FDA Accepts Application Approval Request of REMICADE(reg) for Psoriatic Arthritis

Supporting Data Show Significant Reduction of Joint and Skin Symptoms in Psoriatic Arthritis -


Centocor, Inc, announced today that the U.S. Food and Drug Administration (FDA) has accepted its filing of a supplemental
Biologics Licensee Application (sBLA) for REMICADE(reg) (infliximab) for the treatment of psoriatic arthritis (PsA) in patients
with active disease. PsA is a chronic, potentially debilitating disease, which affects approximately one million people and
causes joint inflammation frequently associated with active psoriasis.


"We are pleased that the FDA has accepted this application for REMICADE(reg) in the treatment of psoriatic arthritis," said
Cynthia Guzzo, senior director, Clinical Research, Centocor, Inc. "The results we have seen are extremely encouraging and we
hope to gain approval for patients impacted by this disease."


The filing is based on the results of two double-blind, placebo-controlled trials, IMPACT and IMPACT 2. The study results
were presented in October 2004 at the American College of Rheumatology Annual Scientific Meeting and in June 2004 at the
European League Against Rheumatism's Annual European Congress of Rheumatology.


IMPACT 2 is a Phase III, multi-center, randomized, double-blind, placebo-controlled trial that demonstrated that treatment
with REMICADE(reg) 5 mg/kg resulted in marked improvements in patients with PsA and significant improvement in both joint and
skin disease was evident as early as week two. These data showed that at week 14, more than half of the patients in the
REMICADE(reg) treatment group achieved significant improvements in the signs and symptoms of PsA as measured by the proportion of
patients achieving ACR 20 (58 percent of the REMICADE(reg) patient group versus 11 percent placebo, p less than 0.001) and 75
percent improvement in PASI (63.9 percent of the REMICADE(reg) treatment group versus 2.3 percent placebo, p less than 0.001).
The ACR 20 and PASI 75 responses were achieved regardless of concomitant methotrexate use or level of joint involvement at
baseline.


Furthermore, compared to placebo, significantly more subjects in the REMICADE(reg) treatment group achieved ACR 70 or PASI 90 as
early as week six and improved or maintained these results at later points in the study. At week 24, results showed that 27
percent of patients treated with REMICADE(reg) exhibited a 70 percent improvement in symptoms of arthritis (as measured by ACR
70) compared with two percent in the placebo group (p less than 0.001).


Thirty-nine percent of patients showed a 90 percent improvement in psoriasis (as measured by PASI 90) compared with zero
percent in the placebo group (p less than 0.001). In the first study, IMPACT, 104 people were randomized to REMICADE(reg) (5
mg/kg) or placebo. At week 16, 65 percent (n=34) of people on REMICADE(reg) therapy achieved ACR 20. Additionally, of the 38
people with evaluable psoriasis, 68 percent (n=15) achieved a 75 percent or greater improvement from baseline (PASI 75)
indicating clinically meaningful improvement in psoriasis. Significant improvements were maintained through one year.
















REMICADE(reg) was generally well tolerated in these studies, with similar numbers of patients experiencing adverse events (AE) in
each group. No deaths, cases of tuberculosis or other opportunistic infections were reported and serious infections and
infusion reactions were uncommon. Also, with the exception of one case of basal cell carcinoma in the placebo group, no
malignancies were reported. In general, the AE observed in these studies were consistent with those reported in other
indications, and most common AE included events that commonly occur in the general population. Significant laboratory
abnormalities were unusual, with an elevation in liver function tests during the IMPACT 2 trial being the most common
abnormality. Overall, there were slightly more patients with serious AE in the REMICADE(reg) group than in placebo. See Important
Information below.


About Psoriatic Arthritis


PsA involves joint pain and swelling that can lead to debilitation coupled with inflamed, scaly, red patches of psoriasis.
Symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and
redness and pain of the eye. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected.
Approximately one million Americans have PsA, and the disease affects both men and women equally, most commonly between the
ages 30 and 50.


About REMICADE(reg)


REMICADE(reg) is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent
approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union
and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE(reg) is
indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological
markers of inflammatory activity and who have responded inadequately to conventional therapy.


In September, the European Commission gave approval for expanded labeling for REMICADE(reg), in combination with methotrexate,
for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease
modifying anti-rheumatic drugs.


REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately-to-severely active Crohn's disease who
have had an inadequate response to conventional therapy. REMICADE(reg) 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(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to
inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or
office setting. In RA and CD patients, REMICADE(reg) is a two-hour infusion administered every eight weeks, following a standard
induction regimen that requires treatment at weeks zero, two and six.


As a result, REMICADE(reg) patients may require as few as six treatments each year. The safety and efficacy of REMICADE(reg) have
been well established in clinical trials over the past 12 years and through commercial experience with more than a half
million patients treated worldwide.


Important Information


Many people with heart failure should not take REMICADE(reg); so prior to treatment discussion of any heart condition with a
doctor is necessary. A doctor should be informed right away of new or worsening symptoms of heart failure (such as shortness
of breath or swelling of your ankles or feet.)


There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal.
Tell your doctor if you have had recent or past exposure to people with TB.


Evaluation for TB should be performed. If latent (inactive) TB exists, a doctor should begin TB treatment before starting
REMICADE(reg). REMICADE(reg) can lower one's ability to fight infections, so if prone to or if a history of infection(s) exists, or
one develops any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE(reg), tell a doctor right
away. Also tell a doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders
have been reported, some fatal. Tell a doctor if you develop possible signs of blood disorders such as persistent fever,
bruising, bleeding or paleness while taking REMICADE(reg). Nervous system disorders have also been reported.


Tell a doctor if there is a history of a disease(s) that affects the nervous system, or if one experiences any numbness,
weakness, tingling or visual disturbances while taking REMICADE(reg). Reports of lymphoma (a type of cancer) in patients on
REMICADE(reg) and other TNF blockers are rare but occur more often than in the general population; tell a doctor if there exists
a history of cancer.


Serious infusion reactions have been reported with REMICADE(reg), including hives, difficulty breathing and low blood pressure.
Reactions have occurred during or after infusions. 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 infusion such as rash or itchy skin.


About Centocor, Inc.


Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield
long-term benefits for patients and the health care community. The company is dedicated to the research and development of
treatments for a wide range of Immune-Mediated Inflammatory Disorders (IMID), such as arthritis and inflammatory skin
diseases and for 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, Inc., is a wholly
owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.


Centocor, Inc., has exclusive marketing rights to REMICADE(reg) in the United States. Schering-Plough Corporation has rights to
market REMICADE(reg) in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku,
Ltd., markets the product.