New Antibiotic Against Serious Infections

European Authority Recommends Approval of ZEVTERA™ a Broad-spectrum, Anti-MRSA Cephalosporin Antibiotic to Treat Complicated Skin and Soft Tissue Infections

Beerse, Belgium . – The Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the antibiotic, ZEVTERA™ (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections. The CHMP’s positive opinion is now referred for final action to the European Commission.

Ceftobiprole is the first, broad-spectrum, anti-MRSA cephalosporin antibiotic with activity against a range of difficult-to-treat Gram-positive and Gram-negative hospital- and community-acquired infections including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.

In clinical trials, ceftobiprole has demonstrated high cure rates in patients with complicated skin infections, including those with deep wound and diabetic foot infections, and in infections caused by the potentially deadly MRSA.

Data from the European Antimicrobial Resistance Surveillance System (EARSS) show that the prevalence of MRSA - a difficult to treat cause of hospital-and- community acquired infections - while varying considerably among countries, has been rising across Europe for the past six years.1

The use of ceftobiprole in adults for the treatment of complicated soft tissue infections is under regulatory review in the United States, and Australia, among other countries. Ceftobiprole was approved in Switzerland in November 2008. In Canada, it was approved and launched in August 2008, and is marketed under the trade name ZEFTERA.

Ceftobiprole is licensed from and co-developed with Swiss based Basilea Pharmaceutica Ltd. Janssen-Cilag AG, and Basilea Pharmaceutica Ltd will co-promote the drug in North America and key European markets and in North America subject to approval.

About Complicated Skin Infections

Complicated skin and soft tissue infections are among the most common infections in the hospital setting. Staphylococcus aureus is the predominant pathogen in these infections. In recent years, resistant strains (MRSA) have become increasingly common and have been associated with increased morbidity and mortality. There is a high unmet medical need for new antibiotics such as ceftobiprole that cover resistant bacteria including MRSA, but also clinically important and problematic Gram-negative pathogens.

Patients with chronic wounds or those who have recently received antibiotics may also be infected by Gram-negative pathogens. This is frequently the case for diabetic patients with foot infections. Adequate treatment of diabetic foot infections can require hospitalization, surgery and broad-spectrum intravenous antibiotics.