Acquisition to Accelerate Development of Research and Therapeutic
Products
BioTime, Inc. (NYSE Amex: BTIM), a biotechnology company that develops
and markets products in the field of human stem cells and regenerative
medicine, today announced that it has completed its acquisition of the
Singapore company ES Cell International Pte Ltd ("ESI"). Established in
2000, ESI has been a worldwide leader in the development of human
embryonic stem ("hES") cell technology, being one of the initial
providers of human embryonic stem cell lines to the research community,
having filed numerous early stem cell patent applications, and having
built important relationships within the worldwide stem cell research
community. Additional ESI assets include a bank of six new
clinical-grade human embryonic stem cell lines produced following the
principles of current Good Manufacturing Practice ("cGMP"), and equity
in the Israel-based stem cell therapeutics company Cell Cure
Neurosciences, Ltd. BioTime expects that the addition of ESI's assets
and scientific team will enable it to more quickly develop its research
products and potential therapeutic products, and establish new
commercial relationships.
ESI is based in Singapore's iconic Biopolis, a world-class biomedical
science research and development hub for Asia. The Biopolis has
attracted leading researchers and pharmaceutical companies from around
the world, not only because of its laboratory facilities and skilled
workforce but also because of its proximity to China, India, and other
rapidly growing markets. Singapore has a long history as a regional
center for product distribution throughout Asia. In addition to research
and manufacturing activities, the ESI facility will be a shipping point
for BioTime's product sales in Asia.
Through transactions with ESI's former shareholders and debtholders,
BioTime has acquired all of the outstanding shares and debt instruments
of ESI, which has now become a wholly-owned subsidiary of BioTime. ESI
has no significant liabilities to third parties, and BioTime has no new
debt obligations of its own as a result of this acquisition. In exchange
for all of ESI's shares and debt, BioTime has issued to ESI's former
shareholders and debtholders 1,383,400 BioTime common shares, and
warrants to purchase an additional 300,000 common shares at an exercise
price of $10 per share. The BioTime warrants issued in the acquisition
will expire four years after the date of issue.
"ESI has been responsible for important advances in the field of
regenerative medicine," said Michael D. West, Ph.D., President and Chief
Executive Officer of BioTime, Inc. "We are pleased to welcome ESI's
scientific team to BioTime. ESI's clinical-grade cell banks will provide
BioTime with a leading manufacturing platform for a wide array of
potential human therapeutic products, and will accelerate the
development of our research products. Together with our subsidiary
BioTime Asia, Limited, ESI will also advance our business in Asian
markets. We also look forward to working with Cell Cure Neurosciences to
advance their retinal and neuroscience product development."
"ESI has been a pioneer in stem cell research and development in
Singapore, and its technology and assets provide great synergies with
the advanced ACTCellerateTM and ReCyteTM
technologies of BioTime," said Ms. Swee-Yeok Chu, CEO of EDB Investments
("EDBI"), a leading investment firm headquartered in Singapore that
invests globally in the biomedical sciences sector. "Through this
transaction, ESI's intellectual property and technology will enhance the
development of exciting new products in regenerative and cell therapy at
BioTime. We are pleased that BioTime has recognized Singapore's
strengths in infrastructure and business environment and have chosen
Singapore as a hub for the manufacture and distribution of products
throughout Asia, and we look forward to a productive collaboration in
accelerating the marketing of these new and important medical products
to researchers and patients."
Clinical-Grade Human Embryonic Stem Cell Master Cell Banks
The development of clinical-grade human therapeutic products requires
high standards of quality control. The detailed procedures for all
aspects of production and testing of such products with the potential to
impact the safety and quality of a product are commonly called "Current
Good Manufacturing Practice" or "cGMP." The U.S. Food and Drug
Administration ("FDA") enforces cGMP regulations with respect to the
manufacturing of human therapeutics for use in the U.S., and virtually
every country across the globe maintains some analogous standards for
quality control in the manufacture of human therapeutic products.
In 2007, ESI announced the world's first hES cell lines derived
according to the principles of cGMP. ESI and scientists from Sydney IVF,
Australia's leading center for infertility and in vitro fertilization
("IVF") treatment, also published a scientific report titled, "The
Generation of Six Clinical-Grade Human Embryonic Stem Cell Lines." The
paper outlined the procedures used to document the production of
clinical-grade hES cell lines derived on human feeder cells obtained
from an FDA approved source, produced in a licensed cGMP facility, with
donor consent and medical screening of donors. Combined with BioTime's
ACTCellerateTM technology that allows the derivation of human
embryonic progenitor clonal cell lines with high levels of purity and
scalability, BioTime believes that ESI's clinical-grade master cell
banks may be used to generate clonal clinical-grade embryonic progenitor
cell lines with a level of purity and quality unsurpassed in the
industry. BioTime expects that the acquisition of ESI's clinical-grade
hES cell bank will save the Company years of development time and
thereby accelerate the development of clinical-grade progenitor cells
for potential use in research products and therapeutic products.
BioTime's research products are co-marketed worldwide by Millipore
Corporation.
Intellectual Property
ESI's patent portfolio includes 20 patent families covering various
aspects of hES cell identification, propagation, genetic manipulation,
storage, and directed differentiation of hES cells into other cell types
(for example differentiating cells into neuronal progenitors, pancreatic
progenitors, or cardiomyocytes). ESI currently holds or licenses from
others more than 50 issued patents in various countries, including the
United States, the UK, Australia, Israel, and Singapore. Combined with
BioTime's existing intellectual property portfolio, these patents now
provide BioTime with one of the leading stem cell patent portfolios in
the world. BioTime expects that its intellectual property portfolio's
value will continue to grow over time as the stem cell sector expands,
creating significant licensing revenue opportunities.
Cell Cure Neurosciences, Ltd.
ESI holds over 49% of the shares of Cell Cure Neurosciences Ltd., an
Israel-based biotechnology company focused on developing stem cell-based
therapies for retinal and neurological disorders, including the
development of retinal pigment epithelial cells for the treatment of dry
age-related macular degeneration. The other shareholders of Cell Cure
are Hadasit BioHoldings, Ltd. and Teva Pharmaceutical Industries, Ltd.
Background
Regenerative medicine refers to the development and use of therapies
based on hES cell or induced pluripotent stem ("iPS") cell technology.
These therapies will be designed to regenerate tissues afflicted by
degenerative diseases. The great scientific and public interest in
regenerative medicine lies in the potential of hES and induced
pluripotent stem ("iPS") cells to become all of the cell types of the
human body. Many scientists therefore believe that hES and iPS cells
have considerable potential as sources of new therapies for a host of
currently incurable diseases such as diabetes, Parkinson's disease,
heart failure, arthritis, muscular dystrophy, spinal cord injury,
macular degeneration, hearing loss, liver failure, and many other
disorders where cells and tissues become dysfunctional and need to be
replaced.
Since human embryonic stem cells are derived from discarded human
embryos created in the process of in vitro fertilization, their
use in research has been controversial. However, iPS cells can be
created using noncontroversial adult cells, such as skin cells, rather
than embryonic cells. The alteration of specific genes in adult cells
allows them to be transformed into iPS cells that are very similar to
hES cells. BioTime's stem cell-based therapeutic product development is
in the preclinical stages and will require years of extensive testing
prior to being used in an effort to treat humans.
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology
company focused on regenerative medicine and blood plasma volume
expanders. 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 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, and 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.
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 and
ESI can be found on the web at www.biotimeinc.com.
About EDB Investments
EDB Investments ("EDBI") is a leading investment firm headquartered in
Singapore with worldwide presence. EDBI invests globally in the
innovative and dynamic sector of Biomedical Sciences, as well as in
other key industries such as Clean Technologies and Digital Media. As a
value-adding investor, EDBI works closely with its portfolio companies,
leveraging on its extensive networks and experience to help bridge and
drive the companies' growth strategies for Asia.
For more information please visit www.edbi.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
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(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
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BioTime, Inc.
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com |
