J&J Suspends Enrollment In Golimumab Trials Due To Distribution Issue
This article was originally published in The Pink Sheet Daily
Executive Summary
Suspension is not expected to disrupt filing timeline for the rheumatoid arthritis drug, which is being developed with Schering-Plough.
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Enrollment in Phase III clinical trials for Centocor/Schering-Plough's investigational rheumatoid arthritis drug golimumab (CNTO 148) has been temporarily suspended due to a distribution issue. However, Centocor told "The Pink Sheet" DAILY that it does not expect the issue to hold up a BLA filing for the biologic. "We were ahead of enrollment to begin with, so we should remain on schedule," the Johnson & Johnson subsidiary said. The distribution issue is expected to be resolved by mid-January. In July, J&J said it expected to file a BLA for the tumor necrosis factor agent in late 2007 or 2008, calling it a "new gold standard" in the category (1 (Also see "J&J Could File “New Gold Standard” In Anti-TNF Therapy By Late 2007" - Pink Sheet, 18 Jul, 2006.)). Golimumab is being evaluated in five Phase III trials for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. J&J has been promoting its best-in-class dosing (with the potential for dosing once every four weeks) and comparable efficacy to its Remicade (infliximab) as advantages that will help to establish golimumab as a treatment of choice. It is being studied in both IV and subcutaneous dosages forms. In August, Schering brokered an extension on rights to golimumab, which extend 15 years beyond its first commercial sale in ex-U.S. regions (2 (Also see "Schering Brokers Extension For Golimumab Rights" - Pink Sheet, 18 Aug, 2006.)). Under the deal, Schering maintains worldwide marketing rights to golimumab excluding the U.S., Japan, China, Taiwan and Indonesia. Centocor released preliminary Phase II data evaluating golimumab with methotrexate in patients with severely active RA compared to methotrexate alone during the American College of Rheumatology meeting in November. Data showed that nearly 75 percent of patients with moderately to severely active RA receiving golimumab and methotrexate experienced at least a 20 percent improvement in arthritis symptoms (ACR 20) at week 52. In addition, more than one-third of patients treated with the combination achieved remission at one year, as evaluated by Disease Activity Score 28. At week 16, 62 percent, 31 percent and 12 percent of all patients in the treatment arm experienced ACR 20, ACR 50 and ACR 70 improvements, respectively, compared with 37 percent, 6 percent and zero percent of patients on methotrexate alone. At week 52, ACR 20, ACR 50 and ACR 70 scores improved 74 percent, 45 percent and 22 percent in the treatment group. The trial enrolled 172 patients with active RA for at least three months despite methotrexate treatment. At week 20, patients in the placebo group received Remicade. - Jessica Merrill ([email protected]) |