Jump to content
RemedySpot.com

Treatment has demonstrated improvement in physical function and kept joint damage from progressing

Rate this topic


Guest guest

Recommended Posts

Treatment has demonstrated improvement in physical function and kept

joint damage from progressing

Enbrel plus Methotrexate: First treatment to demonstrate ability to

inhibit radiographic progression of joint damage for three

consecutive years

THOUSAND OAKS, Calif. and COLLEGEVILLE, Pa., November 13, 2005 –

Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth

(NYSE: WYE), today announced data from a long-term blinded study of

anti-TNF agent in patients with rheumatoid arthritis (RA)

demonstrated that more than three quarters of patients treated with

Enbrel® (etanercept) plus methotrexate combination therapy

experienced no progression of joint damage at three years. These new

results from the TEMPO (Trial of Etanercept and Methotrexate with

Radiographic Patient Outcomes) study will be presented at the

American College of Rheumatology's (ACR) Annual Scientific Meeting in

San Diego, California.

" Rheumatoid arthritis is a chronic condition requiring long-term

treatment. It is critical to provide patients with treatment options

that not only reduce the signs and symptoms of the disease, but also

inhibit the progression of joint damage, " said Désirée van der

Heijde, M.D., professor of rheumatology, University of Maastricht in

the Netherlands. " The TEMPO results reinforce the benefits of ENBREL

and methotrexate combination therapy and underscore the importance of

effective treatment. "

At three years, the majority of patients taking ENBREL and

methotrexate combination therapy had no progression of joint damage.

These results were significantly better than those achieved in ENBREL

monotherapy and methotrexate monotherapy-treated patients. Patients

receiving ENBREL monotherapy also had significantly better results

than patients receiving methotrexate monotherapy. Total Sharp Score

was calculated by assessing changes in joint space narrowing and bone

erosion as captured by radiographic imaging.

Further, additional data presented at ACR showed that improvement in

physical function was higher for the ENBREL combination group than

for either therapy alone. Patients treated with ENBREL combination

therapy experienced a 56 percent mean improvement in Health

Assessment Questionnaire (HAQ) scores from baseline, compared to 37

percent mean improvement in patients treated with ENBREL alone and 33

percent mean improvement in patients treated with methotrexate alone.

HAQ scores measure a patient's ability to perform activities of daily

living such as dressing, walking, and grooming.

The ENBREL TEMPO study randomized 686 patients with RA, of which 638

were included in the three-year radiographic analysis. Patients

received either ENBREL (25 mg twice weekly), methotrexate (up to 20

mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate

once weekly. Patients in the ENBREL TEMPO trial had active RA and an

inadequate response to at least one disease-modifying antirheumatic

drug (DMARD) other than methotrexate. The primary radiographic

endpoint was the change from baseline in the van der Heijde-modified

TSS at one year. Secondary radiographic endpoints included changes in

total erosions, changes in total joint space narrowing, number of

eroded joints, and percent of patients with no radiographic progression.

ENBREL was generally well tolerated.

ABOUT RA

More than two million Americans suffer from RA, which can cause

stiffness, swelling, and limitation in the motion and function of

multiple joints. If RA is left untreated, patients can become

disabled from joint damage caused by the disease, limiting their

ability to function.

###

ABOUT ENBREL

ENBREL is the only soluble tumor necrosis factor (TNF) receptor

approved to reduce signs and symptoms, induce major clinical

response, improve physical function, and inhibit the progression of

structural damage in patients with moderately to severely active

rheumatoid arthritis (RA). ENBREL can be used alone or in combination

with methotrexate.

ENBREL is the only treatment indicated to reduce the signs and

symptoms, inhibit the progression of structural damage of active

arthritis, and improve physical function in patients with psoriatic

arthritis. It is approved to reduce the signs and symptoms of

moderately to severely active polyarticular-course juvenile

rheumatoid arthritis (JRA) in patients four years of age or older who

have had an inadequate response to one or more disease-modifying

antirheumatic drugs (DMARDs). It is also the first biologic approved

to reduce the signs and symptoms in patients with active ankylosing

spondylitis (AS). 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.

ENBREL has been used by more than 308,000 patients worldwide across

indications.

ENBREL acts by binding TNF, one of the dominant inflammatory

cytokines or regulatory proteins that play an important role in both

normal immune function and the cascade of reactions involved in the

inflammatory process of RA, JRA, psoriasis, psoriatic arthritis, and

AS. The binding of ENBREL to TNF renders the bound TNF biologically

inactive, 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 immune

system makes called TNF. People with an immune disease, such as

rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis,

and psoriasis, have too much TNF in their bodies. ENBREL can reduce

the amount of 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.

All medicines have side effects, including ENBREL. Possible side

effects 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, market ENBREL

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

Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures

ENBREL. Additional information about ENBREL, including full

Prescribing Information, can be found on the website sponsored by the

companies at www.ENBREL.com or by calling toll-free 1-888-4ENBREL

(1-888-436-2735).

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 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 broad and deep 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 (NYSE:WYE), has leading

products 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 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 nonprescription 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.

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 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 side effects or

manufacturing problems with Amgen's products after they are on the

market.

In addition, sales of Amgen's 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 health care 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, Amgen competes with other companies

with respect to some of Amgen's 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. Amgen's 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 obtains 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 Amgen's 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. Amgen's 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 Amgen's

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.

The scientific information discussed in this news release related to

Amgen's 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 our 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. Health care professionals should refer to

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

information discussed in this news release.

The statements in this press release that are not historical facts

are forward-looking statements based on current expectations of

future events that involve risks and uncertainties including, without

limitation, risks associated with the inherent uncertainty of the

timing and success of pharmaceutical research, product development,

manufacturing, commercialization, economic conditions including

interest and currency exchange rate fluctuations, changes in

generally accepted accounting principles, the impact of competitive

or generic products, trade buying patterns, wars or terrorist acts,

product liability and other types of lawsuits, the impact of

legislation and regulatory compliance and obtaining reimbursement,

favorable drug pricing, access and other approvals, environmental

liabilities, and patent, and other risks and uncertainties, including

those detailed from time to time in the Company's periodic reports,

including current reports on Form 8-K, quarterly reports on Form 10-Q

and the annual report on Form 10-K, filed with the Securities and

Exchange Commission. Actual results may vary materially from the

forward-looking statements. The Company assumes no obligation to

publicly update any forward-looking statements, whether as a result

of new information, future events or otherwise.

CONTACT:

Amgen

Wyeth Pharmaceuticals

Cassiano (media)

Candace Steele (media)

805-447-4587

484/865-5428

Biswas (investors)

(investors)

805/447-1060

Link to comment
Share on other sites

Join the conversation

You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.

Guest
Reply to this topic...

×   Pasted as rich text.   Paste as plain text instead

  Only 75 emoji are allowed.

×   Your link has been automatically embedded.   Display as a link instead

×   Your previous content has been restored.   Clear editor

×   You cannot paste images directly. Upload or insert images from URL.

Loading...
×
×
  • Create New...