New Antibiotic Doribax™ (doripenem) Launched, Offering A New Option In The Battle Against Hospital Acquired Infection

Main Category: MRSA / Drug Resistance
Also Included In: Infectious Diseases / Bacteria / Viruses
Article Date: 01 Oct 2008 - 9:00 PDT

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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

Dr 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)

- 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.

Janssen-Cilag has a long track record in developing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Products include Concerta® XL (ADHD), Durogesic® DTrans® (pain management), Eprex® (anemia), Topamax® (epilepsy, migraine prevention), Risperdal® (schizophrenia, bipolar disorder), Risperdal® Consta® (schizophrenia) and Velcade® (progressive multiple myeloma).

Janssen-Cilag