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Companies agree to joint development of therapy for stroke.

OSAKA, Japan, September 26, 2014 -- Sumitomo Dainippon Pharma Co., Ltd., and SanBio Co., Ltd., acting through its U.S. subsidiary SanBio, Inc., have entered into a joint development and license agreement for exclusive marketing rights in the U.S. and Canada for SB623, a cell therapy for the treatment of patients with chronic stroke discovered and under development by SanBio.

Sumitomo Dainippon Pharma and SanBio will jointly develop SB623 in the U.S. and Canada, and Sumitomo Dainippon Pharma will have the exclusive right to market SB623 in both countries.

In consideration of the rights and licenses granted, Sumitomo Dainippon Pharma will make an initial payment of $6 million and milestone payments totaling an additional $74 million during the clinical development of SB623.

After market launch, SanBio will supply the finished product to Sumitomo Dainippon Pharma and receive double-digit percentage royalties based on sales.

Additionally, SanBio may receive sales milestone payments contingent upon the achievement of annual sales goals, up to a total of US $125 million. The development expenses will be borne equally by the two companies.

SB623 is an allogeneic cell product, derived from bone marrow stromal cells isolated from healthy donors.

Unlike autologous cell therapy, which requires individualized cell preparation for each patient, SB623 production can be scaled up from a single donor's cells, enabling delivery of uniform quality products to a large number of stroke patients. In preclinical and clinical studies to date, SB623 has shown beneficial results on stroke disability with no serious adverse events.

SB623 is the first cell therapy product for stroke that has been approved by the FDA for human clinical trials. Phase l/2a clinical tests have been completed in the U.S., and a summary presentation of the results was made at the International Stroke Conference held on February 13, 2014.

Preparations are under way to begin a Phase lib clinical trial in the U.S.


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Title Annotation:Strategic Alliances
Publication:Stem Cell Business News
Date:Oct 6, 2014
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