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Antibiotics and Drug Resistance
BioPharm Reports (VennBio Ltd.), Jan 2008, Pages: 174
New drug innovation and the strategy to combat antibiotic resistance mechanisms
This report reviews new drug innovation and strategy to combat antibiotic resistance mechanisms. This embraces current research-stage activities, patents published in the last five years, the entire pharmaceutical development pipeline and today's existing armoury of anti-bacterial drugs. The report reviews 370+ pipeline antibiotics and anti-bacterial technologies (from pre-clinical to Phase III/initial launch), 340+ antibiotic patents published between Jan 2002 and May 2007 and more than 200 fully launched antibiotics. It identifies and discusses new antibiotics, technologies and strategies at the anti-bacterial mechanistic level, that are specifically being developed to combat resistance mechanisms. The opportunities which they potentially offer in tackling the increasing global threat of antibiotic resistance, are discussed.
Overview: This report gives a comprehensive and detailed review of pipeline, emerging and current antibiotics and anti-bacterial technologies and their potential to provide more effective long-term therapies. More than 900 drugs, drug candidates and developmental compounds are identified, discussed and classified on the basis of their mode of action, developmental stage, activities and capabilities and by companies and research groups responsible for taking these activities forward. Moreover, they are considered in terms of their importance and potential to combat resistant pathogens, as part of the global effort to find alternatives to current antibiotics, which have lost or are losing their effectiveness against common and serious pathogens. The report looks in depth at current developments and thinking on how antibiotic resistance can be tackled technically and strategically, from improvements to existing drugs and drug combinations, to novel molecules, new and more promising drug targets and approaches to tackling resistance at its source. More detailed information on this report is given in the printable Report Description, which is linked to this page.
Combating Antibiotic Resistance: This review examines more than 370 pipeline candidates and 340 antibiotic patents, published between Jan 2002 and May 2007. These patents were selected from more than 1800 patents citing “anti-infectives”, published over the same period. Strategies being developed to combat resistance mechanisms include the identification of new selective targets, the selection of targets which may preclude genomic/phenotypic adaptation by bacteria, or where this is considered more difficult, combined activity molecules, molecules which inhibit stress-induced mutational emergence of resistance genes in response to synthetic antibiotics, novel antibacterial technologies, new targeting strategies and synthetic or semi-synthetic approaches vs. drugs of natural origin. Other areas reviewed include virulence targeting, the dissemination of adaptable traits, predicting resistance and the developing importance of pathogenomics.
Global Surveillance and Costs: This report gives detailed recently published figures on antibiotic resistance, from more than 35 countries. These data were obtained from the European Antimicrobial Resistance Surveillance System (EARSS) in Europe, by the Health Protection Agency in the UK, by the Active Bacterial Core surveillance (ABCs) Project in the US, by China's National Center for Antimicrobial Resistance and other sources. These data show increasing levels of antibiotic resistance globally and the report lists them by pathogen and antibiotic. Whilst definitive statistics are not available, there is a strong link between antibiotic resistant pathogens and levels of hospital-acquired infections. In the US it is reported that 50–60% of all hospital-acquired infections are caused by antibiotic resistant bacteria, whilst some experts suggest that the vast majority of nosocomial infections are due to resistant pathogens. The costs associated with these infections therefore provide an important measure of the failure of current antibiotics. According to the US Centers for Disease Control and Prevention (CDC, 2002), 1.7 million patients per year in the US acquire an infection whilst in hospital, resulting in 99,000 (5.8%) deaths. Recent figures from the US indicate that costs associated with these infections in the US at $6.7 billion and are around $1.7 billion in the UK. This report estimates that hospital-acquired infections in the developed world costs more than $32.5 billion, higher than current global sales on antibiotics. Others estimate that outpatient costs due to antibiotic resistance in the US lie between $400 million and $18.6 billion and inpatient costs several times higher. It is estimated in this report that hospital-acquired infection levels in the developed world could be higher than 7 million and deaths could exceed 400,000. Given the rapid rise of bacterial resistance in China, with a population of 1.3 billion (where resistance levels are reported to be growing faster than in any other country) and in Asia as a whole (total population 3.7 billion), these figures are likely to be significantly higher.
Questions Answered 1) What strategies, drug molecules and technologies are being developed specifically to combat antibiotic resistance and where are they positioned in the development programme (from research, pre-clinical to Phase III/initial launch through to present day fully launched) 2) Which technologies at the anti-bacterial mechanistic level offer the greatest hope of success 3) Which companies and research groups are developing new drugs and technologies to fight antibiotic resistance 4) What is the current full-listing of pipeline, patent (research) stage and fully launched anti-bacterials 5) What are the current official global resistance antibiotic resistance levels and trends 6) What are the costs of antibiotic resistance financially and in human terms, and how will this drive new drug development
Examples of Key Findings:
- Antibiotic Resistance: The need for drugs that combat or circumvent antibiotic resistance mechanisms is now pivotal to the development of new anti-bacterial agents. The nature of bacterial resistance mechanisms means that the activities of new anti-bacterials at the bactericidal mechanistic level is a fundamental consideration and new drugs must target bacterial pathogens in new ways, compared with many long-established antibiotics. A new drug discovery era is emerging, based on the development of agents that directly combat or circumvent antibiotic resistance mechanisms.
- Current Antibiotics: Four antibiotic classes (ß lactams, quinolones, aminoglycosides and macrolides), against which there is rapidly developing resistance, represent almost three-quarters of all currently available drugs. Whilst these remain important first-line antibiotics and others such as Vancomycin and more recently Zyvox (Pfizer), Tigecycline (Wyeth) and Daptomycin (Cubist) are important in the treatment of some difficult infections, resistance is developing against these agents too. Today’s armoury of antibiotics is substantially reliant on antibiotics that have been used for many years and there is increasing dependency on a small number of drugs, some of which have only recently entered the market.
- Development Pipeline: Currently there are around 370 anti-bacterials in the development pipeline, around 60% of which are at the pre-clinical stage. Whilst a number of promising developmental compounds are in late-stage development such as Pfizer’s Ramoplanin and GSK’s Retapamulin, around three quarters of late stage candidates are based on or closely related to existing fully launched drugs. Of the 315 candidate anti-bacterials at the pre-clinical to Phase II stages, around 40% are closely related to established classes of anti-bacterials. In contrast, 60% of pre-clinical to Phase II candidates can be categorised as novel or recently developed. The current development pipeline shows substantial reliance on anti-bacterial classes that are similar to those already in use and against which resistance is continuing to rise, and a high proportion of novel candidates are still at the pre-clinical stage.
- Targeting Resistance Mechanisms: Many new approaches are being developed to directly target bacterial resistance mechanisms. These include new target identification, the identification of targets which may preclude or circumvent genomic/phenotypic adaptation by bacteria or where this is considered more difficult, unique combined-activity molecules, inhibitors of the mutational emergence of resistance genes in response to synthetic antibiotics, novel anti-bacterial technologies, new targeting strategies and synthetic or semi-synthetic approaches vs. drugs of natural origin. Other areas include virulence targeting and novel technologies.
- Research and Patents: Analysis of global patent filings for the period Jan 2002 to May 2007, shows that more than 1800 documents citing the terms “antibiotic” or “anti-bacterial” were published during this period, under IPC Class coding A61K. Of these, 340 were selected for further examination in this report and show important areas of innovation relating to the combating of antibiotic resistance.
- Global Surveillance: Surveillance data from more than 35 countries show that antibiotic resistance levels continue to rise globally. In the US it is reported that between 50–60% of all hospital-acquired infections are caused by antibiotic resistant bacteria, however some experts believe that the vast majority of hospital-acquired infections are the result of drug resistant pathogens.
- Deaths from hospital-acquired infections in the US were 13,300 in 1992, compared with around 100,000 today. This shows around a 700% increase over the following decade, equivalent to around a 20% annual growth during that time. This report estimates that healthcare costs due to hospital-acquired infections in the developed world, exceed $30 billion.
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