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FDA grants QIDP status to Basilea antibiotic
September 2015
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BASEL, Switzerland—Basilea Pharmaceutica Ltd.’s investigational drug ceftobiprole has received Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration. This designation is tied to the drug candidate’s indication for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. QIDP status offers incentives for antibiotic development such as priority review and a five-year extension of certain market exclusivity periods if the product gains approval.
 
“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 U.S.,” noted Ronald Scott, CEO of Basilea.

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