East Hills, NY (June 27, 2005) - - Pall Corporation (NYSE:PLL) and the Transfusion Technology subsidiary of Fresenius Kabi AG entered into a collaborative commercialization agreement to accelerate adoption of prion reduction technology for blood transfusions in Europe, the epicenter of variant Creutzfeldt-Jakob Disease (vCJD). Prions are believed to be the causative agent of vCJD, the human form of Bovine Spongiform Encephalopathy (BSE), also known as Mad Cow Disease. The dual-branded marketing agreement will facilitate the ability of blood centers to integrate prion reduction filters into routine practice to safeguard the blood supply from this insidious and fatal disease.
Under the 5-year agreement, both companies will sell the Pall prion reduction filter throughout Europe as their own brand. Pall began marketing the Leukotrap® Affinity Prion Reduction Filter System in Europe following its May 2005 CE marking. It is the first and only technology that removes infectious prions from red cell blood products, the most widely transfused blood components. The system is currently being evaluated by the UK National Blood Service and the Irish Blood Transfusion Service for implementation into their respective blood processing practices. Results are expected later this year or in early 2006.
The agreement between the two companies complements and builds upon Pall's expertise in developing and commercializing innovative filtration technologies. It also leverages Fresenius Kabi's strong presence and established relationships in blood centers throughout Europe. Fresenius Kabi, a subsidiary of the health care group Fresenius AG, is one of Europe's leading providers in the field of transfusion technology.
Fresenius Kabi will integrate the Pall prion reduction filter with its own bag and tubing set to market its own system throughout Europe. Throughout the life of the agreement, Pall will also provide Fresenius Kabi with an opportunity to incorporate each new technology enhancement it develops in relation to the prion reduction filter.
"This agreement is an important step forward in transfusion safety for blood centers, donors and recipients," said Allan Ross, President of Pall Medical. "Fresenius Kabi's endorsement of our technology further validates the urgent need for prion reduction to become a routine part of blood processing to help prevent further transmission of vCJD."
"Through the joint initiative with Pall we make a unique prion reduction technology available to meet this emerging critical blood safety need," said Marc-A. Mahl, M.D., Executive Vice President of the Fresenius Kabi Transfusion Technology Division. "Prion reduction is a significant market opportunity that naturally aligns with our portfolio of products for the blood banks."
Variant CJD is a fatal neurodegenerative disease transmitted by eating contaminated beef and also by blood transfusion. According to the world's leading prion experts, the risk of a second wave or outbreak of vCJD is greater than initially estimated. New calculations indicate that the number of reported BSE infected cattle and the number of identified vCJD cases to date may only be a fraction of what actually exists. Variant CJD is asymptomatic for about 10 to 16 years and there is no accurate way to determine how many people could be harboring the disease without clinical symptoms and also be blood donors. This presents a problem of uncertainty about the actual magnitude of future cases and the possibility of a vCJD epidemic.
Pall developed the prion reduction technology to help blood authorities around the world stop the transmission of prions as part of the Company's mission to help safeguard the global blood supply. The adoption of the new prion reduction filter has the potential to support the global public health need for adequate supplies of safe blood. Pall is continuing its prion research and development program to apply its technologies to meet the specific requirements of each nation starting in Europe, the epicenter of vCJD, followed by North America. The Company is also developing an ante mortem test to detect infectious prions in cattle prior to entering the food supply.
About Pall Corporation Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2004 were $1.8 billion. The Company headquarters are in East Hills, New York with extensive operations throughout the world. Visit Pall at http://www.pall.com/
About Fresenius Kabi Fresenius Kabi is the leader in Infusion Therapy and Clinical Nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Fresenius Kabi's core product range includes infusion solutions for fluid substitution, blood volume replacement, intravenously administered drugs as well as parenteral and enteral nutrition. Furthermore, the company offers medical devices for the application of Infusion Therapy and Clinical Nutrition and Infusion Management. Fresenius Kabi is also active in the field of Transfusion Technology, supplying blood bank processing systems, apheresis systems as well as blood bags and filters. The Transfusion Technology Division of Fresenius Kabi is a leading supplier of these products in Europe and in South America. Fresenius Kabi is focused on the therapy and care of critically and chronically ill patients in and outside the hospital.
The company has more than 11,500 employees worldwide and has a global network of 50 sales organizations and 35 productions sites. Fresenius Kabi achieved sales of € 1,491 million and an operating profit of € 176 million in 2004. Fresenius Kabi AG is a 100% subsidiary of the health care group Fresenius AG. Please visit http://www.fresenius-kabi.com/
Forward Looking Statements This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current Company expectations and are subject to risks and uncertainties which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at http://www.pall.com/ and is included in the Company's reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at http://www.sec.gov/.
Management uses certain non-GAAP measurements to assess Pall's current and future financial performance. The non-GAAP measurements do not replace the presentation of Pall's GAAP financial results. These measurements provide supplemental information to assist management in analyzing Pall's financial position and results of operations. Pall has chosen to provide this information to facilitate meaningful comparisons of past, present and future operating results and as a means to emphasize the results of on-going operations.