MALVERN, Pa., May 20, 2003 /PRNewswire-FirstCall via COMTEX/ --
Centocor Inc., maker of REMICADE(R) (infliximab), today announced that the company will provide $500,000 in Fellowship Grants to support new and ongoing research for Inflammatory Bowel Disease (IBD). Two grants -- one to the American Gastroenterological Association (AGA) to engage senior research fellows in additional full-time clinical research, and one to the Crohn's & Colitis Foundation of America (CCFA) to support new research programs aimed at identifying a cure for inflammatory bowel disease -- were announced during a reception held during the annual Digestive Disease Week meeting being held May 17-22 in Orlando, Florida. IBD is a physically and emotionally devastating disease affecting nearly one million Americans, ten percent of whom are children.
"We are proud to provide these grants to help support the work that brings hope to the many Americans suffering from IBD," said Tony Vernon, President of Centocor. "By partnering with organizations such as the AGA and CCFA, we can build on the pioneering clinical research that Centocor has conducted in this field."
Since first receiving FDA approval in 1998, Centocor has sponsored two landmark Crohn's disease trials, ACCENT I and ACCENT II. Last month, based on the results from the ACCENT II trial, and following a priority review, the FDA granted approval to REMICADE for use in maintaining fistula closure in patients with fistulizing Crohn's disease (CD) using a maintenance dose every eight weeks.
IBD is a group of disorders that cause inflammation of the digestive tract. Crohn's disease (CD) and ulcerative colitis (UC) are the most common types. According to CCFA, while there is no medical cure for IBD, treatment options include 5-ASA preparations, antibiotics, corticosteroids, immunomodulators and REMICADE, which is the only FDA approved drug for the treatment of patients with moderate-to-severe CD.
About IBD
Inflammatory Bowel Disease is characterized by chronic intestinal inflammation that results in mild to severe symptoms such as diarrhea, bleeding, abdominal pain, fever, joint pain, and weight loss. Crohn's disease and UC are the most common forms of IBD. CD most commonly affects the lower part of the small intestine and the large intestine. Like CD, the average age of onset for UC is late childhood or early adulthood, however, inflammation occurs in the colon.
About REMICADE
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.
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.
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.
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 biomedicine 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. markets the product.
About the American Gastroenterological Association
Founded in 1897, the American Gastroenterological Association is one of the oldest medical specialty societies in the United States. Its members include physicians and scientists who research, diagnose, and treat disorders of the gastrointestinal tract and liver. Representing almost 13,000 gastroenterologists worldwide, the AGA serves as an advocate for its members and their patients, supports gastroenterology practice and scientific needs, and promotes the discovery, dissemination, and application of new knowledge, leading to the prevention, treatment, and cure of digestive and liver diseases.
About the Crohn's & Colitis Foundation of America
Founded in 1967, the Crohn's & Colitis Foundation of America (CCFA) is a non-profit, volunteer-driven organization whose mission is to cure and prevent Crohn's disease and ulcerative colitis through research, and to improve the quality of life of children and adults affected by these digestive diseases through education and support. CCFA sponsors basic and clinical research of the highest quality. The foundation also offers a wide range of programs and services, including educational seminars for patients and medical professionals, brochures, books, a comprehensive Web site (www.ccfa.org), and support groups. CCFA programs are supported solely by contributions from the public.
Contact:
Craig Buchholz
Director of Franchise Communications
Phone: 610-651-6875
Mobile: 215-206-9062
SOURCE Centocor Inc.
Craig Buchholz, Director of Franchise Communications, Centocor Inc., +1-610-651-6875, or mobile, +1-215-206-9062
http://www.remicade.com
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