Athersys Inc.

Athersys Inc. is a clinical-stage biotechnology company developing MultiStem, a patented, adult-derived "off-the-shelf" stem cell product platform for the cardiovascular, neurological, inflammatory and immune disease areas. The company currently has five clinical stage programs involving MultiStem, including those for treating inflammatory bowel disease (partnered with Pfizer Inc.), ischemic stroke, damage caused by myocardial infarction and for the prevention of graft-versus-host disease. Athersys has additional pharmaceutical programs in the metabolic and neurological areas, and a broad international network of collaborations with leading clinical and research institutions.

Expert Comments:

"On March 2, Chugai Pharmaceutical Co. Ltd. and Athersys Inc. announced a deal using Athersys' MultiStem (allogeneic multipotent adult progenitor cells) product for the treatment of ischemic stroke. Multistem could very well be among the first few products approved in Japan. . .I don't think the Athersys/Pfizer failure was a dramatic problem. Understand that if we look at the fundamentals and properties of Athersys' cell technology, they are still rock solid. Looking at the details of that Phase 2 trial with MultiStem, Athersys and Pfizer set a very, very high bar for success in terms of trial design. One reason this was so challenging was that they were essentially attempting to treat patients who were very sick, and who had already failed several types of therapy. . ." read more >

Jason Kolbert, Maxim Group (3/13/15)
"Athersys Inc. completed patient enrollment of double-blind, placebo-controlled Phase 2 study of MultiStem cell therapy for ischemic stroke—initial results are expected in mid-April; established collaboration with Chugai for development and commercialization of MultiStem cell therapy for ischemic stroke in Japan. . .if data is good in stroke, we could see MultiStem on the market without a pivotal trial. We expect that a small bridging study may be all that is needed. New government regulations in Japan have created a fast-track pathway to the marketplace. Japan is all upside for Athersys. . .in fact, good data on stroke would be transformative for Athersys."

Jason Kolbert, Maxim Group (3/9/15)
"Stay tuned for top-line data coming from Athersys Inc.'s Phase 2 stroke trial. . .the company is in prime position with Japanese partners to take advantage of [regulatory] changes in Japan. . .Chugai, a pharma leader in Japan, just signed a significant partnership with Athersys to develop MultiStem for stroke in Japan. The deal terms are attractive: Athersys receives an up-front cash payment of $10M and additional payments ($45M) as the program advances, as well as sales and royalty milestones ($150M), plus tiered, double-digit royalties on any net sales, as well as payments for product supplied to Chugai."

Christian Glennie, Edison Investment Research (3/5/15)
"Our near-term focus remains on results in April from Athersys Inc.'s Phase 2 study in ischemic stroke, but the Chugai deal puts MultiStem in pole position to take advantage of a new regulatory framework in Japan. . .headline results are now expected in April. Positive results would allow Athersys/Chugai to take advantage of an accelerated approval pathway now available in Japan for regenerative medicines. . .having Chugai on board now signals confidence in the product and the opportunity in Japan. . .positive Phase 2 data could significantly rerate the stock."

Henry McCusker, Regenerative Medicine Investors (3/2/15)
"Athersys Inc. and Chugai Pharmaceutical Co. Ltd. have announced a partnership and license agreement to exclusively develop and commercialize MultiStem cell therapy for ischemic stroke in Japan. . .Chugai will be responsible for the development and commercialization of MultiStem for ischemic stroke in Japan, and Athersys will have responsibility for product supply."

Jason Kolbert, Maxim Group (3/2/15)
"Athersys Inc. announced a partnership with Japanese pharmaceutical giant Chugai Pharmacetical Co. Ltd. . .a highly experienced leader in Japan and considered to be not only one of the 'Japanese Core' pharmaceutical companies but a pioneer in the introduction of new products. . .especially strong for its hospital-based salesforce. . .Chugai will be responsible for clinical development (trials and cost) and approval in Japan. . .new governmental regulations in Japan have created a fast-track pathway to the marketplace. Japan is all upside for Athersys."

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