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District Court Judge Denies Preliminary Injunction in Ortho v. Amgen Suit.


THOUSAND OAKS, Calif. -- Amgen (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AMGN), today announced that United States District Court United States District Court

In the U.S., any of the 94 trial courts of general jurisdiction in the federal judicial system. Each state, as well as the District of Columbia and the Commonwealth of Puerto Rico, has at least one federal district court.
 Judge Stanley R. Chesler Stanley R. Chesler (born 1947, Brooklyn) is a United States District Judge for the District of New Jersey. Judge Chesler was nominated to his seat by President George W. Bush on January 23, 2002, to a seat vacated by Judge Anne E. Thompson and was confirmed by the U.S.  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 American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. , 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 de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 chemotherapy-induced anemia and prices have fallen.

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 Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.

Mentioned in: Bone Marrow Transplantation

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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) in September 2001 for the treatment of anemia associated with chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be  (CRF CRF
abbr.
chronic renal failure


CRF Chronic renal failure
), also known as chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is  (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 Erythropoietic
Referring to the creation of new red blood cells.

Mentioned in: Porphyrias


erythropoietic

emanating from or pertaining to erythropoiesis.
 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 pure red cell aplasia Hematology A type of anemia caused by selective depletion of erythroid cells

Pure red cell aplasia types

Acute
 (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.

About Amgen

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 accessed via our Web site at www.amgen.com. Journalists and media representatives may sign up to receive all news releases electronically at time of announcement by filling out a short form in the Media section of the Web site.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Nov 22, 2006
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