Basilea Pharmaceutica International Ltd., a Swiss subsidiary of Basilea Pharmaceutica Ltd. has received confirmation from European health authorities that the Marketing Authorization Application (MAA) for its novel investigational antibiotic ceftobiprole for the treatment of pneumonia in hospitals has been accepted for review under the decentralized procedure.

"We are very pleased that our ceftobiprole Marketing Authorization Application has been accepted for review and look forward to working closely with the European health authorities during the review process," stated Dr Anthony Man, CEO of Basilea. "Basilea is committed to address the rising threat of bacterial resistance against current antibiotics. Ceftobiprole is a next generation antibiotic from the well-studied class of cephalosporin antibiotics with bactericidal activity against a broad spectrum of clinically relevant Gram-positive and Gram-negative pathogens that may cause pneumonia. Ceftobiprole has activity against Gram-positive bacteria, including methicillin-resistant and vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP) as well as Gram-negative pathogens, including Enterobacteriaceae and Pseudomonas aeruginosa."

The MAA submission is supported by two international, double-blind, controlled phase III studies assessing the efficacy and safety of first-line empiric ceftobiprole versus single or combination drug comparators to treat hospitalized community-acquired and hospital-acquired pneumonia.

Community-acquired pneumonia is a common condition with up to 60 per cent of the patients requiring hospital admission and intravenous antibiotics. Hospital-acquired (nosocomial) pneumonia is one of the most common infections acquired in the hospital, accounting for approximately 25 per cent of all intensive care unit (ICU) infections, and is associated with significant mortality. Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is accepted as best medical practice. In both diseases the increasing incidence of resistant bacteria is a major concern.

Basilea Pharmaceutica International Ltd. focuses on innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and non-response to current treatment options.