NEWS | BEAM Alliance


Basilea provides update on New Drug Application to the US Food and Drug Administration for antibiotic ceftobiprole

Ad hoc announcement pursuant to Art. 53 LR

Basel/Allschwil, Switzerland, April 18, 2023

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial or fungal infections, provided an updated timeline for its New Drug Application (NDA) submission for its antibiotic ceftobiprole to the US Food and Drug Administration (FDA).

Basilea estimates that an additional three to six months of preparatory work will be required to ensure that one of its third-party contract manufacturing organizations (CMOs) is ready for inspection by the FDA, which is a prerequisite for an NDA review. Basilea, therefore, now expects to submit the NDA for the three indications of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in the third quarter of 2023.

David Veitch, Basilea’s CEO, said: “We have compiled our NDA dossier and are ready to make a submission to the FDA. However, after completion of the FDA inspection-readiness preparations within our supply chain, it became clear that the quality systems of one of our CMOs need to be adapted prior to an FDA inspection. We estimate this process to require between three to six months, with the NDA submission planned to occur immediately afterwards in the third quarter of 2023, leading to an expected regulatory decision by the FDA in the second quarter of 2024. Importantly, ceftobiprole, if approved in the US, will have ten years of market exclusivity from approval, based on its Qualified Infectious Disease Product (QIDP) status designated by the FDA.”

The updated timelines for the NDA submission in the US do not have any impact on Basilea’s financial guidance.

Basilea’s ceftobiprole phase 3 program is funded in part (up to USD 136.4 million, which is approximately 70% of the total potential program costs) 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.

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