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Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients
Date:12/8/2008

SAN FRANCISCO, Dec. 8 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today released updated results from the ongoing, open-label extension study of the long-term safety and efficacy of Nplate(TM) (romiplostim) in adult patients with chronic immune thrombocytopenic purpura (ITP). Chronic ITP is a chronic and serious autoimmune disorder characterized by lower than expected platelet counts in the blood, sometimes leading to serious bleeding events. The results were presented today as an oral presentation at the 50th Annual Meeting of the American Society of Hematology (ASH Abstract # 402). Results from a study of Nplate in myelodysplastic syndromes (MDS) also were presented.

"These data show Nplate increased platelet counts in most patients for most of the time, and clinically relevant bleeding was reduced over time," said David J. Kuter, M.D., Chief of Hematology, Massachusetts General Hospital, Boston. "This is significant because Nplate can be a long-term treatment for adult chronic ITP patients, who are at risk of serious bleeding events if their platelet counts drop to less than 30,000 per microliter. These patients have had limited availability to long term treatment options."

These study results showed that overall 74 percent of patients (160/215) achieved a platelet response defined as a platelet count of 50,000 platelets per microliter and doubling of the baseline platelet count (median:17,000 platelets per microliter). A platelet response was achieved by 30 percent (61/207) of patients after the first dose and by 47 percent (94/199) of patients after the third dose. The average treatment period was 76 weeks and the longest duration of treatment was 204 weeks.

Additional key findings from the Extension study show:

-- Platelet counts increased: Platelet counts of Nplate-treated pati
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SOURCE Amgen Inc.
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