Amgen 2007 Annual Report Download - page 34

AMG 222
AMG 222 targets inhibition of DPP-IV for the treatment of type II diabetes. We acquired the rights to this
compound in 2007 through our acquisition of Alantos. A phase 2a study is ongoing in this disease setting in col-
laboration with Servier, which owns the rights outside the United States.
General Medicine
Aranesp®(darbepoetin alfa)
The Trial to Reduce Cardiovascular Events with Aranesp®Therapy (“TREAT”) phase 3 study, initiated in
2004, is a large (4,000 patient), multi-center, randomized, double-blind, controlled trial designed to determine the
impact of anemia therapy with darbepoetin alfa on mortality and non-fatal cardiovascular events in patients with
CKD, anemia and type 2 diabetes. In July 2007, we disclosed that the independent Data Safety Monitoring
Committee (“DSMC”) completed a pre-specified, unblinded review of the data at a point where 40% of the tar-
geted number of fully adjudicated events had been recorded. The DSMC recommended that the study continue
without modification. In December 2007, the TREAT study completed enrollment.
The Reduction of Events with Darbepoetin alfa in Heart Failure (“RED-HF™”) Trial phase 3 study, ini-
tiated in 2006, is a large (3,400 patient), global, randomized, double-blind, placebo-controlled study to evaluate
the effect of treatment of anemia with darbepoetin alfa on morbidity and mortality in patients with symptomatic
left ventricular heart failure. The RED-HF™ Trial continues to enroll patients.
AMG 223
AMG 223 is a novel polymeric phosphate binder being evaluated for the treatment of hyperphosphatemia in
CKD patients on hemodialysis. We acquired the rights to this compound in 2007 through our acquisition of Ilyp-
sa. A phase 2 study in this disease setting was completed by Ilypsa in 2007. We are currently conducting a phase
2b study in this disease setting.
Other Programs
Kepivance®(palifermin)
Kepivance®is approved to decrease the incidence and duration of severe oral mucositis (mouth sores) in pa-
tients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without irradiation,
followed by bone marrow transplant. In January 2008, we disclosed results from a preliminary analysis of two
clinical studies, in resected and unresected HNC. Kepivance®met its primary endpoint of reducing the incident
of severe oral mucositis in patients who are undergoing chemotherapy. At the same time we also saw a trend fa-
voring a reduction in duration and severity of oral mucositis and the use of narcotic analgesics. However these
trends when adjusted for multiple comparisons were not statistically significant. The safety profile for Kepiv-
ance®in this setting was similar to what was seen in the placebo treated patient. We also have ongoing phase 2
studies to determine safety and anti-mucositis activity in patients receiving radiation and/or chemotherapy for
NSCLC and colon cancer.
Competition
The competitive environment among biotechnology, pharmaceutical and other companies that research, de-
velop, manufacture or market biologics and pharmaceuticals is intense and increasing. We compete with these
entities in all areas of our business, including attracting and retaining qualified scientific, technical and opera-
tional personnel. (See “Item 1A. Risk Factors — Our marketed products face substantial competition and other
companies may discover, develop, acquire or commercialize products before or more successfully than we do.”)
Our products’ competitive position among other biologic and pharmaceutical products may be based on,
among other things, patent position, product efficacy, safety, reliability, availability, patient convenience/delivery
devices, price and reimbursement. Certain of our products face substantial competition from products marketed by
large pharmaceutical corporations, which may have greater clinical, research, regulatory, manufacturing, marketing,
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