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European Biopharmaceutical Review
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| Over the last 25 years, the development of new antibiotics has decreased alarmingly
(1). The cost of developing any new drug is generally in excess of US$500 million,
and it usually takes eight to 10 years from identifying a potential drug candidate to
the time it is launched into the market (2). In addition to this, many countries have
implemented increased regulation of antibiotic usage, and there has been a
tightening of requirements to obtain regulatory approval of drugs (1). It is not
surprising, therefore, that many pharmaceutical companies consider antibiotic
research to be of lower financial attractiveness compared with that for other
chronic indications (such as depression or heart disease, for example).
However, the emergence and spread of
antibiotic-resistant bacterial pathogens has
continued to increase substantially over
the same period of time. For example:
- Methicillin-resistant Staphylococcus
aureus (MRSA) rates now range from
25 to 50 per cent in most of the
Americas, Australia and some southern
European countries (3)
- Vancomycin-resistant enterococci
(VRE) have emerged as one of the
most common antibiotic-resistant
nosocomial pathogens in American
healthcare institutions (4) and continue
to spread throughout hospitals in
Europe (5)
- Worryingly, vancomycin-resistant
staphylococci have emerged (6)
- Escherichia coli susceptibility to
aminopenicillins, third generation
cephalosporins, fluoroquinolones and
aminoglycosides is diminishing
- Klebsiella pneumoniae show high
levels of resistance to third generation
cephalosporins, fluoroquinolones and
aminoglycosides
- Almost 20 per cent of invasive
Pseudomonas aeruginosa isolates
have become resistant to three or
more antibiotics (5)
To summarise, antimicrobial resistance
is becoming more and more of a public
health problem each year, and the growing
threat of antibiotic resistance continues to
drive the need for new antibiotic
development. But, despite this, the
pharmaceutical industry is under
considerable financial pressure and many
companies believe that they need to
become larger if they are to survive and
to afford the research needed to license
a drug (1). |
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