Pluristem Enters Into Strategic Partnership and Licensing Agreement With Cha Bio&Diostech for the Development and Commercializa
June 26 2013 - 3:00AM
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) today
announced that its wholly owned subsidiary, Pluristem Ltd., has
entered into an exclusive out-license and strategic partnership
agreement with Cha Bio&Diostech (Kosdaq:CHA) for the use of
Pluristem's PLacental eXpanded (PLX) cells for peripheral artery
disease (PAD), specifically in two indications: the treatment of
Critical Limb Ischemia (CLI), and Intermediate Claudication
(IC) in South Korea.
Under the terms of the agreement, Cha will perform and fund
multiple clinical trials in South Korea for treating CLI and IC
using PLX-PAD under the supervision of the Korea Food & Drug
Administration (KFDA). Upon the first regulatory approval for a PLX
product in South Korea, Pluristem and Cha will establish a joint
venture (JV) co-owned by the parties. The purpose of the JV will be
to commercialize PLX cell products in South Korea. According to
market research firm Clearstate, 1 million people in South Korea
have PAD and the growth forecast for the number of people diagnosed
and treated in the country is moderate-to-high.
While Cha will bear the costs of conducting the clinical trials
for the agreed upon indications, Pluristem will continue to retain
rights to its proprietary manufacturing technology and cell-related
intellectual property. Additionally, Pluristem will be able to use
the data generated by Cha to pursue the development of PLX product
candidates outside of South Korea. The agreement contemplates
adding products for indications beyond CLI and IC by mutual
agreement and is intended to serve as the foundation of a broad
based long-term partnership.
In addition, and upon the completion of certain milestones,
which is expected by September 2013, Pluristem will issue to Cha
2,500,000 shares of its common stock in consideration for the
issuance to Pluristem of 1,011,504 shares of Cha Bio&Diostech,
which reflect a total consideration of $10 million for such
Pluristem shares (based on average closing price of CHA common
shares over the last 30 trading days) and accordingly valued at a
price of $4 per each Pluristem share.
Zami Aberman Chairman and CEO stated, "We are pleased and proud
to enter into a partnership agreement with such a meaningful
partner as Cha Bio&Diostech, part of the CHA Health Systems
Group. We believe the alliance of Pluristem with a recognized
leader of advanced healthcare systems in South Korea will provide
multiple opportunities to strengthen our pipeline and develop PLX
cells products for new indications. Cha Bio&Diostech's
commitment to the PAD markets is an important milestone for us. We
will be able to receive data from multiple CLI and IC trials that
will enable us to optimize the clinical development of PLX-PAD. The
co-owned joint venture will take advantage of Cha's unique and
leading position in regenerative medicine in South Korea and
Pluristem's proprietary 3D cells culturing capabilities. Pluristem
is committed to a long and fruitful partnership with the CHA Health
Systems Group."
Won S Yang, President & CEO of Cha Bio&Diostech
states, "I believe the partnership between Pluristem and CHA
Bio&Diostech carries far more significance with distinguished
long-term business potential compared to other similar
collaborations in the field of cell therapeutics by combining two
companies' unique and unequaled technological prowess and
outstanding leaderships in the industry. Particularly, Pluristem's
pipeline PLX leveraging CHA Health Systems group's R&D,
clinical development, regulatory and commercialization
infrastructure focused on cell therapies in Korea will provide huge
strategic advantage to entering Korea and global market territory
in the future. Going forward, we expect PLX cells will be the first
Pharmaceutical-like stem cell therapy product as well as the first
allogenic product approved for the mass market to treat numerous
patients suffering from serious disease such as the CLI and IC with
limited cure."
About Cha Bio&Diostech
CHA Bio&Diostech Co., Ltd. is a leading biopharmaceutical
company headquartered in South Korea with R&D focus in stem
cells, cell therapeutics, medical device, and new drug development.
The company is a member of CHA Health Systems Group, which comprise
of medical university, medical centers and hospitals located in the
US and Korea with in excess of two thousand beds under care, stem
cell research centers, personal & preventive medicine and bio
venture divisions. CHA Bio&Diostech has multiple stem cell
R&D pipelines in therapeutic areas including Stargardt's
disease, age-related macular disease, Parkinson's disease,
Alzheimer disease, Cerebral Palsy and glioblastoma in mid to late
development stages. With seasoned experience and research infra
structure, CHA Bio&Diostech has built up multiple strategic
relations with major research institutions in the field of stem
cell research and infertility areas. For more information visit
www.chabio.com, the content of which is not part of this press
release.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of
placenta-based cell therapies. The Company's patented PLX
(PLacental eXpanded) cells are a drug delivery platform that
releases a cocktail of therapeutic proteins in response to a host
of local and systemic inflammatory and ischemic diseases. PLX cells
are grown using the company's proprietary 3D micro-environmental
technology and are an "off-the-shelf" product that requires no
tissue matching prior to administration.
Pluristem has a strong intellectual property position,
company-owned GMP certified manufacturing and research facilities,
strategic relationships with major research institutions and a
seasoned management team. For more information visit
www.pluristem.com, the content of which is not part of this press
release.
The Pluristem Therapeutics Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6882 Safe
Harbor Statement
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995 and federal securities
laws. For example, when we discuss that our expectation that
certain milestones pursuant to our agreement with CHA will be
completed by September 2013, or when we discuss adding products for
indications beyond CLI and IC and is intended to serve as the
foundation of a broad based long term partnership, or when we
discuss that our alliance in South Korea will provide multiple
opportunities to strengthen our pipeline and develop PLX cells
products for new indications, or when we discuss that we will be
able to receive data from multiple CLI and IC trials that will
enable us to optimize the clinical development of PLX-PAD, or when
it is discussed that our PLX leveraging CHA group's R&D,
clinical development, regulatory and commercialization
infrastructure focused on cell therapies in Korea will provide huge
strategic advantage to entering Korea and global market territory
in the future, or when this press release discusses the expectation
that PLX cells will be the first Pharmaceutical-like stem cell
therapy product as well as the first allogenic product approved for
the mass market to treat numerous patients suffering from serious
disease such as the CLI and IC with limited cure we are using
forward-looking statements. 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; we may
encounter delays or obstacles in launching and/or successfully
completing our clinical trials; our products may not be approved by
regulatory agencies, our technology may not be validated as we
progress further and our methods may not be accepted by the
scientific community; we may be unable to retain or attract key
employees whose knowledge is essential to the development of our
products; unforeseen scientific difficulties may develop with our
process; our products may wind up being more expensive than we
anticipate; results in the laboratory may not translate to equally
good results in real surgical settings; results of preclinical
studies may not correlate with the results of human clinical
trials; our patents may not be sufficient; our products may harm
recipients; changes in legislation; 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: Pluristem Therapeutics Inc.:
William Prather R.Ph., M.D. Sr. VP Corporate Development
1-303-883-4954
William.PratherMD@pluristem.com
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
daya@pluristem.com