|Amgen Inc. (AMGN)
|Amgen Inc. Graph source Edgar Online Pro on April 10th, 2006
The Following data is sourced from the ANNUAL REPORT ON FORM 10-K For the Year Ended December 31, 2005 . The overview of the company was:
Amgen Inc., a biotechnology company, engages in the discovery, development, manufacture, and marketing of human therapeutics based on advances in cellular and molecular biology. It offers human therapeutic products in the areas of inflammation, nephrology, and supportive cancer care. The company’s principal products include Aranesp and EPOGEN, which stimulate the production of red blood cells to treat anemia; Neulasta and NEUPOGEN that stimulate the production of neutrophils, a white blood cell that enables the body fight infections; and Enbrel, which blocks the biologic activity of tumor necrosis factor (TNF) by inhibiting TNF, a substance induced in response to inflammatory and immunological responses, such as rheumatoid arthritis and psoriasis. The company offers its products to healthcare providers, including clinics, dialysis centers, hospitals, and pharmacies primarily in the United States, Europe, Canada, and Australia. It has a joint venture with Kirin Brewery Company, Limited, as well as a co-promotion agreement with Wyeth. The company was incorporated 1980 and is based in Thousand Oaks, California.
We market human therapeutic products in the areas of inflammation, nephrology, and supportive cancer care. Our principal products include Aranesp ® (darbepoetin alfa), EPOGEN ® (Epoetin alfa), Neulasta ® (pegfilgrastim), NEUPOGEN ® (Filgrastim), and Enbrel ® (etanercept), which is marketed under a co-promotion agreement with Wyeth in the United States and Canada. Aranesp ® and EPOGEN ® stimulate the production of red blood cells to treat anemia. 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 competitively inhibiting TNF, a substance induced in response to inflammatory and immunological responses, such as rheumatoid arthritis and psoriasis. For the years ended December 31, 2005, 2004, and 2003, our principal products represented 98%, 99%, and 99% of total product sales, respectively.
We maintain sales and marketing forces in the United States, Europe, Canada, and Australia. We market our principal products to healthcare providers including clinics, dialysis centers, hospitals, and pharmacies. In addition, we have entered into licensing and/or co-promotion agreements to market our principal products in certain geographic areas. In the United States, we sell primarily to wholesale distributors. Outside the United States, we sell principally to hospitals and/or wholesalers depending upon the distribution practice in each country. Sales of our principal products are dependent, in part, on the availability and extent of reimbursement from third-party payers, including governments and private insurance plans. Further, competition in all areas of our business is intense and is expected to increase.
We market our principal products in the areas of inflammation, nephrology, and supportive cancer care. Our principal products include Aranesp ® (darbepoetin alfa), EPOGEN ® (Epoetin alfa), Neulasta ® (pegfilgrastim), NEUPOGEN ® (Filgrastim), and Enbrel ® (etanercept).
Aranesp ® (darbepoetin alfa)
Aranesp ® is Amgen’s registered trademark for one of its novel erythropoiesis stimulating proteins, a protein that stimulates red blood cell production. Red blood cells transport oxygen to all cells of the body. Without adequate amounts of erythropoietin, the red blood cell count is reduced. A deficient red blood cell count could result in anemia, a condition where insufficient oxygen is delivered to the body’s organs and tissues. Anemia can be associated with chronic renal failure, both in patients on dialysis and not on dialysis. Anemia can also result from chemotherapy treatments for patients with nonmyeloid malignancies. Aranesp ® relieves anemia symptoms and reduces the need for blood transfusions.
We were granted an exclusive license by Kirin-Amgen, Inc. (“KA”), a joint venture between Kirin Brewery Company, Limited (“Kirin”) and Amgen (see “Joint Ventures and Business Relationships — Kirin Brewery Company, Limited”) 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.
We primarily market Aranesp ® in the United States and Europe. Darbepoetin alfa is also marketed under the brand name Nespo ® in Italy. Aranesp ® was initially launched in 2001 in the United States and Europe and is indicated for the treatment of anemia associated with chronic renal failure (both in patients on dialysis and patients not on dialysis) as well as for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
During 2005, we filed U.S. Food and Drug Administration (“FDA”) submissions requesting label changes to include extended dosing frequency in the treatment of chemotherapy-induced anemia and anemia associated with chronic renal failure.
Worldwide Aranesp ® sales for the years ended December 31, 2005, 2004, and 2003 were $3,273 million, $2,473 million, and $1,544 million, respectively.
EPOGEN ® (Epoetin alfa)
EPOGEN ® is Amgen’s registered 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 (see “— Aranesp ® (darbepoetin alfa)”). People with chronic renal failure suffer from anemia because they do not produce sufficient amounts of erythropoietin, which is normally produced in healthy kidneys.
We were granted an exclusive license to manufacture and market recombinant human erythropoietin in the United States under a licensing agreement with KA. We have retained exclusive rights to market EPOGEN ® in the United States for dialysis patients. We 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, hereafter referred to as “Johnson & Johnson”) a license to commercialize recombinant human erythropoietin as a human therapeutic in the United States in all markets other than dialysis (see “Joint Ventures and Business Relationships — Johnson & Johnson”). Johnson & Johnson markets recombinant human erythropoietin under the trademark PROCRIT ® in the United States (see Note 1, “Summary of significant accounting policies — Product sales” to the Consolidated Financial Statements).
We launched EPOGEN ® in the United States in 1989 for the treatment of anemia associated with chronic renal failure for patients who are on dialysis. 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.
EPOGEN ® sales for the years ended December 31, 2005, 2004, and 2003 were $2,455 million, $2,601 million, and $2,435 million, respectively.
Neulasta ® (pegfilgrastim)
Neulasta ® is Amgen’s 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 (see “— NEUPOGEN ® (Filgrastim))”. Neutrophils defend against infection. Treatments for various diseases and diseases themselves can result in extremely low numbers of neutrophils, a condition called neutropenia. Myelosuppressive chemotherapy, one treatment option for individuals with certain types of cancers, targets cell types that grow rapidly, such as tumor cells. Normal cells that also divide rapidly, such as those in the bone marrow that become neutrophils, are also vulnerable to the effects of cytotoxic chemotherapy, resulting in neutropenia with an increased risk of severe infection. Very often, neutropenia is the dose limiting side effect of chemotherapy and can thus be responsible for a reduction in the amount of chemotherapy that can be administered safely. Such reductions in chemotherapy dose can compromise the effectiveness of chemotherapy on the cancer it is being used to treat, with the result of a higher treatment failure rate. By addressing the dose limiting side effect of neutropenia, full doses of chemotherapy can be given, resulting in the potential for an improved treatment success rate in certain types of cancer such as early stage breast cancer and in intermediate grade non-Hodgkin’s Lymphomas. As mentioned above, the pegfilgrastim molecule is based on the Filgrastim molecule. A polyethylene glycol molecule or “PEG” is added to enlarge the Filgrastim molecule, thereby extending its half-life and causing it to be removed more slowly from the body. Because pegfilgrastim works by binding to its receptor on the neutrophils and its precursors, pegfilgrastim remains in the circulation until neutrophil recovery has occurred. This neutrophil-mediated clearance allows for administration as a single dose per chemotherapy cycle, compared with NEUPOGEN ® , which requires more frequent dosing. Neulasta ® is prescribed more frequently 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.
We were granted an exclusive license to manufacture and market pegfilgrastim in the United States, Europe, Canada, Australia, and New Zealand under a licensing agreement with KA.
We primarily market Neulasta ® in the United States and Europe. Pegfilgrastim is marketed under the brand name Neupopeg™ in Italy. Neulasta ® was initially launched in the United States and Europe in 2002 and is indicated for reducing the incidence of infection associated with chemotherapy-induced neutropenia in cancer patients with non-myeloid malignancies.
In September 2005, the FDA approved an update to the Neulasta ® prescribing information to include data from a landmark phase 3 study demonstrating that Neulasta ® helps protect patients with breast cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia. Administration of Neulasta ® in all cycles of chemotherapy is now approved for patients receiving myelosuppressive chemotherapy associated with at least a 17% risk of febrile neutropenia.
Worldwide Neulasta ® sales for the years ended December 31, 2005, 2004, and 2003 were $2,288 million, $1,740 million and $1,255 million, respectively.
NEUPOGEN ® (Filgrastim)
NEUPOGEN ® is Amgen’s registered trademark for its recombinant-methionyl human granulocyte colony-stimulating factor (“G-CSF”), a protein that selectively stimulates production of certain white blood cells known as neutrophils (see “— Neulasta ® (pegfilgrastim)”) for additional information on neutrophils). Similar to Neulasta ® , NEUPOGEN ® is prescribed more frequently 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.
We were granted an exclusive license to manufacture and market G-CSF in the United States, Europe, Canada, Australia, and New Zealand under a licensing agreement with KA.
We market NEUPOGEN ® primarily in the United States and Europe. Filgrastim is marketed under the brand name GRANULOKINE ® in Italy. NEUPOGEN ® was initially launched in the United States and Europe in 1991. NEUPOGEN ® is indicated for the following: to reduce the incidence of infection as manifested by febrile neutropenia for patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy; to reduce the duration of neutropenia and neutropenia-related consequences for patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of neutropenia-related consequences in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (collectively, severe chronic neutropenia); for use in mobilization of peripheral blood progenitor cells (“PBPC”) for stem cell transplantation; and to reduce the recovery time of neutrophils and the duration of fever following induction or consolidation chemotherapy treatment in adult patients with acute myelogenous leukemia (“AML”).
Worldwide NEUPOGEN ® sales for the years ended December 31, 2005, 2004, and 2003 were $1,216 million, $1,175 million, and $1,267 million, respectively.
Enbrel ® (etanercept)
ENBREL is Amgen’s registered 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. TNF is one of the chemical messengers that help regulate the inflammatory process. 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 is similar to a protein that the body produces naturally, and like this protein, it binds and deactivates certain TNF molecules before they can trigger inflammation.
We acquired the rights to ENBREL in July 2002 as part of our acquisition of Immunex Corporation (“Immunex”).
We market ENBREL under a co-promotion agreement with Wyeth in the United States and Canada (see “Joint Ventures and Business Relationships — Wyeth”). The rights to market ENBREL outside of the United States and Canada are reserved to Wyeth. ENBREL was initially launched in November 1998 by Immunex. In June 2005, the FDA approved an expanded indication for ENBREL as the first and only treatment to improve physical function in patients with psoriatic arthritis. In addition, the FDA approved an update to the ENBREL label to include new radiographic data demonstrating that ENBREL continued to inhibit the progression of joint destruction for two years among most psoriatic arthritis patients who received ongoing therapy. In addition to the approvals received in 2005, 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. ENBREL is approved in a 50 mg/ml pre-filled syringe as the recommended dosing form for treatment in all approved adult indications. The pre-filled syringe eliminates the need to mix drug prior to injecting and allows most patients receiving ENBREL to take only one injection per week, instead of two 25 mg injections previously used weekly by patients.
ENBREL sales for the years ended December 31, 2005, 2004, and 2003 were $2,573 million, $1,900 million, and $1,300 million, respectively.
Other marketed products are principally comprised of Sensipar ® (cinacalcet HCl). Sensipar ® is Amgen’s registered trademark for its first small molecule medicine used in treating chronic kidney disease (“CKD”) patients on dialysis who produce too much parathyroid hormone, a condition known as secondary hyperparathyroidism. Sensipar ® was initially launched in 2004 and is indicated for CKD patients on dialysis with secondary hyperparathyroidism as well as for the treatment of hypercalcemia in patients with parathyroid carcinoma. Cinacalcet HCl is marketed in Europe as Mimpara ® .
Sensipar ® sales for the years ended December 31, 2005 and 2004 were $157 million and $37 million, respectively.
Highlights of Risks Related to Our (AMGN) Business
For further detail please review the 10k report in detail.
1. Before we commercialize and sell any of our product candidates, we must conduct clinical trials in humans; if we fail to adequately manage these trials we may not be able to sell future products and our sales could be adversely affected.
2. Our product development efforts may not result in commercial products.
3. Our sales depend on payment and reimbursement from third-party payers, and, to the extent that reimbursement for our products is reduced, this could negatively impact the utilization of our products.
4. Certain of our raw materials, medical devices and components are single-sourced from third parties; third-party supply failures could adversely affect our ability to supply our products.
5. Our current products and products in development cannot be sold if we do not maintain regulatory approval and comply with manufacturing regulations.
6. We formulate, fill, and finish substantially all our products at our Puerto Rico manufacturing facility; if significant natural disasters or production failures occur at this facility, we may not be able to supply these products.
7. Difficulties, disruptions or delays in manufacturing may limit supply of our products and limit our product sales.
8. We are dependent on third parties for a significant portion of our bulk supply and the formulation, fill, and finish of ENBREL.
9. We have grown rapidly, and if we fail to adequately manage that growth our business could be adversely impacted.
10. Our marketed products face substantial competition and other companies may discover, develop, acquire or commercialize products before or more successfully than we do.
11. Concentration of sales at certain of our wholesaler distributors and consolidation of freestanding dialysis clinic businesses may negatively impact our bargaining power and profit margins.
12. Our marketing of ENBREL will be dependent in part upon Wyeth.
13. Our business may be impacted by government investigations or litigation.
14. We may be required to defend lawsuits or pay damages for product liability claims.
15. We may be required to perform additional clinical trials or change the labeling of our products if we or others identify side effects after our products are on the market.
16. Guidelines and recommendations published by various organizations can reduce the use of our products.
17. Our stock price is volatile, which could adversely affect your investment.
18. Our corporate compliance program cannot guarantee that we are in compliance with all potentially applicable U.S. federal and state regulations and all potentially applicable foreign regulations.
19. Our revenues may fluctuate, and this fluctuation could cause financial results to be below expectations.
20. We may not realize all of the anticipated benefits of our merger with Abgenix, Inc.
21. Continual manufacturing process improvement efforts may result in the carrying value of certain existing manufacturing facilities or other assets becoming impaired.
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