Singapore, Feb 22, 2010: Basilea Pharmaceutica has announced that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

The sponsor Janssen-Cilag International, a Johnson & Johnson company, has been notified that the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI.

The MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag in June 2007. After a positive opinion from the CHMP in November 2008, the European Medicines Agency took the unusual step of halting the European Commission authorization process on ceftobiprole pending completion and assessment of Good Clinical Practice (GCP) inspections.