Janssen Biotech Inc.'s REMICADE(R) Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis

HORSHAM, Pa., Sept. 23, 2011 /PRNewswire/ -- Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This marks the 16th approval of REMICADE® in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC. It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease. An estimated 150,000 children under age 17 are living with symptoms of IBD.(1)

"Ulcerative colitis can be a devastating disease and previously there had been no approved therapeutic options for pediatric patients who had an inadequate response to conventional therapy," said Dr. Jeffrey Hyams, Head of the Division of Digestive Diseases and Nutrition at Connecticut Children's Medical Center and Professor of Pediatrics at University of Connecticut School of Medicine, and lead study investigator. "The approval of infliximab represents an important treatment milestone in the care of children stricken with this inflammatory bowel disease."

The approval is supported by evidence from adequate and well-controlled studies of REMICADE in adults with ulcerative colitis plus additional data from a pivotal Phase 3 randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADE® in the treatment of pediatric patients with moderately to severely active UC. Results from the pediatric UC study presented in May showed that treatment with REMICADE® 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.

"Today's approval of REMICADE® is significant for children and their families who are affected by this devastating disease and are seeking an effective treatment option," said Rob Bazemore, President, Janssen Biotech, Inc. "We are proud of our heritage in the continued pursuit of expanding treatment options for patients living with immune-mediated inflammatory diseases like IBD."

REMICADE® was designated orphan drug status by the FDA on November 12, 2003, and the supplemental Biologics License Applications (sBLA) for pediatric UC received priority review following its submission to the FDA in December 2010. The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended the approval of REMICADE® in pediatric patients with UC.

On September 1, 2011, Janssen Inc. announced Health Canada approved REMICADE® for the treatment of pediatric patients (age six to 17 years) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

About the Study

The Phase 3 randomized, multicenter, open-label trial was designed to evaluate the efficacy of a 3-dose REMICADE® regimen in inducing clinical response in pediatric patients with moderately to severely active UC and to evaluate the safety of REMICADE® during induction and maintenance treatment. A total of 60 patients, aged 6-17, with a median disease duration of 1.4 years were included in the study. Patients had a median Mayo score of 8.0, and median Pediatric Ulcerative Colitis Activity Index (PUCAI) score of 55. All patients had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylates. Patients received REMICADE® 5 mg/kg at weeks 0, 2, and 6. The primary endpoint, clinical response at week 8, was defined as a decrease from baseline in the Mayo score of at least 30 percent and at least 3 points, with a decrease in rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0/1. Patients who achieved clinical response at week 8 were randomized to receive REMICADE® 5 mg/kg every 8 weeks through week 46 or every 12 weeks through week 42. Non-responders were discontinued from study agent.

Safety data from the pediatric UC trial were consistent with current REMICADE® labeling. No new safety concerns emerged in evaluating REMICADE® in the treatment of a pediatric UC population.

For more information regarding the safety profile for REMICADE®, please see "Important Safety Information" below.

About Ulcerative Colitis

Ulcerative colitis (UC) is a chronic IBD of the colon. It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease. An estimated 150,000 children under age 17 are living with debilitating symptoms of IBD.(1)

About REMICADE®

REMICADE® was the first anti-TNF-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology. REMICADE® has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease, psoriasis, and pediatric UC. The safety and efficacy of REMICADE® have been well established in clinical trials over the past 17 years and through commercial experience with more than 1.5 million patients treated worldwide.

In the U.S., REMICADE® is approved for the following indications:

• Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.
• Reducing signs and symptoms in patients with active ankylosing spondylitis.
• Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
• Reducing signs and symptoms, inducing and maintaining 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.
• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis.
• Treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE® is unique among available anti-TNF-alpha biologic therapies. It is the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office setting. REMICADE® is a two-hour infusion administered every 6 or 8 weeks (indication-dependent), 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 as maintenance therapy.

Janssen Biotech, Inc. discovered and developed REMICADE® and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE® in Canada, Central and South America, the Middle East, Africa, and Asia Pacific.

In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE® to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.

Important Safety Information

Only a doctor can recommend a course of treatment after checking a patient's health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

Patients should discuss any concerns about their health and medical care with their doctor.

Patients should let their doctors know if they have or ever had any of the following:

• Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.
• Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
• Infections that keep coming back, have diabetes or an immune system problem.
• Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
• Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.
• Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
• Nervous system disorders (like multiple sclerosis or Guillain-Barre syndrome). Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), Orencia (abatacept) and Actemra (tocilizumab) and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while taking REMICADE®.

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®. Patients should tell their doctors right away if you have any of the signs listed below:

• Infections (like TB, blood infections, pneumonia) -- fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.
• Lymphoma, or any other cancers in adults and children.
• Heart failure -- new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
• Reactivation of HBV -- feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
• Liver injury -- jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
• Blood disorders -- fever that doesn't go away, bruising, bleeding or severe paleness.
• Nervous system disorders -- numbness, weakness, tingling, changes in your vision or seizures.
• Allergic reactions during or after the infusion -- hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
• Lupus-like syndrome -- chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
• Psoriasis -- new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Please read important information about REMICADE®, including full U.S. prescribing information and Medication Guide, at www.remicade.com.

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech, Inc. is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and health care professionals have access to the latest treatment information, support services, and quality care. Janssen Biotech, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world.

For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com or follow us on Twitter at www.twitter.com/JanssenUS.

References:
1. Crohn's & Colitis Foundation of America and the Starlight Children's Foundation. Give me some numbers! What are the most current IBD-related statistics? Available at: http://www.ucandcrohns.org/src_subarticle.php?c=&id=2&page=3&tbl=src_faq. Accessed August 15, 2011.

SOURCE Janssen Biotech, Inc.