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New Phase 3 Data Show Potential Benefits of Aranesp(R) Dosed Every Three Weeks for Chemotherapy-Induced Anemia; Aranesp Treatment Achieved and Maintained Target Hemoglobin Levels and Reduced Incidence of Red Blood Cell Transfusions
ATLANTA--(BUSINESS WIRE)--Dec. 12, 2005--Amgen (NASDAQ: AMGN), the world's largest biotechnology company, today announced results from the first multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial of Aranesp(R) (darbepoetin alfa) administered every three weeks in cancer patients with chemotherapy-induced anemia. The study revealed that Aranesp increased and maintained patient hemoglobin levels to the target level of greater than or equal to 11 grams per deciliter (g/dL) and reduced the need for red blood cell transfusions by almost half compared to placebo. The data were presented at the American Society of Hematology (ASH) 47th Annual Meeting and Exposition. (Abstract #3556)
"These results on every-three-week dosing of Aranesp are encouraging," said Kerry Taylor, MD, Mater Hospital, South Brisbane, Queensland, Australia. "If approved, this extended dosing of Aranesp may allow physicians to treat anemia on the same schedule as chemotherapy, which is frequently administered every three weeks. This may reduce the number of visits patients and their caregivers need to make to the clinic."
Researchers reported results for 386 patients (n=193 per arm) treated for up to 16 weeks and found that 77 percent of patients achieved target hemoglobin levels in the Aranesp-treated group versus 55 percent in the placebo group. Additionally, from week five to the end of treatment phase, the incidence of red blood cell transfusions was significantly lower for the Aranesp-treated group (24 percent) than for the placebo group (41 percent).
The number and type of adverse events were consistent with the adverse event profile for this population of anemic cancer chemotherapy patients receiving Aranesp. Cardiovascular and thromboembolic adverse events were reported in few patients in either treatment group, and were not associated with increases in hemoglobin levels.
In May 2005, Amgen announced the submission of a supplemental biologics license application to the U.S. Food and Drug Administration (FDA) for every-three-week dosing of Aranesp for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
About the Phase 3 Study
This multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial assessed the efficacy and safety of a fixed dose of 300 mcg of Aranesp administered every three weeks to patients with chemotherapy-induced anemia. Eligible patients had been diagnosed with anemia (hemoglobin levels less than 11g/dL) and non-myeloid malignancy with at least 12 weeks of planned chemotherapy. Patients enrolled in the study had mean hemoglobin concentrations at baseline of approximately 10 g/dL in both the Aranesp and placebo groups.
About Chemotherapy-Induced Anemia
Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs. Anemia occurs when there are too few red blood cells and the body's tissues are "starved" of oxygen, which can make a patient feel short of breath, very weak, faint and tired.
This year, an estimated 1.3 million cancer patients will undergo chemotherapy in the United States; approximately 800,000 (67 percent) will become anemic. More than half of these patients report that fatigue associated with anemia affects their daily lives more than any other side effect of treatment, including nausea, pain and depression.
Although anemia is a common and often debilitating side effect of chemotherapy, it is often not recognized and frequently under-treated. In fact, approximately half of patients with a hemoglobin level less than the recommended target level of 11 to 12 g/dL in the National Comprehensive Cancer Network(R) (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.
About Aranesp(R) (darbepoetin alfa)
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of red blood cells, which carry oxygen). Amgen revolutionized anemia treatment with the development of recombinant erythropoietin, Epoetin alfa. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains compared to the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life.
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 chronic kidney disease (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.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic events and other serious events. The target hemoglobin (Hb) should not exceed 12 g/dL. If the Hb increase exceeds 1.0 g/dL in any 2-week period, dose reductions are recommended. In a study with another erythropoietic product, where the target Hb was 12 to 14 g/dL, an increased incidence of thrombotic events, disease progression, and mortality was seen.
Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhea, fever, and dyspnea.
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Aranesp prescribing information can be accessed by calling 800-772-6436 or by logging on to www.aranesp.com.
CONTACT: Amgen, Thousand Oaks Trish Hawkins, 805-447-4587 (media) Arvind Sood, 805-447-1060 (investors) Fax: 805-499-3507 www.Amgen.com SOURCE: Amgen