Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting

BASEL, Switzerland, Jan. 10, 2008 - Basilea Pharmaceutica Ltd. (SWX: BSLN) announced that in accordance with the further amendment of Section 505 of the Federal Food, Drug, and Cosmetic Act, ceftobiprole, as a new chemical entity (NCE), has been assigned a review by the FDA Anti-Infective Drug Advisory Committee on February 28th, 2008.

The ceftobiprole New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA) seeks an indication for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin to complete phase III clinical trials, and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C., who submitted the NDA for ceftobiprole.