Two Key BioTime Patents Providing Protection to OpRegen® Remain Upheld
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 14, 2017--
BioTime, Inc. (NYSE American: BTX), a clinical stage biotechnology
company focused on developing and commercializing products addressing
degenerative diseases, and its subsidiaries, today announced the
successful conclusion of the challenge to two key patents before the
European Patent Office Opposition division. As previously announced on
March 28, 2017, the patents were upheld during the opposition proceeding
and today we announce the successful conclusion of the appeals. The two
European patents (EP2554661 and EP2147094), cover the proprietary
directed differentiation methods to produce pluripotent stem
cell-derived cell replacement therapies being developed to treat retinal
degenerative diseases such as age-related macular degeneration (AMD).
OpRegen®, which is being studied for the treatment of the dry form of
AMD, consists of a suspension of Retinal Pigment Epithelial (RPE) cells
that are delivered subretinally during a simple intraocular injection.
RPE cells are essential components of the back lining of the retina, and
function to help nourish the retina including photoreceptors. A
proprietary process that drives the differentiation of human pluripotent
stem cells is used to generate high purity OpRegen® RPE cells. OpRegen®
RPE cells are also “xeno-free," meaning that no animal products are used
at any point in the derivation and production process. The avoidance of
the use of animal products eliminates some potential safety concerns.
Preclinical studies in rats have shown that following a single
subretinal injection of OpRegen®, the cells can rapidly organize into
its natural monolayer structure in the subretinal space and survive
throughout the lifetime of the animal. OpRegen® is designed to be an
“off-the-shelf” allogeneic (non-patient specific) product. Unlike
treatments that require multiple, frequent injections into the eye, it
is expected that OpRegen® would be administered in a single procedure.
OpRegen® was granted Fast Track designation from the FDA, which allows
more frequent interactions with the agency, and eligibility for
accelerated approval and priority review. OpRegen® is a registered
trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary
of BioTime, Inc.
About BioTime, Inc.
BioTime, and its subsidiaries including Cell Cure Neurosciences Ltd.,
are a clinical-stage biotechnology company focused on developing and
commercializing products addressing degenerative diseases. The Company’s
current clinical programs are targeting three primary sectors,
aesthetics, ophthalmology and cell/drug delivery. Its clinical programs
are based on two platform technologies: pluripotent cells and cell/drug
delivery. The foundation of BioTime’s core therapeutic technology
platform is pluripotent cells that are capable of becoming any of the
cell types in the human body. The foundation of the Company’s cell
delivery platform is its HyStem® cell and drug delivery matrix
technology. BioTime also has significant equity holdings in two publicly
traded companies, Asterias Biotherapeutics, Inc. and OncoCyte
Corporation, and one private company, AgeX Therapeutics.
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotimeinc.com.
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Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378