Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

November 26, 2015

Results from the GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) study showed the efficacy of SIMPONI in patients with active RA despite prior treatment with methotrexate. At week 52, 64 percent of patients taking SIMPONI 50 mg plus methotrexate achieved ACR 20 response, and 25 percent achieved a 70 percent improvement in arthritis signs and symptoms as measured by ACR 70 response. There was no clear evidence of improved ACR response with the higher SIMPONI dose group (100 mg). Importantly, investigators also reported that 48 percent of patients receiving SIMPONI 50 mg plus methotrexate achieved a low level of disease activity as measured by Disease Activity Score 28 (DAS 28) C-reactive protein (CRP) <2.6, which measures tender and swollen joints, inflammation and overall disease activity including measurement of serum CRP levels.

"These data show that patients receiving golimumab, a once-monthly anti-TNF therapy, sustained clinical response through one year," said Dr. Mark Genovese, Division Co-Chief of Immunology and Rheumatology at Stanford University and study investigator.

SOURCE Centocor Ortho Biotech Inc.