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European Commission Approves New Indication for Infliximab to Treat Crohn's Disease in Children

HORSHAM, Pa. and KENILWORTH, N.J., June 7 /PRNewswire-FirstCall/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE:SGP) today announced that the European Commission has approved a new indication for Remicade (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. Remicade has been studied only in combination with conventional immunosuppressive therapy. This approval follows a positive opinion granted in March by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA).

"Crohn's disease significantly impacts the quality of life of children suffering from this condition," said Salvatore Cucchiara, M.D., Department of Pediatrics, Gastrointestinal Motility and Endoscopy Unit, University of Naples. "Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the pediatric population."

Remicade is the first and only biologic therapy approved in the EU for the treatment of pediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.

"This approval recognizes the unique value of Remicade as it is the first and only biologic therapy available to children suffering with Crohn's disease in Europe, who previously had limited therapy options," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute.

In May 2006, the United States Food and Drug Administration (FDA) approved Remicade for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. Remicade was first approved in the U.S. for adult Crohn's disease in 1998 and later for adult ulcerative colitis in 2005.

The safety and efficacy of Remicade across all indications have been well established in clinical trials over the past 14 years and through commercial experience with nearly 925,000 patients treated worldwide across all indications.

The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of Remicade over a 2-hour period followed by additional 5 mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter. Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further Remicade treatment in pediatric patients not responding within the first 10 weeks of treatment.

Clinical Trial Information: REACH
The approval was based on data from the Phase III REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody Remicade in Pediatric Subjects with Moderate to Severe Crohn's Disease) trial. In the REACH trial, 112 patients (6 to 17 years of age; all required to be receiving 6-MP, AZA or MTX; 35% receiving corticosteroids) with moderate to severe, active Crohn's disease (median PCDAI of 40) and an inadequate response to conventional therapies received 5 mg/kg infliximab at weeks 0, 2, and 6. Patients assessed by the investigator to be in clinical response at week 10 were randomized and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen. Patients who lost clinical response during maintenance treatment could receive infliximab at a higher frequency or dose.

The proportion of subjects in clinical response at week 10 was 88.4% (99/112). The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112). At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013). At week 54, the proportion of subjects in clinical remission was 55.8% (29/52) and 23.5% (12/51) in the q8 week and q12 week maintenance groups, respectively (p Thirty-two evaluable pediatric patients (9 in the q8 week and 23 in the q12 week maintenance group) lost response and then received infliximab at a higher dose or more frequently. Twenty-four of these thirty-two patients (75.0%) regained clinical response.

Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at weeks 10, 30 and 54, respectively, in the combined q8 week and q12 weeks maintenance group.

In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed.

The following adverse events were reported more commonly in pediatric Crohn's disease patients in the REACH trial than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bone fracture (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%). Other special considerations are discussed below.

Source: Centocor, Inc. and Schering-Plough Corporation

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