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REMICADE® (infliximab) Granted Priority Review by FDA for Long-term Treatment of Crohn's Disease

3/21/2002

MALVERN, Pa., March 21, 2002 – Centocor, Inc. today announced that REMICADE(R) (infliximab) has been designated for priority review by the U.S. Food and Drug Administration (FDA) as a monotherapy for inducing and maintaining clinical remission in patients with moderately to severely active Crohn’s disease (CD), a gastrointestinal disorder that affects more than a half-million Americans. REMICADE is the worldwide market share leader among tumor necrosis factor alpha (TNF-alpha) therapies and the only biologic indicated for the treatment of rheumatoid arthritis (RA) and the short-term treatment of CD.

The FDA grants priority review status to products that are considered to be a potential significant therapeutic advance over existing therapies. Centocor submitted a supplemental biologics license application (sBLA) to the FDA on December 28, 2001, based on 54-week data from the ACCENT I trial.

One of the largest Crohn’s disease studies ever conducted, ACCENT I involved 573 patients with moderate-to-severe CD at 55 centers in North America, Europe, and Israel. The objective of the trial was to evaluate the safety and effectiveness of REMICADE as a maintenance therapy for CD. REMICADE is currently approved for short-term use for the reduction of signs and symptoms of Crohn's disease in patients with moderately-to-severely active Crohn’s disease who have had an inadequate response to conventional therapy.

“We are extremely pleased that the FDA has designated REMICADE for priority review,” said Jerome A. Boscia, M.D., Vice President, Clinical Research & Development. “This designation recognizes the significant unmet medical need facing thousands of Americans currently living with Crohn's disease.”

Crohn's disease is a chronic and debilitating inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. In up to 30 percent of patients, CD causes fistulas -- openings that burrow through the bowel wall into nearby organs or through the surface of the skin.

About REMICADE
REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in RA and CD, and may also be important in a range of other immune-mediated inflammatory disorders.

In 1998, REMICADE became the first and only biologic approved by the FDA for the treatment of CD. It is indicated as a monotherapy for the reduction of signs and symptoms in moderately to severely active Crohn’s disease in patients who have had an inadequate response to conventional therapy. It is also indicated for reducing the number of draining enterocutaneous fistulas in patients with fistulizing Crohn’s disease. The safety and effectiveness of use of REMICADE beyond the recommended duration in Crohn’s disease have not been established.

On February 27, 2002, REMICADE, in combination with methotrexate, made history again when, in addition to reducing signs and symptoms and inhibiting the progression of structural damage, it became the first and only biologic approved by the FDA to improve physical function in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. Nearly 230,000 patients have been treated with REMICADE since its introduction in 1998.

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. Its 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.