Amgen Inc.'Is a global biotechnology company that discovers, develops, manufactures,
and markets human therapeutics based on advances in cellular and molecular biology.
On July'15, 2002, Amgen acquired all of the outstanding common stock of Immunex
Corporation ('Immunex') for stock and cash valued at $17.8'billion in a transaction
accounted for as a business combination. Immunex was a leading biotechnology company
dedicated to developing immune system science to protect human health. The acquisition
has enhanced Amgen's strategic position within the biotechnology industry by strengthening
and diversifying its (1)'product base and product pipeline in key therapeutic
areas, and (2)'discovery research capabilities in proteins and antibodies.
The Company markets human therapeutic products in the areas of hematology,
oncology, and inflammation. The Company's key products include EPOGEN' (Epoetin
alfa), Aranesp' (darbepoetin alfa), Neulasta' (pegfilgrastim), NEUPOGEN' (Filgrastim),
and ENBREL' (etanercept), which is marketed under a co-promotion agreement with
Wyeth. The Company's other products include Kineret' (anakinra)'and Stemgen'
(Ancestim).
EPOGEN' and Aranesp' stimulate the production of red blood cells. EPOGEN' is
marketed in the United States for the treatment of anemia associated with chronic
renal failure in patients on dialysis. Aranesp' is marketed in the United States,
most countries in Europe, Australia, and New Zealand for the treatment of anemia
associated with chronic renal failure, including patients on dialysis and patients
not on dialysis. Aranesp' is also marketed in the United States for the treatment
of chemotherapy-induced anemia in patients with non-myeloid malignancies. Aranesp'
is marketed in Europe for the treatment of anemia in adult cancer patients with
solid tumors receiving chemotherapy and for the treatment of chemotherapy-induced
anemia in adult patients with non-myeloid malignancies.
Neulasta' and NEUPOGEN' selectively stimulate the production of neutrophils,
one type of white blood cell. Neulasta' is marketed in the United States to
decrease the incidence of infection, as manifested by febrile neutropenia in
patients with non-myeloid malignancies receiving myelosuppressive anti-cancer
drugs associated with a clinically significant incidence of febrile neutropenia.
Neulasta' is marketed in most countries in Europe for the reduction in the duration
of neutropenia and the incidence of febrile neutropenia in patients with cytotoxic
chemotherapy for malignancy. NEUPOGEN' is marketed in the United States, certain
countries in Europe, Canada, and Australia for use in decreasing the incidence
of infection in patients undergoing myelosuppressive chemotherapy. In addition,
NEUPOGEN' is marketed in most of these countries for use in increasing neutrophil
counts in various other treatment modalities.
ENBREL' blocks the biologic activity of tumor necrosis factor ('TNF') by competitively
inhibiting TNF, a substance induced in response to inflammatory and immunological
responses. ENBREL' is marketed in the United States for reducing the signs and
symptoms, improving physical function, and inhibiting the progression of structural
damage in patients with moderately to severely active rheumatoid arthritis;
and for reducing the signs and symptoms and inhibiting the progression of structural
damage in patients with psoriatic arthritis. In addition, ENBREL is approved
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; and to treat the signs and symptoms
in patients with active ankylosing spondylitis.
The Company maintains a sales and marketing force in the United States, Europe,
Canada, Australia, and New Zealand. In addition, Amgen has entered into licensing
and/or co-promotion agreements to market certain of its products including Aranesp',
Neulasta', NEUPOGEN', and ENBREL' in certain geographic areas outside of the
United States.
The Company focuses its research and development ('R&D') efforts on human
therapeutics delivered in the form of proteins, monoclonal antibodies, and small
molecules in the areas of hematology, oncology, inflammation, metabolic and
bone disorders, and neuroscience. The Company has research facilities in the
United States, and has clinical development staff in the United States, Europe,
Canada, Australia, and Japan. In addition to internal R&D efforts, the Company
has acquired certain product and technology rights and has established R&D
collaborations.
The Company manufactures EPOGEN', Aranesp', Neulasta', NEUPOGEN', and ENBREL'.
Amgen operates commercial manufacturing facilities located in the United States,
Puerto Rico, and a packaging and distribution center in the Netherlands. Additional
supply of ENBREL' is produced by our contract manufacturer, Boehringer Ingelheim
Pharma KG ('BI'Pharma').
Any products or technologies that are directly or indirectly successful in
addressing anemia could negatively impact the market for EPOGEN' and Aranesp'.
Aranesp' directly competes with other currently marketed products which treat
anemia, including EPOGEN' and the recombinant human erythropoietin product marketed
by Johnson'& Johnson. Aventis Pharmaceuticals Inc. ('Aventis') is developing
gene-activated erythropoietin for the treatment of anemia. Baxter International
Inc. ('Baxter') is developing epoetin omega for the treatment of anemia. Roche
is developing a pegylated erythropoietin product for the treatment of anemia.
Any products or technologies that are directly or indirectly successful in
addressing anemia associated with chemotherapy could negatively impact the market
for Aranesp'. In the United States, Aranesp' directly competes with other currently
marketed products which treat anemia associated with chemotherapy, including
the recombinant human erythropoietin product marketed by Johnson'& Johnson.
In Europe, Aranesp' directly competes with other erythropoietin products marketed
by Ortho Biotech/Janssen-Cilag/Johnson'& Johnson and Roche in the oncology
setting.
Chugai Pharmaceuticals Co., Ltd. ('Chugai') markets a G-CSF product in Japan
as an adjunct to chemotherapy and as a treatment for bone marrow transplant
('BMT') patients. Chugai and Aventis market a G-CSF product in certain EU countries
as an adjunct to chemotherapy and as a treatment in BMT settings. Chugai, through
its licensee, AMRAD, markets this G-CSF product in Australia as an adjunct to
chemotherapy and as a treatment for BMT patients. Under an agreement with Amgen,
Chugai is precluded from selling its G-CSF product in the United States, Canada,
and Mexico.
ENBREL' and PEG-sTNF-R1 could face competition in some circumstances from a
number of companies developing or marketing rheumatoid arthritis and psoriatic
arthritis treatments. Current anti-arthritic treatments include generic methotrexate
and other products marketed by, among others, Centocor, Inc./Johnson'& Johnson,
Abbott Laboratories ('Abbott'), Merck, Pfizer, Novartis, Aventis, and Sanofi-Synth'labo.
In addition, a number of companies have cytokine inhibitors in development including
GlaxoSmithKline, Pfizer, and Taisho Pharmaceutical Co., Ltd. Amgen is currently
developing ENBREL' for the treatment of psoriasis. If ENBREL' is approved for
this indication, it may compete with products marketed by Biogen, Genentech,
and Johnson'& Johnson.
SensiparTM could face competition from products currently marketed by Abbott,
Bone Care International, Inc., Genzyme Corporation, and Roche which treat secondary
HPT. In addition, another product to treat HPT is currently being developed
by Chugai.
The GDNF program could face competition from a deep brain stimulation device
currently marketed by Medtronic Inc.