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European Commission Recommends Extended Dosing of Darbepoetin

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug. 5, 2004--Amgen Inc. (Nasdaq:AMGN), the world's largest biotechnology company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to expand the marketing authorization for Aranesp(R) (darbepoetin alfa) in the European Union (EU). The CHMP opinion recommends authorization of once-every-three-week Aranesp administration in the treatment of anemia in adult cancer patients with non-myeloid malignancies who are receiving chemotherapy and up to once-per-month administration in the treatment of anemia in chronic kidney disease (CKD) patients not on dialysis.

"With the majority of cancer patients receiving chemotherapy on a 21-day cycle, the opportunity to receive Aranesp once every three weeks is a significant added benefit for patients and their physicians. Once approved, patients with CKD not on dialysis, who often visit their physician monthly, can greatly benefit from an up to once-monthly Aranesp treatment regimen," said Beth Seidenberg, senior vice president of development and chief medical officer at Amgen. "Aranesp's ability to effectively correct hemoglobin with less frequent dosing than other erythropoietic agents can simplify anemia management for people with cancer receiving chemotherapy or those afflicted with CKD."

Recommendations from the CHMP are typically endorsed by the European Commission for marketing authorization within three to four months. When approved, Aranesp will be the first and only erythropoietic stimulating protein approved in the EU for once-every-three-week and once-per-month dosing.

In Europe, marketing authorization for Aranesp was granted in 2001 for the treatment of anemia associated with kidney disease. The authorization was expanded in 2002 to include patients with solid tumors and chemotherapy-induced anemia. In 2003, the approval was granted to include cancer patients with lymphoproliferative diseases. Thus, Aranesp is indicated for the treatment of anemia in adult cancer patients with non-myeloid malignancy who are receiving chemotherapy.

About Aranesp
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized anemia treatment with the discovery of recombinant erythropoietin, epoetin alfa, which is currently marketed in the U.S. by Amgen as EPOGEN(R) (Epoetin alfa)(i) and by Ortho Biotech Products, LP, as Procrit(R) (Epoetin alfa)(ii). Building on this heritage, Amgen developed Aranesp, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule resulting in more activity with the added benefit of less-frequent administration.

Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure, also known as CKD, for patients on dialysis and patients not on dialysis. In July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.

Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; dose reductions are recommended if the hemoglobin increase exceeds 1.0 g/dL in any two-week period. The most commonly reported side effects in Aranesp trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.

Source: Amgen

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