Memorandum

Senseonics and Beta Bionics enter into development agreement to integrate Eversense implantable CGM with iLet Bionic Pancreas – June 7, 2018

Executive Highlights

  • Senseonics today announced a development agreement to integrate its Eversense implantable CGM with Beta Bionics’ iLet Bionic Pancreas system. The partnership is a clear win for both companies – Senseonics is now involved in two automated insulin delivery systems (the other being Roche/Senseonics/TypeZero 180-day hybrid closed loop system) and Beta Bionics is the only AID system so far with two partnered CGM companies (the other being Dexcom). We emphasize this is not a commercial agreement, though it’s a wonderful sign of both companies’ goals to propel patient choice in CGM sensors within AID – excellent!

  • We’ve expected this announcement for about six months. MGH’s Dr. Steven Russell shared comparative accuracy data at IDF highlighting Eversense’s superiority to Dexcom’s G5 and Abbott’s FreeStyle Libre Pro, while both Dr. Russell and Dr. Damiano advocated for FDA approval of Eversense at the FDA Advisory Committee in March.

Senseonics today announced a development agreement to integrate its Eversense implantable CGM with Beta Bionics’ iLet Bionic Pancreas system. No deal terms or launch timing were shared, and this will obviously need to advance to a commercial agreement at some point.

The partnership is a clear win for both companies – Senseonics is now involved in two automated insulin delivery systems (the EU pivotal trial for the Roche/Senseonics/TypeZero 180-day hybrid closed loop system is slated to begin in 2H18) and Beta Bionics has become the only AID system so far with two partnered CGM companies (Dexcom’s G5 will be used in the home study of the insulin-only Bionic Pancreas announced in May).

We were encouraged by comments in the press release from Beta Bionics CEO Dr. Ed Damiano, who noted: “We are excited to partner with Senseonics to help make the iLet Bionic Pancreas system a platform of choice for people with diabetes – one that will ultimately allow people to choose between multiple CGMs, to choose between multiple insulin types, and to choose glucagon.”

We love this idea of a system approved with many different components, allowing patients freedom to select their preferred devices and therapies – this is especially true with CGM, where form factors are going to get more diverse. Given the newly created 510(k) FDA pathway for integrated CGM (iCGM), obtaining a single approval for a multi-CGM AID platform may not require two PMAs or pivotal trials. In fact, at the JDRF/HCT Interoperability meeting, MGH’s Dr. Steven Russell proposed that approval for an AID system with an iCGM might be obtained with data from just one representative iCGM; other iCGM devices could then be added without any further clinical data. FDA’s Dr. Courtney Lias responded that such a process is “potentially possible,” though obviously this iCGM framework is new and we’ll have to see what happens. It’s possible Beta Bionics would use both CGMs in its pivotal trials, or choose one and add the other via the iCGM pathway.

As of the last update, Beta Bionics expects to launch its insulin-only system in 2020, with a pivotal slated to start around April 2019.

  • Per Senseonics’ 1Q18 call, it plans to submit a PMA supplement for iCGM classification of its 90-day sensor following FDA approval of Eversense. From our read of the labels/studies to date, Senseonics’ 90-day Eversense is the only other CGM (besides Dexcom) to currently meet the FDA’s rigorous iCGM accuracy specifications. By the time the Bionic Pancreas system comes to market, it’s possible Senseonics’ 180-day-wear Eversense XL may be FDA approved/cleared.

  • We’ve largely expected this news since December, given MGH and Beta Bionics’ expressed interest in Senseonics’ Eversense. In a Roche symposium at IDF, Dr. Russell shared compelling accuracy data from a six-week outpatient Bionic Pancreas study comparing Senseonics’ Eversense, Dexcom’s G5, and Abbott’s FreeStyle Libre Pro head-to-head-to-head. Based on the strong Eversense performance – it was statistically superior to G5 and Libre Pro – MGH and Beta Bionics shared that they were “exploring” the device as an “additional sensor option.” Dr. Russell also gave insightful, impassioned comments on the unmet need for CGM on behalf of Senseonics at its FDA Advisory Committee in March, while Dr. Damiano advocated for Eversense in the open public hearing. Lastly, at the GTC Bio Diabetes Summit, Dr. Russell highlighted accurate CGM as one of the three primary challenges facing Beta Bionics’ bihormonal bionic pancreas, another reminder of why Eversense is an attractive option.

Close Concerns’ Questions

Q: Will Beta Bionics be able to negotiate commercial agreements with two CGM manufacturers? As a reminder, Bigfoot and Dexcom originally had a “development agreement,” but then Bigfoot switched to Abbott – presumably because Bigfoot/Dexcom could not agree on commercial terms. Can Beta Bionics make it happen?

Q: Will the iCGM pathway simplify the regulatory process for AID systems compatible with more than one CGM? Or will companies still need to do trials with each CGM system?

Q: Will CGM ultimately move to exclusive/preferred arrangements with payers, like we’ve seen in BGM and are starting to see in pumps? Or will reimbursement largely stay as it is now, where payers mostly cover all CGM devices and the patient/HCP can choose? If preferred arrangements become more likely, having a multi-CGM AID system will be very important to ensure broad access.

 

-- by Maeve Serino, Adam Brown, and Kelly Close