The submission is for the use of ceftobiprole in the treatment of complicated skin and skin structure infections (cSSSI) including diabetic foot infections. Submissions to other health authorities around the world will follow, said Basilea.
The application is based on data from phase II trials involving 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. Ceftobiprole reached its primary endpoint and was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Dr Anthony Man, CEO of Basilea, said: “We believe the compelling clinical results in this package confirm the profile of ceftobiprole as an innovative anti-MRSA drug providing coverage of a broad range of common Gram-positive and Gram-negative pathogens associated with complicated skin and skin structure infections.”
The NDA filing triggers a milestone payment of approximately $19.5 million from Cilag International, the Johnson & Johnson company with which ceftobiprole is being developed through an exclusive worldwide collaboration.