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FDA Approves Extended Dosing of Aranesp

THOUSAND OAKS, Calif., March 27, 2006 - Amgen, the world's largest biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has approved every-three-week dosing of Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia (low red blood cell count) in patients with non-myeloid malignancies. Aranesp is the only erythropoiesis-stimulating agent approved by the FDA for every-three-week administration.

"Amgen developed Aranesp to provide cancer patients with a long-acting and effective means to treat chemotherapy-induced anemia, a common side effect of chemotherapy," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of an extended dosing protocol for Aranesp is an important milestone allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens. This offers improved convenience for patients and less injection-related burden for patients and healthcare professionals compared to weekly anemia treatment."

Anemia can negatively affect patients and impact their daily activities. This can often manifest as fatigue, trouble breathing or rapid heartbeat, chest pain, dizziness or lightheadedness, inability to concentrate, headache, inability to stay warm, loss of sex drive, and pale skin. Frequent visits to the clinic for anemia treatment can result in significant time spent by patients, caregivers and healthcare providers. Reducing the number of visits required for anemia treatment with less frequent dosing and trying to synchronize anemia treatment with other naturally occurring visits could reduce the amount of patient and caregiver time required for anemia treatment.

"In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every three weeks," said Ralph Boccia, M.D., director of clinical research, Center for Cancer and Blood Disorders, Bethesda, MD. "Now, this less frequent dosing means patients can visit the doctor less frequently, which can result in less time away from loved ones and daily activities."

The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, phase 3 study that evaluated the safety and effectiveness of every-three-week administration of Aranesp. Patients with chemotherapy-induced anemia were randomized to receive 500 mcg of Aranesp every three weeks (n=353) or 2.25 mcg/kg (n=352) administered weekly for up to 15 weeks. In both groups, the starting dose was reduced by 40 percent if hemoglobin levels increased by more than 1 g/dL in a 14-day period, and Aranesp was withheld if hemoglobin levels exceeded 13 g/dL. More than 70 percent of patients in the every-three-week group required dose reductions, resulting in an average weekly dose of 125 mcg for the patients in this group.

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 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 recommended target level of 11 to 12 g/dL in the National Comprehensive Cancer Network (NCCN) guidelines for "Cancer and Treatment-Related Anemia" are never treated with erythropoietic therapy.

About Aranesp

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 July 2002, Aranesp was approved by the FDA for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies. 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.

Source: Amgen

Posted: March 2006