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
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.
EDITOR´S NOTE: An electronic version of this news release may be
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David Polk, 805-447-4613 (media)
Arvind Sood, 805-447-1060 (investors)