New antibiotics are not being registered or sold in Europe in a timely manner

Dear All (and with thanks to Kevin for leading the charge on this newsletter),

While listening to last week’s BEAM-sponsored AMR Conference (really a wonderful conference, thank you Team BEAM, go here to listen to the sessions), we tumbled onto a really, really disturbing trend: New antibiotics are not being registered or sold in Europe in a timely manner!

All the clues were available but we didn’t put them together until we were preparing our comments on the EMA Network Strategy to 2025 (link to a newsletter, link to the comments we submitted). We thought this new insight was worth sharing with the broader community: hence this newsletter. 

In brief, due to the economic issues discussed in other newsletters, the small companies bringing many new antibiotics to market are struggling to survive (go here for one company’s tale of woe, here for Maryn McKenna’s superb article on the financial paradox of antibiotics in Nature, and here for a further series of recent articles and webcasts on this problem).

Adding insult to injury, new drugs are not coming to Europe in a timely manner. Omadacycline (link to withdrawal notice) and plazomicin (link to newsletter, link to withdrawal notice) received positive opinions but have withdrawn their applications, lefamulin was approved but awaits a commercial partner to launch (link to recent SEC filing), and eravacycline has not been commercially launched in Europe to the best of our knowledge despite being approved in 2018. Quite rationally, companies are using their limited resources to reach the US market but then going slowly (or not at all) outside the US.

A full root cause analysis is needed, but we can note a few hints.

For lefamulin, and as noted above, a commercial partner needs to be found (same link as above).

For plazomicin, a key driver appears to be the that the cost of EU-required pediatric trials exceeded any plausible estimate of sales in Europe, leading to the company to withdraw from the process (see this detailed newsletter).

For eravacycline, the issue seems likely to be the overall financial woes of this company: after discussions with several suitors, the company was sold in June to La Jolla Pharmaceutical Company (link to press release). During the sales process, this online commentary on a potential transaction with AcelRx (link) provides this disheartening perspective: “As it stands, the antibiotic market is cursed — it harbors the stink of multiple bankruptcies, a dearth of innovation and is consequently barely whetting the voracious appetites of Big Pharma or venture capitalists.”

Finally, for omadacycline the notice on the EMA website suggests that the issue was that having only one of the two FDA-approved indications drove commercial value to zero in Europe. Here is the key text from the company’s letter (same link as above to EMA’s webpage about the withdrawal; also the link to the letter itself; NUZYRA is the tradename for omadacycline):

“The withdrawal decision was taken for strategic business reasons. This decision is mainly due to the inability of Paratek to secure a partner to support the commercialization of NUZYRA in Europe with only the ABSSSI indication. The insistence for a second CAP study to support approval for this indication in EU has significantly changed the value proposition for NUZYRA in EU and thus all partner discussions have now been discontinued. The inability to find a way forward for this indication will now delay approval for CAP and availability of NUZYRA to patients in Europe by almost 5 years.”

To fully decode this, you need to know that Paratek conducted two studies in ABSSSI (acute skin infection) and one in CABP (community-acquired bacterial pneumonia). FDA approved omadacycline for both indications based on this combination of 3 pivotal studies, whereas EMA only approved it for ABSSSI. FDA also wants a second CABP study but made this a post-marketing commitment rather than requiring it for approval (link to FDA’s approval letter). It appears that Paratek’s funding agreement with BARDA will support that study (link to press release) as well as all other post-marketing requirements.

Incredible! That’s 4 FDA-approved antibacterial (two of which are oral: lefamulin and omadacycline) that will not reach the European market in a timely fashion. Wow! 

If anyone needs further proof that now is the time to act, here it is. With average costs to initial registration of $1.3b (link), a startling five of the last fifteen new antibiotics approved by the FDA in the past decade have gone through bankruptcy or near-zero valuations in the past two years (link)! We really, really need to take action promptly.

The recently announced AMR Action Fund will help agents advance to registration (link), but the G20 nations all need to step up! As was discussed in a newsletter about the launch, it would be great to see the rest of the G20 follow the example of the UK (link) and contribute their fair share to an aligned global approach to a predictable Pull incentive in the range of $1-4b depending on the properties of the antibiotic (link to a newsletter on value). 

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: All opinions are my own.

Current funding opportunities:

  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.

Upcoming meetings of interest to the AMR community:

  • (it’s over now, but you can still watch it!) 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference. Go here to access the recorded sessions. This was a very, very good meeting! In particular, please note these two sessions from the final day … both are free on YouTube:
    • “Spotlight on UK | The Investor Action on AMR” (link). Chaired by Louise Norton-Smith (Head of Global AMR Strategy & Delivery, UK Dept of Health) with a key note by Dame Sally Davies (UK Special Envoy on AMR) in which we learn why we should #SaveTheLobster (see notes in this newsletter).
    • “The future of AMR – How a new post COVID19 policy roadmap could look like” (link). Chaired by Marc Gitzinger (CEO BioVersys and VP of BEAM Alliance, the core sponsor of the AMR Conference), this session has speakers from the Government of India (Renu Swarup), the UK (Dame Sally), FIND (a global non-profit focused on diagnostics), EU Parliament (Tiemo Woelken, MEP), and the US (Evan Loh, CEO Paratek and Chair of the Antimicrobial Working Group).
  • September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • 10 Sep 2020 (online, 7-8.30a EST, noon-1.30p UK): Pfizer-sponsored global roundtable chaired by Dame Sally Davies entitled “The global antimicrobial crisis: Rethinking how we secure and value antibiotics for the future.” This was supposed to be a symposium at ECCMID 2020, but now it’s a webinar. Register here.
  • 24 Sep (online, 9-10.30a EST): “The global movement of microorganisms:  Tracking the spread of difficult-to-treat infections”, from a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality:  How COVID-19 foretells a world without antibiotics”. No registration link yet … watch for it in future newsletters or on meetings page of (link). For now, just mark your calendar. Really unfortunate overlap with the next meeting, but both are being recorded … you’ll have to pick one to attend live and the other for replay!
  • 24 Sep 2020 (online, 15.30-17.30 CEST; 9.30-11.30a EST; 7-9p IST): Antibiotic Bootcamp Series webinar entitled “Moving from preclinical to clinical-stage: Challenges and opportunities.” Moderated by Erin Duffy (CARB-X), this webinar is jointly sponsored by GARDP, CARB-X, Novo REPAIR, JPIAMR, Wellcome Trust, ASM, and ESCMID. Since we can’t the ASM-ESCMID meeting, we’re still going to have the bootcamps! Go here to register.
  • [NEW] 24 Sep 2020 (online, 17.15-18.15 CEST): ECCVID (ESCMID Conference on Coronavirus Disease) includes an AMR-focused symposium entitled “Antimicrobial resistance and COVID-19: learning policy lessons from one another” featuring Christine Ardal (Norway), Chantal Morel (Switzerland), and Kevin Outterson (US). You have to dig a bit in the online program to find this one, but it’s there! Go here to register.
  • 30 Sep 2020 (online, 2pm BST): Longitude Prize Sprint Workshop 2 entitled “Building Medtech Companies: Learn how to attract investment to fund product development and scale your company.” Details and registration are here.
  • 2 Oct 2020 (online meeting): 7th annual Boston Area Antimicrobial Research Network (BAARN) meeting. Go here for details.
  • 21-25 Oct 2020 (online meeting), IDWeek 2020. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27 Oct 2020 (online meeting), BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
  • 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
  • 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
  • 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
  • 6-11 Mar 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.


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