Pluristem Therapeutics to Expand Manufacturing With New GMP Facility Capable of an Annual Production Capacity of Over $1 Billion
New 28,000 Square Foot Facility Strengthens Pluristem's Strategy to Develop Its Top of the Line Intellectual Property and to Manufacture Its Cell Therapy Product Candidates
HAIFA, Israel, Jul 26, 2011 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), announced today that its wholly owned Israeli subsidiary, Pluristem Ltd., has entered into an agreement with MTM -- Scientific Industries Center Haifa Ltd., for the leasing and construction of a new state-of-the-art GMP manufacturing facility. The new facility will be located near the company's headquarters and existing facilities in MATAM Park, Haifa, Israel and will support the manufacturing of Pluristem's PLX (PLacental eXpanded) cell product candidates for the treatment of critical limb ischemia (CLI), intermittent claudication (IC), adjuvant hip replacement surgery, muscle injuries, pulmonary hypertension (PH) and other diseases.
According to the agreement, the lease of the new facility will commence as of January 2012 for a period of approximately 5 years with an option to extend the lease for an additional 5 years. Pluristem's new regenerative medicine facility will be cGMP/GTP compliant for clinical cell manufacturing and designed specifically to meet both EMA and FDA regulatory requirements, as well as the standards outlined by the Israeli Ministry of Health. Once constructed, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually.
As the company widens its clinical product candidate portfolio and prepares to launch large-scale clinical trials in the U.S. and Europe, the facility would enable Pluristem to meet increased manufacturing capacity requirements. It would also enable Pluristem to meet marketing demands following potential approval of its product candidates.
"Over the last few years, we have researched, developed and fine-tuned the manufacturing methods, systems and techniques for the mass production of clinical grade PLX products," said Mr. Zami Aberman, Pluristem's Chairman & CEO. "The new manufacturing site will implement our industry experience and support Pluristem's strategy for potentially treating millions of patients with life threatening diseases, positioning the company for continued global collaborations and potential expansion of its partnerships with pharmaceutical companies."
About Matam Park Matam Park, located at the southern entrance to Haifa, is the largest and oldest business & hi-tech park in Israel. Matam Park is owned and managed (50.1%) by Gav-Yam Company of Property & Building Group IDB, one of the largest real-estate companies in Israel.
About Pluristem Therapeutics Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of standardized cell therapy products for the treatment of life threatening diseases. 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. For more information visit www.pluristem.com, or follow us on Twitter @Pluristem, the contents of which are not part of this press release. |
