14.11.2005 01:30:00

Treatment Has Demonstrated Improvement in Physical Function and Kept Joint Damage from Progressing at Three Years

ENBREL Plus Methotrexate: First Treatment Regimen to Demonstrate Ability to Inhibit Radiographic Progression of Joint Damage for Three Consecutive Years

Amgen (Nasdaq:AMGN) and Wyeth Pharmaceuticals, a division of Wyeth(NYSE:WYE), today announced data from a long-term blinded study ofanti-TNF agent in patients with rheumatoid arthritis (RA) demonstratedthat more than three quarters of patients treated with Enbrel(R)(etanercept) plus methotrexate combination therapy experienced noprogression of joint damage at three years(1). These new results fromthe TEMPO (Trial of Etanercept and Methotrexate with RadiographicPatient Outcomes) study will be presented at the American College ofRheumatology's (ACR) Annual Scientific Meeting in San Diego,California.

"Rheumatoid arthritis is a chronic condition requiring long-termtreatment. It is critical to provide patients with treatment optionsthat not only reduce the signs and symptoms of the disease, but alsoinhibit the progression of joint damage," said Desiree van der Heijde,M.D., professor of rheumatology, University of Maastricht in theNetherlands. "The TEMPO results reinforce the benefits of ENBREL andmethotrexate combination therapy and underscore the importance ofeffective treatment."

At three years, the majority of patients taking ENBREL andmethotrexate combination therapy had no progression of jointdamage(1). These results were significantly better than those achievedin ENBREL monotherapy and methotrexate monotherapy-treated patients.Patients receiving ENBREL monotherapy also had significantly betterresults than patients receiving methotrexate monotherapy. Total SharpScore was calculated by assessing changes in joint space narrowing andbone erosion as captured by radiographic imaging.

Further, additional data presented at ACR showed that improvementin physical function was higher for the ENBREL combination group thanfor either therapy alone. Patients treated with ENBREL combinationtherapy experienced a 56 percent mean improvement in Health AssessmentQuestionnaire (HAQ) scores from baseline, compared to 37 percent meanimprovement in patients treated with ENBREL alone and 33 percent meanimprovement in patients treated with methotrexate alone(2). HAQ scoresmeasure a patient's ability to perform activities of daily living suchas dressing, walking, and grooming.

The ENBREL TEMPO study randomized 686 patients with RA, of which638 were included in the three-year radiographic analysis(3). Patientsreceived either ENBREL (25 mg twice weekly), methotrexate (up to 20 mgonce weekly), or ENBREL (25 mg twice weekly) plus methotrexate onceweekly. Patients in the ENBREL TEMPO trial had active RA and aninadequate response to at least one disease-modifying antirheumaticdrug (DMARD) other than methotrexate. The primary radiographicendpoint was the change from baseline in the van der Heijde-modifiedTSS at one year. Secondary radiographic endpoints included changes intotal erosions, changes in total joint space narrowing, number oferoded joints, and percent of patients with no radiographicprogression.

ENBREL was generally well tolerated.

ABOUT RA

More than two million Americans suffer from RA(4), which can causestiffness, swelling, and limitation in the motion and function ofmultiple joints. If RA is left untreated, patients can become disabledfrom joint damage caused by the disease, limiting their ability tofunction.

ABOUT ENBREL

ENBREL is the only soluble tumor necrosis factor (TNF) receptorapproved to reduce signs and symptoms, induce major clinical response,improve physical function, and inhibit the progression of structuraldamage in patients with moderately to severely active rheumatoidarthritis (RA). ENBREL can be used alone or in combination withmethotrexate.

ENBREL is the only treatment indicated to reduce the signs andsymptoms, inhibit the progression of structural damage of activearthritis, and improve physical function in patients with psoriaticarthritis. It is approved to reduce the signs and symptoms ofmoderately to severely active polyarticular-course juvenile rheumatoidarthritis (JRA) in patients four years of age or older who have had aninadequate response to one or more disease-modifying antirheumaticdrugs (DMARDs). It is also the first biologic approved to reduce thesigns and symptoms in patients with active ankylosing spondylitis(AS). ENBREL is indicated for the treatment of adult patients (18years or older) with chronic moderate-to-severe plaque psoriasis whoare candidates for systemic therapy or phototherapy.

ENBREL has been used by more than 308,000 patients worldwideacross indications.

ENBREL acts by binding TNF, one of the dominant inflammatorycytokines or regulatory proteins that play an important role in bothnormal immune function and the cascade of reactions involved in theinflammatory process of RA, JRA, psoriasis, psoriatic arthritis, andAS. The binding of ENBREL to TNF renders the bound TNF biologicallyinactive, resulting in significant reduction in inflammatory activity.

What important information do I need to know about taking ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF)blocker that blocks the action of a substance your body's immunesystem makes called TNF. People with an immune disease, such asrheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, andpsoriasis, have too much TNF in their bodies. ENBREL can reduce theamount of TNF in the body to normal levels, helping to treat yourdisease. But, in doing so, ENBREL can also lower the ability of yourimmune system to fight infections.

All medicines have side effects, including ENBREL. Possible sideeffects of ENBREL include:

-- Serious infections

-- Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes

-- Some serious infections have been fatal

-- Rare cases of tuberculosis have occurred

What not to do

-- Do not start ENBREL if you have an infection or are allergic to ENBREL or its components

What to do

-- Tell your doctor if you are prone to infection

-- Stop ENBREL if a serious infection occurs

-- Contact your doctor if you have questions about ENBREL or develop an infection

-- Tell your doctor if you have ever been treated for heart failure

-- Serious nervous system disorders such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes

-- Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL

-- Rare reports of serious blood disorders (some fatal)

-- Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness

-- In medical studies of all TNF blockers, including ENBREL, a higher rate of lymphoma (a type of cancer) was seen compared to the general population. The risk of lymphoma may be up to several fold higher in rheumatoid arthritis and psoriasis patients

-- The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown

-- ENBREL can cause injection site reactions

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, marketENBREL in North America. Wyeth markets ENBREL outside of NorthAmerica. Immunex Corporation, a wholly owned subsidiary of Amgen,manufactures ENBREL. Additional information about ENBREL, includingfull Prescribing Information, can be found on the website sponsored bythe companies at www.ENBREL.com or by calling toll-free 1-888-4ENBREL(1-888-436-2735).

Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one of thefirst companies to realize the new science's promise by bringing safeand effective medicines from lab, to manufacturing plant, to patient.Amgen therapeutics have 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. To learn more about our pioneering science and ourvital medicines, visit www.amgen.com.

Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), has leadingproducts in the areas of women's health care, cardiovascular disease,central nervous system, inflammation, transplantation, hemophilia,oncology, vaccines and nutritional products. Wyeth is one of theworld's largest research-driven pharmaceutical and health careproducts companies. It is a leader in the discovery, development,manufacturing, and marketing of pharmaceuticals, vaccines,biotechnology products, and nonprescription medicines that improve thequality of life for people worldwide. The Company's major divisionsinclude Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and FortDodge Animal Health.

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, 2004, 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 Amgen projects. 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 Amgen to completeclinical trials and obtain regulatory approval for product marketinghas in the past varied, and Amgen expects similar variability in thefuture. Amgen develops product candidates internally and throughlicensing collaborations, partnerships, and joint ventures. Productcandidates that are derived from relationships may be subject todisputes between the parties or may prove to be not as effective or assafe as Amgen may have believed at the time of entering into suchrelationship. Also, Amgen or others could identify side effects ormanufacturing problems with Amgen's products after they are on themarket.

In addition, sales of Amgen's products are affected by theavailability of reimbursement and the reimbursement policies imposedby third-party payors, including governments, private insurance plans,and managed care providers, and may be affected by domestic andinternational trends toward managed care and health care costcontainment as well as possible U.S. legislation affectingpharmaceutical pricing and reimbursement. Government regulations andreimbursement policies may affect the development, usage, and pricingof our products. In addition, Amgen competes with other companies withrespect to some of Amgen's marketed products as well as for thediscovery and development of new products. Amgen believes that some ofits newer products, product candidates, or new indications forexisting products, may face competition when and as they are approvedand marketed. Amgen's products may compete against products that havelower prices, established reimbursement, superior performance, areeasier to administer, or that are otherwise competitive with itsproducts. In addition, while Amgen routinely obtains patents for itsproducts and technology, the protection offered by its patents andpatent applications may be challenged, invalidated or circumvented byits competitors and there can be no guarantee of Amgen's ability toobtain or maintain patent protection for its products or productcandidates. Amgen cannot guarantee that it will be able to producecommercially successful products or maintain the commercial success ofits existing products. Amgen's stock price may be affected by actualor perceived market opportunity, competitive position, and success orfailure of its products or product candidates. Further, the discoveryof significant problems with a product similar to one of Amgen'sproducts that implicate an entire class of products could have amaterial adverse effect on sales of the affected products and on ourbusiness and results of operations.

The scientific information discussed in this news release relatedto Amgen's product candidates is preliminary and investigative. Suchproduct candidates are not approved by the U.S. Food and DrugAdministration (FDA), and no conclusions can or should be drawnregarding the safety or effectiveness of the product candidates. Onlythe FDA can determine whether the product candidates are safe andeffective for the use(s) being investigated. Further, the scientificinformation discussed in this news release relating to new indicationsfor our products is preliminary and investigative and is not part ofthe labeling approved by the FDA for the products. The products arenot approved for the investigational use(s) discussed in this newsrelease, and no conclusions can or should be drawn regarding thesafety or effectiveness of the products for these uses.

Only the FDA can determine whether the products are safe andeffective for these uses. Health care professionals should refer toand rely upon the FDA-approved labeling for the products and not theinformation discussed in this news release.

The statements in this press release that are not historical factsare forward-looking statements based on current expectations of futureevents that involve risks and uncertainties including, withoutlimitation, risks associated with the inherent uncertainty of thetiming and success of pharmaceutical research, product development,manufacturing, commercialization, economic conditions includinginterest and currency exchange rate fluctuations, changes in generallyaccepted accounting principles, the impact of competitive or genericproducts, trade buying patterns, wars or terrorist acts, productliability and other types of lawsuits, the impact of legislation andregulatory compliance and obtaining reimbursement, favorable drugpricing, access and other approvals, environmental liabilities, andpatent, and other risks and uncertainties, including those detailedfrom time to time in the Company's periodic reports, including currentreports on Form 8-K, quarterly reports on Form 10-Q and the annualreport on Form 10-K, filed with the Securities and ExchangeCommission. Actual results may vary materially from theforward-looking statements. The Company assumes no obligation topublicly update any forward-looking statements, whether as a result ofnew information, future events or otherwise.

(1)ACR 2005 Late-Breaking Abstract. American College ofRheumatology Annual Scientific Meeting November 12-17 San Diego,California. Three Years of Sustained Halting of RadiographicProgression With Combination Etanercept and Methotrexate: Results fromthe TEMPO Trial. Desiree van der Heijde(1), Lars Klareskog(2), JosephWajdula(3), Ronald Pedersen(3), Saeed Fatenejad for the TEMPO studyinvestigators(3). (1)University Hospital Maastricht, Maastricht,Netherlands; (2)Karolinska Hospital, Stockholm, Sweden; (3)Wyeth,Collegeville, PA. Data to be presented on November 15.

(2)ACR 2005 Abstract. American College of Rheumatology AnnualScientific Meeting November 12-17 San Diego, California. Results ofpatient-reported outcomes in a 3-year double-blind study of etanercept(Enbrel) and methotrexate, alone and combined, in patients with activerheumatoid arthritis. Amitabh Singh(1), Lars Klareskog(2), RonaldPedersen(1), Saeed Fatenejad(1). (1)Wyeth Research, Collegeville,PA;(2)Karolinska Hospital, Stockholm, Sweden. Data to be presented onNovember 14.

(3)ACR 2005 Late-Breaking Abstract. American College ofRheumatology Annual Scientific Meeting November 12-17 San Diego,California. Three Years of Sustained Halting of RadiographicProgression With Combination Etanercept and Methotrexate: Results fromthe TEMPO Trial. Desiree van der Heijde(1), Lars Klareskog(2), JosephWajdula(3), Ronald Pedersen(3), Saeed Fatenejad for the TEMPO studyinvestigators(3). (1)University Hospital Maastricht, Maastricht,Netherlands; (2)Karolinska Hospital, Stockholm, Sweden; (3)Wyeth,Collegeville, PA. Data to be presented on November 15.

(4)American College of Rheumatology Rheumatoid Arthritis FactSheet. Accessed 9/30/2005. Available at:http://www.rheumatology.org/public/factsheets/ra_new.asp?aud=pat.

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