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Europe filing for anti-MRSA drug


Switzerland’s Basilea says its licensing partner Janssen-Cilag International has filed for approval of its new antibiotic ceftobiprole in Europe.

Janssen, a Johnson & Johnson unit, has submitted a marketing authorisation application to the EMEA for ceftobiprole, an investigational antibiotic for treating complicated skin and soft tissue infections, including diabetic foot infections.

Ceftobiprole is the first broad-spectrum cephalosporin to show efficacy in a large clinical trial against methicillin-resistant Staphylococcus aureus (MRSA) and demonstrated clinical activity against Gram-positive as well as Gram-negative pathogens. In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections and the firms noted that a New Drug Application for the antibiotic has already been submitted in the USA.

The drug’s potential is considerable, and the firms noted that data from the European Antimicrobial Resistance Surveillance System show that the prevalence of MRSA, “while varying considerably among countries”, has been growing across Europe over the past six years.

As part of their collaboration, Basilea will co-promote the product with Janssen in the major European markets and the Swiss biotechnology firm recently raised around $240m in a share offering, some of the proceeds of which will be used to set up its own sales and marketing force.

PharmaTimes 18/6/2007


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