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European Advisory Committee Recommends Approval of Infliximab for Treatment of Active Psoriatic Arthritis

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE:SGP) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of expanded labeling for REMICADE(R) (infliximab), in combination with methotrexate, for 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 positive opinion for REMICADE as a treatment for PsA is primarily based on data from IMPACT (Infliximab Multinational Psoriatic Arthritis Controlled Trial)(1), 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 centers in the United States, Canada and Europe. Results demonstrated the safety and efficacy of REMICADE in treating this debilitating disorder.

In IMPACT, patients given REMICADE (5mg/kg) experienced rapid and sustained improvement in their joints, as measured by the ACR 20, 50 and 70 response criteria, measurement tools used to assess disease activity and improvement. Specifically, 34 of the 52 patients (65.4 percent) met the ACR 20 response criteria -- the primary efficacy parameter -- at week 16, compared to five of the 52 patients (9.6 percent) in the placebo group. Responses were sustained through the end of the study (week 50). Results were confirmed in the ACR 50 and ACR 70 scores among those treated with REMICADE: 24 patients (46.2 percent) met the ACR 50 response at week 16 with 26 patients (53.1 percent) meeting it at week 50; 15 patients (28.8 percent) met the ACR 70 response at week 16, with 19 patients (38.8 percent) meeting it at week 50.

The CHMP recommendation serves as the basis for a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-Member states, including the current 15 member states and the 10 new accession countries as well as in Iceland and Norway.

Schering-Plough markets REMICADE in all countries outside of the United States, except in Japan and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States. Centocor plans to submit a supplemental Biologics Application to the U.S. Food and Drug Administration later this year to request approval for this new use.

About Psoriatic Arthritis
The Arthritis Research Campaign estimates 1 in 50 people have psoriasis. Of these, about 1 in 14 will develop PsA.(2) 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 nail changes, including pitting (small indentations in the nail) or lifting of the nail.

About REMICADE
REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha which has been shown to play a role in RA, CD, 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 beenwell established in clinical trials conducted over the past 10 years and through commercial experience with more than 500,000 patients treated worldwide.

REMICADE is the only biologic indicated for the treatment of both RA and Crohn's disease (CD), a serious gastrointestinal disorder. In the EU, REMICADE is also approved for the treatment of Ankylosing Spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine.

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 CD patients, REMICADE is indicated for the treatment of severe, active Crohn's disease 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 Crohn's disease in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

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

Important Information Regarding Labeling for REMICADE
People with heart failure should not take REMICADE. Prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor immediately if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of feet). There are reports of serious infections associated with REMICADE therapy, 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. 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 immediately. Patients should also tell their doctor 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 U.S. prescribing information at http://www.remicade.com/. For complete REMICADE EU prescribing information, call Schering-Plough Corporation at +1 908-298-7616.

(1) Arthritis Research Campaign: About Psoriatic Arthritis Booklet. Available at: http://www.arc.org.uk/about_arth/booklets/6029/6029.htm. Accessed March 23, 2004.
(2) National Psoriasis Foundation: Psoriatic Arthritis Facts. Available at: http://www.psoriasis.org/facts/psa. Accessed March 16, 2004.

Source: Schering-Plough Corporation

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