Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) will build a production facility at the Matam high-tech park in Haifa. The company signed an agreement with Matam Scientific Industries Center Haifa Ltd. to build and lease a new state-of-the-art GMP plant, which will produce Pluristem's PLX (PLacental eXpanded) cell product candidates for the treatment of critical limb ischemia (obstruction of the arteries), intermittent claudication (muscle pain caused by peripheral arterial disease), adjuvant hip replacement surgery, muscle injuries, pulmonary hypertension, and other diseases.
Pluristem's five-year lease of the facility will begin in January 2012, and the company has a five-year option to extend.
The new plant will comply with clinical cell manufacturing, and will be designed to specifically meet US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and Israeli Ministry of Health regulatory requirements. The plant will have a production capacity to produce PLX cells for the treatment of over 150,000 patients annually.
Pluristem said that the plant would enable it to meet increased manufacturing capacity requirements as it widens its clinical product candidate portfolio and prepares to launch large-scale clinical trials in the US and Europe.
Pluristem chairman and CEO Zami Aberman said, "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. 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."
Pluristem's share price fell 2.4% on Nasdaq yesterday to $3.25, giving a market cap of $135 million, but rose 1.8% by mid-afternoon on the TASE today to NIS 11.60.
Published by Globes [online], Israel business news - www.globes-online.com - on July 26, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011