Large Scale Biology Corporation Files for Orphan Drug Status on Plant-Produced Human Alpha-Galactosidase A.Business Editors/Health & Medical Writers VACAVILLE, Calif.--(BUSINESS WIRE)--Sept. 17, 2002 Large Scale Biology Corporation (Nasdaq:LSBC LSBC Law Society of British Columbia LSBC Large Scale Biology Corporation LSBC Lone Star Bulldog Club LSBC Lasalle & Bureau County Railroad Company LSBC Lifesaver for Babies and Children (St John Ambulance, UK) LSBC Lone Star Bit Company ) announced today that it has filed an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the application with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) related to its proprietary LSBC plant-produced human alpha-Galactosidase A for enzyme replacement therapy Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. Usually this is done by giving the patient an intravenous (IV) infusion containing the enzyme. . This molecule may be effective in the treatment of Fabry's disease Fa·bry's disease n. A sex-linked disorder of glycolipid metabolism characterized by a variety of progressive symptoms including fevers, hypertension, and purple skin lesions, with death resulting from renal, cardiac, or cerebrovascular complications. , a multi-systemic, lipid storage disorder Lipid storage disorders (or lipidoses) are a group of inherited metabolic disorders in which harmful amounts of lipids (fats) accumulate in some of the body’s cells and tissues. caused by a deficiency of this lysosomal lysosomal pertaining to or emanating from lysosomes. lysosomal enzymes enzymes located in the lysosomes. lysosomal phospholipidosis enzyme. LSBC has manufactured clinical-grade quantities of alpha-Galactosidase A in its large-scale biomanufacturing facility in Owensboro, Kentucky. Large Scale Biology Corporation is headquartered in Vacaville, California where drug development work is coordinated with the Company's proteomics facility in Germantown, Maryland. The Company's commercial-scale biomanufacturing facility is in Owensboro, Kentucky where proteins are expressed in living plants both in greenhouses and as crops in fields. About Large Scale Biology Corporation Large Scale Biology uses its functional genomics, proteomics, and biomanufacturing technologies to develop and manufacture personalized drugs, vaccines and diagnostics for rapid identification and effective treatment of disease. Corporate offices and the Genomics Division are headquartered in Vacaville, California; the Company's Proteomics Division is located in Germantown, Maryland; and the Company's Bioprocessing Division is located in Owensboro, Kentucky. For more information about Large Scale Biology Corporation, visit the Company's website at www.lsbc.com. This release contains a forward-looking statement about the potential effectiveness of one of our products under development in treating Fabry's disease. We must complete more testing and development of the product, and we cannot assure that the product will ever be effective in treating Fabry's disease. You should not place undue reliance on this forward-looking statement. For a further list and description of risks and uncertainties we face, see the reports filed by Large Scale Biology Corporation with the SEC, including our reports on Forms 10-K and 10-Q. Except as required by law, we do not undertake to update or revise this forward-looking statement, whether as a result of new information, future events or otherwise. Note to Editors: LSBC(TM) is a trademark of Large Scale Biology Corporation. |
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