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Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Date:2/6/2009

can have a significant impact on patient lives. Nplate represents a potentially high value option for these patients."

The EU approval of Nplate is based on data from two separate placebo-controlled Phase 3 studies, demonstrating that platelet counts were raised and sustained in 83 percent of patients for both splenectomised and non-splenectomised groups when treated with Nplate. Additionally, patients treated with Nplate were able to reduce or discontinue concomitant medications such as corticosteroids which are often not well tolerated. Nplate patients also used far less "emergency" medications such as IVIG and Win-Rho, whose effects are transient.

Upon completion of the Phase 3 studies almost 90 percent of patients elected to subsequently enroll into the Nplate long term extension study which demonstrated that Nplate continued to effectively increase and sustain platelet counts. In this open label long term extension study the average treatment period was 76 weeks and the longest duration of treatment was 204 weeks.

Key findings from the extension study showed platelet counts of Nplate-treated patients were increased from baseline by 20,000 platelets per microliter more than 80 percent of the time in 47 percent of patients and more than half the time in 67 percent of patients.

"Amgen is committed to advancing the discovery and development of new therapies for grievous illnesses where there is an unmet need," said Willard Dere, M.D., senior vice president and international chief medical officer at Amgen. "The European approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first approved peptibody, an innovative platform for delivering targeted therapies."

About Adult ITP

In patients with ITP, platelets - or blood elements needed to prevent bleeding - are destroyed by the patient's
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SOURCE Amgen
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