Guest guest Posted April 24, 2003 Report Share Posted April 24, 2003 Centocor, Inc. (JNJ) Announces REMICADE (Infliximab) Milestone With More Than 400,000 Patients Treated Worldwide MALVERN, Pa., April 22 /PRNewswire-FirstCall/ -- Centocor Inc., announced today that since first receiving FDA approval for REMICADE® (infliximab) nearly five years ago, over 400,000 patients worldwide have been treated -- more than any other tumor necrosis factor alpha (TNF-alpha) biologic therapy(1). REMICADE is the global market share leader among TNF-alpha therapies and is the only biologic drug indicated for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD). " This milestone is important not only because it demonstrates the increasing role of biologic therapies, but also because it further supports the direction of our clinical research and development program, " said Jerome A. Boscia, M.D., Vice-President, Clinical Research and Development, Centocor. " Current efforts are focused on exploring common immune pathways and developing therapies that may be effective across a number of disorders. This focus grew from our experience with REMICADE in successfully treating multiple immune-mediated inflammatory disorders. " REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that may require patients to inject themselves weekly or bi-weekly, REMICADE is the only anti-TNF biologic administered as an in-office treatment. RA and CD patients receive REMICADE every eight weeks, following a standard induction regimen, which requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. 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 in Crohn's disease and rheumatoid arthritis, in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied, including psoriasis, psoriatic arthritis and ankylosing spondylitis. About REMICADE REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate. REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. It is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease. 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 or coccidioidomycosis 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 & , 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. Contact: Craig Buchholz Director of Franchise Communications Phone: 610-651-6875 Mobile: 215-206-9062 (1) Data on file, Centocor. SOURCE Centocor Inc. -0- 04/22/2003 /CONTACT: Craig Buchholz, Director of Franchise Communications of Centocor Inc., +1-610-651-6875, or mobile, +1-215-206-9062/ /Web site: http://www.remicade.com / Quote Link to comment Share on other sites More sharing options...
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