Athersys, Inc., an international biopharmaceutical company, operates in the field of regenerative medicine. The company has a portfolio of therapeutic product development programs to address significant unmet medical needs in multiple disease areas. Its MultiStem cell therapy, a patented and proprietary allogeneic stem cell product, is its primary platform product and has been evaluated in two completed Phase 1 clinical trials and is being evaluated in two ongoing Phase 2 clinical trials, as well as an investigator-led Phase 1 trial. The company’s clinical development programs are focused on treating inflammatory and immune disorders, neurological conditions, cardiovascular disease, and other conditions. It is also applying its pharmaceutical discovery capabilities to identify and develop small molecule compounds with potential applications in indications, such as obesity, related metabolic conditions and certain neurological conditions. These represent major areas of clinical need, as well as substantial commercial opportunities. Business Strategy The key elements of the company’s strategy include conducting clinical development to establish clinical proof of concept and biological activity with its lead product candidates; refining and improving its manufacturing and related processes and deepen its understanding of therapeutic mechanisms of action; entering into arrangements with business partners to accelerate development and value creation; exploring new high potential therapeutic applications, leveraging third-party research collaborations and its results from related areas; and expanding its intellectual property portfolio. Programs Inflammatory Bowel Disease (IBD): MultiStem is being evaluated in an ongoing Phase II clinical study involving administration of MultiStem to patients suffering from ulcerative colitis (UC) the common form of IBD. This double blind, placebo controlled trial being conducted with its partner, Pfizer, in UC patients that have an inadequate response or are refractory to treatment, completed enrolling patients in 2013. Ischemic Stroke: In an ongoing Phase 2 clinical study, the company is evaluating the administration of MultiStem to patients who have suffered an ischemic stroke. In contrast to treatment with thrombolytics, which must be administered within 3 to 4 hours after a stroke, the company is treating patients one to two days after the stroke has occurred. This double blind, placebo-controlled trial is being conducted at leading stroke centers across the United States and Europe. The company is targeting to complete enrollment around the end of summer 2014. Acute Myocardial Infarction: The company has evaluated the administration of MultiStem to patients who have suffered an acute myocardial infarction in a Phase I clinical study. The company is preparing for a Phase 2 clinical study of MultiStem administration to heart attack victims and is planning to initiate late 2014. Hematopoietic Stem Cell Transplant/GvHD: The company completed a Phase 1 clinical study of the administration of MultiStem cells to patients suffering from leukemia or certain other blood-borne cancers in which patients undergo radiation therapy and then receive a hematopoietic stem cell, or HSC, transplant. The company has technology licensing arrangements and established product commercialization and co-development partnerships with companies, such as Bristol-Myers Squibb Company, Johnson & Johnson, Wyeth Pharmaceuticals, Inc., Angiotech Pharmaceuticals, Inc., and RTI Surgical, Inc. Intellectual Property The company’s intellectual property portfolio consists of approximately 130 issued patents (of which 17 are United States patents) and approximately 170 global patent applications around its stem cell technology and MultiStem product platform. This includes 14 United States patents and approximately 90 international patents that apply to MAPC and related products, such as MultiStem. The company has six United States patents and three patent applications with broad claims directed to selective 5HT2c agonists discovered at Athersys that provide patent coverage through as late as 2029. From its Histamine H3 program, it has six United States patents with broad claims directed to compounds discovered at Athersys from two distinct chemical series that provide patent coverage through as late as 2028. In addition, the company has 36 issued patents (16 United States patents and 20 international patents) relating to compositions and methods for the RAGE technology that provide patent coverage through as late as 2020, and 5 United States patents relating to human proteins and candidate drug targets that it identified through the application of RAGE and to its other technologies that provide patent coverage through as late as 2022. Research and Development The company’s research and development costs were $20.5 million in 2013. History Athersys, Inc. was founded in 1995. The company was incorporated in Delaware in 1995.
athersys inc (ATHX:NASDAQ CM)
3201 Carnegie Avenue
Cleveland, OH 44115
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