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Infliximab Gains European Approval, Indicated for Psoriatic Arthritis

KENILWORTH, N.J., and HORSHAM, Pa., Oct. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP - News) and Centocor, Inc. today announced that the European Commission has granted approval of REMICADE® (infliximab) in the European Union (EU), in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to disease modifying anti-rheumatic drugs (DMARDs). Psoriatic arthritis is a chronic, autoimmune inflammatory condition involving the joints and the skin. The approval follows a positive opinion granted in July by the Committee for Medicinal Products for Human Use (CHMP), for the European Medicines Agency (EMEA).

"This approval is an important milestone in the management of psoriatic arthritis as these patients now have a new treatment option that addresses the unique aspects of this difficult-to-treat disease," said Robert Spiegel, MD, chief medical officer and senior vice president, Schering-Plough. "Moreover, the new indication further demonstrates the broad utility of REMICADE in improving the lives of patients suffering from a range of inflammatory disorders."

The EU approval for REMICADE as a treatment for psoriatic arthritis is based on data from IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial), a randomized, double-blind, placebo-controlled study involving 104 patients with active PsA who had failed at least one DMARD and were enrolled at nine study centers in the United States, Canada and Europe. Results demonstrated the safety and efficacy of REMICADE in treating this debilitating disorder.

About Psoriatic Arthritis
The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of these, about 1 in 14 will develop PsA. While PsA can develop at any age, onset usually occurs in middle-age, typically in adults between the ages of 30 and 50. Men and women are affected equally. Symptoms include stiffness, pain, swelling and tenderness of the joints and surrounding soft tissue, reduced range of motion, morning stiffness, and tiredness. Other symptoms include psoriatic skin lesions, nail changes, including pitting (small indentations in the nail) or lifting of the nail.

REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriasis, and may also be important in a wide range of other immune-mediated inflammatory disorders. REMICADE is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE is the only anti-TNF biologic administered directly under supervision and monitoring of specialized physicians. In RA and CD patients, REMICADE is administered every eight weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6. As a result, REMICADE patients may require as few as six treatments each year. The safety and efficacy of REMICADE have been well established in clinical trials conducted over the past 12 years and through commercial experience with more than half a million patients treated worldwide. REMICADE is the only biologic indicated for the treatment of both RA and CD. In the EU, REMICADE is also approved for the treatment of AS, a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine.

In CD patients, REMICADE is indicated for the treatment of severe, active CD in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. REMICADE is also indicated for the treatment of fistulizing, active CD in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

For RA patients, REMICADE, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in patients with active disease when the response to disease- modifying drugs, including methotrexate, has been inadequate, and in patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.

In the EU, REMICADE is also indicated for treatment of AS in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

Centocor has exclusive marketing rights to REMICADE in the United States. Schering-Plough Corporation (NYSE: SGP - News) 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.

Important Information Regarding Labeling for REMICADE
Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of your ankles or feet).

There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a skin test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE, tell your doctor right away. Also tell your doctor if you live in a region where histoplasmosis or coccidioimycosis is common. Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE.

Serious infusion reactions have been reported with REMICADE, including hives, difficulty breathing, and low blood pressure. Reactions have occurred during or after infusions. 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 infusion such as rash or itchy skin. (Please read important information about REMICADE, including full prescribing information, at . For complete REMICADE EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616.

Source: Schering-Plough Corporation and Centocor

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