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Title: First Biologic Therapy Approved in Canada for Painful Inflammatory Bowel Disease

"First Biologic Therapy Approved in Canada for Painful Inflammatory Bowel Disease"

Health Canada approves Remicade to reduce signs and symptoms and induce clinical remission in moderate to severe ulcerative colitis MONTREAL, CANADA -- March 30, 2006 -- Remicade® (infliximab) is the first biologic approved to treat Canadians living with the debilitating effects of ulcerative colitis (UC), a chronic and painful inflammatory disease of the colon or large intestine. Health Canada has approved Remicade for the treatment of moderate to severe UC in patients who have had an inadequate response to conventional therapy, making it the only biologic approved in Canada for treating both moderate to severe UC and Crohn's disease (CD), the other inflammatory bowel disease (IBD)[1]. Patients with moderate to severe ulcerative colitis suffer from diarrhea, severe abdominal pain and cramping, rectal bleeding and fatigue. It is estimated that nearly 170,000 Canadians have mild to severe forms of IBD[2], with approximately 10,000 new cases diagnosed each year.[3] Canada has one of the highest incidences of IBD in the world.[4] "I was diagnosed with ulcerative colitis when I was just 32. Needless to say, I was devastated. All I wanted was to be 'normal' again," said Jennifer Kelly, 39, of Stratford, Ontario. "For years, I lived with significant abdominal pain and could not participate in life like everyone I knew. I was lucky enough to gain access to Remicade through a clinical trial and it has literally given me my life back. I can work, travel and keep up with my active children – all things that would have been difficult or near impossible before Remicade." "I've seen Remicade transform patients, who go from living with severe disability and constant pain to leading an active and relatively pain-free life," said Dr. Richard Fedorak, gastroenterologist at the University of Alberta. "Additionally, patients on Remicade have another option to a colectomy (having their large intestine removed), which carries some significant risks such as infertility." Following a colectomy, female fertility can be reduced by as much as 80%.[5] Approximately 50% of patients will develop pouchitis,[6] which causes pain, bloating and watery diarrhea.[7] Surgery also carries the risk of nocturnal fecal incontinence in approximately 24% of patients.[8] For patients who have failed conventional therapies, Remicade provides a new treatment option that enhances quality of life[9], while reducing surgeries[10] and hospitalizations[11]. Remicade is indicated for reducing signs and symptoms, inducing clinical remission, inducing mucosal healing, and reducing or eliminating corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. The approval makes Remicade the first biologic therapy approved to treat moderately to severely active UC in Canada, addressing an unmet medical need for patients who previously had limited treatment options. "Since Remicade's approval for Crohn's disease in 2001, the gastroenterology community has been watching this therapy with great interest, hoping it would have the same benefits for those UC patients, who until now, faced surgery as their only option," commented Dr. Brian Feagan, gastroenterologist and director at Robarts Clinical Trials, Robarts Research Institute Canada. "The data generated by ACT 1 and 2, two relatively large clinical trials, provide compelling evidence of the efficacy of Remicade in patients with active ulcerative colitis." This marks the eighth approval Remicade has received from Health Canada for the treatment of immune-mediated inflammatory disorders (IMID), a group of related diseases in which the immune system attacks the body's own healthy tissues. Remicade is the only drug in Canada approved for all of the following: CD induction, rheumatoid arthritis (RA), CD maintenance, ankylosing spondylitis (AS), RA structural damage, fistulizing CD maintenance, early RA and UC. Basis for Approval[12], [13] The approval is based on data from the ACT 1 and ACT 2 (The Anti-TNF Trials in Moderately to Active Ulcerative Colitis), involving 728 adult patients with moderately to severely active UC who were unresponsive to at least one standard therapy. In both studies, the proportions of patients with sustained clinical response or sustained clinical remission were significantly higher in each Remicade group than in the placebo group. Additionally, the proportion of Remicade treated patients who achieved mucosal healing was significantly greater than placebo-treated patients. Of particular significance for those patients with UC who can experience considerable morbidity as a result of treatment with corticosteroids, ACT 1 demonstrated that a higher percentage of patients (24%) receiving REMICADE 5 mg/kg achieved clinical remission and were able to discontinue corticosteroid treatment, versus 10% of patients receiving placebo (P = 0.006). About Remicade Remicade is a monoclonal antibody that specifically targets and binds to tumour necrosis factor - alpha (TNF-alpha) which has been shown to play a role in rheumatoid arthritis (RA), Crohn's disease (CD), ankylosing spondylitis (AS), and may also be important in a wide range of other immune-mediated inflammatory disorders. Remicade is administered every eight weeks in most cases, following a standard induction regimen that requires treatment at weeks zero, two and six. No Remicade doses are required between infusions and patients do not have to take any Remicade home. The safety and efficacy of Remicade have been established in clinical trials conducted over the past 10 years and through commercial experience with almost 700,000 patients treated worldwide.[14] Remicade is unique among available anti-TNF biologic therapies, where specially trained health care practitioners administer, monitor and assist the patient during each infusion. The Remicade Infusion Network™ (RIN) clinics are conveniently located, and provided at no cost to the patient. Remicade was honoured with the 2005 Belleau-Nickerson Award, a Canadian award presented by the Prix Galien organization. The award recognizes a pharmaceutical product that has distinguished itself through its exceptional contribution to pharmacotherapy and its significant social and economic impact. Remicade also received the Prix Galien International Award in 2000. REFERENCES: 1. http://www.webmd.com/content/article/5/1680_50985.htm. 2. The Crohn's and Colitis Foundation of Canada. Available at http://www.ccfc.ca/English/info/index.html. Accessed on April 20, 2005. 3. Canadian Society of Intestinal Research. Available at http://www.badgut.com/index.php?contentFile=ibd_faq&title=Inflammatory%20Bowel%20Disease%20FAQ. Accessed April 20, 2005. 4. The Medical Post http://www.medicalpost.com/mpcontent/article.jsp?content=20050613_201343_5300. 5. Rutgeerts, P, Sandborn, WJ, Feagan, B, et al. Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. 6. Ibid. 7. HealingWell.Com http://www.healingwell.com/library/ibd/faq3.asp. 8. Rutgeerts, P, Sandborn, WJ, Feagan, B, et al., op. cit. 9. Remicade Product Monograph - March 2006. 10. Järnerot G, Hertervig E, Friis-Liby I, et al. Infliximab as Rescue Therapy in Severe to Moderately Severe Ulcerative Colitis: A Randomized, Placebo-Controlled Study. Gastroenterology. 2005;128:1805-1811. 11. Remicade Product Monograph - March 2006. 12. Rutgeerts, P, Sandborn, WJ, Feagan, B, et al., op. cit. 13. Remicade Product Monograph - March 2006. 14. Centocor data on file. SOURCE: Schering Canada Inc.

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