- Seeking approval for Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP)
- NDA eligible for Priority Review
Ad hoc announcement pursuant to Art. 53 LR
Allschwil, Switzerland, August 04, 2023
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA). With this NDA, Basilea is seeking approval of its antibiotic ceftobiprole for treating patients in three indications: Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Dr. Marc Engelhardt, Chief Medical Officer, said: “Staphylococcus aureus bacteremia is a common bloodstream infection with an estimated 120,000 cases in the US per year and is associated with substantial morbidity and mortality. Our completed phase 3 program demonstrates the efficacy of ceftobiprole in this complicated infection. The additional successfully completed phase 3 studies in ABSSSI and CABP support the broad clinical utility of ceftobiprole. Based on its potent antibacterial activity ceftobiprole could become a valuable new treatment option for severe bacterial infections in the US, especially when methicillinresistant Staphylococcus aureus bacteria, MRSA, are of concern.”
The NDA submission includes clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study in CABP. The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB.
Ceftobiprole has been designated a Qualified Infectious Disease Product (QIDP) under the US Generate Antibiotics Incentives Now (GAIN) Act, which provides for a Priority Review within eight months from submission. Provided that the NDA submission is accepted, Basilea expects a decision by the FDA on the NDA in the second quarter of 2024. Basilea plans to commercialize ceftobiprole in the US through a partner and intends to enter into such a partnership prior to the FDA’s decision on the NDA.
Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.
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