Basilea Pharmaceutica Ltd. announces that ceftobiprole (Zevtera(TM), the first-in-class anti-MRSA broad-spectrum cephalosporin, has obtained regulatory approval from Swissmedic for the treatment of complicated skin and soft tissue infections including diabetic foot infections.
Dr. Anthony Man, CEO of Basilea said, "We are delighted by this approval of ceftobiprole by Swissmedic. This is an important moment for our company and brings a novel and effective treatment against resistant bacteria to patients and physicians here in Switzerland."
The Swiss marketing authorization certificate may be used to facilitate regulatory approval and market entry in other countries including Asia and South America.The regulatory dossier to Swissmedic was submitted by Basilea's license partner Janssen-Cilag AG, a Johnson & Johnson company, who will commercialize ceftobiprole in Switzerland under the trade name Zevtera(TM).
Ceftobiprole is marketed in Canada and is currently under regulatory review by regulatory authorities in the U.S., the European Union and in other countries. Subject to approval, Basilea will co-promote ceftobiprole in the U.S. and in the major European markets together with the respective Janssen-Cilag companies.