Basel, Switzerland, September 16, 2013 - Basilea Pharmaceutica Ltd. (PK5.BE) announced today that the Swiss regulatory authority Swissmedic has accepted the ceftobiprole Marketing Authorization Application for review. Ceftobiprole is an investigational broad-spectrum anti-MRSA (methicillin-resistant Staphylococcus aureus) antibiotic. The intended indication of ceftobiprole is for the treatment of hospital-acquired (nosocomial) pneumonia and community-acquired pneumonia in adults.
Ronald Scott, Chief Executive Officer of Basilea, stated: "We are very pleased that Swissmedic will begin its review of our Marketing Authorization Application for ceftobiprole in pneumonia. Severe pneumonia is a condition associated with morbidity and mortality which is significantly increased when MRSA is a causative organism. Data has shown that ceftobiprole provides broad antibacterial coverage including MRSA and Gram-negative pathogens such as Pseudomonas. We are focused on working with Swissmedic to support their review of ceftobiprole."
Basilea`s submission dossier includes data from two international double-blind, randomized, controlled phase 3 studies in hospital-acquired pneumonia and community-acquired pneumonia. These studies compared the efficacy and safety of empiric ceftobiprole use versus standard-of-care single or combination antibiotic therapy.
Ceftobiprole in pneumonia is currently under review with European regulatory authorities, with a decision anticipated in the second half of 2013.
About ceftobiprole
Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for the potential first-line empiric treatment of severe bacterial infections. Ceftobiprole has demonstrated broad-spectrum 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.
About pneumonia treated in the hospital
Community-acquired pneumonia is a common condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.[1] Hospital-acquired pneumonia is one of the most common infections in the hospital, accounting for approximately 25% of all intensive care unit (ICU) infections, and is associated with significant mortality.[2],[3] Prompt empiric intervention with an appropriate broad-spectrum antibiotic treatment is accepted as best medical practice. The increasing incidence of bacteria resistant to many antibiotics is a major concern.