Advanced Cell Technology and The Roslin Institute Announce Agreement for Storage
and Distribution of Embryonic Stem Cells Using ACT's Blastomere Technology
Embryonic Stem Cells Made Using Proprietary "Embryo-Safe" Technique To Be Made
Available for Companies and Researchers Worldwide
MARLBOROUGH, Mass., Dec 27, 2010 (BUSINESS WIRE) -- Advanced Cell Technology,
Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine,
announced today that it has entered into a Memorandum of Understanding with
Roslin Cells LTD ("Roslin Cells") of Scotland, in which the two companies
contemplate a definitive collaboration agreement in the near future. They will
work together to establish a bank of Good Manufacturing Practice (GMP)-grade
human embryonic stem cell (hESC) lines using ACT's proprietary
"single-ceblastomere" technique for deriving embryonic stem cells without damage
to the embryo.
The collaboration contemplates that the hESC lines will be created and stored
using protocols that meet the regulatory standards of the European Medicines
Agency (EMA) and United States Food and Drug Administration (FDA). Roslin Cells
will be responsible for maintaining the banked hESC lines, which will be made
available for both research and commercial purposes. By utilizing GMP and careful
characterization and documentation of the resulting hESC lines, it is intended
that the banked hESC lines will be suitable to move readily from laboratory
settings into clinic programs, thereby speeding translation research into human
treatments. Predictability in price and commercialization terms is a key feature
of the goals of the collaboration. Roslin Cells will promote access to the hESC
lines from the bank as research reagents to both academic and commercial
entities. In addition, ACT and Roslin Cells will publish a commercialization
license so that third parties will have a reasonable and predictable path to
commercialization of products using the same hESC lines that they may use in
animal model studies for preclinical data. Commercialization licenses will also
provide access to the cell lines biologics master file in order to establish
regulatory compliance. Proceeds from commercialization licenses, including
milestone and royalty payments, will be shared between ACT and Roslin Cells.
"The relationship with Roslin Cells has grown out of our initiatives in Europe
over the past year, and comes as part of our close efforts with the Scottish
Development agency. Along with the recent announcement of our European Orphan
drug designation filing in our Stargardt's disease treatment program, the
relationship with Roslin Cells signals the expansion of our commercial
initiatives in Europe, and, more broadly, markets around the world," said ACT's
Interim Chairman and CEO, Gary Rabin. "Roslin Cells is already one of the leading
organizations in GMP manufacturing of stem cells. Through the creation of hESC
lines derived using our proprietary 'embryo-safe' technique, we fully expect
Roslin Cells to quickly become a leading hESC bank for Europe, North America and
Asia. We foresee major demand for these embryonic stem cells from both
researchers and commercial interests across the globe."
"Until we developed our single blastomere technology, embryonic stem cell
research had been synonymous with the destruction of human embryos," stated
Robert Lanza, MD, Chief Scientific Officer at ACT. "In stark contrast to
embryonic stem cells lines currently available for research, such as those on the
NIH registry, our single blastomere technique does not destroy the embryo. One of
the benefits to an ability to create new hESC lines without destroying embryos is
that it addresses ethical concerns of certain researchers."
The Company's single blastomere technique relies on isolating a single cell from
a 4 to 8 cell embryo utilizing a one-cell biopsy approach similar to that used in
pre-implantation genetic diagnostics (PGD). According to recent literature,
one-cell biopsy as part of PGD is carried out routinely around the world, and one
to two thousand children are born every year in the United States and Europe
after being conceived by in vitro fertilization using one-cell biopsy and PGD.
"The availability of our 'embryo safe' hESC lines has sparked interest in many
quarters, including at institutions that have been opposed to conducting
embryonic stem cell research in the past," continued Dr. Lanza. "We are exploring
opportunities to provide our cells to those institutions.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular
technology in the field of regenerative medicine. For more information, visit
advancedcell.com.
About Roslin Cells
Roslin Cells Ltd was established in 2006 by the Roslin Institute with the support
of the University of Edinburgh, the Scottish National Blood Transfusion Service
and Scottish Enterprise. The company's core mission is to provide ethically
sourced, pluripotent human cells manufactured to the highest quality available
according to Good Manufacturing Practice (GMP standards). Roslin Cells has been
independently verified according to rigorous standards and successfully attained
ISO 9001:2008 certification in February 2009 (certificate number:FS 544151).
Since then, the company has continued to demonstrate their meticulous standards,
with successful annual renewals of their Human Tissue Authority (HTA) and Human
Fertilization and Embryology Authority (HFEA) licenses Roslin Cells is
headquartered in Roslin, Midlothian, and is a not for profit organization.
Further information can be found at roslincells.com.
Forward-Looking Statements
Statements in this news release regarding future financial and operating results,
future growth in research and development programs, potential applications of our
technology, opportunities for the company and any other statements about the
future expectations, beliefs, goals, plans, or prospects expressed by management
constitute forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Any statements that are not statements
of historical fact (including statements containing the words "will," "believes,"
"plans," "anticipates," "expects," "estimates," and similar expressions) should
also be considered to be forward-looking statements. There are a number of
important factors that could cause actual results or events to differ materially
from those indicated by such forward-looking statements, including: limited
operating history, need for future capital, risks inherent in the development and
commercialization of potential products, protection of our intellectual property,
and economic conditions generally. Additional information on potential factors
that could affect our results and other risks and uncertainties are detailed from
time to time in the company's periodic reports, including the report on Form 10-K
for the year ended December 31, 2009. Forward-looking statements are based on the
beliefs, opinions, and expectations of the company's management at the time they
are made, and the company does not assume any obligation to update its
forward-looking statements if those beliefs, opinions, expectations, or other
circumstances should change. Forward-looking statements are based on the beliefs,
opinions, and expectations of the company's management at the time they are made,
and the company does not assume any obligation to update its forward-looking
statements if those beliefs, opinions, expectations, or other circumstances
should change.
SOURCE: Advanced Cell Technology, Inc.
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