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Aranesp ``145 Study'' Shows No Difference in Survival in Patients,with Small-Cell Lung Cancer

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Apr 19, 2007 - Amgen (NASDAQ: AMGN) today announced the results of the "145 study", a randomized, double-blind, placebo-controlled, multicenter Phase 3 study of Aranesp(R) (darbepoetin alfa) in 600 previously untreated patients with extensive-stage small-cell lung cancer (SCLC) receiving platinum-containing chemotherapy. The study demonstrated no statistically significant difference in risk of death (overall survival Aranesp compared to placebo Hazard Ratio (HR): 0.93, 95% CI: 0.78 to 1.11) or investigator determined progression-free survival (HR: 1.02, 95% CI: 0.86 to 1.21).

The study demonstrated a significant change in hemoglobin concentration from baseline in favor of Aranesp (a co-primary endpoint). Aranesp-treated patients also experienced a significantly lower risk of blood transfusions (HR: 0.40, 95% CI: 0.29 to 0.55). The overall safety profile, including thromboembolic events, was consistent with that described in the U.S. label.

"The 145 study is a component of Amgen's ongoing pharmacovigilance program designed to evaluate the effect of Aranesp on long-term survival in patients with chemotherapy-induced anemia. This study had higher initiation and maintenance hemoglobin targets (Hb less than or equal to 13 g/dl) than in the U.S. label," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "These results contribute to the growing body of evidence on ESA safety, reinforcing the neutral impact of ESAs on survival in cancer patients suffering from chemotherapy-induced anemia."

Amgen initiated the SCLC study in 2002 after results from a previous Phase 3 study showed a trend towards improved survival in patients with lung cancer. The 145 study was designed to evaluate whether increasing or maintaining hemoglobin concentrations with Aranesp, when administered with platinum-containing chemotherapy in patien
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