Basilea announced today that the U.S. Food and Drug Administration (FDA) designated its investigational drug ceftobiprole as a Qualified Infectious Disease Product (QIDP). The designation relates to the potential use of the drug in the treatment of bacterial bloodstream infections (bacteremia) caused by Staphylococcus aureus.

QIDP status, granted under the Generating Antibiotic Incentives Now (GAIN) Act in the United States, provides certain incentives for the development of antibiotics, such as priority review if the product is submitted for approval in the United States, and a five-year extension of certain periods of market exclusivity that may be applicable should it be approved.

Ronald Scott, chief executive officer of Basilea, said, “Staphylococcus aureus is a leading cause of bloodstream infections, which are associated with significant morbidity and mortality specifically when caused by methicillin-resistant strains. Basilea is committed to address the issue of resistance in underserved areas of high medical need such as bacteremia. The FDA QIDP designation for ceftobiprole provides important support for us to achieve this goal.”

Basilea is preparing two cross-supportive clinical phase 3 studies with ceftobiprole to support a potential future registration in the United States. Both studies will be conducted under Special Protocol Assessment (SPA) agreements with the FDA. 

The phase 3 program receives funding of up to approximately USD 108 million from the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, under contract number HHSO100201600002C.