Basilea announces commercial availability of antibiotic Zevtera® (ceftobiprole) in the United States

Allschwil, Switzerland, May 20, 2025

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 its antibiotic Zevtera® (ceftobiprole medocaril for injection) is now commercially available in the United States through Basilea’s partner Innoviva Specialty Therapeutics, Inc., a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA). Zevtera is used in hospitals for the treatment of bacterial infections, such as those caused by Staphylococcus aureus bacteria, including methicillin-resistant strains (MRSA). It is the only advanced-generation cephalosporin approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients with Staphylococcus aureus bacteremia (SAB), including those with right-sided infective endocarditis. It is also indicated in the United States to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for the treatment of adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

David Veitch, Chief Executive Officer of Basilea, stated: “We congratulate our partner Innoviva Specialty Therapeutics on making Zevtera commercially available in the United States, which is a significant milestone for the brand. We are proud of Zevtera being the first MRSA active antibiotic approved for SAB in the US in more than a decade. There is a high medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. Our team is pleased to be supporting Innoviva Specialty Therapeutics in bringing Zevtera to patients in the US who are suffering from these severe infections.”

“The availability of Zevtera in the US marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.”

Basilea entered into an exclusive distribution and license agreement with Innoviva Specialty Therapeutics in December 2024. Under the terms of the agreement, Basilea will receive tiered royalties on net sales in the high-teens to mid-twenties percentage range. Basilea will be eligible to receive sales milestones of up to USD 223 million. In addition, Innoviva Specialty Therapeutics will purchase its demand for Zevtera drug product from Basilea.

Full PR available here