New Study Shows REMICADE(R) Provides Rapid and Sustained Response in Patients With Ankylosing Spondylitis

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New Study Shows REMICADE® Provides Rapid and Sustained Response in

Patients With Ankylosing Spondylitis

- Centocor and Schering-Plough Announce Phase III Clinical Data from ASSERT

Trial -

MALVERN, Pa. and KENILWORTH, N.J., Oct. 25 /PRNewswire/ -- Patients with

active ankylosing spondylitis (AS) achieved a dramatic reduction in signs

and

symptoms associated with their disease when treated with

REMICADE®(infliximab), according to data from a major, multi-center,

randomized clinical trial. AS is a chronic and debilitating inflammatory

disease that often leads to stiffening and subsequent fusion of the spine.

" These findings are very encouraging for physicians and patients. This

study underscores the role of tumor necrosis factor in the origins of AS and

may reshape the approach rheumatologists will take toward treatment in the

future, " said Professor Jurgen Braun, M.D., lead physician at the

Rheumatological Center in Herne and Professor at the Free University of

Berlin, and principal investigator for the ASSERT trial (Anklyosing

Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy).

" Treatment options are extremely limited for this very progressive and

disabling disease. Results like those seen with REMICADE are very

encouraging

for patients with AS. "

REMICADE, made by Centocor, is the global market leader among tumor

necrosis factor alpha (TNF-alpha) therapies, and the only biologic drug

indicated for the treatment of both rheumatoid arthritis (RA) and Crohn's

disease in North America, the European Union and Japan. REMICADE was the

first biologic approved for the treatment of AS in the European Union, and

is

now approved in 30 countries. The results of ASSERT will be included in a

supplemental Biologics License Application (sBLA) to the U.S. Food and Drug

Administration (FDA) in the near future. Schering-Plough Corporation has

rights to market REMICADE in all other countries throughout the world,

except

in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the

product.

ASSERT Results

The primary endpoint of the trial was the proportion of patients

demonstrating a 20 percent or greater improvement in signs and symptoms as

measured by the ankylosing spondylitis assessment (ASAS 20) at 24 weeks.

Patients were assessed at baseline and at 24 weeks by standard AS

performance

scores and by magnetic resonance imaging of their joints. In the infliximab

group, 61.2 percent achieved ASAS 20 compared to placebo at 19.2 percent.

The

benefit seen in the REMICADE group was statistically significant (p<0.001).

The most commonly reported adverse events were upper respiratory tract

infections which occurred at a slightly higher rate in the placebo group

(14.7 percent) compared to the infliximab group (13.9 percent). Serious

adverse events were noted in 3.5 percent of REMICADE treated patients

compared

to 2.7 percent of patients receiving placebo.

About ASSERT

ASSERT is a Phase III, randomized, placebo-controlled, double-blind,

30-center trial in North America and Europe. The trial included 279

patients,

two-hundred and one patients were treated with REMICADE (infliximab) and

78 patients were given placebo infusions. Patients were given REMICADE

monotherapy 5 mg/kg infusions at weeks 0, 2, 6, followed by infusions every

six weeks.

About Ankylosing Spondylitis

According to the Spondylitis Association of America (SAA), AS is a

chronic

progressive, debilitating condition that generally strikes young adults in

their 20s and 30s. AS is a chronic rheumatic disease that causes arthritis

of

the spine and sacroiliac joints and can cause inflammation of the eyes,

lung,

and heart valves. The cause of AS is unknown. Symptoms vary from an

occasional flare-up of backpain to a severe chronic disease that attacks the

spine, peripheral joints, and other body organs. As the disease progresses,

it

can lead to severe joint and back stiffness, and loss of motion and

deformity.

The SAA estimates that between 300,000 and one million people in the United

States suffer from AS or a related disease.

About REMICADE

REMICADE is a monoclonal antibody that specifically targets and

irreversibly binds to tumor necrosis factor-alpha (TNF-alpha) on the cell

membrane and in the blood. Overproduction of TNF-alpha is believed to play

a

role in RA, Crohn's disease (CD), a serious gastrointestinal disorder, and

AS,

in addition to a wide range of Immune-Mediated Inflammatory Disorders

(I.M.I.D.) in which REMICADE is currently being studied.

REMICADE is the only anti-TNF biologic therapy that has received

marketing

authorizations for the treatment of both RA and CD and, in the European

Union,

AS. In most countries, REMICADE, in combination with methotrexate, is

indicated for the treatment of patients with moderately to severely active

rheumatoid arthritis who have had an inadequate response to methotrexate

alone. REMICADE is the only biologic indicated for the treatment of

patients

with moderate to severe, active Crohn's disease who have had an inadequate

response to conventional therapy. REMICADE is also indicated for reducing

the

number of draining enterocutaneous and rectovaginal fistulas and maintaining

fistula closure in patients with fistulizing Crohn's disease.

REMICADE is unique among available anti-TNF biologic therapies. Unlike

self-administered therapies that require patients to inject themselves

frequently, REMICADE is the only anti-TNF biologic administered directly by

caregivers in the clinic or office setting. In RA and CD patients, REMICADE

is received every eight weeks, following a standard induction regimen that

requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may

require as few as six treatments each year. The safety and efficacy of

REMICADE is well established with over 10 years of clinical trial experience

and commercial experience and more than 400,000 patients treated

worldwide -- more patients treated than all other TNF inhibitors combined.

Important Information

Many people with heart failure should not take REMICADE; so, prior to

treatment, patients should discuss any heart condition with their doctor.

Patients should tell their doctor right away if they develop new or

worsening

symptoms of heart failure (such as shortness of breath or swelling of their

ankles or feet).

There are reports of serious infections, including tuberculosis (TB) and

sepsis. Some of these infections have been fatal. Patients should tell

their

doctor if they have had recent or past exposure to people with TB. Their

doctor will evaluate them for TB and perform a skin test. If a patient has

latent (inactive) TB, his or her doctor should begin TB treatment before

starting REMICADE. If a patient is prone to or has a history of infections,

currently has one, or develops one while taking REMICADE, he or she should

tell his or her doctor right away. Patients should also tell their doctor

if

they have lived in a region where histoplasmosis or coccidioidomycosis is

common, or if they have or have had a disease that affects the nervous

system,

or if they experience any numbness, weakness, tingling, or visual

disturbances.

There are also reports of serious infusion reactions with hives,

difficulty breathing, and low blood pressure. In clinical studies, some

people experienced the following common side effects: respiratory

infections,

(that may include sinus infections and sore throat) coughing, and stomach

pain

or mild reactions to the infusion such as rash or itchy skin. Please read

important information about REMICADE, including full prescribing

information,

at http://www.remicade.com.

About Centocor

Centocor is a leading biopharmaceutical company that creates, acquires

and

markets cost-effective therapies that yield long-term benefits for patients

and the healthcare community. The company is dedicated to the research and

development of treatments for a wide range of Immune-Mediated Inflammatory

Disorders (I.M.I.D.), such as arthritis, inflammatory skin diseases and

cancer. Centocor's products, developed primarily through monoclonal

antibody

technology, help physicians deliver innovative treatments to improve human

health and restore patients' quality of life. Centocor is a wholly owned

subsidiary of & , the worldwide manufacturer of healthcare

products.

JOHNSON & JOHNSON DISCLOSURE NOTICE: This press release contains

" forward-looking statements " as defined in the Private Securities Litigation

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future events. If underlying assumptions prove inaccurate or unknown risks

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Company's

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forward-looking statements as a result of new information or future events

or

developments.

About Schering-Plough

Schering-Plough markets REMICADE in all countries outside of the United

States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd.

markets the product. Centocor discovered REMICADE and has exclusive

marketing

rights to the product in the United States.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release

includes certain " forward-looking " statements concerning, among other

things,

the future prospects of the company and its products, which the reader of

this

release should understand are subject to substantial risks and

uncertainties.

The company's business prospects and the prospects of its products may be

adversely affected by general market and economic factors, competitive

product

development, product availability, current and future branded, generic and

OTC

competition, market acceptance of new products, federal and state

regulations

and legislation, the regulatory review process in the United States and

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issues and new manufacturing issues that may arise, timing of trade buying,

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destruction in a geographic area important to the company due to reasons

such

as war or SARS. For further details and a discussion of these and other

risks

and uncertainties, see the company's Securities and Exchange Commission

filings, including the company's 8-K filed Oct 22, 2003.

Schering-Plough is a research-based company engaged in the discovery,

development, manufacturing and marketing of pharmaceutical products

worldwide.