Memorandum

Abbott and Sanofi Partner to Share FreeStyle Libre Data with Sanofi’s Future Smart Pens and Titration Apps – September 16, 2019

Executive Highlights

  • Abbott and Sanofi jointly announced a worldwide partnership this morning to allow sharing of data from FreeStyle Libre with insulin dosing information from Sanofi’s future “connected pens, insulin titration apps, and cloud software.” The CGM and insulin data sharing will be bi-directional – Abbott data will flow into Sanofi’s ecosystem via the FreeStyle LibreLink app, and Sanofi data will flow into Abbott’s ecosystem via its in-development apps.

  • Products are targeted to come to market “within the next few years,” and Sanofi currently has two smart pen form factors in development: (i) a reusable pen cap for disposable pens; and (ii) reusable durable pens. There are no details on the product specs (e.g., screen, charging) and more specific timing has not been shared.

  • The collaboration seems like a win for both companies as Sanofi builds up its connected care ecosystem and Abbott looks to combine FreeStyle Libre data with many insulin delivery devices. Sanofi’s smart pen development is well behind Novo Nordisk’s (NovoPen 6 and Echo Plus are CE Marked and expected to launch in 2020, as of today’s update) and Lilly’s (smart pen submitted to FDA as of 1Q19). Given that these products tend to take longer than expected, it could be a while before we see a Sanofi product launch from this partnership.

  • All three insulin companies now have major CGM partnerships: Novo Nordisk is partnered with Dexcom, Abbott, and Medtronic; Lilly is partnered with Dexcom; and Sanofi is now partnered with Abbott (and to some extent Dexcom via Onduo). Abbott is of course also partnered with Bigfoot, who recently pivoted to focus on its smart pen offering. While some complain that the partnerships are taking some time, we applaud the companies for piloting various approaches and taking the time required to launch.

  • It is excellent to see all the movement and partnership between CGM and insulin delivery devices (pens and pumps) – the combination will substantially improve insulin dosing, especially paired with smart titration, pattern recognition, and learning algorithms. Insulin is among the hardest drugs in the world to dose and there is so much upside from CGM – “who” should be taking insulin, “what kind” of insulin, “how much”, and “when.” We view both intermittent and real-time CGM benefiting those taking insulin.

Partnership Details

Sanofi gets…

Abbott gets…

  • Sanofi’s first CGM partner in insulin injection titration (Sanofi has an existing partnership with Dexcom through Onduo)

  • Access to data from the world’s most widely used CGM – with >1.5 million users, Abbott has more documented CGM users than anyone

  • CGM data to propel future connected care ecosystem, which has lagged behind those of competitors

  • Access to real-world outcomes measured via CGM that could support potential value-based pricing models

  • Potential to work with Abbott to develop co-branded apps or pen + CGM bundles

  • Third smart pen partner after Bigfoot (2017) and Novo Nordisk (2019)

  • Access to insulin injection data from two of the three largest insulin companies, extending the ability of Abbott’s FreeStyle Libre to drive therapeutic change

  • Competitive hedge against Dexcom and Medtronic, who also have CGM/insulin partnerships

  • Potential to build up its own decision support software for insulin users

  • Potential to work with Sanofi to develop co-branded apps or pen + CGM bundles

With user consent, data from Abbott’s FreeStyle Libre and FreeStyle Libre 2 CGMs will be combined with insulin dosing information from Sanofi’s future “connected pens, insulin titration apps, and cloud software.” The data sharing will be bi-directional, meaning Abbott could theoretically utilize data from Sanofi’s smart pens and apps – will we see Abbott’s own insulin dose decision support apps, paralleling Dexcom’s own internal efforts (via the TypeZero acquisition)?   

  • We’d assume the end goal here is titration for a range for insulin users (i.e., “closing the loop for injection users”), though presumably this will launch in stages – e.g., CGM + insulin injection data in the same in-app data display first, then moving to more ambitious titration efforts (e.g., basal only, basal-bolus). The global collaboration includes both FreeStyle Libre and FreeStyle Libre 2 (currently under FDA review), with Abbott data flowing into Sanofi’s ecosystem via the FreeStyle LibreLink app.

  • Given the vague “next few years” launch timeline, it seems that Sanofi’s smart pen efforts (in both pen cap for disposable pens and durable/reusable pen forms) are still a few years away from coming to any markets. For context, Lilly and Novo Nordisk’s smart pen efforts have already been in development for years, and both have taken longer than we initially expected to come to market. All that said, we’re assuming “next few years” means a launch in 2022 at the earliest.

  • Abbott and Sanofi are global leaders in diabetes, and while the announcement leaves many questions – product details, timing, differentiation, finances, marketing – these players realize that there is a lot of room here and were willing to commit publicly to this partnership.

Sanofi’s Connected Care Strategy & Competitors’ Partnerships

Today’s announced partnership with Abbott represents Sanofi’s continued investment in its connected care ecosystem. At ATTD 2019, Sanofi first confirmed its smart pen strategy, highlighting plans to launch connected pens in both durable and disposable form factors – at the time, the company claimed connectivity would be built into the body of the pen (rather than into the pen cap or other attachment). We’re not sure if this is cost-effective for disposable pens, unless they use NFC and could be scanned with the phone. The timeline to launch smart pens given in today’s announcement is in line with the timeline given at ATTD: that the devices would launch in the “very next few years.” In the same space, Sanofi also has partnerships with smart pen-cap manufacturers Common Sensing (it is an investor) and Biocorp.

  • The combination of CGM, insulin dosing data, and connectivity could help Sanofi Diabetes accelerate innovation and return to growth after a rough few years of sales (see graph in 2Q19). We continue to see huge time-in-range and A1c upside from titrating insulin continuously based on CGM patterns, and this approach should prove to be far less expensive and faster to deliver than insulin-molecule innovation. The technology for titration already exists, and the key will be stitching it together in a compelling, integrated product with a strong business model. That is not necessarily easy for a pharma company, but it also does not require major scientific leaps.

  • Sanofi’s existing insulin adjustment app, My Dose Coach, now has “over 4,000” users. The app, which requires a prescription, uses once a day fasting blood glucose (fingersticks) and insulin dosing measurements, along with hypoglycemic incidents, to adjust basal insulin dosing for people with type 2 diabetes. A 12-week study in India (n=137 type 2s initiating insulin) reported an impressive 2.7% A1c reduction from a high baseline of 9.9%. Average insulin dose increased by seven units per day with no incidents of symptomatic low blood glucose or hypoglycemia hospitalizations. Despite these impressive results, My Dose Coach and insulin titration apps, in general, have been on the slower side to take off. The need for these apps is obvious, given how infrequently insulin doses are titrated to patterns and how often those patterns change.

  • It’s unclear whether this Abbott partnership will extend to Sanofi’s patch pump with pre-filled Sanofi insulin (a collaboration with Verily and Sensile Medical), which is still in development. If it does, FreeStyle Libre would be the first official CGM partner for Sanofi’s pump, though we’d expect Sanofi to work with Dexcom as well, given the companies’ existing partnership through Onduo. For Abbott, Sanofi would be its second closed loop pump partner, after Bigfoot.

  • Novo Nordisk’s connected pen ecosystem is further along, as it already has data partnerships with Abbott, Dexcom, Glooko, and Roche, and Medtronic was announced this morning. Novo Nordisk’s connected pens, NovoPen 6 and Echo Plus are already CE-Marked (October 2018) and were initially expected to launch in early 2019; as of this morning, the launches are now pushed back to “2020.” Presumably the company is taking time getting it right, and we hope the field does not rush to launch before it’s ready. A re-usable, Bluetooth attachment for disposable pens is also in development, though this morning’s Medtronic partnership left it unclear if this will launch in 2020 or afterwards. Novo Nordisk also has not given any updates on its app/decision-support play, though it is partnered with Glooko and IBM Watson on these fronts. In general, the company has taken a more partnership-based approach, as it “wants to integrate with solutions on the market instead of developing our own copies of what’s already available” – that’s very good news and smart, since digital health is now simple play for pharma. The company may eventually develop its own “solutions for personalized treatment guidance,” potentially an opportunity to utilize its IBM Watson partnership and deliver tailored insulin dosing advice based on exercise, food intake, past personal data, and population trends (“people like you tend to do X in a situation like this”).

  • With its Cambridge Innovation Center, Lilly has taken an independent approach to its ecosystem, with its connected pen submitted to the FDA as of 1Q19. We aren’t sure whether a pen attachment or pen with connectivity built-in was submitted, but at Lilly’s Diabetes Blogger Summit in May 2018, Lilly was focused on a device that fits onto the disposable KwikPen. Lilly’s smart pen will launch with Dexcom first, though there is certainly the potential for other partners, and Abbott’s FreeStyle Libre was mentioned at the time. The company’s “Integrated Insulins Management” system will include a dosage guidance app that uses data from Lilly’s disposable smart pen, in addition to CGM, BGM, and other sensors. Lilly is also working on its own insulin pump and hybrid closed loop system, utilizing an algorithm licensed from Class AP. Dexcom is a development partner for Lilly’s hybrid closed loop, and we assume that will progress into a commercial partnership. Lilly is also an investor in Companion Medical, which technically gives it both disposable and reusable pen form factors.

  • Companion Medical’s reusable InPen, compatible with Novolog and Humalog prefilled cartridges, has been the only connected pen on the US market since December 2017. As of January 2019, InPen’s user base was “nearly 2,000” and since then, Companion has seen strong momentum with retail availability in April and announced partnerships with Dexcom, Glooko, and Rimidi in June. At the end of 2019, the company is planning on expanding its manufacturing capacity to build 10,000 pens/month.

Abbott’s Smart Insulin Pen/Titration Strategy and Competitors’ Partnerships

Abbott’s partnership with Sanofi is its third in the connected pen landscape, after inking a deal with Novo Nordisk in February and Bigfoot in 2017. So far, Abbott hasn’t indicated any intention for using insulin injection data to build its own insulin dose decision support apps, though even simple integrations, such as overlaying insulin doses over CGM traces, would be a major win for users. Abbott told us today that the companies will “provide a connected device experience that will enable users to see their glucose and insulin dosing information in one place.”

Abbott is also partnered with Bigfoot to develop an insulin titration solution for smart pen users (Unity) and a hybrid closed loop (Autonomy) – as of June, Bigfoot had pivoted to focus on Unity, with a product launch expected in 2020. (It has been delayed for years, so it’s unclear whether that timeline will be hit.) We will be very interested to see improvements in outcomes designed to be delivered from decision support for MDI + CGM users – how close can they come to pump-based hybrid closed loop systems? Abbott also has a partnership with Livongo to use Libre Pro with Livongo for Diabetes members “when appropriate and prescribed.”

  • Dexcom continues to boast a very strong set of partners, including all “Big 3” insulin manufacturers (Lilly, Novo Nordisk, Sanofi via Onduo), Insulet, Tandem, Beta Bionics, Diabeloop, Tidepool, Glooko, Companion Medical, etc. In the connected pen arena, Dexcom has stated Dexcom/Novo Nordisk will “give advice” using injection and CGM data, potentially utilizing MDI algorithms from Dexcom’s August 2018 acquisition of TypeZero. Dexcom is also working with Lilly’s “Integrated Insulin Management” solution, which will include an insulin titration app. Sanofi and Dexcom have not officially partnered for Sanofi’s connected pens, but it seems likely given the companies’ existing collaboration through the joint venture (With Verily) Onduo; as of last November, Dexcom became the preferred CGM partner for Onduo. Companion Medical and Dexcom announced a partnership in June to incorporate injection data into Dexcom’s Clarity phone app and web dashboard. In automated insulin delivery, Dexcom has agreements with Insulet, Tandem, Tidepool, Beta Bionics, and Diabeloop; Tandem’s Control-IQ algorithm has already been submitted to the FDA and is expected to launch in 4Q19 and of course many users of DIY Loop are already familiar with AID being powered by Dexcom.

  • Medtronic continues to lag behind Abbott and Dexcom in partnerships, as its collaboration with IBM Watson Health, Sugar.IQ, is its main decision support offering. Medtronic (and IBM Watson Health) have both invested significantly in Sugar.IQ, adding on hypoglycemia warnings (up to four hours in advance) in January. Medtronic also acquired food-logging app Nutrino in 2018, which adds nicely to sources of data for Sugar.IQ’s predictive algorithms. As of 2Q19, “basic” CGM-based insulin dosing guidance, a predictive trace, and some insulin dose advising were scheduled to come to Sugar.IQ by April 2020. Medtronic partnered with Novo Nordisk today to integrate the latter’s smart pen offerings with its CGM data; insulin titration plans were not shared, though presumably that is the ultimate goal.

Close Concerns’ Questions

Q: What is the status of Sanofi’s connected pens and titration apps? When is regulatory submission expected? Where will they launch first? How far behind is Sanofi relative to competitors? How will Sanofi’s smart pen features compare to Companion, Lilly, and Novo Nordisk? What form factor will win in the market – disposable smart pens (with a dose capture attachment) or durable smart pens? Screen or no screen? Rechargeable or not?

Q: When will Novo Nordisk’s and Lilly’s connected pens launch? How much will the insulin companies invest in connectivity and titration vs. molecule innovation? How much near-term upside is there on the smart pen and connectivity fronts – On outcomes? On HCP hassle? On new business models? On revenue and profit?

Q: Does Abbott have plans to build out its own insulin dose decision support software? Or will it focus on providing FreeStyle Libre data for partners to do this? How will Abbott’s partnerships and digital offerings compare to Dexcom and Medtronic?

Q: Will Abbott and Sanofi work together in sales, marketing, or other aspects of Sanofi’s connected pen efforts when they launch?

Q: Are there plans for Sanofi to integrate with other CGM partners? Other data partners (e.g. meal logging apps, heart rate trackers)?

Q: How far along is the Sanofi/Verily/Sensile Medical patch pump? Is it included under the partnership?

 

--by Albert Cai, Adam Brown, and Kelly Close