Healthcare Industry News: Sumitomo Dainippon Pharma
News Release - September 26, 2014
Sumitomo Dainippon Pharma and SanBio Conclude Joint Development and License Agreement for North America over SB623, Therapy for Stroke
OSAKA, Japan, Sept. 26, 2014 -- (Healthcare Sales & Marketing Network) -- Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo Dainippon Pharma") and SanBio Co., Ltd., acting through its U.S. subsidiary SanBio, Inc. ("SanBio"), announced on September 26 that the two companies have entered into a joint development and license agreement for exclusive marketing rights in the U.S. and Canada ("Agreement") for SB623, a cell therapy for the treatment of patients with chronic stroke discovered and currently under development by SanBio.Masayo Tada, President and Chief Executive Officer of Sumitomo Dainippon Pharma said, "Addressing diseases where no approved drugs exist and offering regenerative therapies are important focuses of our research and development efforts. There are no drugs currently available to treat the frequently severe disability resulting from stroke; recovery from such disability represents a profound unmet medical need. SB623 is a novel cell therapy product derived from bone marrow mesenchymal stem cells (MSCs) obtained from healthy adult donors. We believe that SB623 has the potential to become the first effective therapy for stroke disability."
"We are delighted to have a company with the expertise and resources of Sumitomo Dainippon Pharma as our partner for development and marketing of SB623 for stroke in North America," said Keita Mori, Representative Director and President of SanBio Co., Ltd. and Co-CEO and Chairman of SanBio, Inc. "We believe that in partnership with Sumitomo Dainippon Pharma, we can move SB623 quickly through clinical development in order to deliver this breakthrough therapy to patients suffering from stroke-related disability."
The conclusion of the option agreement regarding joint development and licensing of SB623 was announced by the two companies in a joint news release made on October 4, 2010.
About SB623
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 U.S. FDA for human clinical trials. Phase I/IIa 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. Currently, preparations are under way to begin a Phase IIb clinical trial in the U.S.
Source: Sumitomo Dainippon Pharma
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