BioTime expands and strengthens patent estate covering OpRegen®
Expanded and strengthened patent coverage of pluripotent cell
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 17, 2018--
BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology
company developing and commercializing products addressing degenerative
diseases, today announced the issuance of 41 new patents over the past
12 months that are owned by or licensed to BioTime. These new patents
add to the over 800 issued or pending patents worldwide and address many
of BioTime’s key programs, including OpRegen®, which is in a
Phase I/IIa trial for dry-AMD; stroke and orthopedics, which are in
early stages of development; and cell culture methods that are
applicable across the pluripotent cell platform that enables robust
manufacturing processes for many of the products.
“These 41 new patents are significant because they expand and strengthen
our intellectual property portfolio, which is an integral aspect of
BioTime’s clinical development and commercialization strategy,” said Adi
Mohanty, Co-Chief Executive Officer of BioTime.
OpRegen® – 3 patents issued that provide protection for
OpRegen® in the U.S., Canada, and Hong Kong through 2031.
Stroke – 1 new patent provides protection in the U.S. through 2031.
Pluripotent Cell Technology – 34 patents provide protection in the
U.S., Japan, Singapore, India and several countries in Europe of
pluripotent cell technologies, including cell culture techniques,
equipment and differentiation methods.
Orthopedics – 3 new patents provide protection in the U.S. and Japan
OpRegen®, which is in a Phase I/IIa trial 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,
About BioTime, Inc.
BioTime is a late-stage clinical 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 and drug delivery.
Its clinical programs are based on two platform technologies:
pluripotent cells, which can become any type of cell in the human body,
and cell/drug delivery. Renevia®, a cell delivery product,
met its primary endpoint in an EU pivotal clinical trial for the
treatment of facial lipoatrophy in HIV patients earlier this year.
Submission for approval of Renevia® in the EU is expected to
be early 2018, with possible approval and commercial launch in 2018.
There were no device related serious adverse events reported. OpRegen®,
a retinal pigment epithelium transplant therapy, is in a Phase I/IIa
multicenter trial for the treatment of dry age-related macular
degeneration, the leading cause of blindness in developing countries.
There were no related serious adverse events reported. BioTime also has
significant equity holdings in two publicly traded companies, Asterias
Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte
Corporation (NYSE American: OCX), and a private company, AgeX
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.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.biotime.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180117005544/en/
Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378