Basilea Pharmaceutica Ltd. has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ceftobiprole by its co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. This 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.
Ceftobiprole is a novel anti-MRSA broad-spectrum cephalosporin antibiotic. This submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials. These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomised phase III clinical studies, ceftobiprole was effective, demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively. Ceftobiprole was well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Dr Anthony Man, CEO of Basilea commented, "We and our partners at Johnson & Johnson Pharmaceutical Research and Development, L.L.C. are delighted to have been able to prepare and submit this first NDA package in a timely fashion. 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 CHF 24 million from Cilag GmbH International, the Johnson & Johnson company with which ceftobiprole is being developed through an exclusive worldwide collaboration.
Ceftobiprole is currently in clinical phase III testing in hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) and in hospitalised patients with community-acquired pneumonia (CAP) with anticipated completion in the second half of the year.
Ceftobiprole (BAL5788), Basilea's lead antibacterial product, is the first of a new class of broad-spectrum anti-MSRA cephalosporin antibiotics. It is specially designed to bind the penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards -resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP).