Amgen 2012 Annual Report Download - page 35

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28
Phase 1 clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects.
Phase 2 clinical trials investigate side effect profiles and efficacy of a product candidate in a large number of patients who have the disease or condition
under study.
Phase 3 clinical trials investigate the safety and efficacy of a product candidate in a large number of patients who have the disease or condition under study.
The following text provides additional information about selected product candidates that have advanced into human clinical
trials.
AMG 145
AMG 145 is a human monoclonal antibody that inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9). It is being
investigated as a treatment for hyperlipidemia.
Phase 2 study results evaluating AMG 145 were reported at a medical meeting in November 2012 in the following four
areas: as monotherapy, in combination with statin therapy, in heterozygous familial hypercholesterolemia, and in statin-intolerant
subjects. Based on the study results, phase 3 enrollment is underway in these populations.
Aranesp® (darbepoetin alfa)
Aranesp® is a recombinant human protein agonist of the erythropoietin receptor.
The phase 3 study of Aranesp® for the treatment of low risk myelodysplastic syndromes is ongoing.
Brodalumab
Brodalumab is a human monoclonal antibody that inhibits the interleukin-17 receptor. It is being investigated as a treatment
for a variety of inflammatory diseases. Brodalumab is one of five inflammation monoclonal antibodies being jointly developed
in collaboration with AstraZeneca.
In 2012, we initiated three phase 3 studies for the treatment of psoriasis. We completed our phase 2 study in psoriatic arthritis
in 2012. Brodalumab is also being evaluated for the treatment of asthma.
Denosumab
Denosumab is a human monoclonal antibody that specifically targets a ligand known as RANKL (that binds to a receptor
known as RANK) which is a key mediator of osteoclast formation, function, and survival. It is being investigated across a range
of conditions including osteoporosis, treatment-induced bone loss, RA and numerous tumor types across the spectrum of cancer-
related bone diseases, including hypercalcemia of malignancy.
Prolia® (denosumab)
In September 2012, Prolia® was approved by the FDA for the treatment to increase bone mass in men with osteoporosis at
high risk for fracture in the US. A phase 3 study of Prolia® for the treatment of glucocorticoid-induced osteoporosis was initiated
in 2012.
XGEVA® (denosumab)
In June 2012, we submitted a marketing application to the EMA for XGEVA® to treat men with castration-resistant prostate
cancer at high risk of developing bone metastases.
In December 2012, we submitted marketing applications to the FDA and EMA for XGEVA® for the treatment of GCTB in
adults or skeletally mature adolescents.
Phase 3 studies for the delay or prevention of bone metastases in patients with adjuvant breast cancer and prevention of SRE
in patients with multiple myeloma are ongoing.
Rilotumumab
Rilotumumab is a human monoclonal antibody that inhibits the action of hepatocyte growth factor/scatter factor. It is being
investigated as a cancer treatment.
In 2012, we initiated a phase 3 study for the treatment of gastric cancer.