AMR.Solutions

#AMRSOS: Imipenem-relebactam withdrawn from the US market

Dear All:

Oh, no! Hot on the heels of the excellent talk at GAMRIC by Karen Bush in which the importance of relebactam as one of our most advanced beta-lactamase inhibitors was highlighted, we have this:

2026-09-24 (Recarbio withdrawal)(circled)

Screenshot from drugs.com

Yes, that’s right, Merck have notified the US FDA that imipenem-cilastatin-relebactam (RECARBIO) is being withdrawn from the US market. I can only guess that the logic will be grounded in the realities that were (i) recognized by Cipla when they refused registration of plazomicin in Europe (11 Jul 2020 newsletter; note that plazomicin [ZEMDRI] has also been discontinued in the United States) and (ii) probed in depth by Wells et al. (14 Oct 2024 newsletter):

And it’s especially painful to see this just as the product’s label has recently been expanded to included pediatrics.

So, I think we can now take the summary statements from Wells et al. and modify them slightly:

  1. “Novel antibiotics with narrow approval for small patient populations affected by severe resistant infections usually cannot be successfully commercialized in the current US antibiotic market.
  2. “SMEs Companies of all sizes need incentive payments structured to enable them to survive the commercialization cashflow drought.
  3. “These changes are necessary to restore industry and financial investor confidence in the antibiotic SME development model.”

I’ve focused here on the US market as there’s no evidence that it’s being withdrawn from other markets, but I suppose this could follow. Even a big company can’t spend endlessly on a drug! My rule of thumb (7 Jan 2020 newsletter: “Melinta, Part 2 / Bankruptcy is not the end / Post-approval costs for an antibiotic”) is that a newly approved injectable antibiotic needs $350m over its first 10 years of life:($25m/year for manufacturing and $100m for pharmacovigilance and pediatrics) … and most of those costs go indefinitely thereafter.

Deep sigh. #AMRSOS! Antibiotic variety is needed both at the product and supply chain level. On this, recall the story of the collapse of the the piperacillin-tazobactam supply chain (7 Apr 2025 newsletter, “UNSLAP: You reach for the antibiotic … and it’s not there!”) — any given compound can suddenly be in short supply!

So, it really hurts to lose a product with all of 3 of the major Gram-negative indications (nosocomial pneumonia [HABP-VABP], complicated UTI, and complicated intra-abdominal infection) for adults and for children weighing as little as 2 kg).

It’s high time that we make progress on Pull incentives! We heard at GAMRIC that the EU legislation on transferable exclusivity vouchers (TEVs) is moving along. Good! We’re seeing a continued push for PASTEUR in the United States (17 Sep 2026 newsletter: “Global Review of Pull Incentives / PA STEUR Sign-On Letter.” Good again!

But it can’t be just the US, UK and EU … the entirety of the G20 should be in on this. Antibiotics are indeed the #FireExtinguishersOfMedicine… and let’s be sure we have them for ourselves, our children, and our children’s children!

All best wishes, –jr

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.

John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers, the small meeting format of BEAM’s AMR Conference (March) and GAMRIC (September-October; formerly, the ESCMID-ASM conference series) creates excellent global networking. IDWeek (October) and ECCMID (April) are much larger meetings but also provide opportunities for networking with a substantial, focused audience via their Pipeline sessions. Hope to see you there!

  • 21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026, the annual meeting of the Infectious Diseases Society of America. I would expect the program to continue to provide a substantial opportunity to present a product to a large audience (see also adjacent note about ESCMID) as well as opportunities to present at an IDWeek Pipeline Session. Go here to register.
  • 23-24 Mar 2027 (Basel, Switzerland): The 10th AMR Conference (3-4 Mar 2026) is now over and offered a rich program that included a 10-year retrospective (we’ve done a lot!), regulatory updates, discussions of how to pursue development in China, and much more … in addition to being a superb opportunity for networking! You can review the content on the conference website; the 2027 program should post relatively soon.
  • 9-13 April 2027 (Stockholm, Sweden): ESCMID Global 2027, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Details won’t be out for some months, but the website is here. I do know that the meeting schedule will again include a Science Policy Forum on Friday 9 April 2027 (see here the newsletter about the 2026 science policy forum) and all who are interested in Pull incentives and the antibiotic ecosystem should plan to be there!)..
  • [NEW] 7-9 Sep 2027 (Bangalore, India): The 3nd GAMRIC, the Global AMR Innovators Conference. Formerly the ESCMID-ASM (or ASM-ESCMID depending on location) Joint Conference on Drug Development for AMR, 2027 will be the 12th year for this series that is now under the joint sponsorship of CARB-X, ESCMID, LifeArc,GARDP, BEAM Alliance, Boston University, and AMR.Solutions. The 2026 meeting in Lisbon was superb and included substantial networking time (drinks on the lawn!), a keynote lecture by Karen Bush on the threat to beta-lactams due to the emergence of PBP3 mutations and sessions on program design for phage, development for pediatrics, and more. You can expect similar quality in 2027! Mark your calendar — details to follow in the spring of 2027!

  Upcoming meetings of interest to the AMR community:

  • [NEW] 29 Sep 2026 (9a-4.30p ET, in person [Washington DC] or virtual): Jointly sponsored by FDA and the Duke-Margolis Institute for Health Policy, a workshop entitled “RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations.” This looks like a great discussion … all the major statistical gurus are speaking. Go here for the meeting’s webpage and to register for either virtual or in-person attendance..
  • 29 Sep 2026 (7.30-9.00a ET, virtual): REVIVE (GARDP) webinar entitled “The role of investigator-initiated clinical trials in advancing antimicrobial use.” The title of the webinar is a good description of its contents! Go here to register.
  • 10-18 Oct 2026 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance) … and 2026 will be the 10th year for this program. Patrice Courvalin orchestrates content with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Registration for 2026 is now open and runs through June 21, 2026. Go here to register!
  • 21-24 Oct 2026 (Washington, DC, USA): IDWeek 2026. See list of Top Recurring meetings, above.
  • 10-13 November 2026 (Madrid, Spain): The International Society for Infectious Diseases (ISID) has announced its 21st International Congress on Infectious Diseases (ICID). Regular registration rates for ICID 2026 are available through September 30, 2026. Register and view the preliminary program here.
  • 16-18 Nov 2026 (FAO Headquarters, Viale delle Terme di Caracalla, 00153 Rome, Italy): The 4th Annual Plenary Assembly of the AMR Multi-Stakeholder Partnership Platform, of the Quadripartite organizations (FAO, UNEP, WHO, and WOAH). “Organized ahead of the Fifth High-Level Ministerial Conference on AMR, the Plenary Assembly will bring together MSPP members and observers, partners and external stakeholders from across regions and One Health sectors. The Plenary Assembly will focus on moving from political commitments to practical delivery, with particular attention to supporting countries in implementing their AMR NAPs.” Go here for additional details to register.
  • 27-29 Jan 2027 (Las Vegas, USA): IMARI (Interdisciplinary Meeting on Antimicrobial Resistance and Innovation) sponsored by IDSA and ASM. Abstract submissions are open through 19 Aug; registration and housing will open later this summer.
  • [NEW] 9-11 Feb 2027 (virtual, 1-5p GMT each day): ACC2027 (Antimicrobial Chemotherapy Conference 2027), sponsored by GARDP and BSAC (British Society for Antimicrobial Chemotherapy) in collaboration with EUP OHAMR (European Partnership on One Health Antimicrobial Resistance). This 3-day online conference includes both symposia and poster presentations. Go here for details and to register.
  • 23-24 Mar 2027 (Basel, Switzerland): The 11th AMR Conference sponsored by the BEAM Alliance. See list of Top Recurring meetings, above.
  • 9-13 April 2027 (Stockholm, Sweden): ESCMID Global 2026, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 7-9 Sep 2027 (Bangalore, India): GAMRIC  the Global AMR Innovators Conference. See list of Top Recurring meetings, above..
  • ??? Mar 2028 (yes, that’s 2028, with location TBD): The 2028 Gordon Research Conference (GRC, https://www.grc.org/) entitled “Antibacterials of Tomorrow to Combat the Global Threat of Antimicrobial Resistance” and its related Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers will be sometime in March 2028. The organizers hope to coordinate dates and location with the 2028 BEAM-AMR meeting. Details to follow — mark your calendar!
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Self-paced courses, online training materials, and other reference materials:

Current funding opportunities

  • Novo Nordisk Foundation (NNF) have an EUR 20m call for development of rapid, point-of-care diagnostics. See the 28 May 2026 newsletter for details; the deadline for expressions of interest is 7 Oct 2026.
  • BARDA’s VITAL Hub has an open call for innovative antifungals. Non-dilutive funding of up to $250K is available to startups and university-backed projects working on “first-in-class, broad-spectrum antifungal drug candidates with novel mechanisms of action for the treatment of invasive fungal infections.” Candidates for the treatment of infections caused by Candida species, including Candida auris, and Aspergillus species, as well as rare molds, such as Mucorales are eligible. In-scope technologies include small molecules and peptide-based candidates. Neither vaccines nor antibody-based nor topical treatments will be considered for award under this solicitation (considered out of scope). Applications are due by 30 Oct 2026; go here for additional details.
  • CARB-X have announced their second 2026 funding round. The 4 funding themes are as below. The application window runs 10-23 Nov 2026; see the 2 Sep 2026 newsletter for more details:.
    • Direct-acting therapeutics for infections caused by Gram-negative bacteria
    • Novel Chemistry for AMR Challenge – target-based therapeutics.
    • Non-vaccine approaches to prevent neonatal sepsis
    • Diagnostics for neonatal sepsis
  • The India AMR Co-Development Programme (I-AMR-CDP) is a collaboration between Venus Remedies Limited, the Indian Government, GARDP, ADVANCE-ID that seeks to support antibacterial R&D based in India. I have limited insight into how collaborations would work; you can start with this LinkedIn post to learn more. 
  • ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews. 
  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis 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 an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • 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. See also the 7 Feb 2026 newsletter (“The global funding pipeline, 2017-2023: A review”) about an excellent deep dive by the Hub team into patterns of funding over time.
    • Antimicrobial Resistance Research and Innovation in Australia is an actively updated summary that covers Australia’s AMR research and patent landscape. It is provided via collaboration between The Lens (an ambitious project seeking to discover, analyse, and map global innovation knowledge) and CSIRO (Commonwealth Scientific and Industrial Research Organisation, an Australian Government agency responsible for scientific research). Lots to explore here!
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • 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).
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