Amgen 2015 Annual Report Download - page 26

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18
Repatha®
Repatha® is a human monoclonal antibody that inhibits PCSK9.
In September 2015, we announced that we submitted an application to the FDA for a single-dosing option for the monthly
administration of Repatha®. The PDUFA target action date is July 10, 2016.
In February 2016, we announced that the phase 3 GAUSS-3 trial evaluating Repatha® in patients with high cholesterol who
cannot tolerate statins, met its co-primary endpoints.
Additional phase 3 studies to evaluate Repatha® for cardiovascular outcomes, on cognitive function, in subjects with genetic
LDL disorders, and with coronary imaging are ongoing.
Romosozumab
Romosozumab is a humanized monoclonal antibody that inhibits the action of sclerostin. It is being evaluated as a treatment
for osteoporosis. Romosozumab is being developed in collaboration with UCB.
In September 2015, we and UCB announced that the open label phase 3 STRUCTURE trial met its primary endpoint.
Phase 3 studies for the treatment of postmenopausal women with osteoporosis and men with osteoporosis are ongoing.
Vectibix®
Vectibix® is a human monoclonal antibody antagonist of the EGFr.
In June 2015, we announced that results of a phase 3 study evaluating Vectibix® and BSC met its primary endpoint,
demonstrating a statistically significant improvement in OS in patients with chemorefractory wild-type KRAS (exon 2) mCRC
compared to those patients treated with BSC alone.
AMG 157
AMG 157 is a human monoclonal antibody that inhibits the action of TSLP. It is being evaluated as a treatment for asthma
and atopic dermatitis, with phase 2 studies ongoing. AMG 157 is being jointly developed in collaboration with AstraZeneca.
AMG 181
AMG 181 is a human monoclonal antibody that inhibits the action of alpha4/beta7. It is being evaluated as a treatment for
ulcerative colitis and Crohn’s disease, with phase 2 studies ongoing. AMG 181 is being jointly developed in collaboration with
AstraZeneca.
AMG 520
AMG 520 is a small molecule inhibitor of BACE. It is being evaluated for the prevention of Alzheimer’s disease, with phase
2 studies ongoing. AMG 520 is being jointly developed in collaboration with Novartis.
AMG 899
AMG 899 is a small molecule CETP inhibitor. It is being evaluated for the treatment of dyslipidemia and has completed
certain phase 2 studies.
Omecamtiv mecarbil
Omecamtiv mecarbil is a small molecule activator of cardiac myosin. It is being evaluated for the treatment of heart failure.
We are developing this product in collaboration with Cytokinetics, Inc. (Cytokinetics).
In October 2015, we announced that phase 2 data in patients with chronic heart failure showed statistically significant
improvements in several measures of cardiac function.