New Data Demonstrate Benefits of Aranesp(R) Dosed Every Two Weeks in European Haemodialysis Patients With CKD-Related Anaemia

Amgen (Nasdaq:AMGN), the world's largest biotechnology company,today announced new trial results from two studies,(1)(2) showing thatAranesp(R) (darbepoetin alfa) administered every two weeks (Q2W) is aneffective treatment for chronic kidney disease (CKD) anaemia patientsin European dialysis settings. The data were presented today at the2006 European Renal Association - European Dialysis and TransplantAssociation Congress (ERA-EDTA). One of these studies formed the basisfor a European Medicines Agency (EMEA) Aranesp label update in Europeearlier this year. This label update offers the benefit of switchingto Aranesp Q2W from any recombinant human erythropoietin (rHuEPO)dosing regimen without requiring a dose increase.

"For patients with anaemia associated with chronic kidney disease,achieving stable haemoglobin levels within the target range asrecommended by the European Best Practice Guidelines is an importantgoal," said Fernando Carrera, MD, Eurodial Dialysis Clinic, Leiria,Portugal. "The results presented today are good news for patients andphysicians as the Aranesp every two week dosing regimen means thisgoal can be achieved with less frequent injections. This can help toimprove operational efficiency in dialysis centres."

The results showed the Aranesp Q2W was as effective as Aranesponce weekly (QW) or other rHuEPO QW in maintaining haemoglobin (Hb)stability in the normal range (Hb 10-13 g/dL), with no evidence ofovershooting Hb target or increased risk of adverse events.(1)

"Aranesp is the only erythropoietin stimulating agent available inEurope that offers the treatment option of every two week IV dosingfor all haemodialysis patients," said William Sheridan, MD, vicepresident, medical affairs, Amgen International.

"Amgen remains committed to improving the lives of chronic kidneydisease patients and is delighted that the EMEA has recognised theimportance of this new data and labelling to offer a new option to theAranesp dosing regimen."

With nearly two million patients treated with Aranesp worldwide,Amgen continues its commitment to improving the lives of patients withCKD through meaningful offerings, such as label updates and anextensive Phase 3 clinical trials programme to study the effect oftreating anaemia or CKD complications in different patientpopulations. At ERA-EDTA today, Amgen also announced EVOLVE(EValuation Of Cinacalcet HCI Therapy to Lower CardioVascularEvents)(TM), the first international, prospective clinical outcomesstudy designed to determine whether treating secondaryhyperparathyroidism (HPT) with Mimpara (cinacalcet HCl) caneffectively reduce the risk of mortality and cardiovascular morbidityin patients undergoing maintenance dialysis. Amgen recently announcedthe initiation of the large-scale Phase 3 RED-HF (Reduction of Eventswith Darbepoetin alfa in Heart Failure) Trial(TM) that will evaluatethe effect of treatment of anaemia with Aranesp on morbidity andmortality in patients with symptomatic heart failure. Amgen continuesits ongoing TREAT (Trial to Reduce cardiovascular Events and AranespTherapy) trial in diabetic patients with CKD and anaemia not requiringdialysis.

About the Phase 3 Data Presented at ERA-EDTA

This 30-week Phase 3 multicentre, double-blind study of 308haemodialysis patients compared the safety and efficacy of Aranesp Q2Wand QW following a switch from rHuEPO. (2) Patients treated withrHuEPO were randomised to switch to either Aranesp Q2W or Aranesp QWfor 24 weeks, and Hb and dose were reassessed during weeks 25-30.Results showed that Aranesp Q2W and QW were comparable in maintainingHb with no dose increase after switching from rHuEPO. Additionally,Aranesp Q2W was not associated with an increased frequency of Hbgreater than 14 g/dL, a level associated with vascular risk, nor wasthere a difference in the incidence of vascular disorders orcerebrovascular accidents between the two arms.

The investigators concluded that Aranesp Q2W keeps haemodialysispatients within their target range, with no evidence of an increase ofovershooting Hb target or increased risk of adverse vascular events.

Additional Aranesp Data Presented at ERA-EDTA

In another study, 105 haemodialysis patients (41 percent female,mean age 64.4 years) were followed for 12 months.(1) During the firstsix months, they received Aranesp QW, and were switched to receiveAranesp Q2W for the second six months. The investigators found thatswitching dose regimen resulted in no significant differences in meanhaemoglobin levels (P = 0.8) or in mean weekly dose of Aranesp (P =0.3). They concluded that a switch from Aranesp QW or Q2W maintainedefficacy in stabilising Hb levels without the need for increaseddosing.

About CKD and Anaemia

According to recently published research, around ten percent ofEuropeans suffer from CKD,(3) an irreversible condition characterisedby kidney damage and impaired function that often progresses overtime. Patients with CKD often suffer from serious complications suchas anaemia, which occurs when failing kidneys no longer producesufficient erythropoietin, a hormone that stimulates the production ofoxygen-carrying red blood cells (RBCs). RBCs contain Hb, a red,iron-rich protein that carries oxygen from the lungs to all of thebody's tissues. Oxygen provides the energy the body needs for normalactivities. Anaemia occurs when the number of RBCs (or the Hb in them)falls below normal. Anaemia is defined by the World HealthOrganisation (WHO) and European Best Practice Guidelines (EBPG) as Hb less than 12 g/dL in women and Hb less than 13 g/dL in men.

About Aranesp(R) (darbepoetin alfa)

Aranesp is a recombinant erythropoietic protein (a protein thatstimulates production of red blood cells, which carry oxygen). Amgenrevolutionised the treatment of anaemia with the development ofrecombinant erythropoietin, Epoetin alfa. Building on this heritage,Amgen developed Aranesp, a unique erythropoiesis stimulating protein,which contains two additional sialic acid-containing carbohydratechains compared to the epoetin alfa molecule and remains in thebloodstream longer than epoetin alfa as demonstrated by its longerhalf-life.(4)

Aranesp was granted marketing authorisation by the EuropeanCommission in 2001 for the treatment of anaemia associated withchronic renal failure in adults and paediatric subjects 11 years ofage or older. Approval was granted in 2004 for an extended dosing ofup to once monthly for the treatment of anaemia in CKD patients not ondialysis. In 2006, the Aranesp label was updated to allow CKD patientson dialysis to switch from rHuEPO one to three times a week to Aranespevery two weeks.

Aranesp is contraindicated in patients with uncontrolledhypertension. Erythropoietic therapies may increase the risk ofthrombotic events and other serious events.(5) The target haemoglobinshould not exceed 14 g/dL. If the Hb increase exceeds 2.5 g/dL in anyfour-week period, dose reductions are recommended.

Pure red cell aplasia (PRCA) caused by neutralisinganti-erythropoietin antibodies has been reported in association witherythropoietin therapy. These antibodies have been shown tocross-react with all erythropoietic proteins, and patients suspectedor confirmed to have neutralising antibodies to erythropoietin shouldnot be switched to Aranesp.

The most commonly reported side effects in clinical trials wereheadache, hypertension, injection site pain and thrombosis of vascularaccess.(6)

About Amgen

Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of thefirst companies to realise the new science's promise by bringing safeand effective medicines from lab, to manufacturing plant, to patient.Amgen therapeutics has changed the practice of medicine, helpingmillions of people around the world in the fight against cancer,kidney disease, rheumatoid arthritis, and other serious illnesses.With a broad and deep pipeline of potential new medicines, Amgenremains committed to advancing science to dramatically improvepeople's lives.

Forward-Looking Statement

This news release contains forward-looking statements that involvesignificant risks and uncertainties, including those discussed belowand others that can be found in Amgen's Form 10-K for the year endedDecember 31, 2005, and in Amgen's periodic reports on Form 10-Q andForm 8-K. Amgen is providing this information as of the date of thisnews release and does not undertake any obligation to update anyforward-looking statements contained in this document as a result ofnew information, future events or otherwise.

No forward-looking statement can be guaranteed and actual resultsmay differ materially from those we project. Discovery oridentification of new product candidates or development of newindications for existing products cannot be guaranteed and movementfrom concept to product is uncertain; consequently, there can be noguarantee that any particular product candidate or development of anew indication for an existing product will be successful and become acommercial product. Further, preclinical results do not guarantee safeand effective performance of product candidates in humans. Thecomplexity of the human body cannot be perfectly, or sometimes, evenadequately modeled by computer or cell culture systems or animalmodels. The length of time that it takes for us to complete clinicaltrials and obtain regulatory approval for product marketing has in thepast varied and we expect similar variability in the future. Wedevelop product candidates internally and through licensingcollaborations, partnerships and joint ventures. Product candidatesthat are derived from relationships may be subject to disputes betweenthe parties or may prove to be not as effective or as safe as we mayhave believed at the time of entering into such relationship. Also, weor others could identify side effects or manufacturing problems withour products after they are on the market. In addition, sales of ourproducts are affected by the availability of reimbursement and thereimbursement policies imposed by third party payors, includinggovernments, private insurance plans and managed care providers, andmay be affected by domestic and international trends toward managedcare and healthcare cost containment as well as possible U.S.legislation affecting pharmaceutical pricing and reimbursement.Government regulations and reimbursement policies may affect thedevelopment, usage and pricing of our products. In addition, wecompete with other companies with respect to some of our marketedproducts as well as for the discovery and development of new products.We believe that some of our newer products, product candidates or newindications for existing products, may face competition when and asthey are approved and marketed. Our products may compete againstproducts that have lower prices, established reimbursement, superiorperformance, are easier to administer, or that are otherwisecompetitive with our products. In addition, while we routinely obtainpatents for our products and technology, the protection offered by ourpatents and patent applications may be challenged, invalidated orcircumvented by our competitors and there can be no guarantee of ourability to obtain or maintain patent protection for our products orproduct candidates. We cannot guarantee that it will be able toproduce commercially successful products or maintain the commercialsuccess of our existing products.

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(1)Carrera F, Oliveira L, Maia P, Mendes T, Ferreira C. Aranesp
(darbepoetin alfa) administered once every two weeks (Q2W)
maintains recommended haemoglobin (Hb) in chronic kidney disease
(CKD) patients on haemodialysis switched from weekly (QW) dosing.
Abstract presented at XLIII European Renal Association's European
Dialysis and Transfusion Association Congress (ERA-EDTA). 15-18
July 2006; Glasgow, UK.

(2)Locatelli F, Backs W, Del Pino MD, et al. Control of anemia with
Aranesp(R): Hb stability achieved with fewer patients requiring
dose adjustments after switching to Aranesp(R) every two weeks.
Abstract presented at XLIII European Renal Association's European
Dialysis and Transfusion Association Congress (ERA-EDTA) congress.
15-18 July 2006; Glasgow, UK.

(3)De Zeeuw D, Hillege HL, de Jong PE. The kidney, a cardiovascular
risk marker, and a new target for therapy. Kidney Int Suppl 2005;
98: S25-S29.

(4)Macdougall IC, Gray SJ, Elston O, et al. Pharmacokinetics of novel
erythropoiesis stimulating protein compared with epoetin alfa in
dialysis patients. J Am Soc Nephrol 1999; 10: 2392-2395.

(5)Aranesp summary of product information

(6)Aranesp Prescribing Information;
http://www.aranesp.com/pdf/aranesp_PI.pdf.
Last accessed: 27 June 2006.