In the next two or three years, Eli Lilly wants to become more than just an insulin company.
The Indianapolis-based Pharma giant has been quietly working on diabetes technology behind the scenes since 2015, and just recently publicly disclosed that it's working specifically on a tubed insulin pump with infusion set and a smart insulin pen that will deliver insulin, track data, and communicate with the Dexcom CGM for a full mobile health offering.
Yup, in mid-November Lilly announced it had signed a development agreement with Dexcom to weave that CGM data into its future connected devices. Two articles from the Wall Street Journal and FierceBiotech expanded on that news by delving into the broader "connected diabetes ecosystem" the company says it's developing.
This all comes at a time of a major shift in the D-Tech market, with insulin pump choice evaporating thanks to JnJ Animas being shut down and Roche stopping its sales of insulin pumps, along with uncertainty about Tandem's future. Medtronic remains as the big behemoth in diabetes devices, while OmniPod remains the only patch pump in the USA. Most of these vendors are now looking more at closed loop systems rather than stand-alone insulin pumps. On the CGM side, Dexcom and Medtronic may be facing a new kind of competition from the new Abbott Freestyle Libre, a simpler sort of CGM that requires no fingerstick calibrations.
With Lilly publicly putting its name in the ring as a device maker, we may soon be seeing an interesting new dynamic in the market...
Lilly's Diabetes Tech Pipeline
Here's a snapshot of what we understand is in the works, garnered from a combination of what we've been told directly by Lilly Diabetes and what the WSJ reported:
Connected Diabetes Ecosystem: This is the term Lilly's throwing around for its technology, likely to emphasize that it's not just a single insulin pump or Bluetooth-enabled smart pen. Rather, it's two separate devices that would be used to deliver insulin -- whether via pump or pen -- and then connect to a mobile app. Lilly is describing its pump-system as a "hybrid closed loop," meaning it will partially automate the full system to do all the diabetes work.
Under the Radar: Lilly started quietly developing this roughly two years ago, but kept that R&Doff the public radar. It's all happening at the Lilly Cambridge Innovation Center research labs based in Cambridge, MA, announced in 2015. The company's working with New Hampshire-based DEKA Research and Development that's led by medtech innovator Dean Kamen, who invented the first insulin infusion pump way back in the 1970s. Lilly has licensed that device design, which is pretty impressive, given Kamen's track record in innovation. After all, this guy is recognized in the medical device innovation invention Hall of Fame for his work, including on the insulin pump, pacemaker, and Segway scooter. On the algorithm side, Lilly acquired IP from the privately-held Montreal academic startup Class AP, which was founded in June 2016 and bought last year by the Pharma giant. Class AP was developing a closed loop algorithm, so it makes sense for Lilly to moving in that direction.
Not a (Traditional) Patch Pump: In the WSJ story, the pump's described as a round disc about the size of a shoe polish tin that's connected to tubing and will hold a three-day supply of insulin. While Lilly is pretty scant on details, it confirms the insulin pump being developed does have tubing that connects to an infusion set -- but you get a choice, in that it could be work as a patch pump, too. It's a hybrid, in that it can also be adhered directly on the skin (like a patch pump) or carried/worn on a belt, etc. Lilly also says it will have functional buttons on the device, though the final design is still in the early stages. This should clear up some confusion in the D-Community over use of the word "tubing," as some wondered if that might mean just the cannula where the insulin is infused or if it might be a patch pump like the OmniPod.
Dexcom's CGM: Language in the recent development agreement announced Nov. 21 is a bit vague, but we're told Lilly will weave the CGM sensor (likely the G5 and eventually the G6) into its future delivery options for both the new pump and pen devices. All of that diabetes data analytical power can then be channeled into mobile apps for data-sharing.
More Details (Kinda) from Lilly Diabetes
We asked Lilly Diabetes spokeswoman Julie Williams for more detail, and here's what she told us, directly from the mouth of Corporate, so to speak:
DM) What exactly is Lilly developing?
JW) As it pertains to our internal programs, the automated insulin delivery system is inclusive of the pump (licensed from DEKA), the CGM (partnered with Dexcom) and the algorithm (acquired from Class AP). This system includes a dedicated controller and a companion app.
The integrated insulin management system combines a connected insulin pen with glucose-sensing technologies and software applications to deliver personalized insulin dose recommendations.
So we’re talking multiple devices?
You are correct. Our development agreement with Dexcom currently includes integrating CGM data into our pump. The dedicated controller and companion app for the Automated Insulin Delivery system (i.e., pump) will have both the CGM and insulin information. The Dexcom CGM sensor and transmitter will also be part of the system.
Can you elaborate on the pump design itself?
We cannot disclose further details of the pump’s form factor beyond what has already been disclosed. However, for clarity's sake, the tubing referenced in the article is the infusion set which connects the pump to the body.
While it would be premature to comment on the final configuration, the automated insulin delivery system will have an infusion set and can be body worn or carried. More details will be released as the development program advances. At this time, we are not sharing photos or conceptual designs.
Lilly has also invested in other similar development efforts, like the smart pen from Companion Medical and the iLET closed loop system… Can you talk more about that?
In addition to our internal programs, we have previously announced several investments or co-development efforts in both pen and pump-based systems which remain important pieces of our innovation strategy, as well.
What is the timing and where is this in the prototype stages?
We’re working to roll out the first generations of these platforms to people as soon as possible – which we expect will be in the next two to three years. We have moved from what Lilly defines as our research phase into development, which allows us to initiate clinical trials with our development-stage prototypes.
When will the clinical trials begin?
Will this be specific to just Lilly insulin, or will the devices be compatible with other brands made by different manufacturers?
Lilly believes in choice for our customers. As a result, all aspects of the Connected Diabetes Ecosystem are being developed with as much flexibility as possible. It will be compatible with Lilly insulins and other companies’ insulins as well, where possible.
Pricing and Market Impact
These days, questions of Access and Affordability are immediately tied to any new product or even conceptual discussions on innovation. So the question is, how affordable might this new tech from Lilly be, especially given the insulin manufacturer's track record on skyrocketing insulin prices?
And what impact might this development have on insulin prices themselves? T1D blogger Chris Stocker raised this very issue on a recent podcast, pondering how this could go either way: Lilly could potentially raise insulin prices to justify its R&D for this new D-tech, or possibly lower the prices due to a revenue offset from the new connected devices.
"Lilly is always looking for ways to keep our medicines affordable," Lilly's Williams says in response to a question about possible impacts on insulin pricing. "Our Connected Diabetes Ecosystem is two to three years from reaching patients, and while we cannot speculate on the future prices of insulin or other medicines, we believe in choice of treatment and technology for people with diabetes. Our goal is for our (new technology) to help improve the long-term health of people managing diabetes."
We also reached out to competing insulin giants Novo and Sanofi about any plans they might have to develop future diabetes tech internally. Neither company responded by deadline. We also contacted the Sanofi - Verily Life Sciences/Google joint venture Onduo (announced in October 2016) about their pipeline plans, but the startup told us they still aren't ready to speak publicly about any specifics.
Blast from the Past
Keep in mind, this isn't the first time Lilly, or any insulin manufacturers, have had a direct stake in the insulin pump market.
Lilly had an insulin pump of its own back in the '80s -- the Betatron I and Betatron II insulin pumps, which came through its acquisition of Cardiac Pacemakers, Inc. in the late '70s. That product was on the market through the '80s, but eventually disappeared and Lilly sold its CPI subsidiary in 1994.
More recently, Lilly has also invested in closed loop technology with Beta Bionics in the development of its glucagon and insulin delivery system, named the iLET. That's at least a couple years out, but both Lilly and Novo have invested in the next-gen technology.
Novo Nordisk (actually, it was Nordisk before the two Danish companies fully merged in the late '80s) also had an insulin pump called the Nordisk Infuser. That product went away in the '90s, after Novo Nordisk and Minimed (not yet a part of Medtronic) reached a seven-year agreement and Novo agreed to stop making and selling its insulin pump in order for Minimed to get a stronger handle on the market.
Sanofi hasn't specifically had any insulin pumps, but it has tried to move into the D-tech field... mostly unsuccessfully to date -- from the MedT deal years ago that promised next-gen tech to its iBGstar connected meter five years ago that didn't last long. We'll just have to wait and see what Onduo develops in D-tech.
Competition is Good!
This this isn't a complete surprise, as signs have been pointing to this happening. What's caught many off-guard is how this news has suddently popped up, seemingly out of the blue.
Why is Lilly Diabetes talking about this now -- so early in their development stages? The WSJ story made it pretty clear with this quote from Lilly Senior VP Enrique Conterno:
“Do we want to be just an insulin provider that just goes into a system, or do we want to be the integrator of the system? To me, it’s clear where the business is going.”
As Conterno sees it, not moving beyond insulin and into the delivery systems would lead to Lilly’s diabetes business becoming “obsolete.”
We're glad to see more pump choices possibly coming to be, especially from an established player like Lilly that can immediately compete with the market leader Medtronic. Maybe that will allow for more smaller companies to carve out a space for themselves in this market as well...?
While Lilly's track record on insulin pricing may not inspire confidence on affordability, we're still glad to see new innovations that can translate into benefits for the patient community.
Update: Check out this podcast interview with Lilly execs and Stacey Simms at Diabetes Connection's for more detail on this news development. http://hwcdn.libsyn.com/p/2/8/0/280d824bc53a717b/Ep_133_Final_Lilly_Devices.mp3?c_id=18250553&expiration=1513693661&hwt=015698a9ef821d2174c74c31699fd280