Alan Carr’s Sep 2019 Antibacterial-Antifungal Update; Pews’ updated pipeline review

Dear All,

First, Alan Carr’s Sep 2019 Antibiotic and Antifungal Update (link) is, as usual, required reading (see also this prior blog). Key highlights:

  • He provides an updated by-month sales report from Jan 2016 through Jul 2019 of all products approved since 2009. Sadly, it remains the case that only 4 drugs have sold more than $100m in the 12 months ending Jul 2019 and the maximum for these products is $143m (ceftaroline).
  • Approvals of Recarbrio (imipenem-relebactam) and Xenleta (lefamulin) are reviewed
  • He predicts that the FY2020 CMS Final Rule (go here for details) will reduce some of the financial pressure on hospitals but will not strongly influence sales. I see his point but would add my personal guess that the new severity codes will encourage greater use of diagnostics and (I hope!) increase use of the right drug.
  • Finally, he provides a fascinating analysis of the DISARM legislation introduced this summer.
    • In brief, DISARM would build on the FY2020 CMS FInal Rule by establishing a DRG carve-out for QIDP-designated drugs.
    • Alan analyzes DISARM’s potential impact on the inpatient market by modeling the possibility of physicians using QIDP-designated drugs to replace 50-100% of the use of some older agents.
      • For clarity, note that DRGs apply only to the inpatient setting and hence DISARM will only have an impact on the inpatient market.
    • Importantly, his definition of the older drugs that would be replaced is subtle: he correctly notes that (for example) use of vancomycin is not going to be shifted.
      • Rather the shift to newer drugs would occur in the subset of patients already receiving a more recent (but non-QIDP) drug such as linezolid.
    • Run out over the 10-year period 2020-2029, the net is an incremental growth in market value for QIDP-designated drugs of $8.1b if there is a 50% shift from older to newer drugs. You can of course get higher or lower numbers by varying that % uptake, but I think 50% is a good guess.
    • Translation: If spread out over (say) 10 QIDP-designated drugs, the additional $8.1b in total 10-year sales results in incremental sales of $800m/drug. Again, that’s the total increment over 10 years for each drug.

Overall, this strikes me as a very fair step towards (in aggregate) reimbursing innovators for the $1.3-$1.5b required to bring any given new drug to market and then keep it on the market for 10 years ($1b to get to approval, $0.3-0.5m for post-approval work (e.g., pediatrics), supply chain, pharmacovigilance, surveillance for resistance, etc.)

Relatedly, Pew Trusts have released an updated pipeline analyses for small molecules (link, 42 in development) and non-traditionals (link, 26 in development). Useful related links/documents are:

  • Pew’s animated pipeline for 2014-2018 (link). Watch the molecules move forward and backward!
  • Pew’s 2-page infographic entitled “The Critical Need for New Antibiotics” (link)
  • Two recent in-depth and complementary papers on non-traditional antibiotics (Theuretzbacher and Piddock in Cell Host & Microbe; Rex et al. in Nature Communications; more details on both at this link)

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

  • 10 Sep 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Models for antimicrobial R&D: Advanced and complex in vivo models for infectious disease research.” Go here to register.
  • 3 Oct 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Natural product antibiotics: from traditional screening to novel discovery approaches.” Go here to register.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • 7 Nov 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Converting Gram-positive-only compounds into broad-spectrum antibiotics.” Go here to register.
  • 8 Nov 2019 (London): Launch of “Reviewing Antimicrobial Resistance: Where Are We Now and What Needs to Be Done?”, a follow-up to the UK AMR Review‘s report and recommendations. Go here to register. 
  • 19 Nov 2019 (London): BSAC seminar entitled “Into clinical practice: Meeting the challenges of Gram-negative infection management”. A one-day conference on treatments for Gram-negative infections. Go here for details.
  • 28-29 Nov 2019 (Birmingham, UK): BSAC workshop entitled “ARM (Antibiotic Resistance & Mechanisms)”. This meeting is a research forum for UK-based researchers at all levels, including PhD students and technicians. Go here for details.
  • 16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
  • 21 Jan 2020 (London): BSAC’s 2nd Antimicrobial Chemotherapy Conference – An ABC for everyone involved in developing new antimicrobials. Go here for details.
  • 20 Feb 2020 (London, UK): Westminster Health Forum conference entitled “Antimicrobial resistance – coordinating a global response and progress on the UK strategy.” Go here for details.
  • [NEW] 26-27 Feb 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
  • 12-13 Mar 2020 (Berlin?): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)
  • [NEW] 1-4 Sep 2020 (Dublin): Annual ASM-ESCMID Conference on Antibiotic Development #5! Mark your calendar now, details to follow.
  • [NEW] 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.

Share

Impact of PASTEUR: 9.9m lives saved, ROI of 125:1

Impact of PASTEUR: 9.9m lives saved, ROI of 125:1 Dear All (and with thanks to Kevin Outterson for being lead author on this newsletter), (wonkish alert on this one … refresh your coffee and dig in!) The Center for Global Development have released a blog post and a paper estimating the potential impact of the PASTEUR Act.

Five FDA RFPs! Antifungal animal models, MIC breakpoints, and more!

Dear All, I just today learned that FDA have posted their FY 2023 funding opportunities. All the details are on this webpage and I’m just going to reproduce the text below my signature for your reference. I’ll also add a few details in italics. Lots of good opportunities here! –jr John H. Rex, MD |

WAAW! Must-Read Article, A Quiz, A Video, A Call to Action

Notes: Newsflash … BARDA have opened their long-running BAA-18-100-SOL-00003 to include support for antifungal agents. Search for “antifungal” in the posted .pdf to find the text. The first deadline for proposals is 15 Dec 2022 and further deadlines will doubtless follow: as shown on page 9, this BAA has offered 4 deadlines/year since 2018!  Dear All, In

Fireside Chat with AMR Action Fund CIO Martin Heidecker

Dear All, Ahead of World Antimicrobial Awareness Week, I sat down with AMR Action Fund Chief Investment Officer Martin Heidecker for a Fireside Chat. It was a fabulous conversation that covered everything from how the Fund’s investment process works to what it’s looking for in portfolio companies to broader investment trends in the AMR space.  As

Scroll to Top