MENLO PARK, Calif. & ALAMEDA, Calif.--(BUSINESS WIRE)--
BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Asterias
Biotherapeutics, Inc. (“Asterias”), announced that Asterias has entered
into a settlement agreement with ViaCyte, Inc. (“ViaCyte”) concerning
certain litigation in the United States District Court for the Northern
District of California (Civil Action No. C12-04813) seeking the reversal
of two adverse determinations by the United States Patent & Trademark
Office with respect to two patent applications in U.S. Patent
Interference 105,734, involving U.S. patent 7,510,876 (ViaCyte) and U.S.
patent application 11/960,477 (Geron), and U.S. Patent Interference
105,827 involving U.S. patent 7,510,876 (ViaCyte) and U.S. patent
application 12/543,875 (Geron), along with four Opposition Proceedings
pending before the Australian Patent Office pertaining to priority
rights and the validity of each party’s patents relating to endodermal
precursor cells. Under the terms of the settlement agreement, the
parties granted to each other a royalty free, fully paid license to each
other’s technology relating to endoderm lineage cells including
definitive endoderm and gut endoderm cells, only to the extent necessary
to allow the licensee to make, use, sell, offer for sale, or import
endodermal lineage cells.
Biotherapeutics, Inc. is a new subsidiary which has acquired
the stem cell assets of Geron Corporation, including patents and other
intellectual property, biological materials, reagents and equipment
for the development of new therapeutic products for regenerative
BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
Cure NeurosciencesLtd. is 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 macular degeneration,
and treatments for multiple sclerosis.
BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem®
progenitors and HyStem® hydrogels.
Sciences, Inc. markets, sells, and distributes GeneCards®,
the leading human gene database, as part of an integrated database
suite that also includes the LifeMap
Discovery® database of embryonic development, stem
cell research, and regenerative medicine, and MalaCards,
the human disease database.
Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
Corporation is developing products and technologies to diagnose and
treat cancer, including PanC-Dx™, with three clinical trials
Corporation is developing therapies to treat orthopedic disorders,
diseases and injuries.
Therapeutics, Inc. is developing therapies to treat a variety
of cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
In determining to settle the patent interference proceedings with a
cross-license, Asterias took into account the potential value of the
combined patent estate created by the cross-license, the intellectual
property needs of Asterias based on its current product development
plans, which do not include endoderm cell products, the costs and
uncertain outcomes associated with continued litigation, and the
opportunity to better focus its resources on advancing its current
product development efforts.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company focused on the
emerging field of regenerative medicine. Asterias’ core technologies
center on stem cells capable of becoming all of the cell types in the
human body, a property called pluripotency. Asterias plans to develop
therapies based on pluripotent stem cells to treat diseases or injuries
in a variety of medical fields, with an initial focus on the therapeutic
applications of oligodendrocyte progenitor cells (AST-OPC1) and
antigen-presenting dendritic cells (AST-VAC1 and AST-VAC2) for the
fields of neurology and oncology respectively. AST-OPC1 was tested for
treatment of spinal cord injury in the world’s first Phase 1 clinical
trial using human embryonic stem cell-derived cells. Asterias plans to
seek FDA clearance to reinitiate clinical testing of AST-OPC1 in spinal
cord injury this year, and is also evaluating its function in
nonclinical models of multiple sclerosis and stroke. AST-VAC1 and
AST-VAC2 are dendritic cell-based vaccines designed to immunize cancer
patients against telomerase, a protein abnormally expressed in over 95%
of human cancer types. AST-VAC2 differs from AST-VAC1 in that the
dendritic cells presenting telomerase to the immune system are produced
from human embryonic stem cells instead of being derived from human
In October of 2013, Asterias acquired the cell therapy assets of Geron
Corporation. These assets included INDs for the clinical stage AST-OPC1
and AST-VAC1 programs, banks of cGMP-manufactured AST-OPC1 drug product,
cGMP master and working cell banks of human embryonic stem cells, over
400 patents and patent applications filed worldwide including broad
issued claims to fundamental platform technologies for the scalable
growth of pluripotent stem cells and compositions of matter for several
hESC-derived therapeutic cell types, research cell banks, customized
reagents and equipment, and various assets relating to the AST-VAC2
program and preclinical programs in cardiology and orthopedics.
Asterias is a member of the BioTime family of companies.
Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem®
hydrogels, culture media, and differentiation kits. BioTime is
developing Renevia™ (a HyStem® product) as a
biocompatible, implantable hyaluronan and collagen-based matrix for cell
delivery in human clinical applications, and is planning to initiate a
pivotal clinical trial around Renevia™, in 2014. In addition,
BioTime has developed Hextend®,
a blood plasma volume expander for use in surgery, emergency trauma
treatment and other applications. Hextend® is
manufactured and distributed in the U.S. by Hospira, Inc. and in South
Korea by CJ HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
For more information, please visit www.biotimeinc.comor connect with the company on Twitter,
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
businesses of BioTime and its subsidiaries, including Asterias,
particularly those mentioned in the cautionary statements found in
BioTime's and Asterias’ Securities and Exchange Commission filings.
BioTime and Asterias disclaim any intent or obligation to update these
Asterias Biotherapeutics, Inc.
Mary Ann Dunmire, 650-433-2900
Judith Segall, 510-521-3390, ext 301
Source: BioTime, Inc.