First Ever Trial Comparing Biologic Therapy With Conventional Therapy in Patients With Crohn's Disease

Main Category: GastroIntestinal / Gastroenterology
Article Date: 18 May 2004 - 0:00 PDT

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Centocor, Inc., and Schering-Plough Corporation announced today the initiation of the SONIC (Study of Immunomodulator Naive patients in Crohn's Disease) trial that will evaluate the efficacy of REMICADE® (infliximab) versus azathioprine, a conventional immunosuppressive agent, alone and versus the combination of both drugs for the treatment of patients with Crohn's disease (CD), a serious gastrointestinal disorder. SONIC is the first ever clinical trial to evaluate a biologic therapy compared with a conventional therapy in patients with Crohn's disease. The announcement was made at the 2004 Annual Digestive Disease Week Meeting.

"Although infliximab is a proven, effective treatment for moderately-to-severely active Crohn's disease, many physicians want to know whether they should use REMICADE® before, after or in combination with immunomodulators," said Dr. Thomas F. Schaible, Centocor's vice president of Medical Affairs. "We look forward to receiving the results from the SONIC trial and are confident this trial will provide valuable information on how best to utilize REMICADE® in the management of Crohn's disease."

"We are committed to exploring the full clinical potential of REMICADE® in the treatment of Crohn's disease. The SONIC trial will be very important in helping us understand the further potential benefits of REMICADE® in these patients with active, uncontrolled disease," said Robert Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Corporation.

The SONIC trial will involve immunomodulator-naive, biologic-naive patients with moderately-to-severely active Crohn's disease. The primary endpoint of SONIC is steroid-free remission. Secondary endpoints include mucosal healing and aggregate steroid use.

REMICADE® is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the blood. Overproduction of TNF-a is believed to play a role in RA and CD and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE® is currently being studied.

REMICADE® is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both Rheumatoid Arthritis (RA) and CD. In the European Union, REMICADE® is also approved for the treatment of Ankylosing Spondylitis. In most countries, REMICADE®, in combination with methotrexate, is indicated for the treatment of patients with moderately-to-severely active RA who have had an inadequate response to methotrexate alone.

REMICADE® is the only biologic indicated for the treatment of patients with moderately-to-severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD.

About Crohn's Disease

Crohn's disease is a chronic 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. It is estimated that 500,000 Americans and more than 400,000 people in Europe and Canada suffer from this gastrointestinal disorder.

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 the ankles and 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, weakness, 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: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain 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. For prescribing information for the European Union, call Schering-Plough Corporation at +1 908-298-7616.

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 diseases including cancer, infectious diseases, cardiovascular and metabolic diseases and Immune-Mediated Inflammatory Disorders (I.M.I.D.), such as arthritis and inflammatory skin diseases. 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® in the United States. Schering-Plough Corporation 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.

Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough Corporation discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world.

Schering-Plough Corporation Disclosure Notice:

The information in this press release includes certain "forward-looking" information including the market potential for REMICADE®. Forward-looking statements relate to expectations or forecasts of future events. Please carefully consider any forward-looking statement and understand that many factors cause actual results to differ from Schering-Plough's forward-looking statements. The reader of this release should understand that the extent that REMICADE® will be prescribed will be determined by market forces and the market viability of any particular product is subject to substantial risks and uncertainties. In addition, the forward-looking statements may also be affected by general market and economic factors, product availability, current and future branded, generic or over-the-counter competition, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues, trade buying patterns, patent positions and the outcome of litigation and investigations. Schering-Plough Corporation does not assume the obligation to update any forward-looking statement. For further details and a discussion of other risks and uncertainties that may affect forward-looking statements, see the company's Securities and Exchange Commission filings, including the company's 10-K filed Feb. 26, 2004.

About Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 15-20, 2004, in New Orleans, Louisiana. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.