Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives approval by Swissmedic

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.

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.

About complicated skin infections Complicated skin and soft tissue infections are among the most common infections in the hospital setting. Staphylococcus aureus, a Gram-positive microbe, is the predominant pathogen in skin infections. In recent years methicillin resistant strains of S. aureus (MRSA) have become increasingly common and have been associated with increased morbidity and mortality. Patients with chronic wounds or those who have recently received antibiotics may also be infected by Gram-negative microbes. This is frequently the case for diabetic patients with foot infections. Treatment of diabetic food infections requires broad-spectrum intravenous antibiotics and may include hospitalization and surgery. Broad-spectrum antibiotics that cover resistant bacteria are often needed for the treatment of more severe skin infections.

About Zevtera

Zevtera(ceftobiprole medocaril for injection), Basilea’s lead antibacterial product, is the first approved broad-spectrum anti-MRSA antibiotic belonging to the cephalosporin class. It is designed to bind the penicillin-resistant targets in many Gram-positive bacteria of the cocci-type, resulting in bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae. Ceftobiprole as a single intravenous agent has demonstrated broad-spectrum activity against many other Gram-positive as well as Gram-negative bacteria, frequently associated with community and hospital-acquired infections. In the trials, ceftobiprole was generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics. Swissmedic has indicated Zevtera™ for the treatment of complicated skin and soft tissue infections, including diabetic foot infections without concomitant osteomyelitis caused by susceptible gram-positive pathogens (e.g. MRSA) and/or gram-negative bacteria.

Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International. Basilea Pharmaceutica Ltd. has also exercised its option to co-promote ceftobiprole in the U.S. and in the major European markets together with Ortho-McNeil, Division of Ortho-McNeil- Janssen Pharmaceuticals, Inc. in the U.S. and the respective Janssen-Cilag companies in Europe. Basilea maintains an option to co-promote the drug in Japan and China.