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Basilea ceftobiprole enters Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Basilea initiates a Phase III program for its antibiotic ceftobiprole (BAL5788) for use in complicated skin and skin structure infections, the firm announces Nov. 4. The Swiss company, a spin-off of Roche, describes the agent as "the first of a new generation of anti-[methicillin-resistant Staphylococcus aureus] cephalosporins" that will "combine the well-established advantages of the cephalosporin antibiotic class with an enhanced gram-positive antibacterial spectrum." Ceftobiprole was designed to bind to mutated targets in MRSA. A 700-patient skin/skin structure infections study versus vancomycin is ongoing, with additional studies planned in other severe infection indications. Ceftobiprole has fast-track status for CSSIs due to MRSA and for hospital-acquired pneumonia due to MRSA...
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