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
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.
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
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1301 Harbor Bay Parkway
Alameda, CA 94502
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Hadasit Bio-Holdings Ltd.
JBP Building, Hadassah Ein-Kerem Campus
Jerusalem 91120, Israel
T: 972-2-6779424, F: 972-2-6437712
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