HAIFA, Israel, June 20, 2011 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) today announced that its wholly owned subsidiary, Pluristem Ltd., has entered into an exclusive out-license agreement with United Therapeutics Corporation (Nasdaq:UTHR) for the use of Pluristem's PLacental eXpanded (PLX) cells to develop and commercialize a cell-based product for the treatment of Pulmonary Hypertension (PH).
Under the terms of the agreement, United Therapeutics will receive exclusive worldwide licensing rights for the development and commercialization of the future product for treating PH patients. Pluristem will retain all manufacturing rights; participate in the pre-clinical and clinical trial activities, as well as provide the commercial grade product.
Under the terms of the agreement, United Therapeutics will make an upfront payment of $7 million to Pluristem. Pluristem is eligible to receive regulatory milestone payments and other payments accumulating together with the upfront payment to a total of approximately $55 million and reimbursement of costs of its development and clinical activities. United Therapeutics will bear all the costs of conducting the clinical trials for this indication. Following commercialization, United Therapeutics shall purchase commercial supplies from Pluristem at a specified margin over Pluristem's cost. In addition, United Therapeutics will pay Pluristem specified royalties as a percentage from its gross profits generated from the developed product.
"This is an important milestone for our company, as it exemplifies our belief that Pluristem's PLX cells are a platform technology that can be used for the treatment of numerous diseases. This agreement is in line with our strategy of being a state of the art cell manufacturer while maintaining all the production and Intellectual Property rights for future product candidates," said Zami Aberman, Chairman and CEO of Pluristem. "We are very pleased to partner with United Therapeutics, an expert and a leader in the area of PH, and to cooperate with their talented team to quickly bring this product to market and improve the quality of life of Pulmonary Hypertension patients."
"Our mission to help patients suffering from Pulmonary Hypertension has led us to seek companies exhibiting innovative approaches and cutting edge technology, with whom we could partner for developing new therapies. Pluristem's impressive results of their current clinical trials, their strong intellectual property and unique manufacturing capabilities, convinced us to select Pluristem as our partner in developing an important cell therapy for treating PH," said Roger Jeffs, President and Chief Operating Officer of United Therapeutics. "We are excited to enter into this partnership and to work alongside Pluristem in advancing this exciting platform."
The signing ceremony will be held tomorrow, June 21st at 09:30 Israel time at the Tel Aviv Stock Exchange in the presence of Dr. Roger Jeffs, President and Chief Operating Officer of United Therapeutics, and Mr. Zami Aberman, Chairman and CEO of Pluristem Therapeutics.
Closing of the agreement is subject to certain closing conditions and is expected by the end of August 2011.
About Pulmonary Hypertension (PH)
Pulmonary Hypertension is the damage that occurs to the pulmonary vessels (leading from the heart to the lungs) when the blood pressure in those vessels is abnormally high. The disease can be secondary to other conditions or unrelated to any identifiable disorder. Approximately 1,000 new cases of this catastrophic disorder are diagnosed annually in the US*.
*National Library of Medicine
About United Therapeutics Corporation
United Therapeutics Corporation (Nasdaq:UTHR) is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, including cardiovascular, cancer, and infectious diseases.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory 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. Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage, when administered locally, and in inflammatory bowel disease, MS and stroke, when administered systemically.
Pluristem has a strong patent portfolio, GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
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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, we are using forward looking statements when we discuss the belief that our PLX cells are a platform technology that can be used for the treatment of numerous diseases, when we discuss the timing to bring this product to market and its ability to improve the quality of life of Pulmonary Hypertension patients, when we say that closing of the agreement with United Therapeutics is expected by the end of August 2011 and imply that we may receive future payments if our products are commercialized and generate gross profits or when we say that data from two Phase I clinical trials indicate that Pluristem's first PLX product, PLX-PAD, is safe and potentially effective for the treatment of end stage PAD or that Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in nerve pain and muscle damage when administered locally and in inflammatory bowel disease, MS and stroke when administered systemically. These forward-looking statements 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 our clinical trials; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce or commercialize 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: Investor Relations Contacts: Pluristem: William Prather R.Ph., M.D. Sr. VP Corporate Development 1-303-883-4954 William.PratherMD@pluristem.com Daya Lettvin Investor & Media Relations Director +972-54-647-5580 daya@pluristem.com Media Contact: Pluristem: Matthew Krieger Ruder Finn - for Pluristem +972-54-467-6950 matthew@ruderfinn.co.il
