Market for Novel Antibiotics

Regulatory policies and economic incentives that encourage antibiotic development are vital.

However, it is also critical to address fundamental gaps in basic scientific research that hold back new drug discovery. Auspherix is bridging this gap through its deep understanding of bacterial lifestyles and working on a non-classical antibacterial chemical scaffold to develop a new class of antibiotics with a particular focus on the treatment of serious Gram-negative bacterial infections.

The end of the ‘antibiotic era’

The continued loss of effective antibiotics will further undermine our ability to fight infectious diseases, including the management of complications common in vulnerable patients such as those receiving chemotherapy treatments for cancer, dialysis for renal failure, and organ transplantation, where the ability to treat opportunistic infections is crucial.

When first-line and second-line antibiotics prove ineffective in patients due to drug-resistant bacteria, clinicians are often left with very limited treatment options and may turn to last-in-line antibiotics such as colistin which has a number of serious side-effects. Even if an effective antibiotic can be identified, it is accepted that patients with serious MDR infections have significantly extended stays in hospital, longer periods of recuperation and an increased risk of permanent disability or death.

Deaths Attributable to AMR Every Year

Diagram source: The review on Antimicrobial Resistance, Chaired by Jim O’Neil. Tackling drug-resistant infections globally: Final report and recommendations. May 2016

“The rise of antimicrobial resistance is a global crisis, recognized as one of the greatest threats to health today. The threat is easy to describe. Antimicrobial resistance is on the rise in every region of the world. We are losing our first-line antibiotics. This makes a broad range of common infections much more difficult to treat. Second- and third-choice antibiotics are more costly, more toxic, need much longer durations of treatment, and may require administration in intensive care units.”

Dr Margaret Chan, Director General, World Health Organization, 18 April, 2016.

Economic incentives and drivers of change

The threat posed by antimicrobial resistance, which is present in every country, is now being tackled on a global scale.

In 2016 a landmark declaration agreeing to combat antimicrobial resistance (AMR) was signed by 193 countries at the United Nations General Assembly. This declaration outlined a coordinated global response that encourages:

Innovation in antibiotic drug development
Increasing public awareness
Developing surveillance on use and sales of antibiotics for humans and animals
Improving regulatory systems to manage sales of antimicrobial medicines

This agreement follows the 2015 World Health Organisation (WHO) Global Action Plan on AMR and the G7 (Berlin) Declaration on AMR.

In the UK, concern about AMR resulted in the government commissioning a report by Lord Jim O’Neill, to analyse the economic and social costs of the problem and propose concrete actions to tackle it internationally. The 2016 report, outlined a 10-point intervention plan, which included specific recommendations to stimulate early-stage research through a global innovation fund and an evolution of the currently unattractive commercial model by rewarding drug developers with market entry rewards for effective new treatments. It is anticipated that incentives such as these will help stimulate future R&D investment in the antibiotic sector.

Summary of 10-point intervention plan:

A massive global public awareness campaign.
Improve hygiene and prevent the spread of infection.
Reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment.
Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals.
Promote new, rapid diagnostics to cut unnecessary use of antibiotics – rapid diagnostics could transform their use.
Promote development and use of vaccines and alternatives.
Improve the numbers, pay and recognition of people working in infectious disease.
Establish a Global Innovation Fund for early-stage and non-commercial research.
Better incentives to promote investment for new drugs and improving existing ones.
Build a global coalition for real action – via the G20.

“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.”

David Cameron, Former UK Prime Minister, 14 July, 2014.

What is happening to stimulate R&D and change the commercial model?

In the US, the Generating Antibiotic Incentives Now (GAIN) Act was passed to incentivize the development of new antibiotics in response to the growing threat of antibiotic resistance and a lack of antibiotic products in drug manufacturers’ pipelines. Under the GAIN Act legislation, companies may apply for QIDP (Qualified Infectious Disease Product) designation which offers fast-track status and priority review with the FDA, plus up to 5 years additional market exclusivity.

Many governments and charitable bodies worldwide are also allocating funds to stimulate research and development into new antibiotics. Two key programmes are:

The US Biomedical Advanced Research & Development Agency (BARDA) Broad Spectrum Antimicrobials programme
The European Innovative Medicines Initiative (IMI) New Drugs For Bad Bugs (ND4BB) programme.

Together these programmes provide direct financial support to nearly 20 percent of all antibiotics currently under development globally.

In 2016, CARB-X was launched as one of the world’s largest public-private partnerships focused on preclinical discovery and development of new antimicrobial products. This initiative intends to donate US$44 million in its first year and up to $350 million over the next five years in grants to small companies developing new antibiotics and diagnostics. The funds for CARB-X come from the US government and a public-private initiative in the United Kingdom and it aims to get at least two new drugs into human trials in the next five years.

Auspherix is a member of the BEAM alliance, a group of Biopharmaceutical companies from Europe innovating in AMR research. The Alliance is working to improve the regulatory, investment, and commercial environments for research, development, approval and market viability of new products combating antimicrobial resistance.