Seventy years after their introduction, the rise of bacterial resistance to antibiotics has become a threat to global public health.
As we face the possibility of a future without effective antibiotics for several types of bacteria that cause life-threatening infections, GlaxoSmithKline and other pharmaceutical and biotechnology companies are embarking on a pioneering approach to tackle this resistance and develop new antibiotics.
When antibiotics were first introduced in the 1940s, they dramatically reduced illnesses and deaths caused by bacterial infections. Before their introduction, infectious diseases claimed countless victims. Many of the medical advances in recent years, like organ transplants, hip replacements and even chemotherapy for cancer treatment, are all made possible or improved by the use of antibiotics.
But a hallmark of antibiotics is that they lose their effectiveness over time as bacteria naturally evolve and mutate and so become resistant to the medicine's effects. The rate of growth of antimicrobial resistance has accelerated due to the widespread global use of antibiotics. There have been isolated infections of multi-resistant bacteria that are almost untreatable with current drugs.
The rising problem of multi-drug resistant bacteria
It is estimated that each year about 25,000 people in the European Union die as a result of infections cause by multi-drug resistant bacteria.1 A study from the US estimated that patients with infections due to antimicrobial-resistant organisms increase the costs of care by between $18,000 and $30,000 per patient compared with patients with infections that are caused by bacteria susceptible to antimicrobials.2 Based on this study, it is estimated that the societal costs of antibacterial resistance could cost $35 billion a year in the US.
The challenges of developing new medicines
Despite this critical need for new options, the current antibiotic pipeline is ill equipped to address the problem. Exceptional drug discovery challenges, regulatory complications and commercial issues are all factors that have resulted in many companies leaving this important area.
There are enormous scientific difficulties in finding new compounds to successfully target bacteria. Gram-negative bacteria, such as Pseudomonas, Klebsiella and Acinetobacter species, commonly cause hospital-acquired infections like pneumonia and septic shock. Gram negative bacteria have an additional protective layer that interferes with the penetration of a medicine into the cell. This added challenge has to be overcome in order to find new drug classes for these difficult to treat infections.
New antibiotics created today will be kept in reserve and used as infrequently as possible, to fight infections that have failed to respond to other antibiotics. Also, patients generally only need a two-week course to treat bacterial infections, this makes antibiotics less financially rewarding than longer-term treatments.
As a result of these challenges, research has diminished over the past 15 years and few pharmaceutical companies remain active in this area.
There is a growing recognition that new approaches to stimulate research and reward innovation, de-linking medicine use and financial reward, are going to be needed if antibacterial R&D is to be stimulated and the resulting medicines conserved.
GSK's long legacy of novel anti-infectives
GSK, and the companies that are part of our heritage, has a legacy in the development of new anti-infectives.
In 1959, scientists at one of our heritage companies (Beecham Pharmaceuticals) discovered the penicillin nucleus, 6-APA (6-aminopenicillanic acid) which ultimately led to the development of a number of new semi-synthetic penicillins.
We remain one of only a handful of pharmaceutical companies continuing the search for new antibiotics and have an active pipeline in this research area.
Commenting on the challenge facing the insustry, Patrick Vallance, President, Pharmaceuticals R&D "This is a challenging research area, and there are unique characteristics for this market, which do not always provide the financial incentives for ongoing research.
"In the long term if society wishes to encourage sustainable investment and appropriate use of new antibiotics, alternative approaches to reward successful innovation need to be considered by all stakeholders."
For more information on GSK's product pipeline and clinical studies, visit these resources:
Information on the innovative public-private collaboration launched by Europe's Innovative Medicines Initiative (IMI) to combat antibiotic resistance can be found here:
- GSK press release on collaboration to tackle antibiotic research - 24 May 2012
- Innovative Medicines Initiative
1. European Centre for Disease Control and Prevention/European Medicines Agency Joint Working Group. The bacterial challenge: time to react. 2009.
2. Roberts RR, Hota B, Ahmad I, et al. Hospital and societal costs of antimicrobial‐resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin Infect Dis 2009; 49:1175–84