Basilea submits New Drug Application for anti-MRSA Broad-spectrum Cephalosporin to U.S. Authorities
This submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). 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, randomized 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.
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 hospitalized 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 methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens. In addition it has shown a low potential to select resistance in vitro.
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