Basilea completes ceftobiprole marathon with FDA approval

Basilea Pharmaceutica will finally be able to bring its antibiotic ceftobiprole to the US market, around 15 years after the drug was first turned down by the FDA.

The US regulator has cleared the intravenously-administered beta-lactam antibiotic as Zevtera (ceftobiprole medocaril sodium) for three indications, namely Staphylococcus aureus bacteraemia, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP).

It becomes the first antibiotic in the beta-lactam class to be approved for SAB and, according to the FDA, also becomes an option for SAB patients with right-sided infective endocarditis, a complication that can occur after the placement of medical devices like central venous catheters.

There are approximately 120,000 S. aureus bloodstream infections annually in the US, according to 2017 data from the Centers for Disease Control and Prevention (CDC). Zevtera is also the first new antibiotic for SAB to be approved by the FDA in more than 15 years.

Switzerland-based Basilea said it was “very pleased” that the FDA had approved all three indications it had sought for ceftobiprole, including antimicrobial-resistant (AMR) infections and notably methicillin-resistant S. aureus (MRSA).

The US accounts for 80% to 90% of the total market for anti-MRSA antibiotics, so FDA approval is key to growing ceftobiprole’s revenues, according to analysts. In 2023, Basilea reported CHF 180 million ($200 million) in sales of Zevtera and antifungal therapy Cresemba (isavuconazole), with the latter drug accounting for the bulk of that figure.

Ceftobiprole was turned down by the FDA in 2009 for ABSSSI when the drug was partnered with Johnson & Johnson’s Janssen Cilag unit. It has subsequently been approved as Zevtera or Mabelio in Europe, China, and Canada – as well as in various Latin American, North African, and Middle Eastern countries – for various indications, spanning hospital-acquired bacterial pneumonia (HAP), CABP, ABSSSI, and SAB.

Ceftobiprole has qualified infectious disease product (QIDP) status from the FDA, so will benefit from 10 years’ market exclusivity if approved, and has been developed with around $112 million in federal government funding.

Basilea – which is a rarity in biopharma, as it is entirely focused on antibiotic and antifungal therapies – had said it was hoping to appoint a commercial partner for the drug in the US before approval. That hasn’t happened yet, but the company is expecting to provide an update on the partnership “around mid-year.”

Analysts at Edison said in a recent research note that the US approval of Zevtera is a “key catalyst” for Basilea and “could represent a potentially lucrative commercial opportunity […] given that the MRSA treatment market is projected to be worth [circa] $5.5 billion by 2030.”

Following in Basilea’s pipeline are antifungals fosmanogepix and BAL2062, and antibacterial therapy tonabacase - all added in recent months through licensing deals. Fosmanogepix is due to start two phase 3 trials this year, with BAL2062 heading for a phase 2 study in 2025. Basilea has an option on tonabacase and has said it plans to decide on that if preclinical data coming later this year is positive.