Amgen 2007 Annual Report Download - page 33

Inflammation
AMG 108
AMG 108 is a fully human monoclonal antibody that targets inhibition of the action of interleukin-1
(“IL-1”), a cytokine known to play a role in the joint destruction associated with rheumatoid arthritis. We re-
cently completed a phase 2 clinical study to investigate the treatment of rheumatoid arthritis and are evaluating
the results. We are also evaluating AMG 108 for the treatment of type II diabetes.
AMG 317
AMG 317 is a fully human monoclonal antibody that is under investigation for its ability to block the ac-
tions of interleukin-4 (“IL-4”) and interleukin-13 (“IL-13”), cytokines that are believed to play a role in asthma.
We completed phase 1 clinical studies evaluating the safety and tolerability of AMG 317. In 2007, we initiated
phase 2 dose-ranging studies in patients with moderate to severe asthma.
Bone
Denosumab
Denosumab is a fully human monoclonal antibody that specifically targets the receptor activator of nuclear
factor kappa B ligand (“RANKL”), a key mediator of the cells responsible for bone breakdown. Denosumab is
being studied across a range of conditions, including osteoporosis, treatment-induced bone loss, bone metastases,
rheumatoid arthritis, and multiple myeloma.
Currently, we are conducting a number of phase 3 studies of denosumab in the treatment of PMO. In 2007,
we disclosed that the 48 month data from our phase 2 PMO treatment study met primary and all secondary end-
points. We also disclosed that the phase 3 PMO prevention study met primary and all secondary endpoints. In
January 2008, we disclosed that the head-to-head study comparing the effects of twice-yearly subcutaneous in-
jections of denosumab versus weekly oral doses of alendronate (FOSAMAX®) on bone mineral density
(“BMD”) in postmenopausal women with low BMD met primary and all secondary endpoints. In the second half
of 2008, we expect to receive data from additional PMO trials including the phase 3 fracture study.
Denosumab is also being studied in patients with breast cancer, prostate cancer, other solid tumors or multi-
ple myeloma for treatment to prevent skeletal related events (“SRE”). All of the phase 3 SRE clinical studies are
ongoing. The phase 3 study evaluating denosumab in patients with non-metastatic prostate cancer to prevent
bone metastases is also ongoing. Denosumab is also being evaluated in bone loss induced by hormone ablation
therapy (“HALT”) for breast cancer and prostate cancer. In 2007, we disclosed that the phase 3 HALT breast
cancer study met primary and all secondary endpoints. In 2008, we expect to receive data from our phase 3
HALT prostate cancer study.
Sclerostin Ab (AMG 785)
Sclerostin Ab (AMG 785), an antibody that targets sclerostin, is being developed in collaboration with
UCB. Sclerostin is a protein secreted by bone cells that inhibits bone formation. Sclerostin Ab is being inves-
tigated as a therapeutic for various conditions and diseases associated with bone loss. In September 2007, we
presented data from our phase 1 study for the treatment of diseases associated with bone loss. The data demon-
strated that single doses increased BMD in healthy postmenopausal women.
Metabolic Disorders
Sensipar®(cinacalcet HCl)
The E.V.O.L.V.E.™ (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, ini-
tiated in 2006, is a large (3,800 patient), multi-center, international, randomized, double-blind study to assess the
effects of Sensipar®on mortality and cardiovascular morbidity in patients with CKD undergoing maintenance
dialysis. The E.V.O.L.V.E.™ study completed enrollment in January 2008. Additionally, Sensipar®is being
evaluated for use in primary hyperparathyroidism.
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