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Antibiotic dissonance

Top-line data from Basilea Pharmaceutica Ltd.'s Phase III trial of ceftobiprole in hospital-acquired pneumonia threaten to bog down the company in the minefield of antibiotic development: While the compound met the primary endpoint of non-inferiority against two control drugs in the overall HAP population, it did not in the subgroup of patients who were on ventilators.

Non-inferiority in the ventilator-associated pneumonia (VAP) subgroup was not an endpoint in the study, but those patients accounted for 25% of the total trial population, which corresponds to real-world incidence of the disease.

While Basilea has been aiming to create a single agent capable of addressing a broad spectrum of pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), it and partner Johnson & Johnson now will have to drill down into the data to explain why the antibiotic did not match the comparators in the sickest HAP patients.

Until more answers are found, the question is whether regulators will be willing to approve the agent based on the overall results, ask for a new set of studies because of the VAP results, or attempt

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