Ceftobiprole MAA submitted to EMEA

Belgium's Janssen-Cilag International NV, a unit of US health care major Johnson & Johnson, has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for ceftobiprole, its investigational antibiotic for the treatment of complicated skin and soft-tissue infections (cSSTI) including diabetic foot infections.

The agent, the first broad-spectrum, anti-methicillin-resistant Staphylococcus aureus cephalosporin antibiotic to complete Phase III clinical trials, has demonstrated clinical activity against Gram-positive as well as Gram-negative pathogens. In trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly MRSA. Data from the European Antimicrobial Resistance Surveillance System shows that the prevalence of this difficult-to-treat infection, while varying considerably among countries, has been rising across Europe for the past six years.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica and Cilag GmbH International. Janssen-Cilag companies will market the product in European countries and co-promote the product with Basilea in the major European markets. A New Drug Application (NDA) for ceftobiprole has been submitted in the USA.