Superbugs loom in antimicrobial innovation gap

Brandon How

Australia’s MedTech and Pharmaceutical industry growth centre MTPConnect is warning antimicrobial resistant ‘superbugs’ could cause 10,000 deaths annually by 2050 if immediate action to correct a research and development market failure isn’t taken by the federal government.

The industry growth centre estimates that antimicrobial resistant pathogens could cost the Australian economy up to $283 billion by 2050 if nothing is done to change the current approach to antimicrobial drug research that has stopped producing enough new antibiotics.

Antimicrobials are a class of drugs designed to fight microorganisms like bacteria and fungi as well as viruses. Currently, around 5,200 Australian deaths annually are associated with antimicrobial resistance.

MTPConnect chief executive and AAMRN co-chair Stuart Dignam says Australia is nearing a “post-antibiotic era”

MTPConnect and the Australian Antimicrobial Resistance Network (AAMRN) have made nine recommendations in a ‘Fighting Superbugs’ report, published on Tuesday, to support local research and mitigate the impacts of market failure.

The report was developed by Canberra-based health advisory firm Evohealth.

Among the recommendations are a call for the introduction of a subscription model for two novel antimicrobials, extending data exclusivity provisions for research into antimicrobials, and reducing regulatory barriers for the approval of novel antimicrobials in Australia.

Pharmaceutical companies view antimicrobial drug development as unprofitable due to low sale volumes.

However, this is not a flaw, antibiotics are “designed for short-term and occasional use. In clinical practice, their use is constrained by [antimicrobial stewardship], with novel antibiotics held in reserve for drug-resistant infections”.

R&D costs are also high as novel antimicrobials generally requires 10 to 15 years of research at a cost of $1.5 billion to $3 billion, according to the report. As such, 15 of the world’s 18 largest pharmaceutical companies have withdrawn from antibiotic R&D.

“For example in the US, after passing FDA approval, the antibiotic must earn US$300 million a year just to break even, however, industry records have shown that few antibiotics make even US$100 million per year,” the report reads.

It has meant no novel class of antibiotics have been brought to market in 35 years despite a global need to develop 15 new antibiotics in the next 10 years to combat antimicrobial resistance, the report argues.

The subscription model proposed by MTPConnect could help mitigate revenue problems for pharmaceutical companies’ antimicrobial research teams. The system would charge a fixed price on an ongoing basis – split between Commonwealth and private healthcare contributions – for use of antibiotics across the healthcare system, regardless of the frequency of use.

Further to this, extending existing data exclusivity provisions in Australia would allow an innovator company to withhold its safety and efficacy data used to seek regulatory approval of a new pharmaceutical product.

“The long lead-times often required to bring a new antibiotic to market (particularly for novel products), means that a patent on its own could be insufficient to recoup the significant cost of R&D,” the report reads.

“Data exclusivity runs parallel to a patent and protects the innovative firm’s investment in clinical trials and data collection, regardless of the length of time required to bring the drug to market.”

It highlights a parliamentary inquiry report produced in 2018, by a committee chaired by formal Liberal backbencher Trent Zimmerman, that called for the extension of the data exclusivity period in Australia from five years to 10.

In a statement, MTPConnect chief executive and AAMRN co-chair Stuart Dignam said “we are running out of effective antibiotics and fast approaching a post-antibiotic era where minor infections, currently easily treated with common antibiotics, may become deadly”.

“The innovation pipeline for new antibiotics is drying-up and just not keeping pace with public health needs,” Mr Dignam said.

“The costs of R&D are too high and the commercial returns are currently too low to justify investment in infectious disease medicine, particularly compared to other therapeutic areas.

“Incentives are clearly required to stimulate investment in new discovery, early clinical trials and, for medicines that show promise, suitable reimbursement pathways.”

Do you know more? Contact James Riley via Email.

Leave a Comment

Related stories