"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. 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." said William Lehmann, President and Chief Operating Officer atAthersys.
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. 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." commented Gil Van Bokkelen, Chairman and Chief Executive Officer of Athersys.