Memorandum

Sensile Medical, Verily, and Sanofi to develop and commercialize “all-in-one” pre-filled, connected type 2 patch pump – August 13, 2018

Executive Highlights

  • Toward the end of ADA 2018, Sanofi/Verily and Sensile Medical announced that they intend to develop and commercialize an “all-in-one” connected patch pump together. No development timeline was shared, but the device would target type 2 diabetes, come pre-filled with Sanofi insulin, and leverage Sensile’s micro-pump technology. Verily will supply “micro-electronic integration” and digital health expertise. Notably, this is a “development and commercialization” alliance, the latter implying more confidence than just a development agreement alone.

  • Sensile has a number of pharmaceutical delivery devices in development, including a 3 ml patch pump designed for a “Top 25 Pharma” customer, which could be the technological basis for this strategic alliance. The device has a durable and disposable component, auto-insertion, pre-programmable basal and bolus delivery, what appears to be just two buttons, and is driven by a rotary piston pump.

  • The announcement marks Sanofi’s official public entrance into connected insulin delivery devices, joining Lilly (pump/pens) and Novo Nordisk (pens). Given Verily’s existing diabetes projects, we could see this pump integrating with Dexcom-Verily CGMs, delivering insulin in an automated fashion, and/or being delivered to individuals who can benefit through Onduo’s “virtual diabetes clinic.” To date, Onduo (Sanofi/Verily) have focused more on care models (virtual clinic) and integrating others’ diabetes devices, so this patch pump represents a notable strategic move.

In the fray of ADA’s 2018 Scientific Sessions, Sanofi/Verily and Sensile Medical announced a strategic alliance to develop and commercialize a type 2 diabetes-oriented, connected insulin patch pump. The device is being positioned as “all-in-one,” referring to the fact that it will come pre-filled with Sanofi insulin (presumably Apidra or Admelog, the latter being a biosimilar to Lilly’s Humalog). No launch timing has been provided by any of the involved companies.

Switzerland-based Sensile will provide the micro-pump technology, Sanofi will provide insulin, and Verily will bring its experience in “micro-electronic integration” and digital health technology.

Sanofi and Sensile have not provided details and neither has its own insulin pump on the market. Sensile has yet to receive regulatory clearance to market any products, though does have a rich pipeline of subcutaneous drug delivery devices including patch pumps (20 ml, 3 ml, and 0.6 ml), a tubed pump (20+ ml), an automatic drug reconstitution system, and a pen injector.

Sensile’s 3 ml tubeless patch is currently in the “design output” phase, and its pipeline page says the customer target is a “Top 25 Pharma” – this could very well be referring to Sanofi, though this connection is not stated explicitly. The device is comprised of a durable and a disposable component. Both components together (left) and the disposable unit alone (right) are pictured below. It has an integrated auto-inserter, variable and pre-programmed dosing, and basal and/or bolus delivery. We’re not sure of the pump’s dimensions, as the website just indicates that the reservoir holds 3 ml (the Omnipod holds 2 ml). The size looks pretty similar to Roche’s Accu-Chek Solo. The on-pump user interface is limited, with what appears to just be two buttons – presumable for an on-device bolus. It’s unclear whether the patch would also be controllable by a mobile app. All of the pumps are based on a “micro volumetric rotary piston pump,” dubbed Sensile’s “SenseCore Technology.”

From a competitive standpoint, this patch pump product would enter a still early-stage (but very promising) type 2 insulin delivery market, including Insulet/Lilly’s U500 and U200 Omnipods, BD’s “Swatch” patch pump, CeQur (both PAQ and the newly-acquired Calibra Finesse; the latter’s name will change before launch), and Valeritas’ V-Go. Though Roche has not positioned its Solo patch pump (currently in controlled EU launch) for type 2s specifically, we notice many design parallels between it and the Sensile pump. With Lilly’s proprietary pump and smart pens and an active pilot of Novo Nordisk’s NFC-enabled Novo Pen 6, Sanofi also joins its competitors in publicly disclosing development of connected insulin delivery devices. This is excellent to see, as prefilled, connected patches would be very compelling from a simplicity and outcomes perspective.

The potential for this alliance is great, given the involved parties’ expansive global reach, entrenchment in diabetes, and technical know-how. For example, we could see integration with CGMs (including the fully-disposable Dexcom-Verily CGMs), automation of insulin delivery for type 2s, and possibly even offering to individuals who could benefit through Onduo, Verily and Sanofi’s joint venture. The press release also mentions potential use of the pump in type 1 diabetes, though the clear focus is on type 2.

  • In a Sanofi article that references the Sensile-Verily pump project, Mr. Stefan Oelrich (Sanofi’s Head of Diabetes and Cardiovascular) suggests that pumps are only used by “around 1 in 1,000 people with diabetes.” That estimate is actually low, as it only implies ~425,000 pumpers worldwide; Medtronic’s 2018 Analyst Meeting actually estimated ~1.1 million pumpers worldwide, with its market share at ~70% (~800,000 Medtronic pumpers).

 

-- by Brian Levine, Adam Brown, and Kelly Close