A new generation of inhaled insulin is inching closer to market, as a little-known biopharmaceutical company is gearing up for late-stage clinical research and FDA filing, and has just hired a seasoned CEO to lead commercialization efforts.

You may remember Dance Biopharm, the San-Francisco area startup that came on the scene in roughly 2010, after Pfizer's failed "bong-style" Exubera inhaled insulin was pulled from market and when MannKind's Afrezza was still in development. This startup has been working to create a whole new type of inhaled insulin for almost a decade.

The company is now making headlines with its recent hiring of former Sanofi exec Anne Whitaker, who's quite familiar with the inhaled insulin universe and the business side of bringing new medicines to market. She's based in North Carolina, where Dance Biopharm is actually preparing to relocate its HQ in the coming months. They'll stay on the West Coast for research, but the execs will be on the East Coast while Dance also prepares to open offices in China and England before long.

“We have been off the radar, one might say working in stealth mode. But when you look at the progress made, it’s notable. All of those things coming together… now is the time to bring this forward," Whitaker says of their novel product currently dubbed Dance 501 (the internal working name).

In a recent phone chat, Whitaker gave us the low-down on why she joined the Dance team and what we can expect in the next couple of years. But first, let's take a look at this new inhaled insulin, and what advantages it offers to patients.

 

Sizing Up Dance 501, aka Inhaled Insulin 3.0

The FDA will review and approve any proposed product brand name for this new inhaled insulin, which some refer to as Generation 3.0. Here's a look at the properties of what's still known as Dance 501:

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Soft Mist: Unlike Afrezza insulin by MannKind that is an inhalable white powder, Dance 501 is a mist formulation, i.e. an ultra-concentrated recombinant insulin that requires only a few drops that are vaporized into mist form as you breath it deep into the lungs through a small handheld device.

Pure: Unlike other insulins, this product is preservative-free, which is important for the 1-2% of PWDs who actually have allergies to insulin – creating issues ranging from insulin site rashes to anaphylactic shock. It comes in liquid form in a small bottle, which is used to fill the handheld device just prior to each dose.

Handheld Inhaler: Small and easy to use, it's about the size of an old-school beeper that can fit into a pants pocket. This is quite different than early prototypes we saw; in December 2017 the company teamed up with industrial designer Phillips-Medisize for a revamped version. The result is an electronic inhaler that uses patented vibrating mesh technology designed to produce consistently-sized particles of liquid insulin in the form of a soft mist. (Fun fact: there are 120,000 vibrations in one second!). The device is breath-activated and it only takes a few breaths to inhale the Dance 501 insulin mist, with a green light indicating you're breathing in the mist appropriately before a blue light on the device flashes to indicate you’ve finished. Whitaker says they've recently sent the FDA their design recommendations for the initial device and expect to hear regulatory feedback by early November.

Next-Gen Inhaler Device: While the first generation uses a pair of AA batteries, Whitaker says that will likely change as quickly as six months after launch with a second-gen rechargeable device. That will reduce the size and weight of the device by 50%, to look more like a Chanel Lipstick tube.

Faster Acting: Whitaker says Dance 501 is faster acting than traditional insulins (Humalog, specifically) and improves upon Afrezza inhaled insulin, because the insulin action peaks just as quickly but has a "longer tail" that more closely mimics the body's natural reaction without a need for follow-up doses. Phase II studies are showing few hypos and very little cough from those using this inhaled insulin mist, which goes more naturally into the lungs without irritating the throat.

Data Tracking & Connectivity: Since the inhaler device is basically a little computer, it records insulin use data such as dosage amounts, when taken, rate of inhalation, insulin dosage amounts, and how much mist actually goes into the lungs based on breathing depth. Dance also plans to launch a mobile app for the smartphone containing that same data, for patients to view along with healthcare providers, and eventually to connect with other D-devices like CGMs and data platforms. All of that is unique, since other inhaled insulin devices to date haven't offered tracking or device connectivity.

R&D Timing: As exciting as Dance 501 may be, patience will be a virtue here... we're talking at least a few years out, if not longer. Dance has published early clinical research over the past several years, and that continues with Phase II trials ongoing through what it expects to be mid-2019. From there, they expect to begin late-stage Phase III trials in 2020 and probably get to the regulatory filing point by the end of that year. Of course, funding is key to all of this, so timing may vary depending on that, as well as whatever the research shows and what regulators eventually say.

Pricing: Whitaker also says the are still studying price-point and cost. She doesn't believe Dance 501 will be "an outlier for existing insulins today," but by going global instead of just US, that will help offset prices for patients. Of course they also plan to work with payers before moving to market.

Liquid Formulation, Too: Just because Dance is developing this mist-form of inhaled insulin, that doesn’t mean they aren’t also looking at a liquid version for use in a vial/syringe, pen, or insulin pump, similar to the traditional brands on the market now, Whitaker tells us.

Very exciting, but of course we impatient patients can't help wondering: What the heck has taken so long to get to this point, and why are we still years away from seeing this product from Dance?

There are many moving parts, explained nicely in our chat with Whitaker.

 

Behind the Scenes with Dance Biopharm CEO Anne Whitaker

Whitaker has quite the resume with more than a quarter-century in the Pharma, life sciences and biotech industries -- from diabetes to oncology, cardiovascular, respiratory and gastroenterology. Her background includes President and CEO of KNOW Bio, Novoclem Pharmaceuticals, Inc. and Synta Pharmaceuticals, Inc. Most notably for our D-Community, of course, is her time as President of the North American Region for Sanofi from 2011-2014, where she had responsibility for all pharmaceutical, device and consumer healthcare business units.

During those three years at Sanofi, Whitaker says the company tried to drive insulin use with Lantus and focused largely on trying to get PWDs (people with diabetes) to actually pick up their prescriptions and use the meds adequately. She says that only 30% of their T2 previously non-insulin-dependent patients got their prescriptions filled due to fear and confusion around insulin use. 

She knew about Dance way back during her time at Sanofi, and did a full company review as the Pharma giant was prepping to enter into the inhaled insulin market. Whitaker notes that Sanofi chose to partner with MannKind (makers of Afrezza) because of an “immediate opportunity” in getting a product to market more quickly than Dance could. That was viewed as a great way to drive insulin use away from injectables, she explains. But she says the company didn’t commercialize Afrezza the way they should have in order to make it a stronger presence for PWDs, and she ended up leaving Sanofi in 2014.

Former Sanofi Exec Says: "I Was Frustrated"

“You can’t launch a product in a tertiary position,” she said. “I was frustrated, honestly, by that in watching it from afar. Because I saw the potential of inhaled insulin. That's why Dance wanted to bring on someone with this commercialization experience... we need to start focusing on commercial readiness now. We're beginning that process now and the entire Diabetes Community will be hearing more from us as we prepare for launch."

Whitaker adds that she grew up in Alabama in the middle of the Southern "diabetes belt," and because she also has an aunt and uncle living with type 2 and her father-in-law has diabetes, she’s observed the emotional roller coaster that PWDs endure, and how physicians too often use insulin as a threat for those with T2D.

“I hope to be able to change that and drive earlier use of insulin before they go through this continuous decline in their diabetes journey,” Whitaker says. “Dance has a product with Dance 501 that can offer another option. It’s certainly not to replace pumps or basal insulin, but it has a place earlier in the paradigm of treatment.” 

Of course, Whitaker knows that it’s an uphill battle trying to convince investors and others about the potential of inhaled insulin. But she believes that what’s changed in the past decade – following Exubera’s failure, MannKind’s launch and re-launch of Afrezza, and the overall evolution of technology and nebulization worldwide – has set the stage for Dance 501 in a way that wasn’t possible before.

Dance founder John Patton was the cofounder and chief science officer of Nektar Therapeutics, which provided the scientific basis for Exubera, and he remains part of Dance now with a seat on the board of directors. Another exec we talked with back in 2011 is Samantha Miller, who remains a strategic consultant for the company as it preps for commercialization.

Interestingly, Whitaker says Dance Biopharm had planned to file for an IPO (initial public offering) right around late 2015, but when Sanofi dumped MannKind’s Afrezza that plan changed. Instead the company has pushed ahead on clinical studies and revising its device to be sleeker and more sophisticated.

A Ripe Environment for Inhalables

Times have certainly changed -- giving Dance reason to believe people are more open to the idea of inhalables.

These days, e-cigarettes and vapes have become common worldwide, and Whitaker points out that medical nebulization is exploding and becoming more accepted globally. She cites how 8% of the US medicine market uses handheld nebulizers for steroid meds, compared to 12% in Europe and 20% in China.

“The potential to go to market and commercialize Dance 501 successfully, is there. The timing is right for Dance," Whitaker says.

Manufacturing cost is certainly a concern on Whitaker’s mind, being well aware of how much Exubera and Afrezza cost to make and get to market – upwards of 1 Billion dollars (!) But she says Dance can expect to spend only a fraction of those costs, as they’re working with Asia’s largest insulin maker in order to have FDA-inspected plants for manufacturing Dance 501 for the US overseas.

“We’re also fortunate that we stand on the shoulders of those inhaled insulin that came before us, because there’s now an abundance of data on it about safety, efficacy, and patient use to draw on," she adds.

Whitaker also adds that the company's research and manufacturing teams will stay in the San Francisco area, while the commercial HQ for Dance Biopharm will be moving to Research Triangle Park in North Carolina within the next 6-9 months, and until then they're operating remotely. They also plan to open a European office as well as one in China, she said.

Inhaled Insulin Gaining Traction?

We remain cautiously optimistic about the potential of this new product. Take MannKind's Afrezza as an example: Both of us here at the 'Mine use it and love it. But the fact is that MannKind has struggled and their prescription numbers remain low, with many doctors still generally hesitant about the powder formulation that's been on the market since 2015. The insulin market is a competitive and fickle one, and nothing's guaranteed (except the fact that we PWDs with T1D can't go without it!).

Still, with all that in mind, here's hoping that Dance makes it to market and can succeed where Exubera failed and where MannKind is struggling to gain a strong foothold.