Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication

HORSHAM, Pa., Dec. 29, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of 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.  REMICADE was designated orphan drug status by the FDA on November 12, 2003 for the treatment of pediatric UC.  REMICADE is currently approved for the treatment of adults with moderately to severely active UC who have not responded adequately to conventional therapy.  

The sBLA is supported by data from a pivotal Phase 3, randomized, open-label trial that assessed the safety and efficacy of induction and maintenance REMICADE treatment in pediatric patients age six through seventeen who were diagnosed with moderately to severely active UC.  Eligible patients had an inadequate response to treatment with conventional treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids, and/or 5-aminosalicylate (5-ASA) treatments.  

"Data from the Phase 3 trial support the efficacy of REMICADE in inducing clinical response, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in pediatric patients with ulcerative colitis, an orphan disease that is in need of treatment options," said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc.  "We are pleased to work with the FDA as we seek approval of REMICADE for the treatment of this very challenging disease."

About Ulcerative Colitis (UC)

UC, a chronic inflammatory bowel disease affecting nearly 500,000 people in the U.S., is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining where they bleed and produce pus and mucus. Symptoms of the disease may lead to loss of appetite, subsequent weight loss, and fatigue.  UC is a chronic disease, and there is no cure.  Although progress has been made in inflammatory bowel disease (IBD) research, investigators do not know what causes this disease.

About REMICADE

REMICADE was the first anti-tumor necrosis factor (TNF)-alpha treatment to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE has demonstrated broad clinical utility with indications 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 17 years and through commercial experience with more than one 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 AS.
• 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.  
• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD.  
• 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 PsA.  
• Treatment of adult patients with chronic severe plaque PsO who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE is unique among available anti-TNF biologic therapies.  It is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting.  REMICADE is a two-hour infusion administered every 4 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.

Centocor Ortho Biotech Inc. discovered and developed REMICADE and has exclusive marketing rights to the product in the United States.  

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), 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 Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and healthcare professionals have access to the latest treatment information, support services, and quality care. For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com.  Centocor Ortho Biotech Inc. is a wholly owned subsidiary of Johnson & Johnson.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech Inc.'s and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

SOURCE Centocor Ortho Biotech Inc.