Athersys, Inc. has received key patents from the Japan Patent Office for several inventions involving its proprietary cell therapy technology. Patent No. 5398941 covers non-embryonic, multipotent stem cells, such as MultiStem, and applies to all therapeutic applications. Patent No. 5399709 covers the use of such stem cell therapies for the treatment of immune dysfunctions, such as graft-versus-host disease (GvHD), and inflammatory diseases and autoimmune disorders (e.g., inflammatory bowel disease (IBD)). And, the third patent covers the treatment of brain injuries, such as stroke and traumatic brain injury, with such multipotent stem cells.

"These patents will provide the Company important protection for its cell therapy products in Japan and their use in a number of significant disease areas, including stroke, IBD, GvHD and others," said William Lehmann, president and chief operating officer at Athersys. "Additionally, we are encouraged by regulatory events in Japan, which have created an accelerated development path for stem cell therapies. Recognizing these developments, Japan's sizable pharmaceutical market, and the expected growth in demand for more effective treatments of age- and lifestyle-related diseases and conditions, we consider Japan a high priority market for the development of MultiStem cell therapy product candidates."

Recently, Japan's parliament enacted new legislation to promote the safe and accelerated development of treatments using stem cells. The new regenerative medicine law and revised pharmaceutical affairs law define products containing stem cells as regenerative medicine products and allow for the conditional approval of such products if safety has been confirmed in clinical trials, even if their efficacy has not been fully demonstrated. The legislation creates a new, faster pathway for cell therapy product approval, and offers the potential to enable more rapid entry into the Japanese market. The Ministry of Health, Labour and Welfare has been directed to develop and adopt new rules and procedures to implement this legislation.

"Japan is showing tremendous international leadership in an area that it recognizes has the potential to effectively address areas of serious unmet medical need. The new framework is intended to benefit patients through the rapid development and approval of innovative and cost-effective stem cell therapies," commented Gil Van Bokkelen, chairman and chief executive officer of Athersys. "We are actively evaluating the potential for accelerated development of MultiStem cells in a number of therapeutic areas in Japan, and will seek to establish strategic collaborations to assist in the rapid development of products that will help Japanese patients."

MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas. It represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged a strategic partnership with Pfizer Inc. to develop MultiStem for treating inflammatory bowel disease, while independently evaluating it as a novel therapeutic approach for indications in the neurological, cardiovascular and transplant support areas, as well as other potential opportunities.

Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life.