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Interim Data Suggest Potential Benefits of Aranesp(R) Dosed Every Three Weeks with Intravenous Iron for Chemotherapy-Induced Anemia; 94 Percent of Patients Achieved Target Hemoglobin Level
ATLANTA--(BUSINESS WIRE)--June 3, 2006--Amgen (NASDAQ:AMGN), the world's largest biotechnology company, today announced interim Phase 3 data suggesting Aranesp(R) (darbepoetin alfa) administered every three weeks with intravenous (IV) iron has the potential to further enhance the effectiveness of increasing patient hemoglobin levels to the recommended target of greater than or equal to 11 g/dL and reducing the need for red blood cell transfusions in cancer patients with chemotherapy-induced anemia. The data were presented at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. (Abstract #8612)
"Every-three-week dosing of Aranesp has demonstrated effectiveness in managing chemotherapy-induced anemia and allows physicians to synchronize anemia treatment and chemotherapy, offering improved patient convenience," said study investigator Johan Vansteenkiste, M.D., Ph.D., Respiratory Oncology Unit, University Hospital Gasthuisberg. "The results of this study suggest that Aranesp administered every three weeks in combination with intravenous iron may help maximize the proportion of patients reaching target hemoglobin levels."
Interim results from 196 patients in this Phase 3b study demonstrated that, among patients receiving 500 mcg Aranesp administered every three weeks in combination with IV iron (n= 100), 94 percent achieved the target hemoglobin level of greater than or equal to 11 g/dL between week five and the end of treatment. In the group who received Aranesp and iron administered according to standard practice (oral iron or no iron) (n= 96), 89 percent of patients achieved the target hemoglobin level. Fewer patients in the group administered IV iron received a red blood cell transfusion between week five and the end of treatment compared to patients in the group receiving standard iron administration (12 percent versus 25 percent).
The safety profile for patients receiving Aranesp administered with IV iron appeared to be comparable to patients receiving Aranesp administered with either oral iron or no iron. Treatment-related adverse events were similar between the two groups (six percent in the IV iron group compared to three percent in the oral or no iron group) and were consistent with the adverse event profile for this population of anemic chemotherapy patients receiving Aranesp. Cardiovascular and thromboembolic adverse events were reported in few patients (six patients in each group) and were not associated with increases in hemoglobin levels.
About the Phase 3b Study
This randomized, multicenter, open-label, 16-week study of 400 patients with chemotherapy-induced anemia is being conducted in Europe. The study is designed to evaluate the safety and efficacy of 500 mcg Aranesp administered every three weeks with either IV iron (200 mcg administered either every three weeks on the same schedule as Aranesp or, if required, as two doses (200 mcg total) within a three-week period) or iron administered according to standard practice. Study endpoints include changes in hemoglobin level from baseline, incidence of transfusions and incidence of adverse events and serious adverse events, in particular thromboembolic events.
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. Approximately 63 percent of European chemotherapy patients will develop anemia as a result of their treatment. More than half of chemotherapy patients report that fatigue, a common symptom of anemia, affects their daily lives more than any other side effect of treatment, including nausea, pain and depression.
Although anemia is one of the most common side effects of chemotherapy, it is often not recognized and frequently under-treated, despite treatments that have been available for more than a decade. In fact, approximately half of patients with a hemoglobin level less than the target level of 11 to 12 g/dL recommended in the National Comprehensive Cancer Network(R) (NCCN) and the European Organisation for Research on Treatment of Cancer (EORTC) evidence-based guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.
Amgen revolutionized anemia treatment with the development of Epoetin alfa, a recombinant erythropoietin (a protein that stimulates the production of oxygen-carrying red blood cells). Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis-stimulating protein that can be dosed less frequently.
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 (CRF), also known as chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. In 2002, Aranesp was approved for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in the U.S. and European Union (EU). Today, Aranesp is the only erythropoiesis-stimulating protein approved in the U.S. and EU for weekly and every-three-week administration, which allows physicians to synchronize anemia treatment with the majority of chemotherapy schedules. Since its introduction in 2001, more than 1.7 million CKD and chemotherapy patients with anemia have received treatment with Aranesp.
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 -- 14 g/dL, an increased incidence of thrombotic events, disease progression, and mortality was seen.
Cases of pure red cell aplasia (PRCA) and of severe anemia, with or without other cytopenias associated with neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp. This has been reported predominately in patients with CRF receiving Aranesp by subcutaneous administration. A sudden loss of response to Aranesp, accompanied by severe anemia and low reticulocyte count, should be evaluated. If anti-erythropoietin antibody-associated anemia is suspected, withhold Aranesp and other erythropoietic proteins. Aranesp should be permanently discontinued in patients with antibody-mediated anemia. Patients should not be switched to other erythropoietic proteins.
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.
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CONTACT: Amgen, Thousand Oaks Kristen Davis, 805-447-4587 (media) Arvind Sood, 805-447-1060 (investors) SOURCE: Amgen Inc.