This afternoon, Companion Medical announced that its Bluetooth-enabled, reusable InPen has received a CE mark for both iOS and Android use, and initial European commercialization is expected in 2019. The EU approval comes later than originally expected (“end of 2017” and then “2Q18”), perhaps reflecting the novel product category or simply unexpected snags. All this is new – we’re excited to watch it move forward.
In a Q&A with the company, we learned that they will go through distributors, though this is subject to change based on “possible strategic relationships” – will Series B investor Lilly become involved? In addition, “at least” Humalog and Novolog cartridge compatibility will be on tap at launch (Apidra cartridges are also available in Europe), and the current plan is to ship each InPen with a Bluetooth-enabled AgaMatrix BGM (as in the US, but “subject to change for regulatory, country-specific, reimbursement, or other reasons”).
Companion hasn’t determined which markets it will enter first (depends on the distributors selected), nor pricing and reimbursement. In the US, an impressive ~70% of purchases are being reimbursed with an average co-pay of $50-$60 nationwide, but Mr. Saint said Europe “is a different landscape.” As a reminder, the pen lasts a year (that seems like a long time).
One thing we can say about the European landscape is that demand for a connected, reusable pen could be as big or bigger than in the US. The press release notes that “durable insulin pens are particularly well utilized in Europe,” and that insulin pump therapy “comprises less than 10% of US insulin delivery and even less in Europe.” (The latter obviously includes people on basal alone, which Companion doesn’t service at the moment.) Those on syringes/injections do not have accurate, passively-collected logs of insulin use, nor do their providers; we’re excited to see that change as this nascent market gets built. Plus, as decision support is built out for injection users, we expect uptake of smart pens to accelerate.
Companion isn’t the first smart pen to enter the EU – Novo Nordisk’s NFC-enabled Novo Pen 6 (piloting in Sweden and shown at ADA), Pendiq’s reusable pen, Emperra’s ESYSTA smart pen (+app), Insulclock’s smart cap, and Biocorp’s Easylog attachment (CE-marked, expected to launch in 2018) are all on or about to be on the market in some capacity – but Companion will be the first to our knowledge to offer an intuitive app, bolus calculator, plus great reports (Insights by InPen) with built-in CGM data.
Companion announced FDA 510(k) clearance for an Android InPen app last week, with a US launch expected by 4Q18. The CE Mark covers both iOS and Android – a definite win as the latter is more popular in Europe.
When asked about US retail pharmacy launch (InPen is currently only available through mail order), Mr. Saint responded: “For the moment we are focusing on providing the best experience we can to each customer. We lose that control when going to retail. We will continue to provide the high-touch model for the time being.” This is a smart move from our perspective – when growing a new category, it is crucial to retain strong reputation and goodwill in the early users. Limited launches are now the norm in diabetes – e.g., BD FlowSmart set, MiniMed 670G, Dexcom G6, Omnipod Dash, Guardian Connect – and we think that will only continue!
Some of the biggest questions in this field surround product design tradeoffs (reusable smart pen with cartridges OR disposable pen with reusable cap?; screen or no screen on the device?), business models and reimbursement, dosing decision support inputs/outputs, and outcomes comparison to closed loop with a pump. We also wonder how much the insulin companies will drive this market with their own products vs. startups like Companion, Common Sensing, and Bigfoot…
-- by Brian Levine, Adam Brown, and Kelly Close