Amgen 2009 Annual Report Download - page 46

In 2009, we initiated phase 2 studies of AMG 785 for the treatment of PMO and fracture healing.
AMG 827
AMG 827 is a fully human monoclonal antibody that binds to and blocks signaling via the interleukin-17
(“IL-17”) receptor. It is being investigated as a treatment for a variety of inflammatory disorders.
In 2009, we initiated phase 2 studies of AMG 827 as a potential treatment for psoriasis and RA. We expect
data from the phase 2 study in psoriasis to be available in 2010.
AMG 853
AMG 853 is an orally-administered small molecule antagonist of the CRTH2 and D-prostanoid receptors of
prostaglandin D2. It is being investigated as a treatment for asthma.
Phase 1 single- and multiple-ascending dose studies have been completed. A global, randomized, double-
blind, placebo controlled, multiple dose phase 2 study in subjects with inadequately controlled asthma was
initiated in December 2009.
Aranesp®(darbepoetin alfa)
Aranesp®is a recombinant human protein agonist of the erythropoietic receptor.
In 2009, we announced the results from TREAT, the large, randomized, double-blind, placebo-controlled,
phase 3 study of patients with CKD (not requiring dialysis), anemia and type-2 diabetes. Treatment of anemia
with Aranesp®to a Hb target of 13 g/dL failed to meet either of two primary endpoints compared with placebo
treatment with Aranesp®when the Hb level was less than 9 g/dL. The two primary endpoints were a composite
of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke or hospital-
ization for myocardial ischemia) and a composite of time to all-cause mortality or chronic renal replacement
therapy. Among the components of the TREAT outcomes measures, stroke was more likely to occur in the pa-
tients who received Aranesp®(101 patients [5.0%] versus 53 patients [2.6%]; Hazard Ratio (“HR”): 1.92 [95%
Confidence Interval (“CI”) 1.38 to 2.68; P<0.001]). Although stroke has been noted in the Aranesp®label since
2001, the risk of stroke observed in TREAT was of a higher magnitude than that seen in previous clinical trials in
CKD patients not on dialysis. Further, among patients who reported a history of cancer, there were 60 deaths
from any cause in the 188 patients assigned to Aranesp®and 37 deaths in the 160 patients assigned to placebo
(P=0.13 by the log-rank test). In this subgroup, 14 of the 188 patients assigned to Aranesp®died from cancer, as
compared with 1 of the 160 patients assigned to placebo (P=0.002 by the log-rank test). Aranesp®treatment was
associated with a statistically significant reduction in blood transfusions.
The Reduction of Events with Darbepoetin alfa in Heart Failure (“RED-HF™”) Trial phase 3 study, initiated
in 2006, is a large (2,600 subjects), 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 subjects. On December 8, 2009, the RED-HF™
Trial Data Monitoring Committee (“DMC”) reviewed approximately 43% of the target number of primary end-
points. After careful review of outcomes and adverse events, including the results of TREAT (which was
conducted in subjects with CKD, anemia and type 2 diabetes who were not receiving dialysis), the RED-HF™
Trial DMC recommended that the study continue as designed.
Conatumumab (AMG 655)
Conatumumab is a fully human monoclonal antibody agonist that targets death receptor 5 (“DR5”) and in-
duces apoptosis in sensitive tumor cells. It is being investigated as a cancer treatment.
We received the results from the phase 2 NSCLC and the soft tissue sarcoma studies in the second half of
2009 and we continue to analyze the data. We also received results from the phase 2 pancreatic cancer study and
we plan to present the results at an upcoming medical meeting. We expect data from an on-going phase 2 study
in mCRC to be available in 2010.
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