New antibiotic Doribax (doripenem) launched, offering a new option

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New antibiotic Doribax (doripenem) launched, offering a new option in the
battle against hospital acquired infection
Janssen-Cilag
Posted on:30 Sep 08
[30 September 2008] High Wycombe, UK. /PRNewswire/ — Janssen-Cilag Ltd today
announced the launch of its new carbapenem antibiotic, Doribax™, for the treatment
of complicated intra abdominal infections, as well as nosocomial pneumonia and
ventilator associated pneumonia in adult patients. Doripenem is a broad-spectrum, I.V.
antibiotic with activity against a wide range of Gram-positive and Gram-negative
pathogens and was developed to meet a rapidly growing need for new antibiotics as
hospital bacteria become increasingly resistant to existing antibiotic therapies.
Bacterial resistance against a wide range of antibiotics is on the increase in almost all
European countries.1 Potentially life threatening infections caused by Gram-negative
bacteria, such as Pseudomonas aeruginosa, are a particular problem as there are
relatively limited antibiotic options available. Patients who acquire an infection in
hospital are seven times more likely to die in hospital than uninfected patients2 and
they currently cost the NHS an estimated £930 million per year.3
Dr David Livermore, Director of the Health Protection Agency's Antibiotic Resistance
Monitoring & Reference Laboratory (ARMRL) commented, 'Carbapenems are powerful
weapons against severe hospital infections and the development of new antibiotics in
this class is critical to the fight against resistance - along with good infection control
and appropriate use of all antibiotics, old and new.'
Doripenem belongs to a class of antibacterial agents called carbapenems, which are
important for treating serious infections, and is active against both Gram-positive and
Gram-negative bacteria. In a clinical trial in patients with ventilator associated
pneumonia, doripenem was associated with a five day reduction in total length of
hospital stay (p=0.01) and a three day reduction in mechanical ventilation (p=0.03)
when compared to imipenem.4
Professor Robert Masterton, Consultant Microbiologist, at Crosshouse Hospital,
Kilmarnock, said 'In an era when no new classes of antibiotics active against difficult to
treat Gram-negative pathogens are available, doripenem is a development within an
existing group of antibiotics - the carbapenems - which presents clinicians with
potential useful advantages over the existing drugs of this type. These benefits
promise to deliver real patient benefits, particularly in severe sepsis, which are to be
welcomed and so will help maintain our armoury of weapons against such pathogens.'
Doripenem is the first product from Janssen-Cilag's antibiotic pipeline to be launched
and represents a significant commitment to the investment in and development of
novel antibiotics.
Dr Peter Barnes, Medical Director for Janssen-Cilag commented; 'Healthcare
professionals have highlighted a critical need for the development of new antibiotics.
The development of novel antibiotics, such as doripenem, will help to tackle the
growing problem of microbial resistance.'
References
1. European Antimicrobial Resistance Surveillance System, EARSS Annual Report 2005,
October 2006.
2. Department of Public Health & Policy, London School of Hygiene & Tropical
Medicine, Research Briefing: Hospital acquired infections.
3. Plowman R et al. The rate and cost of hospital acquired infections occurring in
patients admitted to selected specialties of a district general hospital in England and
the national burden imposed.
Journal of hospital infection. 2001; 47:198-209
4. Merchant S et al. Hospital resource utilization with Doripenem versus Imipenem in
the treatment of ventilator-associated pneumonia. Clinical Therapeutics. 2008; 30(4):
717-733.
5. Doribax Summary of Product Characteristics (2008)
Notes to editors
Doripenem is licensed in the UK for the treatment of serious hospital acquired
infections including nosocomial and ventilator associated pneumonia, complicated
urinary tract infections and complicated intra abdominal infections.5
The recommended dose for doripenem is 500 mg administered every 8 hours by IV
infusion over 1 hour, or as a 4 hour infusion for more serious infections.
In clinical trials doripenem was generally well tolerated.
About Janssen-Cilag
Doripenem is the first product from Janssen-Cilag's antibiotic pipeline and represents a
significant commitment to the investment in and development of novel antibiotics.
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