Basilea Wins FDA Approval for Antibiotic Ending 15-Year Regulatory Quest

FDA Entrance_iStock, Grandbrothers

Pictured: Facade of the FDA's office in Maryland/iStock, Grandbrothers

Basilea Pharmaceutica received FDA approval Wednesday for its antibiotic  Zevtera (ceftobiprole medocaril sodium for injection) in adults with Staphylococcus aureus bloodstream infections and two other indications, marking the end of a 15-year odyssey.

The authorization covers the use of Zevtera in adults with Staphylococcus aureus bloodstream infections (SAB), including those with right-sided infective endocarditis and acute bacterial skin and skin structure infections, as well as adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).

Peter Kim, director of the FDA’s Division of Anti-Infectives, said in a statement that the approval will “provide an additional treatment option for a number of serious bacterial infections.” In particular, Vance Fowler, professor in the departments of medicine and molecular genetics and microbiology at the Duke University School of Medicine, noted there are limited treatments for SAB, a condition with a high mortality rate that causes substantial morbidity.

The FDA approved the beta-lactam antibiotic after seeing results from three clinical trials that enrolled between 390 and 679 participants. The studies showed Zevtera has similar efficacy to comparator drugs in the three adult populations. The FDA relied on the adult CABP trial and a study in 138 pediatric subjects to inform the approval in children with pneumonia.

Basilea partnered with Johnson & Johnson to develop the molecule in 2005 but the program ran into regulatory problems. The FDA hit J&J with a warning letter over clinical trials of ceftobiprole and rejected a filing for approval in 2009. Basilea regained the asset, plus compensation for lost payments, in 2010 and brought it to market with partners outside the U.S. The Swiss drugmaker had its own issues, notably a delay to the FDA submission.

The FDA approval gives Zevtera 10 years of market exclusivity, starting now, and Basilea is looking for a partner to commercialize the drug. The company had planned to find a commercial partner for the U.S. market before winning FDA approval.

Basilea is aiming to complete the process around mid-year to allow it to “explore fully all potential partnering opportunities,” CFO Adesh Kaul said in a statement. Kaul added that Basilea is taking “preparatory steps to shorten the launch timelines, once we have entered into a commercialization partnership.”

Basilea CEO David Veitch told investors on an earnings call in February 2024 that the company was in talks with “a few potential partners.” Veitch added that the goal is “to secure an appropriate participation over the lifetime of the product.” That goal is informing the deal structure that Basilea wants to secure.  

“We want to participate over the entire 10-year period,” Veitch said. “The focus is, therefore, more on having an appropriate royalty rate, having milestones as the product is commercialized. We’re not necessarily looking at front-loading the transaction.”

Basilea reported CHF 150 million ($166 million) in revenues related to Cresemba and Zevtera last year, up 23% compared to 2022. The company expects sales to rise by 20% this year to hit CHF 180 million.

Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

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