Basilea signs deal with BARDA for phase 3 development of ceftobiprole antibiotic

Ceftobiprole is a broad-spectrum antibiotic for intravenous administration with bactericidal activity against certain Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus and susceptible Pseudomonas spp.

Under the agreement, the US Government’s Biomedical Advanced Research and Development Authority (BARDA) will provide about $20m of funding over an initial period of 18 months.

For the initial period, Basilea will work towards regulatory approval to start clinical phase 3 studies that are anticipated to start by the end of this year or the starting of next year.

BARDA has the option to extend the agreement for up to a total of four-and-a-half years, bringing the total value of the contract to about $100m.

The extension is subject ti completion of pre-defined milestones such as pre-clinical, clinical, manufacturing and related regulatory activities.

Basilea Pharmaceutica CEO Ronald Scott said: "Our agreement with BARDA demonstrates the potential value of ceftobiprole to treat life-threatening infections and will enable us to start a phase 3 program, initially in bacteremia and acute bacterial skin and skin structure infections, with the goal of achieving U.S. regulatory approval and to expand ceftobiprole’s label in other territories."

The company is preparing protocols for three phase 3 studies with ceftobiprole to support the potential submission of new drug applications to treat patients with Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia (CABP).

Basilea plans to submit the protocols to the US Food and Drug Administration, seeking the agency’s agreement on special protocol assessments.