It's a New Year's tradition here at the 'Mine to look ahead at the new treatments and technology we expect to see coming down the pike in the year ahead. 2016 seems to be starting out with a bang with yesterday's announcement that Sanofi is dropping MannKind's Afrezza inhaled insulin - wow!
We've been listening to earnings calls and talking with company execs, industry insiders and PR teams to get a sense of what else is on the horizon for this new year, compiled in the following report.
(In case you're curious about our previous predictions, you can have a look back at our reports for 2014 and 2015.)
Afrezza Adrift, Among Insulin Wars
Afrezza: Sadly, this year kicked off with the breaking news on Tuesday that Sanofi had nixed its agreement with MannKind Corp. to manufacture and sell Afrezza inhaled insulin. Available since early 2015 following FDA approval the prior year, sales have been disappointing and rumors of Sanofi's pull-out have been circulating for months.
No, the news is not that MannKind is discontinuing Afrezza at this time. They've just lost their backing from pharma giant Sanofi, so all of the rights and responsibilities now default back to MannKind, which is left holding the bag. MannKind will be taking over the production of Afrezza from Sanofi in the next three to six months, according to reports. In a mid-day webinar Tuesday, MannKind's CFO Matt Pfeffer said the company is exploring strategic plays on what it will do next, hinting at finding a new partner. He assured users there will be "no interruption in therapy" and was quite bullish about MannKind's prospects, stating that the split with Sanofi is "not a setback but an opportunity for Afrezza."
We truly hope he is right, because many PWDs (including 'Mine editor AmyT and my own mother who lives with T1D) have been using and loving Afrezza this past year. Now, the Afrezza Era could very well be coming to an untimely end... we shall see.
Meanwhile, the uncertainty around inhaled insulin remains just one piece of the ongoing Insulin Wars that continue among the Big Three makers -- Eli Lilly, Novo Nordisk, and Sanofi -- that will only intensify in 2016 as they pursue both insulin and other new, competitive diabetes drugs.
Sanofi: Aside from the Afrezza news, Sanofi's new highly concentrated U-300 basal insulin Toujeo ("the Son of Lantus") hit the market this past year, to some excitement and also a bit of confusion on dosing conversion. Now Sanofi is setting its 2016 sights on GLP-1 agonists and GLP-1/basal insulin combo drugs here in the U.S. In September, they filed an FDA New Drug Appliaction for Lyxumia (lixisenatide). That paves the way for the combo drug Lixilan (Lyxumia + Lantus) once approved.
Novo: The New Jersey company's new long-lasting basal insulin Tresiba hit the market in 2015, and has been going head-to-head against Sanofi's Toujeo. Novo is also developing a faster-acting version of Novolog, which doesn't yet have a name other than its clinical trial moniker NN11218. Novo has finished Phase III clinical studies on this drug, and hopes to have it ready for market sometime in 2016.
Eli Lilly: In mid-December, the FDA approved their new basal insulin Basaglar, described as a less-expensive version of Sanofi's Lantus, that's been dominating the market for a decade now. Lilly has stated that Basaglar will be ready for market at the end of 2016. Of course, they'll have to compete with Toujeo and Tresiba as well, so expect marketing wars, Insulin Users!
All in One Meter... Finally
Just as we were chuckling about another year going by without those elusive "all-in-one" meters coming to market... Bam! A few days before Christmas, the FDA approved the Dario meter made by Israel-based LabStyle Innovations that's been under regulatory review since early 2014. We've covered the device before, and were definitely not holding our breath based on the FDA's traditional reluctance to approve these type of meters. It seems the tides have now turned, and we're anxious to see Dario live in the U.S. soon in 2016.
Dario is a nifty little compact meter that snaps into the phone jack on your smartphone, and as soon as you connect the device your smartphone switches to BG-monitoring mode. You then click open the self-contained lancing device that contains disposable lancets and an integrated cartridge of 25 proprietary test strips, allowing you to poke your finger just like any other meter. The reading you get is transmitted directly to the smartphone through an app that'll be available for free.
Spokesman Todd Durniak, Executive VP and General Manager for LabStyle Innovations U.S. division, tells us that Dario is on a fast track to being prepped for launch; distribution agreements are being finalized and will be announced soon. He says the cost will be "competitive and comparable" to other meter systems. Dario will be compatible with iPhone first, and Android later pending FDA approval for that OS.
CGM Pipeline: Dexcom & Medtronic
Dexcom: We're just a few months past the much-anticipated launch of the G5 that eliminates the need for a separate receiver by offering direct-to-smartphone capability, but there’s more coming soon. Dexcom's VP of Strategy and Corporate Development Steven Pacelli says earnings calls have contained all the clues the company is able to disclose publicly at this point. From what we can glean, there is a good amount of progress on the horizon for the coming months:
- Android compatibility for the G5, which so far is still only for iPhones
- More progress on the Apple Watch integration is coming soon, that will allow G5 users to view their own data on the Watch
- New one-button insertion device is expected at some point in mid-2016. From prototype images we've seen, it appears to resemble the Medtronic Enlite sensor inserter that can be operated with one hand
- Reduced-size G5 transmitter, that will be more compact than the current G5 and even smaller than the previous G4 model
Most exciting? Dexcom still plans to file its next-gen G6 in the coming months, which is expected to be a true leap forward in CGM tech with 10 days of wear instead of the current 7, only one calibration required instead of two, and improved accuracy and reliability.
Dexcom says it will file the G6 by April, and plans on a 2017 launch. But in the past FDA has moved surprisingly fast on Dexcom developments, so perhaps we could see a G6 launch before the end of 2016 for both adults and children. That may be optimistic, but it seems within the realm of possibility to us.
Medtronic: New devices from MedT may not hit the market in the next 12 months, but it will likely be a big year of progress in developing next-gen tech and data-sharing.
Medtronic spokeswoman Amanda Sheldon says the company plans to file its Minimed 640G system early in 2016. The device is available overseas for the past year and clinical trials are completed here in the U.S., so while this device may not get cleared in time for a 2016 launch, the filing in itself is an important step forward. The 640G will have a whole new sleek modern look and vertical design, compared to the horizontal design and longtime look these pumps have had.
Like its predecessor the 530G, the device will be able to shut off insulin automatically in the event of a low blood sugar. But it will also be able to predict hypos ahead of time and suspend dosing to actually prevent the lows, something the current 530G can't do until you cross a low threshold.
The 640G will incorporate a fourth-generation sensor, the Enlite 3 -- the next generation beyond what's currently available in Europe, known as Enlite 2 or the Enhanced Enlite. Sheldon says the 640G clinical studies were conducted in ages 14 and older, so it will at least have more pediatric approval than what MedT's typically had with its newest tech.
We asked about pediatric designation for the current Minimed 530G pump-CGM combo approved back in September 2013, but MedT still hasn't gotten that through the FDA and doesn't have a planned timeline. Disappointing to hear, as it forces young folks to wait for the 640G.
Into the future, we understand the Minimed 670G will be a hybrid closed loop system that Medtronic is hoping to study from the get-go in all age groups. That future tech is projected sometime in 2017-18.
Abbott Freestyle Libre
Many industry observers and experts expect Abbott's novel FreeStyle Libre Flash Glucose Monitoring (FGM) tech to finally make its way to the U.S. in 2016 or soon after. This system combines fingerstick testing and existing CGM (continuous glucose monitoring) with a splash of non-invasive tech. That is, it consists of a little round white sensor worn on the skin, and a "receiver" that looks similar to a handheld PDM, which you wave over the sensor to wirelessly pick up glucose readings.
You can do this as much or as little as you might want, making it a potential way to eliminate the need for expensive test strips without committing to a full CGM device if you wish.
The Libre has been available overseas for the past year, and it's getting mostly positive feedback. While Abbott won't comment specifically on a timeline for the U.S., it confirms plans to bring it Stateside based on the Pro version it's already submitted to the FDA. There's also a pivotal study that completed last year for the Personal version, and a PR agency for Abbott tells us the company "has had positive discussions with the FDA and is encouraged by the approval of the plan for (another new) clinical trial."
In Europe they've also recently launched LibreLink, a mobile app that lets FreeStyle Libre users access glucose data directly on their smartphones. Developed by AirStrip, the LibreLink app is the only app approved and certified for use with the FreeStyle Libre sensor.
While we still can't get over the fact that Abbott discontinued the FreeStyle Navigator CGM here in the U.S. years ago in such a sloppy way, we are excited about the Libre opening offering a new type of tool for PWDs. We hope to see significant progress by year's end.
Insulin Pump Progress
In addition to market leader Medtronic, what can we expect from insulin pump makers in 2016?
TANDEM DIABETES CARE
This company was not forthcoming about its plans for the coming year, so we’re left with what we already know to expect for 2016 – updates on Project Odyssey, the new product upgrade process that Tandem plans to file with the FDA. The aim is to be able to provide products updates remotely, just like you would with a new smartphone system update. To make this happen, they need the FDA to give them the green light to turn on Bluetooth in existing t:slim pumps so users can begin to update features without the need to buy entirely new hardware -- and even potentially "flip on" integration with the new Bluetooth-enabled Dexcom G5 just recently approved in late 2015.
INSULET / OMNIPOD
Marketing director Christopher Gilbert tells us theyre targeting to submit their next-gen PDM product to the FDA in the middle of 2016. "We are also looking at integration options for the G5 sensor with the OmniPod device. Our market research demonstrates that patients really want to see this information ideally on their phone along with additional OmniPod information. And so we (in conjunction with Dexcom) are evaluating ways to accelerate CGM integration...”
We caught a glimpse of a prototype of their new PDM at the big ADA Scientific Sessions in June 2015, and there was a lot of excitement in the booth from all those who got to hold and play with it. While this is moving slower than expected from first mentions a couple years ago, we are happy to hear the filing is coming soon, and just maybe we will see FDA approval by year’s end.
It’s also worth noting that Insulet’s continuing development work with Eli Lilly on a U-500 OmniPod that will use a higher-concentrated insulin for those who need more units per day. In recent moths, a clinical trial began for this with Type 2s patients that will run through December 2016. So while we won’t see a launch this calendar year, we’re hoping the science is finished up this year and it can get to market in 2017.
Last year's big news was the Animas Vibe pump-CGM combo device finally hitting the market after many years of waiting, and of course we wondered if they planned any updates, like launching data-sharing tools or next-gen intregration with the G5 like Tandem is pushing toward.
Lifescan Communications Director Dave Detmers says our D-Community can watch for two specific things this year:
- Animas Vibe for Kids: They're awaiting FDA approval of the pediatric indication for Animas Vibe. Even though doctors have been prescribing this to kids off label, that hasn't been FDA approved and it's officially only been an option for adults.
- OneTouch Verio Flex Meter: Expect a product launch in the first half of 2016 for this meter that's already available in Canada and Europe. Verio Flex is a new Bluetooth-connected meter that has a slim white design, big easy-to-read numbers, and a three-color range indicator for easy recognition of whether your BG result is Low, High, or In Range.
Also, During the second quarter earnings call in July 2015, J&J noted plans to finally launch the Calibra Finesse Patch Pump at some point in 2016. This is a bolus-only, wearable insulin patch device with a very profile that can be worn on the body for up to three days. It holds 200 units of fast-acting insulin and allos PWDs to take two-unit boluses by pushing buttons right on the patch, without the need for a separate controller unit. This patch pump alternative was FDA approved way back in 2010 for both T1 and T2 diabetes and eventually bought by J&J in 2012, but it never materialized and seemed to slip into oblivion... until now!
BD Flowsmart Infusion Set
As we reported back in October, it's likely that patients will have access to a new, much-improved insulin infusion set in 2016 -- one that eliminates much of the unreliability of current sets.
BD is a recognized leader in insulin delivery for injections, but the BD Flowsmart will be its first foray into pump infusion sets. This will actually come to market as the Minimed Pro-Set with BD FlowSmart Technology, based on BDs collaboration with Medtronic in which MedT will commercialize this new BD-made set.
More than 20 types of infusion sets exist across the market, but the fact is that occlusion errors are rampant. Flowsmart aims to reduce these errors with a second side port that allows an alternative path for insulin, plus a swiveling tubing connection and special type of low-pressure infusion tech to help reduce blockages. It also offers the smallest catheter on the market.
While BD hasn't shared any specific launch date, Dr. Aaron Kowalski of JDRF told us that could happen in early 2016 and BD confirms it does plan for an expected launch within 2016.
Glucagon Up Your Nose
By the end of the year, it's possible we'll be able to sniff a powdered glucagon up our nose as a better way to boost blood sugars quickly in emergencies.
Thrilling news came in October when Eli Lilly acquired the novel nasal glucagon Locemia (clever name combining Low and Hypoglycemia). This is of course a revolutionary improvement over the current glucagon emergency kits, with their complex and intimidating mixture mixture instructions.
Locemia is designed like a Flonase vial that you insert in a nostril, and then just push a button and sniff the powder -- and within a few minutes, it's already working! We've covered Locemia extensively here at the 'Mine, including my own clinical trial experience using it in 2014.
Locemia had originally talked about getting this filed with FDA by mid-2016, so we have to assume that Lilly will follow that same timeline -- especially as the Phase III trials are now finishing up. Lilly spokeswoman Julie Williams tells us, "We are working hard to ensure new drug application submissions are supported by a robust clinical package and reliable supply chain strategy. Once these elements are in place, we look forward to executing regulatory submissions." OK, good!
Without a doubt, a lot more is happening out there for 2016 on the research side, and in data-sharing and closed-loop technology, etc. Plus the ever-expanding world of mobile health is certainly going to bring us more excitement during 2016, no doubt.
What's listed above is stuff we can pretty much count on in the product world.
So tell us, Diabetes Friends: What do YOU have your eyes on for 2016?