Pluristem Signs Collaboration Agreement With Thermo Fisher Scientific
July 09 2018 - 7:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading
developer of placenta-based cell therapy products, announced today
that it has entered into a strategic collaboration with Thermo
Fisher Scientific to advance fundamental knowledge of cell therapy
industrialization and to improve quality control of the end-to-end
supply chain.
The collaboration combines Thermo Fisher’s
experience in cell therapy development and bioproduction scaleup
with Pluristem’s expertise in cell therapy manufacturing, clinical
development and quality control. Together, the companies hope to
transform cell therapy manufacturing into a large-scale, high
capacity industry that will enable the production of millions of
therapeutic doses of regenerative medicines.
Currently, over 850 companies worldwide are
developing regenerative medicine and advanced therapies. There are
more than 900 clinical trials underway, with several approved and
marketed products worldwide. This sector holds the promise of
addressing many unmet medical needs, but requires a change in the
supply chain of equipment, consumables, reagents and storage
systems to enable the treatment of millions of patients.
Bryan Poltilove, General Manager of Cell and
Gene Therapy at Thermo Fisher, commented, “The cell therapy
industry is expanding at an explosive pace, and Thermo Fisher
provides total solutions for cell therapy research, development,
and manufacturing. We look forward to advancing our relationship
with Pluristem to further enable commercial manufacturing and
benefit the broader global industry.”
“From early on, our strategy was to build an
in-house manufacturing facility. Having achieved that, we are now
in a unique position within the industry, and have a broad
understanding of its needs. Thermo Fisher, known for its
biopharmaceutical infrastructure, materials supply, logistics, and
manufacturing expertise is a perfect partner for Pluristem. This
initiative has the potential to advance the industry significantly,
allowing regenerative medicine to realize its potential, treating
millions of patients globally while reducing healthcare spending.
We look forward to a long-term, mutually beneficial partnership,”
stated Pluristem President and Co-CEO Yaky Yanay.
About Pluristem
Therapeutics
Pluristem Therapeutics Inc. is a leading
developer of placenta-based cell therapy products. The Company has
reported robust clinical trial data in multiple indications for its
patented PLX cells and is entering late-stage trials in several
indications. PLX cell products release a range of therapeutic
proteins in response to inflammation, ischemia, muscle trauma,
hematological disorders, and radiation damage. The cells are grown
using the Company's proprietary three-dimensional expansion
technology and can be administered to patients off-the-shelf,
without tissue matching. Pluristem has a strong intellectual
property position; Company-owned and operated, GMP-certified
manufacturing and research facilities; strategic relationships with
major research institutions; and a seasoned management team.
Safe Harbor Statement
This press release contains express or implied
forward-looking statements within the Private Securities Litigation
Reform Act of 1995 and other U.S. Federal securities laws. For
example, Pluristem is using forward-looking statements when its
discusses its collaboration with Thermo Fisher generally as well as
its belief that such collaboration will advance fundamental
knowledge of cell therapy industrialization and improve quality
control of the end-to-end supply chain, that the companies hope to
transform cell therapy manufacturing into a large-scale, high
capacity industry that will enable the production of millions of
therapeutic doses of regenerative medicines. These forward-looking
statements and their implications are based on the current
expectations of the management of Pluristem only, and are subject
to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the
forward-looking statements. The following factors, among others,
could cause actual results to differ materially from those
described in the forward-looking statements: changes in technology
and market requirements; Pluristem may encounter delays or
obstacles in launching and/or successfully completing its clinical
trials; Pluristem’s products may not be approved by regulatory
agencies, Pluristem’s technology may not be validated as it
progresses further and its methods may not be accepted by the
scientific community; Pluristem may be unable to retain or attract
key employees whose knowledge is essential to the development of
its products; unforeseen scientific difficulties may develop with
Pluristem’s process; Pluristem’s products may wind up being more
expensive than it anticipates; results in the laboratory may not
translate to equally good results in real clinical settings;
results of preclinical studies may not correlate with the results
of human clinical trials; Pluristem’s patents may not be
sufficient; Pluristem’s products may harm recipients; changes in
legislation may adversely impact Pluristem; inability to timely
develop and introduce new technologies, products and applications;
loss of market share and pressure on pricing resulting from
competition, which could cause the actual results or performance of
Pluristem to differ materially from those contemplated in such
forward-looking statements. Except as otherwise required by law,
Pluristem undertakes no obligation to publicly release any
revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events. For a more detailed description of the risks
and uncertainties affecting Pluristem, reference is made to
Pluristem's reports filed from time to time with the Securities and
Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
efratk@pluristem.com
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