Basilea Pharmaceutica and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, announced they have agreed on the details of Basilea’s wide-spectrum antibiotic ceftobiprole clinical Phase 3 development, and its regulatory approval process in the U.S.
Development of the therapy could lead to a novel treatment for community-acquired bacterial pneumonia, among other infections.
Under the agreement, BARDA will support the development with $20 million over the first 18 months, while Basilea, based in Switzerland, will continue to seek an agreement on the clinical development program with the U.S. FDA.
The contract stipulates BARDA can raise the total amount of the agreement up to $100 million over an additional 4.5 years, if Basilea meets important milestones in pre-clinical, clinical, manufacturing, and regulatory activities.
“Resistance against currently available antibiotics is a global healthcare risk,” Basilea 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.”
Basilea is preparing protocols for three Phase 3 clinical trials of ceftobiprole to support its submission of FDA New Drug Applications for the treatment Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP).
Basilea plans to submit the clinical protocols to the FDA to reach an agreement on the Special Protocol Assessments, which provides FDA written guidance and documents agreement that a study is adequately designed to meet regulatory objectives.
“Based on recent FDA feedback we understand that any two adequate and well-controlled studies in either SAB, ABSSSI or CABP, demonstrating safety and efficacy in each of those studies, would be sufficient to support regulatory approval of ceftobiprole in the United States,” said Prof. Achim Kaufhold, Basilea’s chief medical officer.
“We believe that within the three indications under consideration the highest medical need is in Staphylococcus aureus bacteremia, where new antibiotics with bactericidal activity against both methicillin-susceptible and resistant strains are urgently needed. Ceftobiprole offers a potential treatment option for this area of high medical need,” Kaufhold said.