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Amgen’s Third Quarter 2010 Revenue Unchanged at $3.8 Billion Versus Prior Year
Date:10/25/2010

d in patients not on dialysis, and how those results inform the appropriate use of erythropoiesis-stimulating agents (ESAs) in patients with chronic kidney disease (CKD).  The Company will continue to work with the FDA to develop information that will optimize the use of ESAs in CKD patients.

Denosumab:  The Company reaffirmed that the Prescription Drug User Fee Act (PDUFA) action date for its application for denosumab for the treatment of bone metastases to reduce skeletal related events in patients with cancer is Thursday, Nov. 18, 2010.  The FDA granted priority review designation to denosumab for this indication. Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

The Company reaffirmed that data from study ‘147 for denosumab in the prevention of prostate cancer bone metastases is expected to be available in the fourth quarter of 2010.  

Vectibix:  The Company announced that it plans to file supplemental Biologics License Applications for first- and second-line metastatic colorectal cancer indications in the U.S. during the fourth quarter of 2010.

Non-GAAP Financial MeasuresManagement has presented its operating results in accordance with GAAP and on an “adjusted” (or non-GAAP basis) for the three and nine months ended Sept. 30, 2010 and 2009. In addition, management has presented its outstanding debt in accordance with GAAP and on an “adjusted” (or non-GAAP basis) as of Sept. 30, 2010.  The Company believes that the presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors.  The Company uses these non-GAAP financial measures in connection with its own budgeting and financial planning.  These non-GAAP financial measures are in addition to, not a substitute for, or superior to, m
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