Beckman Research Institute of City of Hope
BioTime company ES Cell International Pte. Ltd. BioTime Licensed Beckman Research Institute of City of Hope to Manufacture Clinical Grade Stem Cells
City of Hope is a new model of cancer center, focused on rapidly transforming scientific discoveries into better treatments.
ALAMEDA, Calif.–(BUSINESS WIRE)–Apr. 22, 2015– BioTime, Inc. (NYSE MKT: BTX) today announced a nonexclusive License Agreement between BioTime’s subsidiary ES Cell International Pte Ltd (ESI) and Beckman Research Institute of the City of Hope (BRICOH, Duarte, CA) through which ESI’s clinical-grade human embryonic stem (hES) cells will be manufactured and provided to BRICOH’s clinical collaborators, including medical research organizations intent on using the hES cells to develop and commercialize therapeutic products to treat human disease. The Agreement is a critical part of BioTime’s strategy to leverage third party funding and generate future revenues by placing its hES cells in programs developing a wide array of therapeutic applications made possible with pluripotent stem cell technology, products that are currently not being developed by BioTime or its subsidiaries. Successful medical research organizations will need to obtain separate licenses from BioTime in order to advance their products based on ESI’s hES cells into clinical trials and commercialization. Those licenses may entitle BioTime to receive additional revenues such as milestone payments related to the attainment of clinical trial and commercial milestones and royalties on product sales. BioTime and BioTime subsidiaries will retain the rights to manufacture their own stem cell-based products as well as to license rights to other third parties.
ESI, established in 2000 in Singapore, is distinguished as being the first company to derive and manufacture clinical-grade hES cell lines under strict regulatory standards, commonly known as current Good Manufacturing Practices (cGMP). These cell lines have been used by a number of researchers over the last seven years. ESI provides its hES cells as both inexpensive research-grade cells through its ESI BIO division and as cGMP-compliant clinical grade cells for translation into clinical applications, allowing researchers to conduct research with hES cells that can also be used in the clinic.
BRICOH has established clinical cell manufacturing facilities to produce clinical grade banks of cGMP grade hES stem cells for its affiliates and collaborators, including academic and other medical research institutions or companies engaged in research and development into cell replacement therapies for the treatment of diseases addressed by the emerging field of regenerative medicine.
According to Larry Couture, Ph.D., Vice President, Center for Applied Technology Development, BRICOH, “Clinical grade master cell banks of pluripotent stem cells are foundational to building on the vision of regenerative medicine. We value our relationship with BioTime and ES Cell International and government-funded organizations such as the California Institute for Regenerative Medicine (CIRM) and look forward to our future collaborative efforts with academia, industry, and CIRM to speed these desperately-needed potential therapies into the clinic.”
According to Jeffrey Janus, ESI’s CEO and BioTime’s VP of Sales and Marketing, “BioTime and ES Cell International take pride in providing ease of access to the highest quality clinical grade human embryonic stem cells to address human disease. Our partnership with BRICOH will further this goal by facilitating the availability of our cells to a wide spectrum of companies and research institutions working to develop many types of therapies. We look forward to working with BRICOH and their collaborators to further this effort.”
Users of BioTime’s hES cells, including those who acquire ESI hES cells through BRICOH, may need to obtain a license or other permission from Wisconsin Alumni Research Foundation or other third parties to conduct research or to make or sell any products based on the ESI hES cells.
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage biotechnology company. BioTime and its subsidiaries are leveraging their industry-leading experience in pluripotent stem cell technology and a broad intellectual property portfolio to facilitate the development and use of cell-based therapies and gene marker-based molecular diagnostics for major diseases and degenerative conditions for which there presently are no cures. The lead clinical programs of BioTime and its subsidiaries include: OpRegen®, currently in a Phase I/IIa trial for the treatment of the dry form of age-related macular degeneration; AST-OPC1, currently in a Phase I/IIa trial for spinal cord injuries; Renevia™, currently in a pivotal trial in Europe as an injectable matrix for the engraftment of transplanted cells to treat HIV-related lipoatrophy; and PanC-Dx™ cancer diagnostics, which are completing initial clinical studies for bladder, breast, and lung cancer. AST-VAC2, a cancer vaccine, is in the pre-clinical trial stage.
BioTime’s subsidiaries include: publicly-traded Asterias Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem cell-based therapies for retinal and neurological disorders, including OpRegen®; OncoCyte Corporation, developing PanC-Dx™ cancer diagnostics; LifeMap Sciences, Inc., developing and marketing an integrated on-line database resource for biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary of LifeMap Sciences, developing mobile health (mHealth) products; ES Cell International Pte Ltd, which has developed cGMP compliant human embryonic stem cell lines that are being marketed by BioTime for research purposes under the ESI BIO branding program; OrthoCyte Corporation, developing therapies to treat orthopedic disorders, diseases and injuries; and ReCyte Therapeutics, Inc., developing therapies to treat a variety of cardiovascular and related ischemic disorders.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
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Source: BioTime, Inc.
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