Promising New Results Reported for REMICADE(R) (Infliximab) in the Treatment of Psoriasis -- www1.internetwire.com

MALVERN, PA -- (INTERNET WIRE) -- 03/21/2003 -- New data was presented today at the annual meeting of the American Academy of Dermatology (AAD) in San Francisco from a Phase II study investigating the use of REMICADE® (infliximab) in patients suffering from moderate-to-severe psoriasis. Investigators reported improvements in disease severity compared to patients treated with placebo. Approximately one third of the seven million Americans with psoriasis suffer from moderate-to-severe disease, which can be both physically and emotionally debilitating. "Many patients and physicians are interested in learning more about potential new therapies in the treatment of moderate-to-severe psoriasis," said Kenneth Gordon, M.D., associate professor of medicine, division of dermatology, director of the psoriasis translational research program, Loyola University. "The results of this study warrant further investigation in large, well-controlled studies and will likely be the subject of considerable interest for the many patients who suffer with psoriasis." REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role not only in psoriasis, psoriatic arthritis, rheumatoid arthritis and Crohn's disease, but also in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied. Study Findings SPIRIT is a multi-center, randomized, double-blind, placebo-controlled trial involving 249 patients with moderate-to-severe psoriasis. The primary objective was to evaluate safety and efficacy of REMICADE as compared to placebo through week 10. Patients were randomized to receive placebo (n=51) or either 3 mg/kg (n=99) or 5 mg/kg (n=99) REMICADE monotherapy at weeks zero, two, and six. Efficacy was assessed every two weeks through week 10 using the Psoriasis Area Severity Index (PASI), a scale for assessing the severity and extent of psoriasis. At week 10, 88 percent and 72 percent of patients treated with 5 mg/kg and 3 mg/kg of REMICADE, respectively, experienced a greater than or equal to 75 percent improvement from baseline in PASI compared to 6 percent of those treated with placebo. Among those treated with 5 mg/kg of REMICADE, nearly half achieved a greater than or equal to 75 percent improvement in PASI score as early as week 4 and 58 percent achieved 90 percent improvement in PASI by Week 10. The most commonly reported side effects versus placebo were headache (11.2 percent vs. 5.9 percent), pruritus (8.6 percent vs. 0 percent) and upper respiratory tract infection (7.6 percent versus 9.8 percent). There was one serious adverse event, cholecystitis, reported in the 3 mg/kg treatment group. About Psoriasis According to the National Psoriasis Foundation, psoriasis is a chronic skin disease that generally appears as patches of raised red skin covered by flaky white scales. While the exact cause is unknown, psoriasis is believed to be related to faulty inflammatory signals sent by the body's immune system that causes development of skin plaques. Psoriasis affects more than seven million Americans. This immune-mediated inflammatory disorder most commonly appears in adults between the ages of 15 and 35. About REMICADE® REMICADE, in combination with methotrexate, is indicated to reduce signs and symptoms, inhibit progression of joint damage, and improve physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone. REMICADE is also approved to reduce signs and symptoms and induce and maintain clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. It is also approved for use as a short-term treatment for reducing the number of draining enterocutaneous fistulas in patients with fistulizing Crohn's disease. REMICADE was the first anti-tumor necrosis factor (TNF) biologic approved by the FDA and is the worldwide market share leader among anti-TNF therapies. REMICADE is the only biologic drug indicated for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD). 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 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 is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, 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: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE, including full prescribing information, at 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 Johnson & Johnson, the worldwide manufacturer of healthcare products. Centocor has exclusive marketing rights to REMICADE in the United States. Schering-Plough Corporation (NYSE: SGP) 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. will market the product.