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New Analysis Shows Efficacy of Simponi™ (GOLIMUMAB) in Anti-TNF Experienced Rheumatoid Arthritis PatientsJune 10, 2009Anti-TNF Experienced Patients Demonstrated Improvements with Every Four-Week Subcutaneous COPENHAGEN, Denmark - 10 June 2009 - A new analysis demonstrated that a greater proportion of patients with moderately to severely active rheumatoid arthritis (RA) who had prior treatment with anti-tumor necrosis factor (TNF)-alpha agents and received subcutaneous injections of SIMPONI" (golimumab) once every four weeks experienced significant improvements in signs and symptoms through week 24, compared with patients receiving placebo.? Patients continued to receive stable doses of methotrexate, sulfasalazine and/or hydroxychloroquine if receiving them at baseline.? These data were presented at the 2009 European League Against Rheumatism (EULAR) Annual Congress. Findings from the GOlimumab After Former anti-TNF Therapy Evaluated in RA (GO-AFTER) study, demonstrated that patients previously treated with adalimumab, etanercept or infliximab responded to and tolerated SIMPONI regardless of the type of prior anti-TNF therapy, as well as the number of prior therapies or reason for discontinuation.? According to the study, 39 percent of patients receiving SIMPONI whose prior anti-TNF-alpha therapy had been discontinued due to a lack of efficacy achieved at least a 20 percent improvement in arthritis symptoms (ACR 20) at week 14, compared with 18 percent of patients receiving placebo (p<0.001).? Thirty-four percent of patients receiving SIMPONI whose prior anti-TNF-alpha therapy had been discontinued for all other reasons achieved ACR 20, compared with 20 percent of patients receiving placebo (p=0.027). "Golimumab has shown promise in the treatment of rheumatoid arthritis patients who have previously discontinued other anti-TNF-alpha therapies," said Josef S. Smolen, MD, Professor and Chairman, Department of Rheumatology, Medical University of Vienna, Vienna, Austria, lead investigator.? Regardless of the reasons for discontinuation of prior anti-TNF-alpha agents, golimumab has demonstrated efficacy and tolerability, and provides hope for people struggling with rheumatoid arthritis. Regardless of the particular anti-TNF-alpha agent previously used in treatment (adalimumab, etanercept or infliximab), the findings were consistent and showed SIMPONI to be effective in improving signs and symptoms of RA. Eighty percent of patients received prior anti-TNF-alpha therapy for at least 12 weeks and 49 percent received prior anti-TNF-alpha therapy for at least 48 weeks.? At week 14, 32 percent of patients previously treated with adalimumab, 41 percent of patients previously treated with etanercept and 41 percent of patients previously treated with infliximab achieved ACR 20.? At week 24, 34 percent, 44 percent and 48 percent of patients, respectively, achieved ACR 20.? Patients also experienced significant improvement in disease activity at six months as measured by DAS28. Investigators reported that the safety profile of SIMPONI among anti-TNF-alpha experienced patients in the GO-AFTER trial was similar to findings from two additional Phase 3 trials that evaluated SIMPONI in biologic-na?e patients. The efficacy of SIMPONI demonstrated in this Phase 3 study is encouraging news for patients with moderately to severely active rheumatoid arthritis who have been previously treated with anti-TNF agents, said Robert J. Spiegel, MD, chief medical officer, Schering-Plough Research Institute.? The study demonstrates that every four-week subcutaneous injections of golimumab may benefit these patients by reducing the signs and symptoms of rheumatoid arthritis. About the GO-AFTER Trial Subgroup analyses were performed for ACR 20 response at week 14 across disease-modifying anti-rheumatic drug use, number of prior anti-TNF-alpha agents and reason for discontinuation of prior TNF inhibitor. ?Ninety-five percent confidence intervals were calculated comparing the proportions of ACR 20 responders at week 14 in the combined SIMPONI versus placebo groups. ?A subset of patients receiving a single prior anti-TNF-alpha agent was also examined to assess the impact of TNF inhibitor types (P75 receptor-fusion protein versus monoclonal antibody) on SIMPONI response. The occurrence of adverse events (AEs) through week 24 was similar among patients previously receiving only adalimumab (76 percent), etanercept (70 percent) and infliximab (78 percent), as well as among patients who received one, two and three prior anti-TNF-alpha agents in both placebo (74 percent, 77 percent, 71 percent, respectively) and SIMPONI (75 percent, 70 percent, 77 percent respectively) treated patients.? SIMPONI was generally well tolerated in this study.? Through week 24, 72 percent, 66 percent and 78 percent of patients in the placebo, SIMPONI 50 mg and SIMPONI 100 mg groups, respectively, experienced at least one AE.? Seven percent of patients in the placebo group experienced serious AEs, compared with 5 percent and 3 percent of patients in the SIMPONI 50 mg and SIMPONI 100 mg groups, respectively.? Serious infections were reported in 3 percent, 3 percent and 1 percent of patients, and injection site reactions (ISR) through week 16 occurred in 3 percent, 4 percent and 11 percent of patients in the placebo, SIMPONI 50 mg and SIMPONI 100 mg groups, respectively.? The most commonly reported ISR was erythema.? No serious or severe ISRs were reported, and none led to the discontinuation of patients in the study.? Antibodies to SIMPONI were detected in 4 percent of golimumab-treated patients (50 mg and 100 mg). The GO-AFTER study was supported by Centocor Ortho Biotech Inc. and Schering-Plough Corporation. About Rheumatoid Arthritis About SIMPONI Indications in the US: Indications in Canada: SIMPONI is also being studied as an intravenous infusion therapy for the treatment of moderately to severely active rheumatoid arthritis. In March 2008, Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) requesting the approval of SIMPONI as a once monthly subcutaneous treatment for adults with RA, PsA and AS. Centocor Ortho Biotech Inc. developed and discovered SIMPONI and has exclusive marketing rights to the product in the United States.? Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where SIMPONI will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where SIMPONI will be exclusively marketed by Janssen-Cilag; and China, where SIMPONI will be exclusively marketed by Xian-Janssen. Important Safety Information 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.? 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:
Tell your doctor about all the medications you take or if you are scheduled to or recently received a vaccine. 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:
If you take SIMPONI" or other TNF blockers, your risk for developing lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers. Heart failure can occur or get worse in people who use TNF blockers like SIMPONI".? Your doctor will monitor you closely 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 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.? 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. 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, or chest pain. Common side effects of SIMPONI" include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness or tingling. 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. The Full Prescribing Information and Medication Guide for SIMPONI will be available at www.SIMPONI.com. About Centocor Ortho Biotech Inc. (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. 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 & Johnsons Annual Report on Form 10-K for the fiscal year ended December 28, 2008. 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.) About Schering-Plough SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for SIMPONI. Forward-looking statements relate to expectations or forecasts of future events.? Schering-Plough does not assume the obligation to update any forward-looking statement.? Many factors could cause actual results to differ materially from Schering-Ploughs forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties.? For further details about these and other factors that may impact the forward-looking statements, see Schering-Ploughs Securities and Exchange Commission filings, including Item 1A. "Risk Factors" in Schering-Plough's 2009 10-Q, filed May 1, 2009. Media Contact: Investors: Media Contact: Investors: |
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