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ZLB Behring Receives FDA Approval for New Labeling for Carimune® NF on Product Safety Related to TSE Agents ZLB Behring today announced that the U.S. Food and Drug Administration (FDA) has approved additional labeling information for Carimune® NF, its human plasma-derived intravenous immunoglobulin preparation. The new labeling includes data from experimental studies that show that manufacturing steps used in the production of Carimune® NF have the capacity to substantially decrease infectivity of transmissible spongiform encephalopathy (TSE)1. TSEs include variant Creutzfeldt-Jakob Disease (vCJD), the human form of mad cow disease. To date, there has been no evidence of TSE (also known as prion disease) transmission through plasma-derived protein therapeutics. Nevertheless, minimizing the risk of TSE transmission is a primary consideration in the manufacture of human plasma-derived products. "The FDA approval for the new labeling on reducing TSE infectivity is an important milestone that demonstrates our commitment to continuous improvement and leadership," said Paul Perreault, ZLB Behring Vice President, U.S. Commercial Operations. "The quality and safety of our products is ZLB Behring's highest priority in order to ensure the health and well being of patients who rely on our life-saving therapies." Experimental Results The labeling approval is based on the results of experimental studies that ZLB Behring submitted to the FDA. The studies determined the capacity in which the manufacturing process for Carimune® NF could decrease the infectivity of an experimental TSE agent, considered a model for vCJD and other prion diseases. The results have been confirmed by using two different TSE model systems. The data shows that several distinct production steps significantly reduce TSE infectivity, including precipitation (3.5 logs), depth filtrations (7.3 logs) and nanofiltration (4.4 logs). These steps have also been shown to contribute to virus inactivation and elimination during Carimune® NF manufacturing. The new results offer further confirmation that even if a low level of CJD/vCJD infectivity was potentially present in the starting material, it would be removed. About Carimune® NF Carimune® NF is a sterile, highly purified, plasma-derived Immune Globulin Intravenous (Human) (IGIV) product used for replacement therapy in patients who do not produce adequate levels of antibodies (or immunoglobulins), e.g., those with primary immunodeficiencies, or PID. These antibodies are essential in fighting infectious diseases. Carimune® NF also is used to treat certain immune-mediated disorders, such as acute and chronic immune thrombocytopenic purpura (ITP). Carimune® NF is the first IGIV in the United States to employ nanofiltration - a technology that filters out pathogens above a certain size. About ZLB Behring ZLB Behring is a global leader in the plasma therapeutics industry. Dedicated to improving the quality of life for patients throughout the world, ZLB Behring provides safe and effective plasma-derived and recombinant products and offers patient communities a wide range of related services. The company's broad portfolio of life-saving therapeutics are used in the treatment of individuals with hemophilia, immune deficiency disorders and inherited emphysema; the prevention of hemolytic diseases for the new born; cardiac surgery patients; and shock and burn victims. ZLB Behring is a wholly-owned subsidiary of CSL Limited, a leading biopharmaceutical company based in Melbourne, Australia, and was formed when CSL acquired Aventis Behring and combined the business with CSL's existing subsidiary, ZLB Bioplasma, in April 2004. For more information, please visit www.zlbbehring.com. Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Reference: 1. Gregori L et al. Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals, 2004; 32:1-10. Kontaktinformationen: Mimi Garner Department: Communications - Global Phone: +1 610-878-4155 Fax: +1 610-878-4913 Location: King of Prussia Headquarters Address: P.O. Box 61501 1020 First Avenue King of Prussia, PA 19406 USA Email: Mimi.Garner@zlbbehring.com Name: Philippe Müller Title: Director Department: Media inquiries - Switzerland Phone: +41 31 344 1036 Fax: +41 31 344 1480 Location: ZLB Behring AG Address: Wankdorfstrasse 10 CH-3000 Bern 22 Switzerland Email: philippe.mueller@zlb.com
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