THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Nov. 22, 2006--Amgen (NASDAQ:AMGN), today announced that United States District Court Judge Stanley R. Chesler has denied Ortho Biotech's request for a preliminary injunction against the 2006 Amgen Portfolio Contract. The lawsuit involves Amgen sales discounts on Aranesp(R) (darbepoetin alfa) to its best customers.
"We believe that Amgen does not engage in anti-competitive practices in the sale of Aranesp," said David Scott, Amgen's senior vice president and general counsel. "Oncologists look to the unique benefits Amgen's products offer and make the right decisions for patients. Amgen's contract terms support competition and lower prices. We now look forward to vigorously defending our position in court."
Treating anemia is an essential part of delivering quality cancer care, as evidenced by clinical guidelines from the American Society of Clinical Oncology, the American Society of Hematology and the National Comprehensive Cancer Network. Aranesp brings value to patients and health care providers by offering the ability to synchronize anemia management with most chemotherapy schedules using a secure and simple delivery option. Since Aranesp introduced competition, more patients have been treated for their debilitating chemotherapy-induced anemia and prices have fallen.
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 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.
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)