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Clinical Studies Show Remicade Reduces Incidence of Bowel Surgeries in Ulcerative Colitis Patients

Separate Analysis Reveals Colectomy Increases Healthcare Utilization and Costs

PHILADELPHIA, October 15, 2007 /PRNewswire/ -- Clinical data presented today at the annual meeting of the of Gastroenterology (ACG) show that REMICADE significantly reduces the incidence of colectomy surgeries for patients with moderately to severely active ulcerative colitis (UC). According to a primary analysis of long-term extension data from the Active Ulcerative Colitis 1 and 2 trials (ACT trials), there is a 43 percent reduction in the incidence of colectomy, the surgical removal of the colon, in patients receiving REMICADE through 54 weeks, compared to those receiving placebo (p=0.012). REMICADE is the first and only biologic approved for the treatment of ulcerative colitis.

The analysis of the ACT extension trials included 728 patients from the initial ACT 1 and 2 trials, of whom 630 (86 percent) had complete follow-up through 54 weeks to ascertain whether they underwent colectomy surgery.

"These data illustrate that treatment with REMICADE significantly reduces the need for life-altering colectomy in patients with refractory ulcerative colitis," said Paul Rutgeerts, M.D., Ph.D., University Hospital Gasthuisberg, University of Leuven; Leuven, Belgium. "REMICADE may offer patients who fail other therapies the possibility of avoiding costly surgeries and hospitalizations while managing the symptoms of this debilitating disease long-term."

Separate data also presented at ACG today show the significant impact of colectomy on ulcerative colitis patients' use of healthcare services, including inpatient and outpatient hospital procedures, emergency room and physician visits, and laboratory and drug costs. A retrospective analysis of 411 patients, identified from the U.S. PharMetrics database as having UC and a colectomy between January 1, 2000, and June 30, 2005, found that total utilization of healthcare services increased significantly in the 12 months following colectomy, including inpatient and outpatient procedures (P < 0.05).

"These diseases are devastating to patients and their loved ones and we are excited to see more and better therapies become available to ease their suffering," said Richard J. Geswell, President, Crohn's & Colitis Foundation of America.

About the ACT Long-Term Extension

Patients with moderate to severe UC, defined as a baseline Mayo score greater then or equal to 6 and less then or equal to 12, who were unresponsive to or intolerant to at least one standard therapy, including corticosteroids, immunosuppressants or 5ASAs, were enrolled in ACT 1 (n=364) or ACT 2 (n=364). The 728 patients were randomized to receive REMICADE 5 mg/kg, REMICADE 10 mg/kg or placebo at weeks 0, 2, 6 and every subsequent 8 weeks through week 22 (ACT 2) or week 46 (ACT 1). Patients were allowed to continue to receive conventional therapy.

Patients who completed treatment through the final infusion visit and who, in the opinion of the investigator, could benefit from continued treatment with REMICADE could enroll in the extension trials. Across multiple sites, one hundred and eighteen (118) patients were entered into the ACT 1 extension and 111 patients were entered into the ACT 2 extension.

During the extension, patients continued to receive the study drug to which they were originally randomized (REMICADE 5 mg/kg, REMICADE 10 mg/kg or placebo) every 8 weeks. Patients in the extension trials were assessed using the Physician's Global Assessment (PGA), which is 1 of 4 measures of disease activity included in the Mayo score. Of the 229 patients who entered the extension, 181 have been followed through one year, and 92 have completed two years. Patients who had responded to placebo also enrolled in the extension to maintain the blind and continued to receive placebo every 8 weeks.

Overall, REMICADE was generally well tolerated in the long-term extensions, with less than five percent of patients discontinuing therapy due to an adverse event (AE). As previously reported, other notable serious adverse events (SAEs) included: prostate cancer, breast cancer, pneumonia, sarcoidosis, abscess and a death following Histoplasmosis pneumonia. (See Important Safety Information below.)

About the PharMetrics Analysis

This retrospective analysis examined medical and pharmacy claims from the PharMetrics Patient Centric database to determine healthcare resource utilization among patients with UC before and after a colectomy. The PharMetrics database contains enrollment data, pharmacy and medial claims from approximately 82 different managed care organizations, consisting of more than 46 million patients in the United States. It is considered representative of the insured population of the United States. Patient data was collected from January 1, 2000 through June 30, 2005, for any patient with a previous diagnosis of UC who had two distinct claims for treatment of UC and had a Current Procedural Terminology (CPT) code indicating colectomy.

A total of 411 patients were included in the analysis, and researchers collected data for each patient both 12 months prior to the colectomy and 12 months following colectomy. The researchers focused on the levels of inpatient, outpatient, emergency room, physician, laboratory and drug costs of care and found that healthcare utilization increased during the 12 months following colectomy. The increases were primarily driven by inpatient and outpatient visits.

The data showed that inpatient encounters increased during the 12 months after colectomy, compared with the number of encounters during the 12 months before colectomy (1.8 vs. 0.9). There were also increases in outpatient visits (19.4 vs. 8.7), emergency room visits (0.9 vs. 0.8), physician visits (14.9 vs. 13.9) and laboratory visits (2.2 vs. 2.1) during the post-colectomy period, compared with the pre-colectomy period.

About Ulcerative Colitis

UC is a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S. The disease is characterized by inflammation and ulceration of the colonic mucosa, or innermost lining of the intestine, which causes bloody stools and severe diarrhea. Tiny open sores, or ulcers, form on the surface of the intestinal lining where they bleed and produce pus and mucus. Because the inflammation makes the colon empty frequently, symptoms often lead to unwanted weight loss, blood loss and a host of secondary complications. The cause of UC is not known and there is no cure.

About REMICADE

REMICADE is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and is the only anti-TNF-alpha treatment approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE has demonstrated broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have been well established in clinical trials over the past 14 years and with more than 925,000 patients treated worldwide through commercial experience.

REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA. REMICADE is the only biologic indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD. In December 2004, REMICADE was approved for reducing signs and symptoms in patients with active AS. In May 2005, REMICADE was approved for reducing signs and symptoms of active arthritis in patients with PsA. Additionally, in September 2005, REMICADE was approved 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 approval makes REMICADE the first and only biologic approved for the treatment of moderate to severe UC. In addition, on May 19, 2006, REMICADE was approved for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. This approval establishes REMICADE as the first and only biologic therapy approved for the treatment of pediatric CD. In August 2006, REMICADE received the expanded indication for inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. In September 2006, REMICADE was approved for the treatment of adult patients with chronic severe plaque psoriasis. In October 2006, REMICADE was approved for maintaining clinical remission and mucosal healing in patients with moderately to severely active UC, who have had an inadequate response to conventional therapy.

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 by caregivers in the clinic or office setting. In RA (3 mg/kg), CD (5 mg/kg), PsA (5 mg/kg), UC (5 mg/kg), PCD (5 mg/kg), and PsO (5 mg/kg), REMICADE is a two-hour infusion administered every 8 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. In AS (5 mg/kg), REMICADE is a two-hour infusion administered every 6 weeks, following a standard induction regimen that requires treatment at weeks 0, 2 and 6.

Important Safety Information

There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. Tell your doctor if you have had recent or past exposure to people with TB. Your doctor will evaluate you for TB and perform a TB test. If you have latent (inactive) TB, your doctor should begin TB treatment before you start REMICADE. REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, flu or warm, red or painful skin while taking REMICADE, tell your doctor right away. Also, tell your doctor if you are scheduled to receive a vaccine or if you have lived in a region where histoplasmosis or coccidioidomycosis is common.

Reports of a type of blood cancer called lymphoma in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in general. People who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, or plaque psoriasis for a long time, particularly those with highly active disease may be more prone to develop lymphoma. Cancers, other than lymphoma, have also been reported. Children and young adults who have been treated for Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. These patients also were receiving drugs known as azathioprine or 6- mercaptopurine. If you take REMICADE or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should also tell your doctor if you have had or develop lymphoma or other cancers or if you have a lung disease called chronic obstructive pulmonary disease (COPD).

Many people with heart failure should not take REMICADE; so prior to treatment you should discuss any heart condition with your doctor. Tell your doctor right away if you develop new or worsening symptoms of heart failure (such as shortness of breath, swelling of your ankles or feet, or sudden weight gain).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF blockers, such as REMICADE. Some of these cases have been fatal. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.

There have been rare cases of serious liver injury in people taking REMICADE, some fatal. Tell your doctor if you have liver problems and contact your doctor immediately if you develop symptoms such as jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe fatigue.

Blood disorders have been reported, some fatal. Tell your doctor if you develop possible signs of blood disorders such as persistent fever, bruising, bleeding, or paleness while taking REMICADE. Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, visual disturbances or seizures while taking REMICADE.

Allergic reactions, some severe, have been reported during or after infusions with REMICADE. Signs of an allergic reaction include hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills. Tell your doctor if you have experienced a severe allergic reaction. The most common side effects of REMICADE are: respiratory infections, such as sinus infections and sore throat, headache, rash, coughing, and stomach pain.

Please read the Medication Guide for REMICADE and discuss it with your doctor.

About Centocor

Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis.

The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

CONTACT: Melissa Katz of Centocor, Inc., +1-215-325-6875, or Mobile,+1-215-514-0957

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Posted: October 2007

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