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Osiris Bolsters Its Stem Cell Intellectual Property Estate

Osiris Therapeutics, Inc. (NASDAQ: OSIR), announced today the expansion of its intellectual property protection around Prochymal® (remestemcel-L). The United States Patent and Trademark Office recently granted Osiris two patents that cover multiple mechanisms of action related to cardiac tissue repair. Additionally, Osiris has enhanced its mesenchymal stem cell (MSC) patent estate with the issuance of patents across Europe and Australia covering stem cells expressing all therapeutically useful levels of cell surface receptors for TNF-alpha, a receptor essential to the cell's ability to counteract inflammation. These patents further support Osiris' considerable intellectual property position, which includes 48 issued U.S. patents around the production, composition, testing and use of the mesenchymal stem cell from both allogeneic and autologous sources.

"These recent additions to Osiris’ patent estate, combined with the existing broad coverage of our pioneering MSC platform technology, reinforce our industry leading IP portfolio and bolster our dominant position regarding the manufacture and use of mesenchymal stem cells for the treatment of a broad range of diseases,” said Chris Alder, Chief Intellectual Property Counsel of Osiris. “We have invested significant time and resources building our intellectual property estate, and with the commercialization of Prochymal, we are preparing to take the necessary action to enforce our considerable rights.”

Prochymal is now approved in Canada and New Zealand, and is currently available in seven other countries including the United States under an Expanded Access Program. With Prochymal (remestemcel-L) entering commerce, Osiris has initiated the process of identifying entities that may be infringing upon its intellectual property rights and will take appropriate action as necessary.

About Prochymal (remestemcel-L)

Prochymal is the world’s first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute graft-versus-host disease (GvHD) in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial 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.

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