J&J/Basilea ceftobiprole positive Phase III data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Swiss firm Basilea announces positive results for its first-in-class antibiotic ceftobiprole. The antibiotic met its primary endpoint of statistical noninferiority versus combination therapy in complicated skin and skin structure infections (cSSSIs) in a second pivotal Phase III trial (STRAUSS II) in resistant Staphylococcus aureus skin infections. Data indicate that single-agent ceftobiprole was as effective as a combination regimen of standard broad-spectrum agents, the company said. Johnson & Johnson licensed rights to the broad-spectrum cephalosporin from Basilea in February 2005 (1Pharmaceutical Approvals Monthly February 2005, p. 19)...