Basilea Superbug Drug Application Accepted By Authorities
July 19, 2007
Biotech firm Basilea says US and European regulators have accepted its application for a new superbug drug.
Ceftobiprole, an anti-MRSA antibiotic, was granted fast track designation by the FDA.
The regulatory dossiers were submitted by Basilea’s co-development partner Johnson & Johnson in the US and in Europe by its license partner Janssen-Cilag.
“This underscores the potential of this new antibiotic in the treatment of complicated skin and skin structure infections in which MRSA or gram-negative pathogens are a concern. In addition, we plan to report topline data for the pneumonia program, including hospital-acquired and community-acquired pneumonia requiring hospitalization, later this year,” commented Dr Anthony Man, CEO of Basilea.