Full Description

Amgen Inc. (AMGN.O) (Nasdaq)
As of  20 Nov 2009
55.38USD
Price Change
-0.68
Percent Change
-1.21%
 
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Amgen Inc., incorporated in 1980, is a biotechnology company that discovers, develops, manufactures and markets human therapeutics-based on advances in cellular and molecular biology. The Company operates in human therapeutics. It markets human therapeutic products in the areas of supportive cancer care, nephrology and inflammation. Its principal products include Aranesp (darbepoetin alfa), EPOGEN (Epoetin alfa), Neulasta (pegfilgrastim), NEUPOGEN (Filgrastim) and Enbrel (etanercept). Aranesp and EPOGEN stimulate the production of red blood cells to treat anemia and belong to a class of drugs referred to as erythropoiesis-stimulating agents (ESAs). On January 4, 2008, the Company completed the acquisition of Dompe Biotec, S.p.A.

Aranesp is used for the treatment of anemia both in supportive cancer care and in nephrology. EPOGEN is used to treat anemia associated with chronic renal failure (CRF). Neulasta and NEUPOGEN selectively stimulate the production of neutrophils, one type of white blood cell that helps the body fight infections. ENBREL blocks the biologic activity of tumor necrosis factor (TNF) by inhibiting its binding to TNF receptors, a substance induced in response to inflammatory and immunological responses, such as rheumatoid arthritis and psoriasis. During the year ended December 31, 2008, its principal products represented 94% of total product sales.

The Company maintains sales and marketing forces primarily in the United States, Europe and Canada. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies. It markets ENBREL under a co-promotion agreement with Wyeth in the United States and Canada (Joint Ventures and Business Relationships-Wyeth). In addition, it 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 of pharmaceutical products. Outside the United States, it sells principally to hospitals and/or wholesalers depending upon the distribution practice in each country.

The Company focuses its research and development (R&D) efforts on therapeutics for the treatment of grievous illness in the core areas of oncology, inflammation, bone, metabolic disorders and neuroscience. Its research takes a modality-independent approach to drug discovery, in which it chooses the possible approach to block a specific disease process before considering the type of drug (modality) that may be required to pursue that approach. It studies molecules across a range of modalities in the areas of proteins (sometimes referred to as large molecules), including monoclonal antibodies and peptibodies, and small molecules. It has major R&D centers in several locations throughout the United States and in the United Kingdom, as well as, smaller R&D centers in certain other countries throughout the world.

The Company’s manufacturing operations consist of bulk manufacturing, formulation, fill and finish activities, which produce Aranesp, Epoetin alfa, Neulasta, NEUPOGEN, ENBREL and other marketed products and product candidates for both commercial and clinical purposes. It operates commercial and clinical manufacturing facilities in several locations throughout the United States and in Puerto Rico, as well as performs certain finishing activities in the Netherlands. Third-party contractors manufacture some or all of certain of its marketed products and/or product candidates.

Aranesp

Aranesp is the Company’s registered trademark for one of its erythropoiesis-stimulating proteins, a protein that stimulates red blood cell production. The Company was granted a license by Kirin-Amgen, Inc. (KA), a joint venture between Kirin Holdings Company, Limited (Kirin) and Amgen, 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. It markets Aranesp primarily in the United States and Europe. Darbepoetin alfa is also marketed under the brand name Nespo in Italy.

EPOGEN

EPOGEN is the Company’s registered trademark for its recombinant human erythropoietin product, a protein that stimulates red blood cell production. It was granted a license to manufacture and market recombinant human erythropoietin in the United States under a licensing agreement with KA. The Company markets EPOGEN for the treatment of anemic adult and pediatric patients with CRF who are on dialysis.

Neulasta (pegfilgrastim)/NEUPOGEN (Filgrastim)

Neulasta is its registered trademark for a pegylated protein that selectively stimulates production of certain white blood cells known as neutrophils and is based on the Filgrastim molecule. It markets Neulasta and NEUPOGEN primarily in the United States and Europe. NEUPOGEN is the Company’s registered trademark for its recombinant-methionyl human granulocyte colony-stimulating factor (G-CSF), a protein that selectively stimulates production of of neutrophils. It markets NEUPOGEN primarily in the United States, Europe and Canada. Filgrastim is marketed under the brand name GRANULOKINE in Italy. Filgrastim is also marketed under the brand name GRANULOKINE in Italy.

Enbrel

ENBREL is the Company’s registered trademark for its TNF receptor fusion protein that inhibits the binding to TNF receptors, which can result in a significant reduction in inflammatory activity. It markets ENBREL under a co-promotion agreement with Wyeth in the United States and Canada.

Other

The Company’s other marketed products comprises Sensipar (cinacalcet), Vectibix (panitumumab) and Nplate (romiplostim). Sensipar is the Company’s registered trademark in the United States and Mimpara is its registered trademark in Europe, for the Company’s first small molecule medicine used in treating CKD patients on dialysis who produce too much parathyroid hormone, a condition known as secondary hyperparathyroidism. Vectibix is the Company’s trademark for its first entirely human monoclonal antibody for the treatment of patients with Epidermal Growth Factor Receptors (EGFr) expressing metastatic colorectal cancer (mCRC) after disease progression on, or following fluoropyrimidine-, oxaliplatin- and irinotecan- containing chemotherapy regimens.

On August 22, 2008, the Food and Drug Administration of Untied States (FDA) approved Nplate, the platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the FDA approved peptibody protein, works by raising and sustaining platelet counts. On February 6, 2009, the Company announced that the European Commission granted marketing authorization for Nplate for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (such as corticosteroids, immunoglobulins).

The Company competes with Johnson & Johnson, Hospira Enterprise B.V., Stada Arzneimittel AG, Sandoz GmbH, Hexal Biotech Forschungs GmbH, Medice Arzneimittel Putter GmbH & Co. KG, F.Hoffmann-La Roche Ltd., Shire Pharmaceutical Group Plc, Bayer HealthCare Pharmaceuticals, Chugai Pharmaceuticals Co., Ltd., Sanofi-Aventis Novartis AG, Ratiopharm, CT Arzneimittel, Teva, Procter & Gamble, Eli Lilly and Company, Merck & Company, Inc., Centocor, Inc., Schering Plough Corporation, Abbott Laboratories, Duramed Pharmaceuticals, Inc., DAVA Pharmaceuticals, Inc., Genentech, Inc., Biogen IDEC Inc., Genzyme Corporation and Connetics Corporation.

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