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Anti-TNF Golimumab Continues to Show Promise in Phase II Rheumatoid Arthritis Study

June 14, 2007

Golimumab Demonstrated Sustained Improvement in Signs and Symptoms Of Moderate to Severe Rheumatoid Arthritis With One-Third of Patients Achieving Disease Remission at One-Year Mark

One-year data show nearly 75 percent of patients with moderate to severe rheumatoid arthritis (RA) receiving golimumab (CNTO 148) and methotrexate (MTX) experienced and maintained at least 20 percent improvement in arthritis symptoms (ACR 20). This was according to findings from a double-blind, placebo-controlled, dose-ranging Phase II study presented today at the European League Against Rheumatism (EULAR) Annual Congress of Rheumatology. The same study also showed that, on average, more than one-third of these patients achieved disease remission at one year as evaluated by Disease Activity Score 28.

Golimumab is a fully-human anti-TNF-alpha monoclonal antibody that targets and neutralizes both the soluble and the membrane-bound form of TNF-alpha. Developed by Centocor, Inc and Schering-Plough Corporation (NYSE: SGP), golimumab is being investigated for administration by both subcutaneous (SC) injection and intravenous (IV) infusion.

“The maintained therapeutic effect demonstrated by these results is very promising,” said Iain B. McInnes, FRCP, Ph.D., Professor of Experimental Medicine at the University of Glasgow; Honorary Consultant Rheumatologist, Centre for Rheumatic Diseases, Glasgow Royal Infirmary in Glasgow, United Kingdom, who serves as a lead investigator in a Phase III study of golimumab. “Physicians treating patients with RA are always looking for advanced medications that offer sustained efficacy to keep this serious, life-altering condition in remission.”

Data from the study showed that significantly greater percentages of patients treated with golimumab plus MTX achieved ACR 20, 50 and 70 responses (marked improvement in arthritis symptoms according to the American College of Rheumatology scoring criteria) at Week 16 compared with patients treated with placebo plus MTX group. Adults with active RA for at least three months' duration despite methotrexate therapy were randomized to one of five treatment groups: placebo or golimumab 50 or 100 mg every two weeks or every four weeks. All patients received stable doses of methotrexate of at least 10 mg/week. Moreover, through week 52, fewer patients discontinued therapy in the combined golimumab group (21 percent) than in the placebo/infliximab (control) group (40 percent). There was no clear dose response; through week 52, the reduction in the signs and symptoms of RA observed at week 16 was maintained for all doses.

“The fact that golimumab maintained its efficacy over the course of a full year is very encouraging,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “Schering-Plough is a leader in bringing forward innovative therapies, such as Golimumab, to patients, helping physicians alleviate their suffering. We are committed to further investigating golimumab as an effective treatment for these patients.”

About the Study

This Phase II, randomized, double-blind, placebo-controlled, dose-ranging trial involved 172 patients with active rheumatoid arthritis for at least three months' duration despite methotrexate therapy. Patients were randomized to one of five treatment groups and beginning at week 20, patients randomized to the placebo group received infliximab (3 mg/kg) at weeks 20, 22, 28, 36, and 44. Patients receiving golimumab continued at their assigned dose (50 or 100 mg) every four weeks from week 20 to week 48.

The Disease Activity Score 28 (DAS28) was developed to measure the disease activity in patients with Rheumatoid Arthritis and has been validated for its use in clinical trials in combination with the EULAR response criteria. DAS 28 measures, the number of swollen joints and tender joints (assessed using 28-joint counts ), inflammation and overall disease activity including measurement of serum C-reactive protein (CRP) levels. The DAS28 provides a number on a scale from 0 to 10 indicating the current activity of the rheumatoid arthritis in the patient. A DAS 28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by A DAS28 lower than 2.6 indicates remission has been achieved

American College of Rheumatology 20 (ACR20) is utilized to determine improvement in arthritis signs symptoms. ACR20 represents an improvement of at least 20 percent in tender joint count and swollen joint count and at least 20 percent improvement in 3 out of the 5 end points: acute-phase reactant, patient pain assessment, physician global assessment, patient global assessment, and patient self-addressed disability. ACR50 and ACR70 represent improvements of 50 and 70 percent.

Golimumab was generally well tolerated in the study through week 52. Serious adverse events (AEs) reported prior to crossover at week 20 were eight percent for the combined golimumab groups compared with six percent for the placebo group. Through week 20, serious adverse events were reported for 8.8% of the subjects in the combined golimumab plus methotrexate groups and 5.9% in the placebo plus methotrexate group. Through week 52, at least 1 serious adverse event was reported for 16.1% of subjects in the combined golimumab plus methotrexate groups; serious adverse events were reported in three subjects after cross over to infliximab plus methotrexate. After crossover from weeks 20 to 52, serious AEs were seven percent in the combined golimumab groups, compared to 12 percent in the control group. No deaths, cases of tuberculosis or other opportunistic infections were reported through 52 weeks, and serious infections were uncommon. The most common clinically relevant serious AEs through week 52 were pneumonia (three patients), lung cancer (unrelated, one patient), cardiac tamponade (one patient), and cardiac failure (one patient). One patient died from coronary artery disease approximately four months after completing 52 weeks of the study.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, debilitating inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. Symptoms of RA include inflammation of the joints, swelling, difficulty moving, and pain. The most commonly affected joints are the hands and feet. The joint pain of RA can impact a patient's ability to perform normal daily activities, limit job opportunities, and make family and household responsibilities a challenge. RA afflicts more than 9.7 million people worldwide; according to the World Health Organization, the incidence of RA in Europe is expected to increase over the next decade as the population ages.

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