Ceftobiprole meets Phase III cSSSI endpoint

Ceftobiprole ( BAL5788) from Basilea (SWX:BSLN) and Johnson & Johnson (JNJ) met the primary endpoint of non-inferiority vs. combination therapy with ceftazidime plus vancomycin in the Phase III STRAUSS II trial to treat Gram-positive and Gram-negative complicated skin and skin structure infections (cSSSIs). In the double-blind, international trial in 828 patients, 91% of those given ceftobiprole were cured vs. 90% of those given combination therapy. BSLN said JNJ expects to submit an NDA this year. Last year, ceftobiprole met the primary endpoint in the Phase III STRAUSS trial to treat Gram-positive cSSSIs (See BioCentury Extra, Thursday, March 02, 2006). ...