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    American Heart Association Scientific Sessions 2009

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ESAs in the News

Amgen Statement on TREAT Results Presented at the
American Heart Association Scientific Sessions 2009

THOUSAND OAKS, Calif. (Nov 16, 2009) – Amgen (NASDAQ:AMGN) issued the following statement on the presentation of results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy) at the American Heart Association (AHA) Scientific Sessions 2009 in Orlando.

The full results from TREAT were published online in the New England Journal of Medicine (NEJM) and presented at the annual meeting of the American Society of Nephrology (ASN) on October 30, 2009. TREAT failed to meet the primary endpoints and showed a two-fold increased risk of stroke in patients with chronic kidney disease not on dialysis treated with Aranesp (darbepoetin alfa) to a hemoglobin target of 13 g/dL. These data were presented again today to the cardiology community at AHA, along with additional analyses, including the risk of cardiovascular events or death in patients with a history of stroke.

The analyses presented at ASN, AHA and published in NEJM are part of Amgen’s ongoing commitment to fully understand and communicate the results from TREAT. Analyses are still ongoing to better understand these results. We anticipate that the TREAT data will be included in labeling once they have been more fully analyzed, and after discussions with regulatory authorities are complete.

As discussed in our press release on October 30, ESAs should not be used in the manner tested in TREAT, specifically to a hemoglobin target of 13 g/dL. Amgen continues to believe that ESAs are an important treatment for anemia and have a positive benefit: risk profile when used according to the label in patients with chronic renal failure not on dialysis for whom reducing the need for transfusion is a meaningful clinical goal.

CONTACT: Amgen, Thousand Oaks
Emma Hurley: 202-585-9647 (media)
Arvind Sood: 805-447-1060 (investors)


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