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