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Title: FDA Approves Remicade (infliximab) as First and Only Biologic to Treat Ulcerative Colitis

"FDA Approves Remicade (infliximab) as First and Only Biologic to Treat Ulcerative Colitis"

Approval Marks Major Treatment Breakthrough for Patients With Debilitating Disease HORSHAM, PA -- September 16, 2005 -- Centocor, Inc. announced today that Remicade(R) (infliximab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ulcerative colitis (UC), making Remicade the first and only biologic approved for UC, a chronic inflammatory bowel disease (IBD). Remicade is now indicated for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This is an unprecedented milestone in the treatment of moderate-to-severe UC; to date, no therapy has ever been indicated for mucosal healing and eliminating the use of corticosteroids. "The approval of Remicade for the treatment of UC represents a major breakthrough for patients suffering from this often debilitating disease," said William J. Sandborn, MD, professor of medicine, Mayo Clinic College of Medicine and head of the IBD Interest Group and director of the IBD Clinical Research Unit at Mayo Medical Center. "Not only did many patients in clinical trials experience a significant reduction in the occurrence of symptom flare- ups with Remicade, some achieved clinical remission and mucosal healing as well. This is welcome news for these patients whose only option otherwise may have been surgery to remove their colons." Remicade's efficacy in the treatment of IBD is well established. First approved in the United States for the treatment of Crohn's disease (CD) in 1998, Remicade remains the only anti-tumor necrosis factor (TNF-alpha) therapy indicated for the treatment of CD. With this new approval for the treatment of ulcerative colitis, Remicade is now the only biologic indicated for the treatment of both types of inflammatory bowel diseases, CD and UC. In addition to UC and CD, Remicade is also indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. More than 600,000 patients have been treated with Remicade worldwide. This new approval for the treatment of UC continues to demonstrate the benefit of Remicade across immune-mediated inflammatory diseases. UC is a debilitating chronic disease affecting more than 500,000 Americans, for whom there is no medical cure, and while UC affects more people in the United States than multiple sclerosis or cystic fibrosis, general awareness of the disease is lower. Characterized by inflammation and ulceration of the inner lining of the colon, UC symptoms can often include unwanted weight loss, severe - sometimes uncontrollable - bloody diarrhea, fatigue and frequent abdominal pain. For some patients, symptoms may lead to surgical removal of the colon or to secondary complications such as colorectal cancer. "We are optimistic that the use of a treatment like Remicade will provide many people with relief from the debilitating symptoms that have had such a profound impact on their lives," said Rodger DeRose, president and CEO of the Crohn's & Colitis Foundation of America. "Results from a recent patient survey revealed that UC affects many aspects of people's lives, from their relationships with families and employers to the ability to participate in social activities." Clinical Trial Information: ACT 1 and ACT 2 The approval of Remicade is based on positive results seen in two randomized, placebo-controlled pivotal Phase 3 clinical trials, ACT 1 and ACT 2, which were conducted to evaluate the safety and efficacy of Remicade in people with active, moderate-to-severe UC. In each trial, 364 patients with active UC who were unresponsive to at least one standard therapy - including corticosteroids, immunosuppressants or 5-ASAs - were enrolled. Patients in ACT 1 and ACT 2 had evidence of moderate or severe UC (total Mayo score of 6 to 12 and an endoscopy score greater than or equal to 2). In both trials, patients were randomized to receive placebo or Remicade 5 mg/kg or 10 mg/kg. ACT 1 patients received the study agent at weeks 0, 2 and 6 and then every 8 weeks through week 46 and had their last evaluations at week 54. ACT 2 patients received the study agent at weeks 0, 2 and 6 and then every 8 weeks through week 22 and had their last evaluations at week 30. In ACT 1, significantly higher proportions of patients receiving Remicade 5 mg/kg (69%) and 10 mg/kg (62%) achieved clinical response at week 8 versus placebo-treated patients (37%; P <.001 for both). In addition, at week 30, 52% of patients in the 5 mg/kg and 51% of patients in the 10 mg/kg Remicade treatment group were in clinical response versus 30% of placebo-treated patients (P <.001 and P <.01, respectively). At week 8, 39% and 32% of patients treated with Remicade 5 mg/kg and 10 mg/kg, respectively, were in clinical remission compared to 15% of placebo-treated patients (P <.001 and P <.01). These differences in remission rates persisted at week 30 (34%, 5 mg/kg; 37%, 10 mg/kg versus 16%, placebo; P <.001 for both). Mucosal healing was achieved at week 8 in 62% and 59% of patients receiving Remicade 5 mg/kg and 10 mg/kg, respectively, versus 34% of placebo-treated patients (P <.001). This difference in mucosal healing was maintained at week 30 (50%, 5 mg/kg; 49%, 10 mg/kg versus 25%, placebo; P <.001 for both). The proportion of patients who were able to discontinue corticosteroids while in clinical remission at week 30 was greater in both Remicade groups compared to the placebo group (24%, 5 mg/kg; 19%, 10 mg/kg; 10%, placebo; P =.030 and P =.125, respectively). In ACT 2, significantly higher proportions of patients receiving Remicade 5 mg/kg (65%) and 10 mg/kg (69%) were in clinical response at week 8 versus 29% who received placebo (P <.001 for both). At week 30, 47% of patients receiving Remicade 5 mg/kg and 60% receiving 10 mg/kg were in clinical response versus 26% of patients receiving placebo (P <.001 for both). Clinical remission was achieved at week 8 in 34% and 28% of Remicade 5 and 10 mg/kg patients, respectively, compared to 6% of placebo-treated patients (P <.001 for both). Differences in remission rates persisted at week 30 (26%, 5 mg/kg; 36%, 10 mg/kg; 11%, placebo; P <.01 and P <.001). Mucosal healing was achieved at week 8 in 60% and 62% of patients receiving Remicade 5 mg/kg and 10 mg/kg, respectively, compared to 31% of placebo-treated patients (P <.001 for both). Mucosal healing at week 30 was achieved in 46% and 57% of patients receiving Remicade 5 and 10 mg/kg, respectively, compared to 30% of placebo-treated patients (P <.01 and P <.001). The proportion of patients who were able to discontinue corticosteroids while in clinical remission at week 30 was significantly greater in both Remicade groups compared with the placebo group (18%, 5 mg/kg; 27%, 10 mg/kg; 3%, placebo; P=0.010 and P <.001, respectively). The serious adverse events reported in these trials were similar to those reported in previous Remicade clinical trials. SOURCE: Centocor

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