Final Results of a Phase 3 European Study Demonstrate Aranesp(R) Dosed Once Every Three Weeks is at Least as Effective as Weekly Dosing in Treating Patients With Chemotherapy-Induced Anaemia
Stockholm, Sweden (ots/PRNewswire)
Amgen Inc., (NASDAQ: AMGN) the world's largest biotechnology company, announced that new data from a randomised, double-blind Phase 3 study demonstrate that Aranesp(r) (darbepoetin alfa) administered as a fixed dose of 500 mcg once every three weeks is at least as effective as 2.25 mcg/kg of darbepoetin alfa administered once weekly with respect to the need for red blood cell transfusions in cancer patients with chemotherapy-induced Anaemia and is effective in increasing haemoglobin to Evidence Based Practice Guidelines target levels[1]. The results were presented at the 10th Congress of the European Hematology Association. [Abstract #471]
In 2004, darbepoetin alfa was approved by the European Committee for Medicinal Products for Human Use (CHMP) for every-three-week dosing in patients with chemotherapy-induced Anaemia.
"Anaemia is one of the most common side effects of chemotherapy. However, it is often under-treated, despite the availability of treatments that have been available for more than a decade," said Jean-Luc Canon, MD, Centre Notre Dame et Reine Fabiola, Charleroi, Belgium. "The every three-week dosing schedule of Aranesp is consistent with most chemotherapy regimens and may allow physicians to effectively treat Anaemia while reducing the time spent by patients, physicians and caregivers for Anaemia management."
In this study, patients with chemotherapy-induced Anaemia from 110 centres in Europe were randomised to receive either a fixed dose of 500 mcg of darbepoetin alfa every three weeks or 2.25 mcg/kg of darbepoetin alfa once a week. Of the 672 patients assessed from week five through the end of the treatment period, the difference between treatment groups was 6.8 percent with respect to the need for red blood cell transfusion (23 percent of patients receiving darbepoetin alfa once every three weeks compared to 30 percent who received once weekly dosing). Additionally, from week five through the end of the treatment period, 82 percent of patients receiving darbepoetin alfa every three weeks compared to 70 percent of patient receiving darbepoetin alfa once a week achieved the target haemoglobin range (11 to 13 g/dL) consistent with the current evidence based practice guidelines issued by the European Organisation for Research and Treatment of Cancer, American Society of Clinical Oncology, American Society of Hematology and the National Comprehensive Cancer Network.
There were no differences in the safety profile between the two treatment groups. The most frequently reported adverse events were nausea, vomiting, fatigue and pyrexia.
About Aranesp
Aranesp is a recombinant erythropoietic protein (a protein that stimulates production of oxygen-carrying red blood cells). Amgen revolutionized Anaemia treatment with the development of recombinant erythropoietin, Epoetin alfa. Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis stimulating protein, which contains two additional sialic acid-containing carbohydrate chains than the Epoetin alfa molecule and remains in the bloodstream longer than Epoetin alfa because it has a longer half-life. By virtue of its longer half-life, Aranesp should be administered less frequently than Epoetin alfa in patients with chronic kidney disease (CKD).
Darbepoetin alfa was initially granted marketing authorization by the European Commission in 2001 for the treatment of Anaemia associated with chronic renal failure in adults and paediatric subjects 11 years of age or older. In 2002, the European Commission approved darbepoetin alfa for the treatment of Anaemia in adult cancer patients receiving chemotherapy with solid tumours. This patient population was subsequently expanded in 2003 to include all adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Important Safety Information
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum haemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information. 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.
Pure red cell aplasia (PRCA) has been observed in patients treated with recombinant erythropoietic proteins. This has been reported predominantly in patients with chronic renal failure. Aranesp should be discontinued in any patient with evidence of PRCA and the patient evaluated for the presence of antibodies to erythropoietin products. The most commonly reported side effects in clinical trials were fatigue, edema, nausea, vomiting, diarrhoea, fever and dyspnea.
About Amgen
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
www.amgen.com
Forward-Looking Statement
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, pre-clinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modelled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, sales of our products are affected by the availability of reimbursement and the reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products.
In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
Reference:
[1] Evidence based Practice Guidelines target level is 11 to 13 g/dL according to the European Organisation for Research and Treatment of Cancer, the National Comprehensive Cancer Network and the American Society of Clinical Oncology.
Contact:
Contact: Amgen Europe: Sabeena Ahmad, Phone: +41-41-369-2530 or
Porter Novelli: Inge Boets, Phone: +32-2-413-03-40