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BASILEA ANNOUNCES DATA ON BROAD-SPECTRUM CEPHALOSPORIN

January 12, 2007

Basilea Pharmaceutica announced that the second pivotal ceftobiprole Phase III study in complicated skin infections met its primary endpoint of statistical non-inferiority versus combination therapy. Ceftobiprole demonstrated high cure rates in patients with complicated Gram-positive as well as Gram-negative skin infections, including diabetic patients with foot infections. A first regulatory submission is planned this year. Ceftobiprole is a broad-spectrum cephalosporin developed in collaboration with Cilag.

The double-blind study, STRAUSS, treated 828 patients with either ceftobiprole or the combination of ceftazidime plus vancomycin in a 2-1 randomization. Almost one-third of patients had diabetic foot infections of which three-quarters were moderate to severe cases.

Ninety-one percent of clinically evaluable patients were cured with ceftobiprole compared with 90 percent of patients treated with combination therapy. The clinical response in patients with diabetic foot infections was 86 percent for ceftobiprole and 82 percent for comparator combination therapy, respectively.

More than 20 percent of microbiologically evaluable patients had confirmed methicillin-resistant Staphylococcus aureus (MRSA) infections. The clinical cure rate for ceftobiprole in MRSA patients was 91 percent compared with 86 percent for the comparator regimen.

One-third of patients had infections involving a Gram-negative pathogen. The microbiologic eradication rates in these patients were similar at 84 percent in both treatment groups. Ceftobiprole was well tolerated. Adverse events were comparable between the two treatment groups.