Amgen 2004 Annual Report Download - page 29

The U.S. Food and Drug Administration (FDA) approves
Amgen’s fi rst small-molecule therapy, Sensipar® (cinacalcet
HCl), for the treatment of secondary hyperparathyroidism
caused by chronic kidney disease. It is approved for the
same indication in Canada, and, under the name Mimpara®,
in Europe.
FDA approves Kepivance™ (palifermin) to decrease the
incidence and duration of severe oral mucositis (mouth sores)
in patients with hematologic (blood) cancers undergoing
high-dose chemotherapy, with or without radiation,
followed by bone marrow transplant. The safety and effi cacy
of Kepivance™ have not been established in patients with
non-hematologic malignancies.
The European Commission approves extended Aranesp®
(darbepoetin alfa) dosing intervals.
FDA approves the use of ENBREL® (etanercept) for the
treatment of adult (18 years or older) patients with chronic
moderate to severe plaque psoriasis who are candidates for
systemic therapy or phototherapy.
FDA approves a 50 mg/mL pre-fi lled syringe as the recom-
mended dosing form for ENBREL® for use in all approved
adult indications. The new pre-fi lled syringe eliminates the
need to mix the drug prior to injecting and allows many adult
patients receiving ENBREL® to take only one injection per
week, instead of two 25 mg injections per week.
Amgen initiates a landmark trial to evaluate the impact on
cardiovascular outcomes of treating anemia in patients with
chronic kidney disease and type 2 diabetes. TREAT (Trial
to Reduce cardiovascular Events with Aranesp® Therapy) is
one of the largest clinical trials in the company’s history.
Ten new molecules are cleared to enter development.
Amgen commences fi ve new fi rst-in-human clinical trials
in the United States and four in Japan.
Pivotal studies of Sensipar® and Kepivance™ are published
in the New England Journal of Medicine.
Phase 3 trials begin for AMG 162, a fully human monoclonal
antibody being investigated for potential use in postmeno-
pausal osteoporosis and treatment-induced bone loss. The trials,
in which Amgen intends to enroll thousands of patients, will
be the largest ever conducted by the company.
FDA grants fast-track designation to AMG 706, an investiga-
tional anti-cancer therapy, and AMG 531, a potential treatment
for immune thrombocytopenic purpura (a bleeding disorder).
Amgen acquires South San Francisco-based Tularik Inc.,
a pioneer in drug discovery related to cell signaling and the
control of gene expression.
Helix, a state-of-the-art biotechnology research campus,
opens at Amgen’s Seattle site.
Amgen launches Amgen Ventures, a $100 million venture
capital fund that invests in early-stage human therapeutics
and biotechnology companies.
The company continues to advance major expansions of
its manufacturing facilities in Puerto Rico and Rhode Island,
on schedule.
The Amgen Foundation gives more than $16 million to
advance science education, improve quality of care and access
for patients, and support vital community resources. The
company gives $125 million in product donations and tens
of millions in corporate cash giving. The Amgen Foundation
expands by launching a giving program in Puerto Rico.
In the wake of the devastating tsunami that struck southern
Asia on December 26, Amgen makes a $1.25 million cash
donation to the International Federation of Red Cross and
Red Crescent Societies, and the Amgen Foundation provides
a dollar-for-dollar match for contributions made by staff.
Amgen is named “Company of the Year” by Forbes, which
reports that “Amgen is on the verge of a research renaissance.”
Amgen is again included in Fortune’s “Best Companies to
Work For” list and in Science magazine’s annual survey of top
employers in the biotechnology and pharmaceutical industries.
In addition, Amgen is chosen by The Scientist as one of the
“Best Places to Work in Industry.”
Facing page (clockwise, from top left )
At Amgen San Francisco, from left to right, Tassie Collins,
senior principal scientist; Frank Kayser, senior principal scientist;
and Dan Lin, senior scientist
At Amgen Australia, from left to right, Max Colao, director
of Sales and Marketing; Kaylene O’Shea, director of Scientifi c
Affairs; and Russell Edwards, regional director, Southeast Asia,
Amgen Australia Pty Ltd.
Jewell Sparks, Infl ammation sales representative, California
Kepivance™ packaging and vial
At Amgen France, from left to right, Philippe Kiefer, medical
leader; Valerie Bouchara, development operations manager;
and Sylvie Lanniaux, customer service associate
Volunteering at a food bank in Boulder, Colorado, from left to
right, Terry Quirk, site security manager for Amgen Colorado,
and Hunyen Lee, engineering project manager
Amgen 2004 highlights
Amgen 2004 Annual Report page 27