The need for new anti-infective drugs – a global imperative
Infections caused by Antibiotic Resistant (AR) strains of bacteria continue to rise at an alarming rate. They pose a threat to humanity.
Antibiotics represent the foundation for all modern medicine. However, this has been taken for granted and now we find that bacteria have become resistant to almost every antibiotic developed by man and the vast majority of bacterial infections are now caused by AR strains. These AR bacteria, dubbed by the media as ‘Superbugs’, are harder to treat, cause greater mortality, and additional cost to the healthcare system.
Unless action is taken to address this huge global issue, the Independent Review on antimicrobial resistance (Lord O’Neill) estimates that it will cost the world an additional 10 million lives a year by 2050, more than the number of people currently dying from cancer annually. It will also have a cumulative cost of $100 trillion, more than one and a half times annual world GDP today.
New antibiotics will ‘buy time’, however perhaps more importantly we need to adopt strategies that may reduce the emergence of AR strains. At Destiny Pharma, one such strategy is being developed in the form of a new group of antibacterial drugs ‘the XF Drug platform’, who’s novel, ultra-rapid mechanism endows them with the extraordinary ability to reduce the chance of bacteria becoming resistant to their action.
Government/health agency support
Many initiatives to spur the development and approval of new antibiotics/antibacterial drugs are under consideration. The US government is particularly active in this area. Key initiatives in recent years are set out below:
January 2019 5 Year AMR Plan
The UK Government announced its 20-year vision and second five‑year action plan on AMR which outlines how the government will contribute to the global effort against AMR through optimising use of antimicrobials and investing in innovation, supply and access.
Davos announcement, February 2018
$1 billion rewards proposed at Davos 2018 for new antibiotics: the study, titled “Revitalizing the Antibiotic Pipeline: Stimulating Innovation while Driving Sustainable Use and Global Access”, was produced by an international group made up of 23 partners from big pharma, academic institutions and public health organisations. The complementary measures laid out in the study cover 30 incentives on how to drive antibiotic innovation.
G20 Declaration, May 2017
Recognised the importance of reactivating the R&D pipeline through incentive mechanisms that avoid the reliance on high price/volume combinations and the need to promote prudent and responsible use of antimicrobials. In the Hangzhou G20 Leaders’ Communiqué, G20 leaders called on the WHO, FAO, OIE and OECD to collectively report back in 2017.
21st Century Cures Act, December 2016 (US)
Instructs the FDA to enable approval of QIDPs in Limited Patient Populations which will allow more efficient clinical trial design and greater ease of drug approval for a limited label population.
United Nations, September 2016
The UN recognises the threat from AMR and the UN General Assembly has, for only the fourth time in its history, published a directive on a healthcare issue, requesting UN, WHO, FAO, OIE and OECD to report on actions to address this global threat in 2018.
Independent Review on Antimicrobial Resistance, May 2016
Predicts ten million deaths and $100 trillion cost of AMR globally by 2050 if not addressed. Recommends global fund to drive R&D and $1 billion market entry rewards for new drugs.
US President’s 2016 Budget, January 2015
$1.2 billion proposed to specifically tackle antibiotic resistance; a doubling of the budget.
Generating Antibiotic Incentives Now (GAIN) Act, 2012 (US)
Qualifying Infectious Disease Products (“QIDPs”), rapid review by FDA and five years of additional US market exclusivity.
“Preventing infections is essential and our new plan has a strong focus on infection prevention and control.”
Tackling AMR 2019-2024
UK Action Plan
“Unless action is taken the O’Neill report estimates AMR will cost the world an additional ten million lives a year by 2050, more than the number of people currently dying from cancer each year.”
The Review on Antimicrobial Resistance
Chaired by Lord Jim O’Neill