US GAIN act welcomed but more needed to make antibiotics attractive for business – says Norwich Research Park Scientist

As the US senate votes in favour of the GAIN (Generating Antibiotic Incentives Now) act, Norwich Research Park scientist Professor David Livermore warns that despite the desperate need for new antibiotics there are still three major challenges to overcome in order to get them to market – discovery, regulation and profitability.

The introduction of new antibiotics has slowed down. Between 1950 and 1960, 8 classes of antibiotic were introduced for human use, in the last 40 years there have been just 5.

David Livermore, Professor in Medical Microbiology at the University of East Anglia and Lead on Antibiotic Resistance at the Health Protection Agency explains why:

“Although there is worldwide recognition of the need for new approaches to antibiotic developments it is not a currently a desirable business opportunity. The science is complex and more must be done to simplify the regulatory route to market,” he says.

The big conundrum is that only big pharmaceutical companies have the resources needed to negotiate the minefield of regulation, but this field of medicine is too fragmented to be attractive to them, as Professor Livermore explains:

“The focus of current research is to develop specific, closely targeted antibiotics so by definition the markets are relatively small. Additionally, if successful, the patient will only take the treatment for a few days. This makes antibiotics less attractive to big pharma than the development of drugs that will prolong the quality of life.

“These niche markets would be desirable for smaller biotechnology companies however the clinical trials regulations are structured around the need for large samples of patients with similar pathology profiles. Obtaining these patients is extremely difficult and makes the trials prohibitively expensive.

“Anecdotal evidence suggests that the regulators are also unsure about how to structure the protocols for these types of early stage trials. This is creating uncertainty in the industry and damages prospects for investment.”

The GAIN act aimed to overcome some of these issues by making the development of antibiotics more attractive by extending the length of time the approved drug is free from competition and clarifying the regulatory pathway for new antibodies.

However Professor Livermore believes that the GAIN does not go far enough.

“New antibiotics are difficult to find and this is only part of the challenge. The antibiotics need to reach the right body site, penetrate the bacteria and then work on the target. This requires a freedom in the developmental pathways and the licenses are currently too restrictive.”

Professor Livermore is hosting a symposium of fellow researchers across the Norwich Research Park to look at the new approaches being developed and also the regulatory and investment challenges faced by business.

Guest speakers are to include: Professor Robert E.W. Hancock, Department of Microbiology and Immunology, University of British Columbia and Richard Bax, Senior Partner at TranScript Partners who has successfully taken 13 antibiotics to market.

The Norwich Research Park is uniquely placed to support rapid development of antibiotics, located on the park is the: Norwich and Norfolk Hospital with its clinical trials facility; the Genome Analysis Centre offering whole genome sequencing, the Institute for Food Research with its specialists in gut flora and the John Innes Centre and University of East Anglia with their microbial specialists. The Norwich BioIncubator is home to several businesses with interests in this area including Procarta and London Pharma and there is follow-on space available in the Innovation Centre.

The Norwich Research Park was recently awarded £23m to develop a ‘next generation science and innovation park’ and there is a range of business support facilities available.

The symposium is aimed at an internal audience but expressions of interest are encouraged and these should be directed at Dr Matthew Hill.

Written by Nina Beadle

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