Why the antibiotic pipeline is running dry: the solution-small biotech companies.
Since 1998 the US Food and Drug Administration has approved just 13 new antibiotics (and none in 2011-13) and European Medicines Agency (http://www.ema.europa.eu/ema/) has produced no new classes of antibiotics in the past 30 years.
In the same period of time drug-resistant bacteria have spread into the community and healthcare becoming common, and an almost permanent headline in the press. The World Health Organisation stated in 2011 that we are in “a race against time to develop new antibiotics.”
Yet pharmaceutical companies are abandoning attempts to develop new drugs due to cost (it takes on average $5 billion to bring a drug to market) and failure (80% drugs fail efficacy or safety tests). It is a far more profitable to focus on drugs with a guaranteed effectiveness and revenue stream (such a cardiovascular drugs and anti-inflamatories).
Pharma companies worldwide have been closing facilities, or shutting antibiotic research down. To lure companies back into antibiotic research and development, legislations are are finally being implemented (the US: GAIN-Generating Antibiotics Incentive Now in 2012, and in the UK: the Clinical Research Collaboration 2008-15). Encouragingly the Technology Strategy Board is offering money to biotechs and the Longitude Prize (https://longitudeprize.org) was this year awarded to development of rapid, reliable point of care diagnostics to enable more effective use of antimicrobials.
This is decisive action with backing from the UK Prime Minister David Cameron who said: “This is not some distant threat, but something happening right now. If we fail to act, we are looking at an almost unthinkable scenario where antibiotics no longer work and we are cast back into the dark ages of medicine.” However large drug companies need huge annual drug sales to cover their costs. This is where smaller biotech companies come in and many are having success in bringing new antibiotics to market: Astra Zeneca, Cubist, being examples.
The fifth point of The UK Five Year Antimicrobial Resistance Strategy 2013-2018 states (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/244058/20130902_UK_5_year_AMR_strategy.pdf) is that “there is a sustainable supply of new effective antimicrobials”.
Small biotech companies can create the economic model that makes financial sense, they have the scientific drive and with active public and private sector partnerships they can be the solution to providing a sustainable supply of new antibiotics.