Message #31 From:
Stock News Bot Date: March 29, 2007 05:30:00 AM
PLRS News Pluristem Upgrading Its Manufacturing Facility to Support $200 Million in Production Capacity for PLX - I
NEW YORK--(BUSINESS WIRE)--Pluristem Life Systems, Inc. (OTCBB:PLRS), a cell therapy Company dedicated to the commercialization of cell therapy products for a variety of indications, has announced it will upgrade and enlarge its existing manufacturing facility to Support $200 Million in Production Capacity for PLX– I. The additional 6,900 square foot will double in size the Company’s facilities and is expected to be ready this summer. This facility will manufacture PLX-I, the Company’s introductory product to address the bone marrow transplant market, for Phase I clinical trials and large scale commercial production.
Zami Aberman, Pluristem CEO, stated: “We continue to execute our strategy of controlling the entire commercialization process, from harvesting placenta cells and umbilical cord blood to product development and expansion, and product sales. We anticipate completion of the new facilities and GMP (Good Manufacturing Practice) certification prior to the initiation of Phase I clinical trials, planned to begin during 2007.” The Company intends to commercialize PLX-I and several prospective cell therapy products in the United States as well as the rest of the world.
Once complete, Pluristem’s initial annual production capacity for its proprietary PLX (PLacenta eXpanded) cells will be approximately 14,000 doses of PLX-I per year with an estimated value of $200 million. Pluristem is spending about $500,000 to lease additional space adjacent to its current facilities, adding bioreactors, support equipment and other infrastructure improvements.
Mr. Aberman added, “We are able to increase the production capability of this new facility by another 300% very quickly. This enables us to scale our production as we gain market share and still keep our expenses under control.”
Pluristem is in the process of implementing GMP controls to provide a reliable quality assurance environment per US Food and Drug Administration (FDA) requirements. These requirements call for process and organizational controls to ensure authenticity, integrity and confidentiality for all product records from design, manufacture, testing, packing, storage and other product development processes.
About Pluristem
Pluristem Life Systems, Inc. is life sciences driven Company that is developing and commercializing stem cell expansion technology products for the potential treatment of a variety of disorders. The Company is discovering and developing cell-based therapeutics that utilizes adult stem cells expanded in a three-dimensional proprietary bioreactor termed the PluriX™ that mimics different naturally occurring physiological environments. Pluristem expects its first product, PLX-I, will be involved as an efficient and superior alternative to the standard procedure of bone marrow transplantation (BMT). PLX-I is intended to target a critical global shortfall of matched tissue for BMT since BMT is often the only cure for patients suffering from leukemia, lymphoma, myeloma and many other hematological diseases. The Company has made a strategic decision to work only with adult stem cells since the practical use of embryonic stem cells is severely restricted by various religious, ethical and legal considerations.
This press release contains statements, which may constitute "forward-looking statements" regarding our intent, belief or current expectations. Forward-looking statements in this release, include that we are upgrading and doubling our manufacturing facility to support $200 million in production capacity for PLX - I; that we expect to complete the expansion of the production area as well as the implementation of the GMP controls before the initiation of the Phase I clinical trials which we are expecting to start during 2007; that we are able to increase the production capability of this new facility by another 300% very quickly; That this enables us to scale our production as we gain market share and still keep our expenses under control. Factors that could prevent our forward looking statements from being achieved include that we may be unable to get regulatory approval for our products; we may be unsuccessful in developing any products; 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; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient to protect essential aspects of our technology; competitors may invent better technology; our products may not work as well as hoped or worse, our products may harm recipients; and we may not be able raise funds for development or working capital when we require it. As well, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. For further risk factors see the Company's latest 10-KSB filed with the SEC.
