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Remicade (Infliximab) Gains European Approval for Maintenance Dosing In Treatment of Fistulizing Crohn's Disease

KENILWORTH, NJ -- October 23, 2003 -- Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has granted a European Union (EU) approval of Remicade® (infliximab) for maintenance dosing for sustaining clinical response in patients with fistulizing Crohn's disease (CD) who have responded to initial infliximab therapy. The approval follows a positive recommendation by the EU's Committee for Proprietary Medicinal Products (CPMP) for the European Agency for the Evaluation of Medicinal Products (EMEA) in July. No other anti-TNF therapy has demonstrated proven activity in the treatment of Crohn's disease.

"We are pleased that Remicade has been approved for expanded use in maintenance dosing, which reflects the clinical value that regular use of this therapy can bring to patients suffering from the painful and debilitating symptoms associated with this form of Crohn's disease," said Robert J. Spiegel, M.D., senior vice president of medical affairs and chief medical officer, Schering Plough Research Institute. "Our research programs continue to explore the potential value of Remicade in other diseases, with studies under way for use in a wide range of immune-mediated inflammatory disorders, including early rheumatoid arthritis, psoriatic arthritis and psoriasis," he said.

In May, the EU approved Remicade for maintenance dosing for the treatment of patients with severe, active Crohn's disease who have responded to initial infliximab therapy. Remicade is the only biologic indicated for the treatment of CD, rheumatoid arthritis (RA) and ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine. Remicade is the worldwide market leader among TNF-alpha therapies, with nearly 500,000 patients treated to date.

Remicade is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that may require patients to inject themselves weekly or bi-weekly, Remicade is the only anti-TNF biologic administered as an in-office treatment. RA and CD patients receive Remicade every eight weeks, following a standard induction regimen, which requires treatment at weeks 0, 2 and 6. As a result, Remicade patients may require as few as six treatments per year following the induction regimen.

The EU approval for Remicade maintenance dosing in fistulizing Crohn's disease, a serious gastrointestinal disorder, is based on data from the ACCENT II trial, a one-year trial that evaluated the safety and effectiveness of Remicade as a maintenance therapy for fistulizing active CD. The study results demonstrated the ability of Remicade to induce and maintain closure of draining fistulas. In those patients demonstrating benefit after a three-dose induction regimen, Remicade is now indicated for maintenance treatment every eight weeks or when signs and symptoms recur.

In the EU, 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 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 use for the reduction of signs and symptoms and the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. In this patient population, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.

For AS patients, Remicade is approved for use in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

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, CD and AS, and may also be important in a wide range of other immune-mediated inflammatory disorders. Schering-Plough markets Remicade in all countries outside of the United States, except in Japan and parts of the Far East where Remicade will be marketed by Tanabe Seiyaku, Ltd. Centocor, Inc. a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States.

Important Information Regarding EU Labeling for Remicade

Many 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 nervoussystem, 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. For complete Remicade EU labeling information, go to the link: http://www.eudra.org/humandocs/humans/epar/remicade/remicade.htm, on the EMEA web site. In the United States, complete U.S. prescribing information and other product information is available at http://www.remicade.com.


SOURCE: Schering-Plough Corporation

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