We're closely following the latest developments with Afrezza, the inhaled insulin that's now been on the market for a little over two years, and has been struggling to gain traction since Sanofi dropped its marketing deal with manufacturers MannKind Corp. last year.
We at the 'Mine have used Afrezza personally with positive results, and we know there's a keen interest among at least a small but vocal group in the D-Community online.
It's been a bit unnerving to see a slew of business headlines and investor updates predicting an end to California-based MannKind Corp. -- especially lately, with talk of complicated "reverse stock splitting" supposedly aimed at boosting the value of stock prices that have been circling the drain for a while now. We Afrezza users are left wondering how long this medication may yet be available.
So our interest was piqued -- to say the least -- when a MannKind exec recently told us: "We think there's an opportunity to be the Uber of diabetes."
It's true. MannKind itself doesn't seem to be worried -- at least not publicly -- and in fact the company's Chief Commercial Officer Mike Castagna tells us they're ramping up their next phase of promotion, based on:
- New Triple-Variety Packs: In the coming weeks, MannKind will launch a new titration package that has all three dosing amounts inside -- 60 of each the 4, 8, and 12-unit cartridges.
- Sales Reps and Educators: They're bringing more players to the table to start selling and helping patients using Afrezza.
- TV Presence: We're told the company plans to produce TV commercials, and may even support a new diabetes reality TV show.
- The 'Uber of Diabetes Meds': A vision involving flat-rate shipments directly to a PWD's door every 30 days, so they don't have to navigate pharmacy visits or worry about whether meds are out-of-stock or unaffordable due to varying insurance coverage.
Here are some specifics on each of those activities, according to our talks with Castagna:
New Larger Afrezza Variety Pack
A news release issued on Feb. 1 announced a new titration package as well as a sales force expansion to help boost company sales and service.
Sales force training is happening this week, and the launch should happen next week. The new packs will include 180 total units of insulin, divvied up between the three cartridge types -- 60 of the blue 4-units, 60 of the green 8-units, and 60 of the yellow 12-units.
This will allow for better dosing variety and flexibility for PWDs, especially those just starting on Afrezza who might have yet to experience a new way of calculating doses compared to traditional injected insulin. Castagna says a big benefit is that this packaging will also allow for a single co-pay and better prescription-writing for doctors, something that's been a complication for Afrezza users to date.
"There's still a lot of confusion about how to prescribe, and for patients on how to dose," he says. Too true!
Last July, MannKind launched its first new variety pack including 4 and 8 unit cartridges. That's become one of the most popular products for Afrezza, Castagna says, and now this new one including 12-unit cartridges will likely be even more in demand, he believes.
Personally, I'm excited to see this new triple pack. I've been using Afrezza (along with Novolog and long-acting basal insulin) since May, and for the past six months my doctor has been writing two separate prescriptions for my monthly Afrezza -- one box of 4u/8u cartridges, and a box of 8u/12u cartridges -- because that's the only way his computer system allows him to prescribe these varying doses. As a result I've had to pay two distinct co-pays at my local pharmacy each month.
I'm lucky it's affordable for me under current insurance plan, but it's just a pain -- especially since the larger 8u/12u dosing box isn't readily stocked and always seems to take a few days longer than the smaller box. Hopefully with this new triple pack, users like me can avoid those hurdles.
Mobilizing Sales Reps and Educators
Wow, it's amazing how time flies. It seems like just yesterday that MannKind was all excited about its mid-2016 re-launch that would re-energize the company and its inhaled insulin product. Well, here we are in the early part of 2017, having déjà vu.
MannKind says now that initially, they had hired a contract sales force whose efforts were more about "stabilizing sales" than fully transforming the outlook for Afrezza. In other words, the aim of the first-round sales force push was simply to get the word out that Afrezza wasn’t disappearing after Sanofi cut ties.
“Every doctor heard we were coming off the market, so we accomplished the objective of stabilizing and showing we’re still here,” Castagna says. “We could’ve put more reps out there in some places (but) they wouldn’t have worked effectively, and then our 'scripts would have gone down even more than they did.”
Hmmm. OK, then... here's to hoping that the second-round delivers what's needed to get more Afrezza prescriptions rolling in.
There are also two moves the company's working on to improve its marketing to both doctors and patients:
- Label Change: MannKind says it's still pursuing a labeling change with the FDA in order to market Afrezza as a medication that's faster-acting (kicks in within 5 minutes) and one that can reduce the risk of hypoglycemia. The company has filed that label change proposal with regulators and it's being reviewed; no response is expected until the latter half of the year.
- International Afrezza: MannKind says it's also eyeing international markets such as Brazil, Canada, Mexico, UAE, Australia, and even China. They're also exploring filing possibilities in the European Union. Most of that will be done through partners internationally, though some may remain MannKind-led launches worldwide.
Positive steps ahead, it seems.
MannKind on TV
Afrezza Ads: The company's talking with the FDA about airing TV ads, something they didn't originally have in their arsenal to spread awareness among potential users.
Right now, the company has just received patient feedback on three commercial concepts and they'll be deciding which of those to take forward as an actual TV ad.
Castagna says they're anxious to finalize their ad concept and get it filed with FDA asap, as approval can take generally about 45 days. If all goes smoothly, we should start seeing Afrezza TV spots by the second half of the year. It will likely start off in local markets, to determine what works best, before the pilot ads start going national.
"The thing about TV spots is they're not as frequent, because it takes a lot of energy and money," Castagna says. "We'll look for other mechanisms to get our message out there -- YouTube and diabetes channels. But clearly, you'll start seeing a bigger presence from MannKind on TV and on the web."
Reality TV: Castagna says MannKind is also exploring possible sponsorship of a diabetes reality TV show. This came up during an investor update at the big annual JP Morgan Healthcare Conference in San Francisco in January, and it remains in the "exploratory stages" for now.
If that were to happen, Castagna says it wouldn't be a requirement that the people featured on the show use Afrezza or mention MannKind; the company would strictly be a show sponsor.
"It'd be along the lines of The Biggest Loser. There's someone launching a TV show like that for diabetes, and there's another one with Dr. Dre coming (about his battle with diabetes). So... something that highlights what it's like to live with diabetes are what we might consider for sponsorship," Castagna says.
He notes that this is also a discussion topic with FDA, because there's little precedent for Pharma sponsoring reality shows.
"The difficulty is trying to interpret FDA regulations and we're working through all of that... Because with a reality show, we don't control the content or the messaging or products the person chooses to use. There isn't a lot of guidance on this, and that's part of the challenge."
Huh, interesting! Maybe before long, some Afrezza users will be TV stars! Or maybe not... We shall see.
An 'Uber for Diabetes'?
Perhaps most ambitious is Castagna's vision for creating a new type of diabetes drug delivery model.
"It's time for a change, and I'm personally interested in building an Uber-like model for diabetes management," he said. "Anything we can do to streamline people's access to drugs and makes it easier, is where we need to go."
As noted, he envisions shipments directly to a PWD's door every 30 days, eliminating the need for pharmacy visits to pick up the product, which can involve stocking issues and confusion about co-pays.
This delivery model certainly isn't a new concept -- mail-order pharmacies and companies like Liberty Medical were doing this long ago, and newer meter companies like Livongo and OneDrop offer subscription-based test strips delivered directly to you at home. Yet we don't have this for specific devices and their accompanying supplies yet... so that'd be unique.
"I'm really looking to streamline this process, make it a seamless integration into a person's life," Castagna says. "When you think of Uber, you just use the app to get a car, and then you get in the car and everything's done all in one place through the app, the payment and even the feedback. That's what we're looking to do as a company, creating a way for patients to interact in a different way than they have."
Wow, fascinating! We love the idea, and can't wait to see whether Afrezza manages to make this type of business model materialize.
The Road Ahead for Afrezza
No matter the delivery model, it doesn't change the fact MannKind still has an uphill journey (on a steep curvy road) ahead to reach mass acceptance among providers and patients. The overall story of inhaled insulin has been a disappointing one so far, proving that just taking away needles does not a blockbuster drug make.
In our opinion, Afrezza is a really good mealtime insulin option, with a really good design that takes quality of life into account, so we're rooting for it all the way!
We remain cautiously optimistic, in hopes that Afrezza can survive the turbulence of our complex and unforgiving healthcare reimbursement system, and stay on the market long enough for many more PWDs to reap its benefits.