Interim data suggest major response with Aranesp(R) in anemic patients with MDS

THOUSAND OAKS, Calif., Jul 06, 2005 (BUSINESS WIRE) -- Amgen Inc. (NASDAQ:AMGN), the world's largest biotechnology company, today announced new interim data from a Phase 2 study evaluating the use of 500 mcg of Aranesp(R) (darbepoetin alfa) every three weeks to treat anemia in patients with a bone marrow disorder known as myelodysplastic syndromes (MDS). The data were presented at the 17th International Symposium of the Multinational Association of Supportive Care in Cancer (MASCC) in Geneva. (Abstract #02-007)

"The majority of MDS patients develop clinically significant anemia during the course of their disease, which often leads to fatigue and increased red blood cell transfusions," said Janice Gabrilove, M.D., professor of medicine, hematology and medical oncology at Mount Sinai School of Medicine, New York and the study's lead investigator. "In this study, low risk MDS patients receiving Aranesp every three weeks, who had no prior erythropoietic therapy, exhibited an overall response of 77 percent, increased hemoglobin levels and improvements in patient reported fatigue."

Results of an interim analysis were presented from the first 100 patients of an approximately 200 patient, Phase 2, single arm study of low risk MDS patients (those with a low risk of progressing to acute myeloid leukemia) with anemia and treated with Aranesp 500 mcg administered every three weeks. Of the 100 patients evaluated, 63 percent had no prior erythropoietic agent use. The primary endpoint of the study was the proportion of patients achieving an erythroid response (defined in accordance with the International Working Group Response Criteria) during the 13-week test period. Secondary endpoints included changes in hemoglobin level from baseline, incidence of transfusions and impact on patient reported fatigue.

Results were presented for all 100 patients for incidence of transfusion and patient reported fatigue and 90 patients were evaluated for erythroid respon

Contact: Trish Hawkins
Porter Novelli

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