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Janssen-Cilag International NV Submits Marketing Authorization Application in Europe for New Antibiotic
Beerse, Belgium (ots/PRNewswire) - Janssen-Cilag International NV has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ceftobiprole, an investigational antibiotic for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections.
Ceftobiprole, the first broad-spectrum, anti-MRSA cephalosporin antibiotic to complete Phase III clinical trials, has demonstrated clinical activity against Gram-positive(1) as well as Gram-negative(2) pathogens. In clinical trials, ceftobiprole demonstrated high cure rates in patients with complicated skin infections, including those caused by the potentially deadly methicillin-resistant Staphylococcus aureus (MRSA).
Data from the European Antimicrobial Resistance Surveillance System (EARSS) shows that the prevalence of MRSA -- a difficult to treat cause of hospital-acquired infections -- while varying considerably among countries, has been rising across Europe for the past six (6) years(3).
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Janssen-Cilag companies will market the product in European countries and co-promote the product with Basilea in the major European markets. A New Drug Application (NDA) for ceftobiprole has been submitted in the United States.
About Janssen-Cilag International NV, Cilag GmbH International and Janssen-Cilag
Janssen-Cilag International NV, Cilag GmbH International and the Janssen-Cilag companies are members of the Johnson & Johnson family of companies. The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. More information about Janssen-Cilag can be found at www.janssen-cilag.com.
(1) Gram-positive indicates a group of bacteria that become violet-colored when the bacterial cells are treated with the Gram stain. This response is based on the chemical composition of their cell walls and is used to identify the type of bacteria. Some Gram-positive bacteria may cause serious infections.
(2) Gram-negative indicates a group of bacteria that become red when the bacterial cells are treated using the Gram stain method. This response is based on the chemical composition of their cell walls and is used to identify the type of bacteria. Some Gram-negative bacteria may cause serious infections.
(3) European Antimicrobial Resistance Surveillance System (EARSS) 2005 Annual Report. Available at: http://www.rivm.nl/en/
ots Originaltext: Janssen-Cilag
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European Media Contact: Brigitte Byl, +32-(0)14-60-71-72 (Belgium)