Basilea Pharmaceutica Ltd., a commercial-stage biopharmaceutical company, received approval from the U.S. FDA for ZEVTERA (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections, including right-sided infective endocarditis, and adults with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients with community-acquired bacterial pneumonia (CABP).
 
The NDA was supported by clinical efficacy and safety data from phase 3 studies ERADICATE (SAB) and TARGET (ABSSSI), and a phase 3 study in CABP. The ERADICATE study was the largest double-blind randomized registrational study conducted for a new antibiotic treatment in SAB.
 
David Veitch, Chief Executive Officer of Basilea, said, “We are excited with the U.S. approval of ZEVTERA. The positive decision by the FDA is a key milestone towards bringing ZEVTERA to patients in the US. ZEVTERA has 10 years of market exclusivity from the date of approval and we believe the U.S. provides the most important global commercial opportunity for the brand.”
 
Basilea’s phase 3 program for ceftobiprole is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA). Through this partnership, Basilea has been awarded approximately $112 million, or approximately 75% of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.