Amgen 2012 Annual Report Download - page 36

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29
Romosozumab
Romosozumab is a humanized monoclonal antibody that inhibits the action of sclerostin. Romosozumab is being developed
in collaboration with UCB for PMO.
In 2012, we initiated two phase 3 studies for the treatment of PMO in women.
After reviewing the 52-week tibia data and recent regulatory guidance that deemed acceleration of fracture healing a non-
viable endpoint for a phase 3 program, it was determined that we would not pursue this indication. This decision is based on the
regulatory guidance and on the efficacy results from the acceleration of fracture healing endpoint in the tibia trial, not on safety. The
safety profile remains consistent with what has been seen in the PMO program.
Sensipar®/Mimpara® (cinacalcet)
Sensipar®/Mimpara® is an orally-administered small molecule that lowers PTH levels in blood by increasing sensitivity of
the calcium-sensing receptor (CaSR) to extracellular calcium. It is being evaluated in post renal transplant patients.
Talimogene laherparepvec
Talimogene laherparepvec is an oncolytic immunotherapy derived from HSV-1. It is being investigated as a cancer treatment.
The phase 3 study for the treatment of melanoma is ongoing.
Trebananib
Trebananib 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.
Phase 3 studies of trebananib for the treatment of first-line and recurrent ovarian cancer are ongoing. Phase 2 studies of
trebananib for treatment of renal cell carcinoma, hepatocellular carcinoma and NSCLC are ongoing.
Vectibix® (panitumumab)
Vectibix® is a human monoclonal antibody antagonist of the EGFr pathway. It is being investigated as a cancer treatment.
In July 2011, we announced that we received Complete Response Letters from the FDA on the first- and second-line line
mCRC sBLAs requesting additional information from the '181 and '203 studies. We are currently working on addressing the
FDA's requests in the Complete Response Letters.
AMG 151
AMG 151 is a small molecule glucokinase activator. It is being investigated as a treatment for type 2 diabetes. We completed
our phase 2 study in 2012.
AMG 181
AMG 181 is a human monoclonal antibody that inhibits the action of alpha4/beta7. It is being investigated as a treatment
for ulcerative colitis and Crohn's disease, with phase 2 studies initiated in 2012. AMG 181 is one of five inflammation monoclonal
antibodies being jointly developed in collaboration with AstraZeneca.
AMG 416
AMG 416 is a peptide agonist of the human cell surface CaSR. It is being investigated as a treatment for secondary
hyperparathyroidism in patients with CKD receiving dialysis.
We completed two phase 2 studies in 2012. Phase 3 initiation is planned in 2013.
AMG 747
AMG 747 is a small molecule inhibitor of glycine transporter type-1 (GlyT-1). It is being investigated as a treatment for
negative symptoms and cognitive deficits associated with schizophrenia, with two phase 2 studies initiated in 2012.
Blinatumomab
Blinatumomab is an anti-CD19 x anti-CD3 (BiTE®) bispecific antibody. It is being investigated as a cancer treatment.