I can't help it. This reminds me of the movie City Slickers, in which one of the characters has messed up his life, and his friends tell him he's getting a "do-over." The young company Dance Pharmaceuticals, based in downtown San Francisco, is basically on a mission to salvage the good parts of Pfizer's failed inhaled insulin Exubera (not the awkward delivery device!) and launch a second coming of the base product that is "simpler, smaller, easier to use, and lower cost." Godspeed, I thought, upon hearing this!



Last week, I spoke with Dance's President and CEO John Patton, who was part of the Exubera development team, and Chief Business Officer Samantha Miller.

As an intro, John had emailed me this statement:


"Dance is founded by people from Inhale/Nektar and is 100% focused on making good on the inhaled insulin promise.  We're convinced that we can create products that build on the strengths of Exubera and resolve the weaknesses (issues around both device and cost).  Before the launch of Exubera, we were already well along in developing a much smaller, more patient-friendly 2nd generation product when Pfizer pulled the plug on the entire program.  This was devastating to all of us working on it.


We know how to leverage all this previous work and investment to the fast development of a 3rd generation product.  Our product will not be perfect, as we're still dealing with technical constraints and cost constraints, but we believe we are taking a giant step in the right direction and look forward to showing you our technology and potential form factors soon."


Then on the phone, we talked specifics:

DM) I know you're working on a much-improved inhaler device, but how does the drug itself differ from Exubera?

Samantha Miller) A good way to think about what Dance is doing is reformatting the Exubera technology. We're taking the Exubera formulation and just removing some of the additional chemicals they had included — some of the additives.

On the device side ... our formulation is a liquid pulmonary device instead of dry powder pulmonary device.

Your website mentions aerosol technology. Sounds like this is going to be the 'hairspray' version of insulin?

SM) Aerosol is often used as another word for "inhalation" or "pulmonary."  So it's a general tech word that could be misinterpreted. So we probably should use a different word...

John Patton) Actually, aerosol came about when a scientist's little girl who had asthma — who was taking all these horrible oral steroids and things — said, 'Daddy, why can't you put my medicine in a spray like mommy's hairspray?' It originated back in the '50s. But we don't like to be thought of that way at all. Ours is more of a gentle mist.

So you have a prototype that you're testing now?

JP) We have a prototype, but we're improving on it. It is similar to an asthma inhaler — a hand-held mini-nebulizer.


One option is that users would have a vial of special insulin that's separate, and then drop the right number of drops into the inhaler and breathe on it. We're looking at this and a few other possible dosing formats.

This is prandial-only (mealtime) insulin, correct? So users would still need an injection for their long-acting basal dosing?

JP) Yes. And the precision of dosing has been very good (in studies). As a matter of fact, it's identical to shots.

Which diabetics do you expect to use this product?

JP) We're not ruling out type 1s... but type 2 is our primary market.  Those patients tend to put off taking insulin for so many years, and because of that their disease progresses, and healthcare costs go way up.

And when people go off of a series of oral medications — which we think is backwards because they should be going on insulin sooner — the cost of their meds goes down.  Overall, cost is critical. It's one of the reasons the initial (Exubera) program failed, because it was too expensive.

But it wasn't just cost that killed Exubera. The inhaler was not a lifestyle-friendly device by any measure!

We admit the thing was a big, clunky, sort of ridiculous-looking device. It was the first go; give us a break!

But why didn't the developers listen to feedback, pre-launch, from patients and doctors saying it was too big and awkward to use?

JP) We couldn't really change that. That was our first product. It was anchored in stone.  We had a second generation that was like 2.5 inches high. It was a tiny, delightful little device; it would have assuaged you.

But that was the one we did our trials with and changing it would have thrown us back another 3 to 4 years in development.

The reason why that thing was big was to make sure that it was accurate and that patients got the dose they were supposed to get. And then as time went by, we learned how to miniaturize it. You know, like the first personal computer filled a room!


If that's all true, then why did Pfizer dump it? Why didn't they hang onto it and try to do it better in a newer version?

SM) Because they didn't think it was commercially viable from their perspective. They weren't making a lot of money on the product, because there was a cost of goods problem that needed to be resolved.

Is inhalable insulin more expensive to produce than shots then?

JP) Insulin is one of most inexpensive drugs on the planet. And they charged a very small premium. It wasn't exorbitant at all. Instead of a dollar, it was like $1.20 per dose.

But even at that, we'd only shown equivalency to shots.  If the therapy is just the same as injections, then you have no justification for charging more. And because of that, it was not covered by payers in Europe anywhere, and that was one of our big markets.

Is insulin really so cheap? That's not what we're seeing and hearing as patients.

JP) As far as recombinant proteins go, yes. Insulin was the first product that Genentech invented, by DNA engineering, and they licensed it to Lilly. But it had always been sold as a porcine or bovine product, from cows or pigs, and the price was 'grandfathered.'

Most recombinant proteins cost anywhere from $200 to $2,000 a dose; insulin's a dollar.

How does Dance plan to change the economics on producing a fancy inhalable insulin device?

JP) We're not going to be satisfied with some high-end device that only people in America and Europe can afford. So that's really played into our passion — to  somehow make this thing affordable for people in China and India. Over there, there's no way you can charge what we charge here.  So our selection of technology is heavily influenced by cost.

This 'Laptop for every child' campaign — I know that sounds a little bit hokey — but it's really working in Africa. And we want an inhaler for every diabetic in the world.

{Dear readers: I'm thinking, "good luck with that!" And for once, I'm not being snarky.}

Of course there were some people who liked Exubera, but on the whole, I think it's clear that Pfizer's judgment was off in expecting people to come flocking to the product in its current form...


JP) You're right. Absolutely. The CEO was from McDonald's. He was used to seeing hamburger numbers go up every month.

If you look historically at the adoption of all the insulins, the adoption glucose monitoring, or of pumps and pens, none of them take off like rocketships.  The (adoption) curves all look like a hockey stick.

The whole early adopter / bell curve thing is typical. But Pfizer went in so big, invested so much money... and then just 'dumped the product and ran away.' It didn't leave a good taste in the mouth of most patients.

JP) No, and it didn't leave a good taste in the mouth of the people at Pfizer who developed it. They were bitter and ashamed.

We had a fabulous team there, we worked so hard. The second generation was coming and it was looking really good. And then they made this commercial decision. That was devastating for us.

I guess that's the whole point here, is getting past the negative connotations with a product like this...

JP) It's tough. We know it's not going to be easy, but we still think it's a good idea.  We want this thing to look so cool that it'll be a draw just on its own.

Let's talk competition for a moment. How does your product stack up against MannKind's Afrezza?

JP) We're definitely rooting very heavily for those guys to succeed!

Ours is going to be different, in the sense that ours is the same profile that Lilly, Novo, and Pfizer developed, and we think it very well matches the natural secretion of the pancreas in response to a meal.

MannKind's got an ultra-fast insulin that would be absorbed and cleared faster than ours. And they feel that's an advantage to the patient. That's not our strategy.

Wait, how is slower insulin better?

JP) We want to match what the body does physiologically, naturally. If you look in the literature, there's a lot of published studies on the body's response to a normal meal — with protein, fat and carbohydrate. Our profile matches that well, so that's our goal, is to maintain that.

As patients, we're always being told the problem is that current insulins aren't fast enough...?

JP) I know.  You know, when people say that, they need to show you the data. I've written a review covering all the published studies on the pharmacokinetics. An awful lot of what diabetics are told is not true.

But we patients can see for ourselves that no matter how carefully we dose, we get blood sugar spikes after meals.

JP) This is very controversial among insulin suppliers too — whether or not faster and faster insulins are really what you want. The data supporting that is really thin. And I would challenge anybody to immerse yourself in the literature, and not to pay so much attention to some of the sound bites people tell you about insulin.

What is your launch strategy for this new inhalable insulin?

SM) We're in the middle of an angel (investment) round right now. We have a pretty aggressive business development effort.  Right now we're looking for a couple of regional partnerships, and also talking to insulin suppliers.

We're not quite decided on how to launch the product yet — as a small company, or in partnership with a major Pharma company. That strategy is to be determined at this point. We just want to be sure that we develop the best possible product that we can for patient's use.

Clearly this product is a few years out from hitting the market. Are you feeling confident about moving quickly through FDA by then?

JP) We're going to be leveraging $6.5 Billion of other people's work, which is in the public domain — safety studies, special population groups, efficacy and so on.

We'll have to do some specific studies relating to our system, but we won't have to reinvent the wheel in terms of long-term safety and a lot of the efficacy work that's already been done.

Why Dance? Does the name have a special meaning?

JP) Well, we like to dance. And in order to really get in synch with the patients and business partners, you need to 'dance' with them. And also the molecules — insulin is undergoing motion, so it does a dance as it hooks up with its receptor. So there are lots of reasons for the name...

Most of all, we think that diabetics will dance for joy when they get this product.






Well, that's a TBD if I ever heard one. Still, it's exciting to see this technology move forward, no?

Thank you for this dance, John and Samantha.


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