, there’s no com­petitor to Grafix. At least 20 percent of all chronic wounds don’t respond to existing therapies, providing a huge untapped market for the treatment.

Grafix also is effective in salvaging patients with severe burns. The prod­uct represents an entirely new para­digm in skin repair and could find a wide range of military uses.

In a major win for the company, the US Center for Medicare & Med­icaid Services (CMS) announced in May that Grafix had been granted codes to facilitate reimbursement under Medicare’s outpatient pay­ment system.

Also in May, Osiris announced re­sults for the first quarter of 2012, end­ing March 31. Revenue from biosur­gery products, the company’s main division that makes stem cell treat­ments, rose 49 percent from the previ­ous quarter to $1.1 million.

Total revenues were $4.6 million, including license fees from the com­pany’s various partnerships with other biotech firms, down from $10.4 mil­lion from the same period a year ago. Net loss for the first quarter of 2012 was $1.3 million, compared to net in­come of $4 million in the first quarter of 2011.

Future Lifeblood

License fee revenue tends to fluc­tuate, but biosurgery product rev­enue is the company’s future life­blood and it’s growing quickly. Also in the first quarter, the com­pany won four new patents issued in the US and Canada covering the use of mesenchymal stem cells for the treatment of GvHD and cardi­ac disorders. The company finished the quarter with strong cash, receiv­ables and short-term investments of $44.2 million.

Osiris has enough cash to cover op­erating expenses over a long period of time, to ensure survival during the often-protracted clinical trials process. Osiris boasts a market cap of $206.3 million, an operating profit margin of nearly 27 percent and a return on assets of 15.8 percent—more than enough to weather any storm.

As a flood of patent expirations con­tinue to shake up the drug industry, the future growth stocks will be those with the strongest drug development pipe­lines and the most innovative treat­ments. Osiris is suitable for aggressive investors looking for a pure play in stem cell therapies.

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