BioTime, Inc. (NYSE Amex:BTIM), Cell Cure Neurosciences Ltd.,
and Hadasit Bio-Holdings Ltd. (Tel Aviv Stock Exchange:HDST)
jointly announced today that Cell Cure and Teva Pharmaceutical
Industries Ltd. have entered into an exclusive license option
agreement to develop and commercialize Cell Cure's OpRegenTM
product for the treatment of age-related macular degeneration
(AMD). OpRegenTM is a proprietary formulation of embryonic stem
cell-derived retinal pigment epithelial cells designed by Cell Cure
to help save the sight of the baby boomer generation.
AMD is the leading cause of blindness in the aging population.
The US Centers for Disease Control and Prevention estimate that
about 1.8 million people in the United States have advanced stage
AMD and another 7.3 million have an earlier stage and are at risk
of vision impairment from the disease. Most people are afflicted
with the dry form of the disease, for which there is currently no
effective treatment.
“In evaluating potential partners for the development of our
products, we concluded that Teva represents the ideal partner for
this program," said Dr. Charles Irving, Chief Executive Officer at
Cell Cure. "Their longstanding global leadership in development and
commercialization of important new classes of medicines provides a
great foundation for working together.”
The ongoing development of OpRegenTM by Cell Cure is funded
through equity investments by BioTime, Teva, and Hadasit Bio
Holdings, made simultaneously with this agreement. Additional
non-dilutive funding for the development of OpRegenTM has been
provided by the Office of the Chief Scientist of the Ministry of
Industry, Trade and Labor of the State of Israel.
Subject to the terms of the agreement, if Teva exercises its
option to obtain an exclusive license to OpRegenTM, Teva will have
responsibility for funding clinical trials from that point on,
obtaining regulatory approvals, and marketing the product.
Cell Cure will be entitled to receive milestone payments and
royalties if certain development, regulatory, and commercial
milestones are achieved. A portion of the milestone payments and
royalties received by Cell Cure would be shared with BioTime’s
subsidiary ES Cell International Pte Ltd. and with HBL’s affiliate
Hadasit Medical Research Services and Development Ltd., the
technology transfer arm of the Hadassah Medical Organization
(“HMO”), which have licensed to Cell Cure certain patents and
technology used in the development of OpRegenTM invented by Prof.
Benjamin Reubinoff and Prof. Eyal Banin.
“Cell Cure will be collaborating with one of the 15 largest
pharmaceutical companies in the world, and with affiliates of
Hadassah Medical Organization, to develop new treatments for
diseases that rob millions of people of their eye sight,” said Dr.
Michael D. West, Chief Executive Officer at BioTime. “This is
consistent with our focus on making Cell Cure, our majority owned
subsidiary, a center for developing cell based therapies for
retinal and neural degenerative diseases."
Ophir Shahaf, CEO of HBL added: “We are happy and proud to see
the company, which was established on the basis of technology
developed at Hadassah Medical Organization, develop and grow to the
point where it can aggressively advance its lead product into the
clinic, with the support of the ultimate partners in the
field."
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a
biotechnology company focused on regenerative medicine and blood
plasma volume expanders. Its broad platform of stem cell
technologies is developed through subsidiaries focused on specific
fields of applications. BioTime develops and markets research
products in the field of stem cells and regenerative medicine
through its wholly owned subsidiary Embryome Sciences, Inc.
BioTime’s therapeutic product development strategy is pursued
through subsidiaries that focus on specific organ systems and
related diseases for which there is a high unmet medical need. Cell
Cure is BioTime's subsidiary focused on retinal and neural
degenerative diseases. BioTime's subsidiary OrthoCyte Corporation
is developing therapeutic applications of stem cells to treat
orthopedic diseases and injuries. Another subsidiary, OncoCyte
Corporation, focuses on the therapeutic applications of stem cell
technology in cancer. BioTime also plans to develop therapeutic
products in China for the treatment of ophthalmologic, skin,
musculo-skeletal system, and hematologic diseases, including the
targeting of genetically modified stem cells to tumors as a novel
means of treating currently incurable forms of cancer, through its
subsidiary BioTime Asia, Limited. BioTime’s Singapore subsidiary,
ES Cell International Pte Ltd, has been at the forefront of
advances in human embryonic stem (“hES”) cell technology, having
been one of the earliest distributors of hES cell lines to the
research community. ESI has produced clinical-grade human embryonic
stem cell lines that were derived following principles of good
manufacturing practice and currently offers them for potential use
in therapeutic product development. In addition to its stem cell
products, BioTime develops blood plasma volume expanders, blood
replacement solutions for hypothermic (low temperature) surgery,
and technology for use in surgery, emergency trauma treatment and
other applications. BioTime’s lead product, Hextend®, is a blood
plasma volume expander manufactured and distributed in the U.S. by
Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under
exclusive licensing agreements. Additional information about
BioTime, Embryome Sciences, Cell Cure, OrthoCyte, OncoCyte, BioTime
Asia, and ESI can be found on the web at www.biotimeinc.com.
About Hadasit Bio-Holdings Ltd.
Hadasit Bio-Holdings Ltd. ("HBL") (TASE:HDST) was founded to
allow public participation in the highly promising field of
biotechnology. HBL’s investment portfolio includes companies that
utilize technology generated by Israel’s foremost medical research
center – Hadassah University Hospital in Jerusalem, Israel. HBL is
a publicly traded subsidiary of Hadasit Ltd. – the technology
transfer company of the Hadassah University Hospital. Hadasit is a
subsidiary of Hadassah Medical Organization (“HMO”) and was
established for the purpose of promoting and commercializing the
intellectual property and research and development capabilities
generated by HMO, aimed at finding solutions to problems faced by
modern medicine. www.hbl.co.il
About Hadassah University Medical Center
The Hadassah University Medical Center includes two university
hospitals in Jerusalem – on Mt. Scopus and in Ein Kerem. The
flagship of Hadassah, the Women's Zionist Organization of America,
Inc., its two hospitals have 1,000 beds, 31 operating
theaters, nine specially oriented intensive care units
and five schools of allied medical professions, owned and
operated in collaboration with the Hebrew University. Over
half the hospital research conducted in Israel is carried out at
Hadassah. Each department incorporates research units and there are
many interdisciplinary research centers. In both hospitals and
within a number of hospital departments, Hadassah has created
Centers of Excellence: brain trusts of scientists and physicians,
integrating clinical care with the latest laboratory lessons.
About Cell Cure Neurosciences Ltd.
Cell Cure Neurosciences Ltd. was established in 2005 as a
subsidiary of ES Cell International Pte Ltd (ESI), now a subsidiary
of BioTime, Inc. (NYSE Amex:BTIM). Cell Cure is located in
Jerusalem, Israel on the campus of Hadassah University Hospital.
Cell Cure’s mission is to become a leading supplier of human
cell-based therapies for the treatment of retinal and neural
degenerative diseases. Its technology platform is based on the
manufacture of diverse cell products sourced from clinical grade
(GMP) human embryonic stem cells. Its current programs include
developing cells for the treatment of macular degeneration,
Parkinson’s disease, and cells potentially useful in treating
multiple sclerosis. Cell Cure’s major shareholders include: BioTime
Inc. (NYSE Amex:BTIM), Hadasit BioHoldings Ltd. (Tel Aviv Stock
Exchange:HDST) and Teva Pharmaceuticals Industries Ltd
(NASDAQ:TEVA). Additional information about Cell Cure can be found
on the web at www.cellcureneurosciences.com.
Forward-Looking Statements
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for the company 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 company’s business,
particularly those mentioned in the cautionary statements found in
the company’s Securities and Exchange Commission filings. The
company disclaims any intent or obligation to update these
forward-looking statements.
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BioTime, Inc. 1301 Harbor Bay Parkway Alameda, CA 94502 T:
510-521-3390, F: 510-521-3389
www.biotimeinc.com
Hadasit Bio-Holdings Ltd.
JBP Building, Hadassah Ein-Kerem Campus Jerusalem 91120, Israel T:
972-2-6779424, F: 972-2-6437712
www.hbl.co.il
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