QIDP designation from US FDA for Basilea's ceftobiprole

Switzerland-based Basilea Pharmaceutica (SIX: BSLN) has received US Food and Drug Administration designation for 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 community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. QIDP status, granted under the Generating Antibiotic Incentives Now (GAIN) Act, 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, Basilea's chief executive, commented: "Serious bacterial lung and skin infections often involve pathogens resistant to currently available antibiotics. Basilea is committed to address the issue of resistance in underserved areas of high medical need. We are in discussions with potential collaborators for the clinical development of ceftobiprole in the USA."