FORWARD Act For Antifungals, NTAP Achaogen And Melinta, Novo REPAIR Funding Round

Dear All: I hope your summer is going well! Below, three items of interest. See as well several updates to the future meetings list. 

First,Rep. McCarthy recently introduced the FORWARD (Finding Orphan-disease Remedies with Antifungal Research & Development) Act to the United States House. Seeking to support “endemic orphan fungal disease research, incentivize Valley Fever vaccine development, discover new antifungal therapies and diagnostics, and for other purposes”, this bill:

  1. Encourages DHHS to keep working on Valley Fever (aka, coccidioidomycosis),
  2. Creates a Valley Fever Working Group,
  3. Defines the idea of an Endemic Orphan Fungal Disease,
  4. Encourages DHHS to make grants for endemic orphan fungal diseases,
  5. Directs FDA to issue draft guidance on developing therapeutics for coccidioidomycosis,
  6. Recommends that CARB-X add antifungals to its scope of eligible programs, and
  7. Proposes that biologicals should be eligible for QIDP (Qualified Infectious Diseases Product) status. 

That’s an impressive and exciting list of ideas … I look forward to watching this move forward. 

Second, and really good to see, CMS has assigned an NTAP (New Technology Add-on Payment) value to both Melinta’s Vabomere (meropenem-vaborbactam) and Achaogen’s Zemdri (plazomicin).

  • For those not familiar with it, NTAP status is a way for CMS to partially defray the cost of a new technology before its value can be rolled into the Diagnostic Related Group (DRG) codes that would use the new technology.
  • In the case of these two products, the NTAP program will provide hospitals with a payment, in addition to the standard-of-care DRG reimbursement, of up to 50% of the cost of the drug for a period of two to three years, effective in the 2019 fiscal year starting on October 1, 2018.
  • Zemdri has been assigned a maximum payment of $2,722.50 whereas Vabomere was assigned a maximum of $5,544.00.
  • While these amounts are a lot less than those assigned to some other products (e.g., $22-25k for CAR-T products) and the NTAP mechanism still depends on sales volume and hence is not a Market Entry Reward (MER)this is certainly a welcome step forward in our multi-pronged effort to get adequate reimbursement for the value of new antimicrobial agents.

Finally, I have learned that the Novo Holdings REPAIR Impact Fund is going to have an open proposal round during 4 Sep – 11 Oct for companies located in the U.S. and Canada. The official announcement will come later this month, but those who are interested could look now at the description of the EU-focused round that opened back in April. Sharpen your pencils and get to it!

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/

General notes of interest for the AMR community

  • [NEW] Novo’s Novo Holdings REPAIR Impact Fund will have an open proposal round for companies in the US and Canada during the window 4 Sep – 11 Oct. Details are not yet out but I’d expect the basic rules to be similar to those for the prior EU-focused round. Watch for further news here.
  • [NEW] Ankit Mahadevia (CEO, Spero) was interviewed on 8 Aug by Luke Timmerman on his The Long Run biotech podcast. The hour-long podcastis a good listen that covers career choices, reasons to work on AMR, and other broad perspectives.

Upcoming meetings of interest to the AMR community:

  • 21-22 Aug 2018 (FDA White Oak Campus, Silver Spring, MD): workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections”. Meeting notice is here.
  • 21-22 Aug 2018 (Rockville, MD): NIAID-NINDS-DTRA workshop entitled “Infectious Disease in The CNS and Therapeutic Strategies to Cross the Blood-Brain Barrier”
  • 21-23 Aug 2018 (Cardiff, UK): BSAC Standardized Susceptibility Testing Residential Workshop. Register here.
  • 26-29 Aug 2018 (Atlanta, GA): CDC’s International Conference on Emerging Infectious Diseases (ICEID). Register here.
  • [Don’t miss this one!] 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal). Full program is now posted.
  • 24-28 Sep 2018 (Big Sky, Montana): MSG-ERC (Mycoses Study Group) Biennal meeting
  • 3-7 Oct 2018 (San Francisco): ID Week
  • 6-14 Oct 2018 International Course on Antibiotics and Resistance(ICARe, Les Pensières, Annecy, France) 
  • 26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
  • 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
  • .[NEW] 29-30 Nov 2018 (Birmingham, UK): BSAC (British Society Antimicrobial Chemotherapy): Antibiotic Resistance Mechanisms Workshop for Researchers. Register here.
  • [NEW] 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference. Register here.

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