European Medicines Agency Accepts Review of Marketing Authorization Application for New Antibiotic Doripenem

Beerse, Belgium (ots/PRNewswire) - Janssen-Cilag International NV
announced today that the European Medicines Agency (EMEA) has
accepted for review a Marketing Authorization Application (MAA) for
doripenem, an investigational carbapenem antibiotic for the treatment
of nosocomial pneumonia (NP), including ventilator-associated
pneumonia (VAP), complicated intra-abdominal infections (cIAI) and
complicated urinary tract infections (cUTI). Nosocomial pneumonia is
the term used to describe a pneumonia that is acquired in a hospital
or other healthcare setting.

According to the European Commission, healthcare-associated
infections affect an estimated 1 in 10 patients, leading to a
considerable increase in patient suffering, cost and mortality, with
approximately 50,000 patients dying each year as a result. Urinary
tract infections and pneumonia are the two most commonly occurring
healthcare-associated infections in Europe(1). Hospital-acquired
pneumonia, often caused by the bacterium, Pseudomonas aeruginosa, is
associated with high morbidity and mortality.

Doripenem belongs to a class of antibacterial agents called
carbapenems, which are useful in treating life-threatening infections
caused by Gram-negative(2) and Gram-positive(3) bacteria. The data
supporting the MAA demonstrated the effectiveness of doripenem
against infections caused by Gram-negative bacteria, such as
Pseudomonas aeruginosa and Enterobacteriaceae , including strains of
these bacteria that are resistant to other therapies.

In general, there are few antibiotics available or currently in
development to treat the resistant and potentially life-threatening
infections associated with these Gram-negative bacteria.

Following regulatory approval, doripenem will be marketed in
Europe by the Janssen-Cilag companies. Doripenem is licensed from
Shionogi & Co., Ltd., which launched the product in Japan in
September 2005.

About Janssen-Cilag International NV and Janssen-Cilag

Janssen-Cilag International NV 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 and viral infections and
gastrointestinal conditions. More information about Janssen-Cilag can
be found at www.janssen-cilag.com.

(1) http://ec.europa.eu/health/ph_threats/com/cons01_txt_en.pdf

(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) 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.

ots Originaltext: Janssen-Cilag
Im Internet recherchierbar: http://www.presseportal.de

Contact:
European Media Contact: Alexandra Gillespie, +32-(0)14-60-72-14
(Belgium)


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