Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter),
We’ve written before about the UK’s “Netflix” pilot antibiotic Pull incentive in which England leads the way on showing how it plans to provide its fair share of a global antibacterial Pull incentive (for background on Pull incentives, see this superb 5-minute video explainer).
In an exciting update, NICE has now published the draft guidance for the first two pilot drugs: cefiderocol and ceftazidime-avibactam! Both documents are well worth your time to download and read. In addition, NICE have published this commentary and there’s a also good summary posted by FT.
You may remember that these two drugs were chosen competitively to receive subscriptions of up to £10M each every year for up to 10 years, pending the outcome of economic assessments and a Committee review calculating the societal value of these fire extinguishers of medicine using the STEDI principles (Spectrum, Transmission, Enablement, Diversity, Insurance; for a refresher on STEDI, see this newsletter or this YouTube explainer).
The initial numbers are now in and while there remains work to do, it’s also a moment to celebrate: We don’t (yet) have a specific $/£ value but NICE has stated each drug has a QALY-based value to the NHS in England: for ceftazidime-avibactam it is 530 QALYs/year x 10 years; for cefiderocol, the value is 970 QALYs/year x 10 years. As NICE typically uses £20,000 and £30,000 per QALY as a threshold for the idea of good value (that is, things that cost more than this per QALY are too expensive), a simple scaling of these QALYs/year x £20k/QALY = £11-19M/year. We can see that contract negotiations need to be completed to determine the actual £ figure for each drug (and the actual award will be limited by the £10m/year cap in the pilot program), but it’s evident that the math shows that major new antibiotics have a real social value that can be estimated and should be rewarded!
Pop a cork and raise a glass: we are witnessing the successful maiden voyage of the first antibacterial pull incentive! When the rest of the G7 and (at least some of the) G20 follow suit to bring the global Pull reward into the target range of ~$3b for a substantial new antibiotic, we will have a sustainable solution. Thank you to the entire Team UK! This is what leadership looks like! Woot, woot!
Note that the economists quite didn’t have all of the data they wanted to calculate some of the STEDI values of antibiotics, so the UK government committee for the project stepped up and made some reasonable estimates. This was precisely the sort of courage needed in the face of some uncertainty, and shines a light on the need to continue to improve both data and methods.
And, that’s why we run Pilot projects: to work out the kinks and to prepare the way to do better next time. Who wants to go next? The PASTEUR ACT in the US is poised to happen in 2022 … as an early sign, the 2023 US budget recently proposed by the White House includes a proposal that “… would provide annual payments from a contract valued between $750 million and $3 billion to the developers of newly approved antimicrobial drugs” — this is, of course, exactly the PASTEUR concept! With Canada, Europe, and Japan also taking steps, we are seeing the momentum build.
it’s just stunning to contemplate how far we’ve come since the 17 Sep 2009 conference hosted by Sweden on Innovative Incentives for Effective Antibacterials. IDSA had sounded the Bad Bugs, No Drugs call in 2004, but there was really zero momentum on global solutions until the meeting in 2009 triggered a cascading series of actions by multiple stakeholders: New Drugs for Bad Bugs (ND4BB)! CARB-X! DRIVE-AB! UK AMR Review! Novo REPAIR Impact Fund! GARDP! The Global AMR R&D Hub! The IACG on AMR! The $1b AMR Action Fund!
And now we see the creation of the first true Pull incentive that would make it possible for new #FireExtinguishersOfMedicine to reach registration, stay on the market, and be available to the many who will desperately need them! As stated in the NICE commentary: “The NHS will now use its commercial power to secure deals that will enable NHS patients to benefit from these treatments, delivering on its Long Term Plan commitment and paving the way for a pipeline of future treatment options.”
Our world is beset with many vexing problems; the broken economics of antibiotics is a problem we can truly start to fix in 2022.
We’ll say it again: Woot, woot! WELL DONE, TEAM UK!
All best wishes, Kevin and John
Kevin Outterson, JD, Professor of Law, Boston University & Executive Director, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders) @koutterson
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.
Current funding opportunities (most current list is here):
- JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for details.
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
- INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
- CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).
Upcoming meetings of interest to the AMR community (most current list is here):
- 8 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
- The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS!
- 23-26 Apr 2022 (Lisbon): 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). Go here for details.
- 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
- 16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
- 11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
- 24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
- 28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details.
- 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
- [NEW] 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
- 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
- 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for more: https://www.icarecourse.org/
- 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
- 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
- 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.