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Study Showed Half of Patients Treated with Enbrel(R) (etanercept) Plus Methotrexate Can Achieve DAS Clinical Remission and 80 Percent Had No Progression of Joint Damage in Active Early Rheumatoid Arthritis

2008-07-15 17:46:00

Data Demonstrated Benefits of Early Treatment in Patients with

Moderate-to-Severe Rheumatoid Arthritis (RA)

COLLEGEVILLE, Pa. & THOUSAND OAKS, Calif.–(EMWNews)–Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Amgen

(NASDAQ:AMGN) today announced the publication of data from the COMET

(COmbination of Methotrexate and ETanercept in Active Early Rheumatoid

Arthritis) trial demonstrating that half of patients treated with the

combination of ENBREL and methotrexate achieved Disease Activity Score

(DAS) clinical remission and nearly all had no progression of joint

damage. These findings were published online on July 15 by The Lancet,

a leading global medical journal.

According to study results at one year, 50 percent of patients (n = 265)

with active early moderateto-severe

rheumatoid arthritis who received a combination of ENBREL and

methotrexate therapy achieved DAS clinical remission (DAS28 <

2.6) versus 28 percent (n = 263) of those treated with methotrexate

alone. DAS28 is a measure of joint swelling and tenderness (based on 28

joints), as well as overall disease activity measured by a global health

assessment and an objective marker of inflammation (erythrocyte

sedimentation rate). DAS28 is a modified measure of the DAS44, which is

a validated tool used in clinical trials and serves as the basis for the

European League Against Rheumatism (EULAR) response criteria.

We hope that these data encourage physicians

to use clinical remission as a new standard for evaluating symptom

control in the treatment of early RA, said

Paul Emery, M.D., lead COMET trial investigator and Professor of

Rheumatology, University of Leeds, UK. Clinical

remission is highly relevant to patients

daily lives as they cope with their symptoms.

Additionally, at one year, 80 percent of patients (n = 246) receiving

ENBREL and methotrexate had no evidence of progression of joint damage

as seen on x-ray, compared to 59 percent (n = 230) of those treated with

methotrexate alone.

Combination therapy with ENBREL plus methotrexate also helped patients

remain more functionally active. Based on the Health Assessment

Questionnaire (used to assess certain daily life activities), 61 percent

(n = 256) of patients treated with combination therapy demonstrated

improvement in their functionality versus 44 percent (n = 241) of those

treated with only methotrexate. Further, the COMET trial showed that

patients who were treated with combination therapy had a nearly

three-fold reduction in work stoppage compared with those who received

methotrexate alone.

Its important for

people living with a chronic disease like moderate to severe rheumatoid

arthritis to be able to continue with their daily life activities,

said Dr. Emery. These data show that if

patients receive combination treatment early, they are more likely to be

able to continue with their daily activities, including going to work,

than those treated with methotrexate alone.

American College of Rheumatology (ACR) scores were also assessed in the

COMET study and were comparable to the DAS clinical remission data.

Nearly half of patients receiving ENBREL plus methotrexate achieved an

ACR 70 score, versus 28 percent of the methotrexate-only group. The

percentage of patients who achieve an ACR 70 score represent those who

achieve a 70 percent improvement in select RA symptoms, including joint

swelling and tenderness, pain, level of disability, overall patient and

physician disease assessment, and an objective marker of inflammation,

such as erythrocyte sedimentation rate.

The COMET study is a 24-month, double-blind, randomized, parallel group,

multicenter, outpatient study. The data published in The Lancet

represent the results of the first year of treatment, in which patients

were randomly assigned to receive combination ENBREL 50 mg plus

methotrexate therapy, or methotrexate alone, once a week for 52 weeks.

The population under study had less than two years (median seven months)

of moderately to severely active disease.

At one year, there were no differences in rates of serious infections or

malignancies among patients in the ENBREL plus methotrexate group

compared with the methotrexate-only group. No cases of tuberculosis or

demyelinating disease were reported. No new safety signals were

identified.

In other RA clinical trials of ENBREL, the most common adverse events

were injection site reaction, infection, and headache. Rare cases of

tuberculosis and demyelinating diseases have been reported in

post-marketing surveillance.

To view the abstract of this manuscript, please visit the following Web

site: www.thelancet.com/journals/lancet.

ABOUT ENBREL

ENBREL is a soluble form of a fully human tumor necrosis factor (TNF)

receptor and has 16 years of collective clinical experience with an

established safety profile. ENBREL was first approved in 1998 for

moderate to severe rheumatoid arthritis and was later approved to treat

children and adolescents with juvenile rheumatoid arthritis (now called

juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to

treat moderate to severe plaque psoriasis in adults.

ENBREL indications in the U.S.:

  • ENBREL is indicated for reducing signs and symptoms, keeping joint

    damage from getting worse, and improving physical function in patients

    with moderate to severe rheumatoid arthritis. ENBREL can be taken with

    methotrexate or used alone.

  • ENBREL is indicated for reducing the signs and symptoms of moderately

    to severely active polyarticular juvenile idiopathic arthritis in

    patients ages 2 and older.

  • ENBREL is indicated for reducing signs and symptoms, keeping joint

    damage from getting worse, and improving physical function in patients

    with psoriatic arthritis. ENBREL can be used in combination with

    methotrexate in patients who do not respond adequately to methotrexate

    alone.

  • ENBREL is indicated for reducing signs and symptoms in patients with

    active ankylosing spondylitis.

  • ENBREL is indicated for the treatment of adult patients (18 years or

    older) with chronic moderate to severe plaque psoriasis who are

    candidates for systemic therapy or phototherapy.

Important Safety Information

What important safety information do I need to know about taking

prescription ENBREL?

ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker

that blocks the action of a substance your body’s immune system makes

called TNF. People with an immune disease, such as rheumatoid arthritis,

juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic

arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can

reduce the amount of active TNF in the body to normal levels, helping to

treat your disease. But, in doing so, ENBREL can also lower the ability

of your immune system to fight infections.

Serious infections, including tuberculosis (TB), have happened in

patients taking ENBREL. Some of these serious infections have been

fatal. Many serious infections occurred in people prone to infection.

Serious infections have also occurred in patients with advanced or

poorly controlled diabetes. Do not start ENBREL if you have an infection

or are allergic to ENBREL or its components. Once on ENBREL, if you get

an infection or have any sign of an infection, including fever, cough,

or flu-like symptoms, or have open sores, tell your doctor. Your doctor

should test you for TB before starting ENBREL and should monitor you

closely for signs and symptoms of TB.

Serious nervous system disorders, such as multiple sclerosis, seizures,

or inflammation of the nerves of the eyes have been reported. There have

been rare reports of serious blood disorders (some fatal).

In medical studies, more cases of lymphoma (a type of cancer) were seen

in patients taking TNF blockers compared to similar patients who were

not taking TNF blockers. The risk of lymphoma may be several-fold higher

in people with rheumatoid arthritis and psoriasis; the role of TNF

blockers in the development of malignancies is unknown.

Tell your doctor if you:

  • Think you have, are being treated for, have signs of, or are prone to

    infection

  • Have any open sores

  • Have or have had TB or hepatitis B

  • Have ever been treated for heart failure

  • Have ever had or develop a serious nervous system disorder

  • Develop symptoms such as persistent fever, bruising, bleeding, or

    paleness while taking ENBREL

Common side effects in adult clinical trials were injection site

reaction, infection and headache.

In a medical study of patients with JIA, infection, headache, abdominal

pain, vomiting, and nausea occurred more frequently than in adults. The

kinds of infections reported were generally mild and similar to those

usually seen in children. Other serious adverse reactions were reported,

including serious infection and depression/personality disorder.

If you have any questions about this information, be sure to discuss

them with your doctor. You are encouraged to report negative side

effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,

or call 1-800-FDA-1088.

Please visit www.enbrel.com or call

1-888-4ENBREL to request additional information, including the full U.S.

Prescribing Information and Medication Guide.

About Amgen and Wyeth

Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in

North America. Wyeth markets ENBREL outside of North America. Immunex

Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.

Amgen discovers, develops, manufactures 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

and 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.

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the

areas of women’s health care, infectious disease, gastrointestinal

health, central nervous system, inflammation, transplantation,

hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world’s largest research-driven pharmaceutical and

health care products companies. It is a leader in the discovery,

development, manufacturing and marketing of pharmaceuticals, vaccines,

biotechnology products and non-prescription medicines that improve the

quality of life for people worldwide. The Company’s major divisions

include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge

Animal Health. To learn more, visit www.wyeth.com.

Amgen Forward-Looking Statement

This news release contains forward-looking statements that are based on

Amgens current expectations and beliefs and

are subject to a number of risks, uncertainties and assumptions that

could cause actual results to differ materially from those described.

All statements, other than statements of historical fact, are statements

that could be deemed forward-looking statements, including estimates of

revenues, operating margins, capital expenditures, cash, other financial

metrics, expected legal, arbitration, political, regulatory or clinical

results or practices, customer and prescriber patterns or practices,

reimbursement activities and outcomes and other such estimates and

results. Forward-looking statements involve significant risks and

uncertainties, including those discussed below and more fully described

in the Securities and Exchange Commission (SEC) reports filed by Amgen,

including Amgens most recent annual report

on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K.

Please refer to Amgens most recent Forms

10-K, 10-Q and 8-K for additional information on the uncertainties and

risk factors related to Amgens business.

Unless otherwise noted, Amgen is providing this information as of July

15, 2008, and expressly disclaims any duty to update information

contained in this news release.

No forward-looking statement can be guaranteed and actual results may

differ materially from those Amgen projects. 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,

preclinical 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 modeled by computer or cell

culture systems or animal models. The length of time that it takes for

Amgen to complete clinical trials and obtain regulatory approval for

product marketing has in the past varied and Amgen expects similar

variability in the future. Amgen develops 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 Amgen may have believed at the time of entering into such

relationship. Also, Amgen or others could identify safety, side effects

or manufacturing problems with Amgens

products after they are on the market. Amgens

business may be impacted by government investigations, litigation and

products liability claims. Amgen depends on third parties for a

significant portion of its manufacturing capacity for the supply of

certain of its current and future products and limits on supply may

constrain sales of certain of its current products and product candidate

development.

In addition, sales of Amgens products are

affected by the reimbursement policies imposed by third-party payors,

including governments, private insurance plans and managed care

providers and may be affected by regulatory, clinical and guideline

developments and domestic and international trends toward managed care

and health care cost containment as well as U.S. legislation affecting

pharmaceutical pricing and reimbursement. Government and others

regulations and reimbursement policies may affect the development, usage

and pricing of Amgens products. In addition,

Amgen competes with other companies with respect to some of its marketed

products as well as for the discovery and development of new products.

Amgen believes that some of its newer products, product candidates or

new indications for existing products, may face competition when and as

they are approved and marketed. Amgens

products may compete against products that have lower prices,

established reimbursement, superior performance, are easier to

administer, or that are otherwise competitive with its products. In

addition, while Amgen routinely obtain patents for its products and

technology, the protection offered by its patents and patent

applications may be challenged, invalidated or circumvented by its

competitors and there can be no guarantee of Amgens

ability to obtain or maintain patent protection for its products or

product candidates. Amgen cannot guarantee that it will be able to

produce commercially successful products or maintain the commercial

success of its existing products. Amgens

stock price may be affected by actual or perceived market opportunity,

competitive position, and success or failure of its products or product

candidates. Further, the discovery of significant problems with a

product similar to one of Amgens products

that implicate an entire class of products could have a material adverse

effect on sales of the affected products and on Amgens

business and results of operations.

The scientific information discussed in this news release related to

Amgens product candidates is preliminary and

investigative. Such product candidates are not approved by the U.S. Food

and Drug Administration (FDA), and no conclusions can or should be drawn

regarding the safety or effectiveness of the product candidates. Only

the FDA can determine whether the product candidates are safe and

effective for the use(s) being investigated. Further, the scientific

information discussed in this news release relating to new indications

for Amgens products is preliminary and

investigative and is not part of the labeling approved by the FDA for

the products. The products are not approved for the investigational

use(s) discussed in this news release, and no conclusions can or should

be drawn regarding the safety or effectiveness of the products for these

uses. Only the FDA can determine whether the products are safe and

effective for these uses. Healthcare professionals should refer to and

rely upon the FDA-approved labeling for the products, and not the

information discussed in this news release.

Wyeth Forward-Looking Statement

The statements in this press release that are not historical facts are

forward-looking statements based on current expectations of future

events and are subject to risks and uncertainties that could cause

actual results to differ materially from those expressed or implied by

such statements. These risks and uncertainties include the inherent

uncertainty of the timing and success of, and expense associated with,

research, development, regulatory approval and commercialization of our

products, including with respect to our pipeline products; government

cost-containment initiatives; restrictions on third-party payments for

our products; substantial competition in our industry, including from

branded and generic products; data generated on our products; the

importance of strong performance from our principal products and our

anticipated new product introductions; the highly regulated nature of

our business; product liability, intellectual property and other

litigation risks and environmental liabilities; uncertainty regarding

our intellectual property rights and those of others; difficulties

associated with, and regulatory compliance with respect to,

manufacturing of our products; risks associated with our strategic

relationships; economic conditions including interest and currency

exchange rate fluctuations; changes in generally accepted accounting

principles; trade buying patterns; the impact of legislation and

regulatory compliance; risks and uncertainties associated with global

operations and sales; and other risks and uncertainties, including those

detailed from time to time in our periodic reports filed with the

Securities and Exchange Commission, including our current reports on

Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K,

particularly the discussion under the caption “Item 1A, RISK FACTORS.”

The forward-looking statements in this press release are qualified by

these risk factors. We assume no obligation to publicly update any

forward-looking statements, whether as a result of new information,

future developments or otherwise.

Amgen, Thousand Oaks
Sonia Fiorenza, 805-447-1604 (media)
John

Shutter, 805-447-1060 (investors)
or
Wyeth, Collegeville
Danielle

Halstrom, 484-865-2020 (media)
Justin Victoria, 973-660-5340

(investors)

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