Profile: Amgen Inc (AMGN.O)
11 Jul 2014
Amgen Inc., incorporated on October 31, 1986, is a global biotechnology pioneer that discovers, develops, manufactures and delivers human therapeutics. Its medicines help millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis (RA), bone disease, and other serious illnesses. On December 10, 2012, the Company acquired all of the outstanding stock of deCODE Genetics (deCODE). In July 5, 2012, the Company acquired KAI Pharmaceuticals, a privately held company based in South San Francisco. In June 12, 2012, the Company acquired substantially all of the outstanding stock of Mustafa Nevzat Pharmaceuticals (MN). In March 7, 2012, the Company acquired Micromet, Inc. (Micromet), a publicly held biotechnology company focused on the discovery, development and commercialization of antibody-based therapies for the treatment of cancer. In September 2013, Swedish Orphan Biovitrum AB (publ) (Sobi) announced that they have acquired the full rights to develop and commercialize Kineret (anakinra) from Amgen Inc for all therapeutic indications.
The Company’s principal products include Neulasta, NEUPOGEN, ENBREL, Aranesp, EPOGEN, XGEVA and Prolia. Its principal products are Neulasta (pegfilgrastim), a pegylated protein, based on the Filgrastim molecule, and NEUPOGEN (Filgrastim), a recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF), both of which stimulate the production of neutrophils (a type of white blood cell that helps the body fight infection); Enbrel (etanercept), an inhibitor of tumor necrosis factor (TNF), a substance that plays a role in inflammatory diseases; Aranesp (darbepoetin alfa) and EPOGEN (epoetin alfa), erythropoiesis-stimulating agents (ESAs) that stimulate the production of red blood cells; and XGEVA/Prolia (denosumab), two products that contain the same active ingredient but which are approved for different indications, patient populations, doses and frequencies of administration. In addition to its marketed products, the Company has various product candidates in mid-to late-stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone health, nephrology, cardiovascular and general medicine, which includes neuroscience.
Neulasta (pegfilgrastim)/NEUPOGEN (Filgrastim)
The Company has granted a license to manufacture and market Neulasta and NEUPOGEN in the United States, Europe, Canada, Australia and New Zealand under a licensing agreement with Kirin-Amgen, Inc. (K-A), a joint venture between Kirin Holdings Company, Limited (Kirin) and Amgen. Neulasta and NEUPOGEN stimulate production of neutrophils, a type of white blood cell in the body’s fight against infection. NEUPOGEN is registered for Filgrastim, its recombinant-methionyl human G-CSF. Neulasta is registered for pegfilgrastim, a pegylated protein based on the Filgrastim molecule. A polyethylene glycol molecule is added to the Filgrastim molecule to make pegfilgrastim.
The Company markets Neulasta and NEUPOGEN in the United States and Europe. of infection as manifested by febrile neutropenia for patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy associated with a incidence of severe neutropenia with fever; reducing the duration of neutropenia and neutropenia-related consequences for patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; reducing the incidence and duration of neutropenia-related consequences in symptomatic patients with congenital neutropenia, cyclic neutropenia or idiopathic neutropenia (collectively, severe chronic neutropenia); mobilizing peripheral blood progenitor cells (PBPC) in cancer patients who have undergone myeloablative chemotherapy for stem cell transplantation; and reducing the recovery time of neutrophils and the duration of fever following induction or consolidation chemotherapy treatment in adult patients with acute myeloid leukemia (AML).
ENBREL is registered for etanercept, the Company’s TNF receptor fusion protein, which inhibits the binding of TNF to its receptors, which can result in reduction in inflammatory activity. TNF is a chemical messengers. When the body produces too much TNF, it overwhelms the immune system’s ability to control inflammation of the joints or of psoriasis-affected skin areas. ENBREL binds certain TNF molecules before they can trigger inflammation. It markets ENBREL under a collaboration agreement with Pfizer Inc. (Pfizer) in the United States and Canada.
The Company’s Aranesp and EPOGEN are registered for darbepoetin alfa and epoetin alfa, respectively, both of which are proteins, which stimulate red blood cell production in a process known as erythropoiesis. The Company was granted an exclusive license by K-A to manufacture and market Aranesp in the United States, all European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East. It markets Aranesp in the United States and Europe. Aranesp was launched in the United States and Europe for the treatment of anemia associated with chronic renal failure (CRF) (both in patients on dialysis and patients not on dialysis) and is also indicated for the treatment of anemia due to concomitant chemotherapy in patients with non-myeloid malignancies.
Aranesp (darbepoetin alfa)
The Company is granted an exclusive license by K-A to manufacture and market Aranesp in the United States, all European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East. Any products or technologies that are directly or indirectly addressing anemia associated with chemotherapy and/or renal failure could negatively impact Aranesp sales.
EPOGEN (epoetin alfa)
The Company granted an exclusive license to manufacture and market EPOGEN in the United States under a licensing agreement with K-A. The Company have retained exclusive rights to market EPOGEN in the United States for dialysis patients. The Company granted Ortho Pharmaceutical Corporation, a subsidiary of Johnson & Johnson (J&J), a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all indications other than dialysis.
XGEVA and Prolia, both of which contain the same active ingredient but which are approved for different indications, patient populations, doses and frequencies of administration. the Company have a collaboration agreement with Glaxo Group Limited (Glaxo), a wholly owned subsidiary of GlaxoSmithKline plc (GSK), for the commercialization of denosumab in certain countries.
XGEVA is 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. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.
Prolia is 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. It is also for patients who have failed or are intolerant to other available osteoporosis therapy.
Other Marketed Products
The Company’s other marketed products include Sensipar/Mimpara (cinacalcet), Vectibix (panitumumab) and Nplate (romiplostim). Sensipar is its registered trademark in the United States and Mimpara is its registered trademark in Europe for cinacalcet, its small molecule medicine used in treating CKD patients on dialysis who produce too much parathyroid hormone (PTH), a condition known as secondary hyperparathyroidism. Vectibix is its registered trademark for panitumumab, its monoclonal antibody for the treatment of patients with EGFr expressing metastatic colorectal cancer (mCRC) after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens. EGFr is a protein that plays an important role in cancer cell signaling and is over-expressed in many human cancers. Vectibix binds with high affinity to EGFrs and interferes with signals that might otherwise stimulate growth and survival of the cancer cell. Nplate for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP)
The Company competes with Bayer HealthCare Pharmaceuticals, Chugai Pharmaceuticals Co., Ltd., Sanofi-Aventis, Teva Pharmaceutical, rzneimittel GmbH, Teva Pharmaceutical Industries Ltd., Sandoz GmbH, Hexal Biotech Forschungs GmbH, Hospira Inc., J&J, Merck & Company, Inc., Abbott Laboratories, UCB/ Nektar Therapeutics (Nektar), Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Stada Arzneimittel AG, Medice Arzneimittel Putter GmbH & Co. KG, CT Arzneimittel, Genzyme Corporation, Roxane Laboratories, Fresenius Medical Care, Shire Pharmaceuticals Group Plc, Affymax, Inc., Shire Pharmaceuticals Group Plc, Eli Lilly, BMS, Merck KGaA, GSK, Warner Chilcott PLC, Novartis AG and Pfizer.
One Amgen Center Drive
THOUSAND OAKS CA 91320-1799