FDA Licenses Amgen's Colorado Facility Where EPOGEN, NESP Will Be Produced.Business Editors and Biotech/Pharmaceutical Writers NOTE TO MEDIA: Photo available on BW PhotoWire/AP PhotoExpress, NewsCom, PressLink and on Business Wire's Web site at www.businesswire.com THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 6, 2000 Amgen (Nasdaq:AMGN) today announced that 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. ) has licensed the Company's new state-of-the-art multi-product manufacturing plant in Longmont, Colo. at which Amgen will manufacture its breakthrough anemia drug Epoetin alfa e·po·e·tin al·fa n. A recombinant preparation of human erythropoietin used to treat some forms of anemia. epoetin alfa Epogen, Eprex (CA) (UK), Procrit Pharmacologic class: . Amgen also expects to manufacture its new anemia drug, Novel Erythropoiesis erythropoiesis /eryth·ro·poi·e·sis/ (-poi-e´sis) the formation of erythrocytes.erythropoiet´ic e·ryth·ro·poi·e·sis n. The formation or production of red blood cells. Stimulating Protein (NESP NESP Neuroendocrine Secretory Protein NESP Navy EHF SATCOM Program NESP Nurse Educator Scholarship Program NESP Navy EHF Satellite Program NESP National Environmental Studies Project NESP National Education Supercomputer Program ), currently under FDA review, at the Longmont facility. The Longmont Manufacturing Facility, built on 22 acres of a 234-acre site, was designed to manufacture recombinant proteins using mammalian cell lines. The facility is staffed by more than 275 employees. The site comprises four buildings including a 200,000 square-foot manufacturing facility, a 50,000 square-foot central utility plant, a 100,000 square-foot laboratory and support building and a 100,000 square-foot warehouse. The manufacturing plant ultimately will have three times the Epoetin alfa production capacity of Amgen's current plant, which is located in Thousand Oaks. "We are extremely pleased to announce the first FDA licensure of an Amgen bulk drug manufacturing facility outside California," said Kevin Sharer, Chief Executive Officer and President. "The licensure of our Longmont Manufacturing Facility enhances Amgen's capacity to meet the growing demands for our products and future products." Construction on an additional 200,000 square-foot expansion consisting of laboratory and office space is being planned. The Longmont Manufacturing Facility is now licensed for manufacturing Epoetin alfa. Amgen is currently manufacturing test lots of NESP at the facility and plans to file a supplemental license application once NESP receives marketing approval. NESP is a recombinant protein being explored for its potential to stimulate the production of red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells in less frequent doses than Epoetin alfa. NESP is being studied in renal disease to treat the anemia associated with chronic kidney failure Chronic Kidney Failure Definition Chronic kidney failure occurs when disease or disorder damages the kidneys so that they are no longer capable of adequately removing fluids and wastes from the body or of maintaining the proper level of certain , both chronic renal insufficiency (CRI CRI constant-rate infusion. ) -- also known as pre-dialysis -- and chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be (CRF CRF abbr. chronic renal failure CRF Chronic renal failure ) requiring dialysis. People with diabetes and hypertension, among other diseases, are at risk for progressing to chronic kidney failure. In December 1999, Amgen filed regulatory license applications for NESP with the FDA and the European Medicines Evaluation Agency for use in CRI and chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is patients on dialysis. It is planned that, upon FDA approval, NESP will be manufactured at the Longmont facility. In addition, phase 2 clinical studies are underway in treating cancer patients with anemia resulting from chemotherapy. Amgen sells Epoetin alfa as EPOGEN(R) in the United States for treating anemia associated with end stage renal disease. Epoetin alfa is a breakthrough recombinant protein used to treat anemia. EPOGEN is a recombinant protein that stimulates red blood cell red blood cell: see blood. production for patients on dialysis. Dialysis patients whose kidneys have failed produce very little erythropoietin erythropoietin /eryth·ro·poi·e·tin/ (-poi´e-tin) a glycoprotein hormone secreted by the kidney in the adult and by the liver in the fetus, which acts on stem cells of the bone marrow to stimulate red blood cell production , the hormone that stimulates production of oxygen-carrying red blood cells. EPOGEN was approved by the FDA in June 1989. U.S. sales of EPOGEN for patients on dialysis totaled $1.8 billion in 1999. This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent Form 10-K. Amgen conducts research in the biotechnology/pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of our products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Amgen is a global biotechnology company that discovers, develops, manufactures and markets cost-effective human therapeutics based on advances in cellular and molecular biology. EDITOR'S NOTE: An electronic version of this news release may be accessed via our web site at www.Amgen.com. Visit the Corporate Center and click on Amgen News. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Amgen News section of the web site. Photograph available at www.wirepix.com/newsphotos. Note: A direct link to the image is available at URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. : http://www.businesswire.com/cgi-bin/photo.cgi?pw.070600/bw2 |
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