Basilea Pharmaceutica Ltd announced that Johnson & Johnson PRD received confirmation from the European Medicines Agency (EMEA) that it has halted the European Commission decision process on Zevtera (ceftobiprole) for the treatment of complicated skin and soft tissue infections (cSSTI) pending completion of Good Clinical Practice (GCP) inspections.
In November 2008 Zevtera received a positive benefit-risk opinion and recommendation for approval from the EU Committee for Medicinal Products for Human Use (CHMP). Basilea announced on February 24, 2009 that it had been verbally informed that the EMEA would conduct GCP inspections and had halted the EU commission decision process until review of the inspection outcome is completed. Basilea now received written confirmation provided to Johnson & Johnson Pharmaceutical Research and Development, LLC (Johnson & Johnson PRD) that the EMEA has halted the EU Commission decision process on ceftobiprole pending EU led GCP inspections. Basilea anticipates that the final report from the EMEA GCP inspections will be available to the CHMP in the second half of this year.
Ceftobiprole showed in two large multinational, double-blind, randomized phase-III clinical studies, that it was effective in treating cSSTI, as demonstrated by meeting the primary endpoint using a 10 per cent non-inferiority margin. A safety profile consistent with the cephalosporin class of antibiotics was demonstrated. Ceftobiprole has been approved and is marketed in Canada (Zeftera) and Ukraine for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis; and Switzerland (Zevtera) for the treatment of cSSTI including diabetic foot infections.
Basilea Pharmaceutica Ltd is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange. Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology agents to fight drug resistance and on the development of dermatology drugs.