Haifa, Israel -- (SBWire) -- 06/27/2013 --Pluristem Therapeutics Inc. announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license and strategic partnership agreement with Cha Bio&Diostech 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 http://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 http://www.pluristem.com, the content of which is not part of this press release.
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.
Pluristem Enters Into Strategic Partnership and Licensing Agreement with Cha Bio&Diostech
The Joint Venture is for the Development and Commercialization of PLX Cells for the Treatment of CLI and IC in South Korea. Cha will conduct and fund multiple peripheral artery disease clinical trials and invest $10 million valued at $4/share into Pluristem via a share exchange agreement.