Ciara Kennedy: I think that you have to be realistic, and I think that the discussion of transferrable exclusivity is a great concept. I just don’t know that it has the legs to get there from a political standpoint – or a $2bn to $4bn market reward for bringing a product to approval. But [pull incentives don't] have to be that grandiose. It could be a five-year, company-government stockpiling program where the government assures that they’re going to buy $150m worth of the drug for the first three or four years – that would bridge the gap. And then that drug can be used for [the Department of Veterans Affairs (VA)] or for whatever purposes.

I think that there are solutions that aren’t so irrational and that could work, and there’s precedence for those types of programs. I think that something kind of like that would give certainty.

There are enough risks in drug development. What we don’t need is [risk] that we can actually sell the product if we get it across the finish line. So any sort of elimination of some of that risk, I think, would go a long way to bolstering this whole space.

Larsen: That’s pretty close to what we’re articulating, which is really something to take the uncertainty out of the launch, [such as] getting that first five years covered so that you know you’re going to get some return on investment.

You’re not talking about $1bn; you’re in the range of, in my mind, $300m to $500m, depending on the product. If I gave a company $400m when the last two-year sales of the last six antibiotics was $30m to $80m, I’m more than four-to-five-fold increasing that revenue, and that’s going to be pretty decent, I think.

Kennedy: That’s huge. The other challenge with late-stage development in the face of this broken commercial picture is the investment required to get a drug approved from the [chemistry, manufacturing and controls (CMC)] perspective – the amount of drug you have to manufacture, the registration and validation batches that you have to show to FDA [to prove] that you can make oodles of this drug, and then it sits there … it’s soul destroying.

I think that there are probably still some additional gives, if you’d like, on the regulatory side that could help get more product to the finish line that match up with the likely commercial picture that would also help, but we just need to figure out a way to reduce uncertainty.

Ted Schroeder: We’re kind of a poster child for that. We have an antibiotic that’s sold broadly in Western Europe – regulatory authorities have reviewed it; they’ve done all this stuff. Our biggest challenge is really on the manufacturing side.

To your point; they are not really having problems in Europe with the product the way they produce it and release it, but the FDA requirement is so much different that it requires a complete set of reinvestment and reboot of that, and it delays …

Larsen: … entry in health care.

Schroeder: Yeah. It delays getting the product to market, and that’s expensive. There’s probably a pragmatic approach or some middle ground there.

I think there needs to be some recognition that not every manufacturer and every market in the world is the same. When you’re in Western Europe you have a robust regulatory authority. There are other countries of the world where that regulatory authority isn’t as robust. And I’m perfectly fine with saying, if you’re going to manufacture that in those areas, then you know what you’re buying into, and so you have a different standard. But if you’re doing it in areas where we have the same concept and there’s a different philosophy of how you release product ...

In a lot of these instances there’s not a right and a wrong; it’s just a different philosophy of what’s right and wrong or what’s acceptable and what’s not acceptable. I think harmonization is tough, because that’ll take years, but I think [there should be] some pragmatic view [that] these things are critical to get here now. Let’s figure out how to do it. We did it with HIV drugs. We did it with other therapeutic categories. We could do it here, too.

Larsen: The lack of a domestic manufacturing capacity for antibiotics in this country is troubling, and it’s an overarching industry concern. Other than making huge infrastructure investments, regulatory reform would help ease that, because we’re seeing this as a risk to a number of programs.

Kennedy: So, I have one question for Joe. The O’Neill report on AMR was, I think it was a fascinating read, but it talked about the issues with antibacterials, but also antifungals – and CARB-X is purely antibacterial, as is BARDA. (Also see "Wellcome Trust Makes AMR Strategic Priority After Funding O'Neill Review" - Pink Sheet, 5 January, 2017.) and (Also see " O'Neill Review outlines five steps for immediate AMR relief " - Scrip, 6 February, 2015.) Is there a possibility where CARB-X would broaden its scope to include antifungals, or any thoughts about ways to have that private-public partnership model for fungal treatments?

Larsen: Yeah, it’s possible. One of the things that we did when we created CARB-X is we wanted to create kind of a fence around what it was going to do, because we know that we are going to have a set amount of money, and we wanted to have the experts involved that knew antibacterial drug development. We weren’t going to do discovery, and that got academics a little chafed at us, and we were going to do clinical development, because that’s what BARDA normally does, and that was kind of the role we carved out.

AMR Roundtable: Optimism About CARB-X's Success And Prospects For The Future (Part 2)

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