Basilea Pharmaceutica has announced that the Biomedical Advanced Research and Development Authority (BARDA), a division within the U.S. Department of Health and Human Services` Office of the Assistant Secretary for Preparedness and Response, has entered into a contract with Basilea Pharmaceutica International for the clinical phase III development aiming at regulatory approval of Basilea`s broad-spectrum antibiotic ceftobiprole in the U.S.
BARDA will provide funding of approximately $20 million over an initial period of 18 months. During this initial period, Basilea will work towards gaining agreement on the development program from the FDA and obtaining first health authority approvals for the initiation of clinical phase III studies, which are targeted to be started towards the end of this year or the beginning of next year. During the term of the agreement, BARDA may exercise further options, which would bring the total value of the contract up to $100 million over a period of 4.5 years, upon successful completion of pre-defined milestones including preclinical, clinical, manufacturing and associated regulatory activities.
Ronald Scott, Basilea`s chief executive officer, said, "Resistance against currently available antibiotics is a global healthcare risk. Our agreement with BARDA demonstrates the potential value of ceftobiprole to treat life-threatening infections and will enable us to start a phase III 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 III studies with ceftobiprole to support the potential submission of New Drug Applications (NDAs) for the treatment of patients with Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Basilea intends to submit these protocols to the FDA, seeking the agency`s agreement on Special Protocol Assessments (SPAs). An SPA provides written guidance by the FDA and documents agreement between the study sponsor and the agency that a clinical study is adequately designed so that it would support a regulatory submission for drug approval, should the study meet its objectives.
Prof. Achim Kaufhold, Basilea`s chief medical officer, said, "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 U.S. 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."
The project will be funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under Contract No. HHSO100201600002C.