Amgen 2010 Annual Report Download - page 52

The following text provides additional information about selected product candidates that have advanced into
human clinical trials.
AMG 386
AMG 386 is a peptibody that inhibits the interaction between the endothelial cell-selective Tie2 receptor and
its ligands Ang1 and Ang2. It is being investigated as a cancer treatment.
In 2007 and 2008, we initiated five randomized phase 2 studies of AMG 386 for the treatment of renal cell
carcinoma (“RCC”), metastatic breast cancer, ovarian cancer, gastric cancer and colorectal cancer, and numerous
other supportive studies. In June 2010 at a medical meeting, we presented the results from the phase 2 recurrent
ovarian cancer trial. Based on study results, we initiated a phase 3 study in recurrent ovarian cancer in 2010. We also
initiated a phase 1b study in first-line ovarian cancer in 2010. We are initiating other phase 2 studies in 2011.
Ganitumab (AMG 479)
Ganitumab (AMG 479) is a fully human monoclonal antibody antagonist of IGF-1 receptor. It is being
investigated as a cancer treatment.
In 2007, we initiated a phase 2 study of ganitumab (AMG 479) as a potential cancer therapeutic in Ewing’s
sarcoma. We also initiated, in 2008, phase 2 studies for the treatment of advanced breast, pancreatic, colorectal and
small cell lung cancers. We reported the results from the phase 2 Ewing’s sarcoma and pancreatic cancer studies at a
medical meeting in June 2010 and results from the breast cancer study at a meeting in December 2010. Results from
a study in mCRC in combination with Vectibix»were reported at a meeting in January 2011. We are initiating a
phase 3 study in first-line metastatic pancreatic cancer in 2011.
Aranesp»(darbepoetin alfa)
Aranesp»is a recombinant human protein agonist of the erythropoietin receptor.
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 planned), 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 and we anticipate completion of the study in 2012.
Motesanib
Motesanib is an orally-administered small molecule antagonist of vascular endothelial growth factor receptors
1, 2 and 3, platelet-derived growth factor receptors and stem cell factor receptor. It is being investigated as a cancer
treatment. We are developing this product in collaboration with Takeda/Millennium Pharmaceuticals.
Enrollment in the phase 3 first-line NSCLC study (MONET1) evaluating motesanib in combination with
paclitaxel and carboplatin for the first-line treatment of advanced NSCLC is complete. Based on current event rates,
we anticipate completion of the study in the first half of 2011.
At a medical meeting in June 2010, we shared the results of biomarkers as predictors of response to treatment
with motesanib or bevacizumab in combination with carboplatin/paclitaxel in patients with NSCLC or in
combination with paclitaxel in patients with locally recurrent or metastatic breast cancer.
Denosumab
Denosumab is a fully 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.
Denosumab is being studied across a range of conditions including osteoporosis, treatment-induced bone loss, RA
and numerous tumor types across the spectrum of cancer-related bone diseases.
Prolia»(denosumab)
The phase 3 study evaluating Prolia»patients with male osteoporosis is ongoing.
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