Amgen Inc., an independent biotechnology company, discovers, develops, manufactures, and delivers human therapeutics. Products Neulasta (pegfilgrastim)/NEUPOGEN(filgrastim) The company markets Neulasta, a pegylated protein based on the filgrastim molecule, primarily in the United States and Europe. Neulasta is indicated to decrease the incidence of infection associated with chemotherapy-induced febrile neutropenia in cancer patients with non-myeloid malignancies. In 2014, the U.S. Food and Drug Administration granted approval of the Neulasta Delivery Kit, including the On-body Injector for Neulasta. The company markets NEUPOGEN, a recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF), primarily in the United States, Canada, and Europe. NEUPOGEN is used primarily in the indication for reducing the incidence of infection as manifested by febrile neutropenia for patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy associated with a significant incidence of severe neutropenia with fever. Enbrel (etanercept) The company markets ENBREL primarily in the United States. It is used primarily in the indications for the treatment of adult patients with various conditions, including moderately to severely active rheumatoid arthritis; chronic moderate-to-severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy; and active psoriatic arthritis. The rights to market and sell ENBREL outside the United States and Canada are reserved to Pfizer Inc. XGEVA/Prolia (denosumab) The company markets XGEVA and Prolia primarily in the United States and Europe. Both products contain the same active ingredient but are approved for different indications, patient populations, doses and frequencies of administration. XGEVA is used primarily in the indication for the prevention of skeletal-related events (SREs) (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with bone metastases from solid tumors. It is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is used primarily in the indication for the prevention of SREs in adults with bone metastases from solid tumors. In the United States, Prolia is used primarily in the indication for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In Europe, Prolia is used primarily for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. ESAs (erythropoiesis-stimulating agents) EPOGEN (epoetin alfa) The company markets EPOGEN in the United States for dialysis patients. The company markets it for the indication to treat a lower-than-normal number of red blood cells (anemia) caused by chronic kidney disease (CKD) in patients on dialysis to lessen the need for red blood cell transfusions. The majority of its sales are to two large dialysis providers. Aranesp (darbepoetin alfa) The company markets Aranesp primarily in Europe and in the United States. It is indicated for the treatment of anemia associated with CKD (in both patients on dialysis and patients not on dialysis) and the treatment of anemia due to concomitant myelosuppressive chemotherapy in patients with non-myeloid malignancies. Sensipar/Mimpara (cinacalcet) The company markets cinacalcet as Sensipar primarily in the United States and as Mimpara primarily in Europe. This product is used primarily in the indication for the treatment of secondary hyperparathyroidism in CKD patients on dialysis. Other Marketed Products The company markets various other products, including Kyprolis (marketed by Onyx, an Amgen subsidiary), Nplate (romiplostim), Vectibix (panitumumab), and BLINCYTO. Competition The company’s competitors include Teva Pharmaceutical Industries Ltd.; Janssen Biotech, Inc./Merck & Company, Inc.; AbbVie Inc.; Novartis AG; F. Hoffmann-La Roche Ltd.; Eli Lilly/Bristol-Myers Squibb Company; Merck KGaA; Genentech, Inc. (a Member of the Roche Group); GlaxoSmithKline plc; Millennium Pharmaceuticals, Inc.; and Celgene Corporation. Research and Development For the year ended December 31, 2014, the company's research and development expenses were $4.3 billion. Government Regulation In the United States, the Public Health Service Act; the Federal Food, Drug and Cosmetic Act (FDCA); and the regulations promulgated thereunder, as well as other federal and state statutes and regulations govern the raw materials and components used in the production, research, development, testing, manufacture, quality control, labeling, storage, record keeping, approval, advertising and promotion, and distribution of the company’s products. The company is also subject to regulation under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other current and potential future federal, state or local laws, rules and/or regulations. History Amgen Inc. was founded in 1980. The company was incorporated in 1980 in California in 1980 and became a Delaware corporation in 1987.
amgen inc (AMG:XETRA)
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
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