Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label in Treatment of Rheumatoid Arthritis

HORSHAM, Pa., Sept. 27 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI® (golimumab) physician label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance of reducing signs and symptoms and improving physical function in the treatment of moderately to severely active rheumatoid arthritis (RA).  

SIMPONI received U.S. FDA approval in April 2009 and became the first once-monthly anti-tumor necrosis factor (TNF)-alpha therapy approved for the treatment of adults with moderately to severely active RA, active psoriatic arthritis and active ankylosing spondylitis.  For the RA indication, SIMPONI is given in combination with the drug methotrexate.

The sBLA is supported by long-term efficacy and safety data from three pivotal Phase 3 registration trials of three diverse moderately to severely active RA patient populations – patients naïve to methotrexate, patients who had an inadequate response to methotrexate and patients previously treated with one or more anti-tumor necrosis factor (TNF)-alpha agents.  

"This application represents yet another milestone for the SIMPONI clinical development program," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc.  "We look forward to collaborating with the FDA in reviewing the data from our Phase 3 registration trials that support the efficacy of SIMPONI in inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis."

About Rheumatoid Arthritis

RA is a chronic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.  More than one million Americans are living with RA, the majority of whom are women.  The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA.  

About SIMPONI

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the Unites States, Europe and Canada, SIMPONI is approved for the treatment of moderately to severely active RA in combination with methotrexate, active psoriatic arthritis and active ankylosing spondylitis.  SIMPONI is available either through the SIMPONI SmartJect™ autoinjector or a prefilled syringe.  For more information about SIMPONI, visit www.SIMPONI.com.  

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

Important Safety Information

SIMPONI® (golimumab) is a prescription medicine. SIMPONI® can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI® if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

• fever, sweat, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more than normal
• feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI®, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI® should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI®. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI®. 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:

• feel very tired
• skin or eyes look yellow
• little or no appetite
• vomiting
• muscle aches
• dark urine
• clay-colored bowel movements
• fevers
• chills
• stomach discomfort
• skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.  

Rarely, people using TNF blockers, including SIMPONI®, can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.  

Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI®. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.  

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, chest pain.

Common side effects of SIMPONI® include: upper respiratory tract infection, nausea,  abnormal liver tests, skin reaction at site of injection, high blood pressure, flu, and cold sores.  

Please read the Medication Guide for SIMPONI® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology.  The company was created when Ortho Biotech Inc. merged into Centocor, Inc., and Centocor, Inc. was renamed Centocor Ortho Biotech Inc.  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.