Amgen Inc., a biotechnology company, engages in the discovery, development, manufacture, and marketing of human therapeutics based on advances in cellular and molecular biology.
Products
The company markets its primary products in the areas of supportive cancer care, nephrology and inflammation. Its primary products include Aranesp (darbepoetin alfa), Neulasta (pegfilgrastim), NEUPOGEN (Filgrastim), EPOGEN (Epoetin alfa) and ENBREL (etanercept).
Aranesp (darbepoetin alfa): Aranesp is the company’s trademark for erythropoiesis stimulating protein, a protein that stimulates red blood cell production. Red blood cells transport oxygen to all cells of the body. Aranesp relieves anemia symptoms and reduces the need for blood transfusions. The company was granted a license by Kirin-Amgen, Inc. (KA), a joint venture between Kirin Brewery Company, Limited (Kirin) and Amgen to manufacture and market darbepoetin alfa in the United States, Europe, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, North Africa and the Middle East. The company primarily markets Aranesp in the United States and Europe. Darbepoetin alfa is also marketed under the brand name Nespo in Italy. Aranesp is approved for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Neulasta (pegfilgrastim): Neulasta is the company’s trademark for a pegylated protein that selectively stimulates production of certain white blood cells known as neutrophils and is based on the Filgrastim molecule. Neutrophils defend against infection. The company was granted a license to manufacture and market pegfilgrastim in the United States, Europe, Canada, Australia and New Zealand under a licensing agreement with KA. The company primarily markets Neulasta in the United States and Europe. Pegfilgrastim is marketed under the brand name Neupopeg in Italy. Neulasta is indicated for reducing the incidence of infection associated with chemotherapy-induced neutropenia in cancer patients with non-myeloid malignancies. Neulasta also protects patients with breast cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia. Administration of Neulasta in all cycles of chemotherapy is approved for patients receiving myelosuppressive chemotherapy.
NEUPOGEN (Filgrastim): NEUPOGEN is the company’s trademark for recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF), a protein that selectively stimulates production of certain white blood cells known as neutrophils. NEUPOGEN is prescribed in the curative setting, in which myelosuppressive chemotherapy is administered with the intent to cure cancer, rather than in the palliative setting, in which myelosuppressive chemotherapy is administered to treat other complications of cancer by managing tumor growth. The company was granted a license to manufacture and market G-CSF in the United States, Europe, Canada, Australia and New Zealand under a licensing agreement with KA.
The company markets NEUPOGEN primarily in the United States and Europe. Filgrastim is marketed under the brand name GRANULOKINE in Italy. NEUPOGEN is indicated for the following: to limit the incidence of infection as manifested by febrile neutropenia for patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy; to limit the duration of neutropenia and neutropenia-related consequences for patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to limit the incidence and duration of neutropenia-related consequences in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia (collectively, severe chronic neutropenia); to mobilize peripheral blood progenitor cells (PBPC) in cancer patients who have undergone myeloablative chemotherapy for stem cell transplantation; and to limit the recovery time of neutrophils and the duration of fever following induction or consolidation chemotherapy treatment in adult patients with acute myeloid leukemia (AML).
EPOGEN (Epoetin alfa): EPOGEN is the company’s trademark for its recombinant human erythropoietin product, a protein that stimulates red blood cell production. A reduced red blood cell count can result in anemia. The company was granted a license to manufacture and market recombinant human erythropoietin in the United States under a licensing agreement with KA. It has retained rights to market EPOGEN in the United States for dialysis patients. The company granted Ortho Pharmaceutical Corporation (which has assigned its rights under the Product License Agreement to Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson) a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all markets other than dialysis. Johnson & Johnson markets recombinant human erythropoietin under the trademark PROCRIT in the United States.
EPOGEN is approved for the treatment of anemic adult and pediatric patients with chronic renal failure who are on dialysis. EPOGEN is indicated to elevate or maintain the red blood cell level (as determined by hematocrit or hemoglobin measurements) and to decrease the need for blood transfusions in these patients.
Enbrel (etanercept): ENBREL is the company’s trademark for its TNF receptor fusion protein that inhibits the binding of TNF to TNF receptors, which can result in a significant reduction in inflammatory activity. The company markets ENBREL under a co-promotion agreement with Wyeth in the United States and Canada The rights to market ENBREL outside of the United States and Canada are reserved to Wyeth. The company and Wyeth have a contract manufacturing agreement with Boehringer Ingelheim Pharma KG (BI Pharma) for the production of additional supply of ENBREL.
The company also has a global supply agreement with Wyeth related to the manufacture, supply, inventory and allocation of bulk supplies of ENBREL. ENBREL is indicated for reducing the signs and symptoms, improving physical function, inhibiting the progression of structural damage and inducing a Major Clinical Response (a Major Clinical Response represents a high level of disease control) in patients with moderately to severely active rheumatoid arthritis; for the treatment of chronic moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy; for reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying medicines; for reducing the signs and symptoms of active arthritis and inhibiting the progression of structural damage in patients with psoriatic arthritis; and to treat the signs and symptoms in patients with active ankylosing spondylitis.
Other
Other marketed products primarily include Sensipar (cinacalcet HCl) and Vectibix (panitumumab).
Sensipar (cinacalcet HCl): Sensipar (Mimpara in Europe) is the company’s trademark for its first small molecule medicine used in treating chronic kidney disease (CKD) patients on dialysis who produce parathyroid hormone, a condition known as secondary hyperparathyroidism. Sensipar/Mimpara is approved in the United States, Canada and Europe for the treatment of secondary hyperparathyroidism in CKD patients on dialysis and for the treatment of hypercalcemia in patients with parathyroid carcinoma. The company markets Sensipar/Mimpara primarily in the United States and Europe.
Vectibix (panitumumab): Vectibix is the company’s trademark for the first entirely human monoclonal antibody for the treatment of patients with EGFr expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGF receptors. The company acquired ownership of Vectibix as part of its acquisition of Abgenix, Inc. (Abgenix) in April 2006.
Development Stage Products
Denosumab: Denosumab is a human monoclonal antibody that specifically targets the receptor activator of nuclear factor kappa B ligand (RANKL), a key mediator of the resorptive phase of bone remodeling. Denosumab is being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, rheumatoid arthritis, bone metastases and multiple myeloma. The company is conducting various phase 3 studies of denosumab in the prevention and treatment of postmenopausal osteoporosis. In 2006, the company initiated two phase 3 studies. Denosumab is also being studied in metastatic bone disease for the treatment of bone metastases to prevent skeletal related events (SREs) and prevention of bone metastases in patients with prostate cancer. Three phase 3 clinical studies targeting SREs (breast cancer, prostate cancer and solid tumors studies) were initiated in 2006. In addition, the company commenced a phase 3 trial for prevention of bone metastases in patients with prostate cancer.
Vectibix (panitumumab): Panitumumab targets the EGFr. Panitumumab is a human monoclonal antibody directed against EGFr and is being evaluated for the treatment of various types of cancer (solid tumor). A pivotal phase 3 study examining panitumumab monotherapy against the standard of care showed that panitumumab significantly prolongs progression-free survival in patients with metastatic colorectal cancer (CRC). Registrational (phase 3) studies in first-line and second-line treatment of metastatic CRC were started in 2006. Panitumumab is also being studied in the treatment of head and neck cancer, and the company intends to study the drug in the adjuvant CRC setting. In 2007, the company intends to initiate a phase 3 study in metastatic squamous cell cancer of the head and neck (SCCHN) as well as two phase 2 studies addressing the safety and efficacy of panitumumab in the first-line treatment of locally advanced squamous cell cancer of the head and neck.
Panitumumab is also being studied in combination with motesanib diphosphate (AMG 706) in the treatment of various solid tumors. Phase 1b combination studies in CRC, non-small cell lung cancer (NSCLC) and SCCHN are ongoing.
Motesanib diphosphate: Motesanib diphosphate is an oral agent that is being evaluated for its ability to inhibit angiogenesis by targeting vascular endothelial growth factor receptors 1, 2 and 3 (VEGFR1-3). It is also under investigation for its potential direct anti-tumor activity by targeting platelet-derived growth factor receptor (PDGFR) and stem cell factor receptor (c-kit) signaling, which may also confer direct anti-tumor activity. A phase 2 clinical study evaluating motesanib diphosphate monotherapy in imatinib-resistant gastrointestinal stromal tumors (GIST) was completed. A phase 2 trial in advanced thyroid cancer has completed enrollment.
The company has re-launched a head-to-head phase 2 study of this agent versus Avastin in the treatment of metastatic breast cancer. A second head-to-head phase 2 study against Avastin in NSCLC is under way. Additionally, the company intends to conduct a new phase 3 study in NSCLC. Motesanib diphosphate is also being investigated in combination with multiple chemotherapy regimens, with and without panitumumab, in the treatment of solid tumors. Phase 1b combination studies in CRC, NSCLC and other solid tumors are ongoing.
AMG 531: AMG 531 is a protein called a peptibody, which is a molecule. The active peptide component stimulates the thrombopoietin (TPO) receptor. It is being investigated for the treatment of immune (idiopathic) thrombocytopenic purpura (ITP). ITP is an autoimmune bleeding disorder characterized by an abnormal decrease in platelets, a condition known as thrombocytopenia. Two phase 3 clinical studies evaluating AMG 531 in the treatment of ITP were completed in 2006. The company is also evaluating AMG 531 in chemotherapy-induced thrombocytopenia (CIT) and myelodysplastic syndromes (MDS). Phase 2 studies in each setting were initiated in 2006.
AMG 108: AMG 108 is a monoclonal antibody that inhibits the action of interleukin-1 (IL-1), a cytokine known to play a role in the joint destruction associated with rheumatoid arthritis. A phase 2 clinical study is under way to investigate the treatment of rheumatoid arthritis with AMG 108.
Aranesp (darbepoetin alfa): In 2006, the company announced phase 2 data reporting the clinical effects of darbepoetin alfa compared to placebo in subjects with heart failure and anemia. The company has completed an initial analysis of its Anemia of Cancer phase 3 study.
Kepivance (palifermin): Kepivance is being evaluated to determine its safety and anti-mucositis activity in patients receiving radiation and/or chemotherapy for SCCHN, NSCLC and colon cancer (all phase 2 studies).
Sensipar (cinacalcet HCl): Cinacalcet HCl is approved for the treatment of secondary hyperparathyroidism in patients with CKD on dialysis. A phase 3 clinical trial has been initiated to assess the effects of cinacalcet HCl on mortality and cardiovascular morbidity in patients with CKD undergoing maintenance dialysis. The company has completed an investigational phase 3 study to determine the safety and efficacy of cinacalcet HCl for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease stage 3 & 4 (CKD not on dialysis).
Acquisitions
In October 2006, the company acquired Avidia, Inc. (Avidia), a privately held company that discovered and developed a new class of human therapeutic known as Avimer proteins. The transaction provided the company with Avidia’s main product candidate, an inhibitor of interleukin 6 (IL-6) for the treatment of inflammation and autoimmune diseases, which is in phase 1 clinical trials.
Customers and Markets
The company markets its products to healthcare providers, including clinics, dialysis centers, hospitals, and pharmacies. In addition, the company has entered into licensing and/or co-promotion agreements to market its products in certain geographic areas. In the United States, the company sells primarily to wholesale distributors. Outside the United States, the company sells to hospitals and/or wholesalers. The company operates in the United States, Europe, Canada, and Australia. The company's major customers include AmerisourceBergen Corporation, Cardinal Health, Inc., and McKesson Corporation.
The company through its wholly owned subsidiary Amgen Technology focuses on clinical development and trials of it drugs, working with contract research organisations (CROs) in India and East Asia.
Joint Ventures and Business Relationships
Kirin Brewery Company, Limited: The company has formed KA, a 50-50 joint venture with Kirin. KA develops and commercializes certain of its and Kirin's technologies, which have been transferred to this joint venture. KA has given licenses to the company to manufacture and market: darbepoetin alfa in the United States, all European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, North Africa and the Middle East; pegfilgrastim and G-CSF in the United States, Europe, Canada, Australia and New Zealand; and recombinant human erythropoietin in the United States. The company is marketing darbepoetin alfa, pegfilgrastim, G-CSF and recombinant human erythropoietin under the brand names Aranesp, Neulasta, NEUPOGEN and EPOGEN, respectively.
KA has also given licenses to Kirin to manufacture and market: darbepoetin alfa in Japan, the People's Republic of China (China), Taiwan, Korea and certain other countries in Southeast Asia; G-CSF and pegfilgrastim in Japan, Taiwan and Korea; and recombinant human erythropoietin in Japan. Kirin markets G-CSF and recombinant human erythropoietin in China under a separate agreement with KA. Kirin markets its G-CSF product in its respective territories under the trademark GRAN. Kirin markets its recombinant human erythropoietin product in Japan under the trademark ESPO. KA has licensed to Johnson & Johnson rights to recombinant human erythropoietin in certain geographic areas of the world.
Johnson & Johnson: The company granted Johnson & Johnson a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all markets other than dialysis. In the United States, all recombinant human erythropoietin sold by Johnson & Johnson is manufactured by the company and sold by Johnson & Johnson under the trademark PROCRIT (Epoetin alfa). Outside the United States, with the exception of China and Japan, Johnson & Johnson was granted rights to manufacture and commercialize recombinant human erythropoietin as a human therapeutic for all uses under a licensing agreement with KA. With respect to its sales outside of the United States, Johnson & Johnson manufactures and commercializes its own brand of Epoetin alfa which is then sold throughout the world by Johnson & Johnson under various trademarks, such as EPREX and ERYPO.
Fresenius: In October 2006, the company entered into a five-year sole sourcing and supply agreement with an affiliate of Fresenius Medical Care North America, Inc. (Fresenius), on its behalf and on behalf of certain of its affiliates, to purchase, and the company has agreed to supply, all of Fresenius’ commercial requirements for erythropoietic stimulating proteins for use in managing the anemia of its hemodialysis patients in the United States and Puerto Rico.
Competition
The company's competitors include F. Hoffmann-La Roche, Ltd.; Shire Pharmaceuticals Group plc; Johnson & Johnson; Janssen-Cilag; Berlex, Inc.; MedImmune Oncology, Inc.; Chugai Pharmaceuticals Co., Ltd.; Sanofi-Aventis; Novartis AG; Kyowa Hakko Kogyo Co., Ltd.; Transkaryotic Therapies; Astellas Pharma, Inc.; FibroGen; Affymax, Inc.; Abbott Laboratories; Genzyme Corporation; Centocor, Inc./Schering Plough Corporation; Genentech, Inc.; Biogen IDEC, Inc.; Bristol-Myers Squibb Corporation; DAVA Pharmaceuticals, Inc.; Duramed Pharmaceuticals, Inc.; Connetics Corporation; GlaxoSmithKline plc; Pfizer, Inc.; Repligen Corporation; Taisho Pharmaceutical Co., Ltd.; Imclone Systems Incorporated; Merck & Co., Inc.; Procter & Gamble; and Eli Lilly and Company.
History
Amgen, Inc. was founded in 1980.
