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Swiss Regulatory Authority Grants Accelerated Assessment of Planned Market Authorization Application for Ceftobiprole

01 Jun 2007 - Basilea Pharmaceutica Ltd. announced that Swissmedic granted Janssen-Cilag AG, a Johnson & Johnson company, accelerated assessment of the planned market authorization application ("Beschleunigtes Zulassungsverfahren") for ceftobiprole for the treatment of complicated skin and soft tissue structure infections.
 
Swissmedic accelerated assessment designation is designed to expedite the availability of treatments that address high medical needs and is granted provided all of the following criteria are fulfilled: the therapy must have promising potential for the treatment of a severely debilitating or life-threatening disease, existing therapies are insufficient or not available, and a high therapeutic benefit is expected through the use of the drug.
 
Ceftobiprole (BAL5788), Basilea's lead antibacterial product is specially designed to bind the penicillin-resistant targets in many Gram-positive cocci, resulting in bactericidal activity towards methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive as well as Gram-negative pathogens. In addition it has shown a low potential to select resistance in vitro.