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
Im Internet recherchierbar: http://www.presseportal.de

Contact:
European Media Contact: Brigitte Byl, +32-(0)14-60-71-72 (Belgium)


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