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Nplate(R) Data From MDS Studies Presented at ASH
Date:12/6/2009

NEW ORLEANS, Dec. 6 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced results from three studies on the safety and efficacy of Nplate® (romiplostim) in adult patients with myelodysplastic syndromes (MDS). MDS is a pre-leukemic condition in which early blood forming cells in the bone marrow are unable to mature normally, thereby limiting their ability to produce normal mature blood elements, which can lead to low platelet counts. The results of the studies were presented at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (ASH Abstracts #1769, #1770 and #2765).

Interim Results from Long-Term Open-Label Extension Study of Nplate in MDS (Abstract #2765)

The ongoing, open-label extension study was designed to evaluate the safety and efficacy of Nplate in lower risk MDS patients. The primary endpoints of the interim study for presentation at ASH evaluated adverse event rates with long-term use of Nplate and incidence of antibody development to Nplate and/or thrombopoietin (TPO). Secondary endpoints evaluated the incidence of bleeding events and platelet response during the study period.

Nplate was generally well-tolerated, with the majority of patients (n=28) achieving a platelet response (61 percent) for eight or more consecutive weeks. The primary endpoint evaluating adverse event rates was met, with most patients experiencing adverse events that were mild to moderate with the most common being epistaxis (36 percent), arthralgia (29 percent), anemia (21 percent) and cough (21 percent). The co-primary endpoint was also met, as no neutralizing antibodies to Nplate or TPO were observed, nor progression to acute myeloid leukemia (AML). In addition, no cases of bone marrow fibrosis were reported.

Results for the secondary endpoint showed that 64 perc
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SOURCE Amgen Inc.
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