Full Press Release Details
Medical GmbH and BioTime Subsidiary OrthoCyte Corporation Enter Into
Exclusive Worldwide Development and Licensing Agreements
Provide for the Development of an Innovative Cell Therapy Product for
Bone Grafting in Orthopedic Unmet Needs
Medical to Fund All Product Development and Commercial Sales and
Will Be Responsible for Product Development and Manufacturing
HANAU, Germany & ALAMEDA, Calif.--(BUSINESS WIRE)--September 30,
2015--Heraeus Medical GmbH, one of the leading companies in the field of
bone cement and biomaterials for elective orthopedic and trauma surgery,
and BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage
regenerative medicine company focused on its pluripotent stem cell
technology, today announced that BioTime's subsidiary OrthoCyte
Corporation and Heraeus Medical have entered into exclusive development
and worldwide licensing agreements for the development of innovative
bone grafting therapies based on the use of BioTime's proprietary PureStem
human embryonic progenitor cell technology. Under the terms of the
development agreement, Heraeus Medical would make an initial $1 million
USD upfront payment to OrthoCyte, and additional payments upon
OrthoCyte's attainment of certain product development milestones, and
Heraeus will fund all ongoing product development activities through IND
Heraeus Medical, with its global marketing capability, will be
responsible for worldwide sales if a product is successfully developed,
can be demonstrated through clinical trials to be safe and effective,
and receives regulatory approval for marketing. OrthoCyte will be
responsible for product development and initially for manufacturing.
Pursuant to the terms of the license agreement, OrthoCyte has licensed
certain technology to Heraeus, and Heraeus has licensed certain
technology to OrthoCyte. The license grant by OrthoCyte to Heraeus is
exclusive and worldwide in the field of bone grafting for all
osteoskeleton diseases and injuries, except oral maxillofacial. The
license grant by Heraeus to OrthoCyte is exclusive and worldwide in all
other fields. Pursuant to the license agreement, each of Heraeus and
OrthoCyte will pay certain specified royalties to each other based on
their respective net sales of the product developed under the
development agreement.
Use of Bone Grafting Products
Bone grafting products are used in surgical procedures to help large
segmental defects or bone voids to heal as a result of trauma, implant
revisions, cancer resection and spinal fusion surgery for example. The
global market for bone grafting products is currently estimated to be
over USD $2 billion annually, and growing at a compound annual growth
rate (CAGR) of 3.8%, according to GlobalData.
"It's a great opportunity to work with a prominent partner such as
Heraeus Medical for the development of an innovative solution for bone
grafting in unmet orthopedic needs," said Francois Binette, Ph.D., Vice
President of Research and Business Development for OrthoCyte
Corporation. "This agreement will allow OrthoCyte to advance its
development work on therapeutic applications in bone repair, while
retaining the rights to other orthopedic indications targeting low back
pain and osteoarthritis, as well as soft tissue diseases and injuries."
Dr. Andr Kobelt, President of Heraeus Medical GmbH said, "The
announcement of this collaboration with BioTime is an important
strategic step in the field of regenerative medicine involving novel
orthopedic applications that could significantly improve the current
approach in targeting osseous indications (orthopedics). We view this
agreement as an exciting opportunity for Heraeus to embark upon as a
pure play orthobiologics initiative targeting a number of key
musculoskeletal areas as we look to continue to expand our global
footprint in the regenerative medicine market."
About OrthoCyte Corporation
OrthoCyte Corporation ("OrthoCyte"), a subsidiary of BioTime, Inc., is a
biotechnology company developing cell-based therapies for bone disease
in collaboration with Heraeus Medical and orthopedic soft tissue
diseases and injuries. OrthoCyte holds a library of proprietary
human progenitors of skeletal tissues including bone, articular
cartilage, intervertebral disc, tendon, and ligament, all of which are
in the preclinical phase of development.
For more information about OrthoCyte, please visit www.orthocyte.com.
BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage
biotechnology company. BioTime and its subsidiaries are leveraging their
industry-leading experience in pluripotent stem cell technology and a
broad intellectual property portfolio to facilitate the development and
use of cell-based therapies and gene marker-based molecular diagnostics
for major diseases and degenerative conditions for which there presently
are no cures. The lead clinical programs of BioTime and its subsidiaries
include OpRegen , currently in a Phase I/IIa
trial for the treatment of the dry form of age-related macular
degeneration; AST-OPC1, currently in a Phase I/IIa trial for
spinal cord injuries; Renevia , currently in a pivotal trial
in Europe as an injectable matrix for the engraftment of transplanted
cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing
the completion of initial clinical studies for the detection of lung,
bladder, and breast cancers. AST-VAC2, a cancer vaccine, is
in the pre-clinical trial stage.
BioTime's subsidiaries include the publicly traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell
Cure Neurosciences Ltd., developing stem cell-based therapies for
retinal and neurological disorders, including OpRegen ; OncoCyte
Corporation, developing cancer diagnostics; LifeMap Sciences, Inc.,
developing and marketing an integrated online database resource for
biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary
of LifeMap Sciences, developing mobile health (mHealth) products; ES
Cell International Pte Ltd, which has developed cGMP-compliant human
embryonic stem cell lines that are being marketed by BioTime for
research purposes under the ESI BIO branding program; OrthoCyte
Corporation, developing therapies to treat orthopedic disorders,
diseases, and injuries; and ReCyte Therapeutics, Inc., developing
therapies to treat a variety of cardiovascular and related ischemic
BioTime common stock is traded on the NYSE MKT and TASE under the symbol