Memorandum

Unilife debuts pre-filled, Bluetooth-connected Imperium patch pump for insulin-dependent type 2s; seeking insulin partners – July 31, 2015

Executive Highlights

  • US-based Unilife (who’s Unilife? See below!) announced the debut of a pre-filled, ready-to-use patch pump with Bluetooth-capabilities for insulin-dependent type 2 patients. The pump has a V-Go-like form factor and will be made available in multiple versions with customizable reservoir sizes and preset basal and bolus rates (no specifics disclosed). Pictures are here and see a video here.
  • To enable a pre-filled device and leverage existing distribution channels, Unilife plans to collaborate with one or more insulin providers. Sanofi has existing partnerships with Unilife outside of diabetes, though multiple partners are possible.
  • The ambitious goal is compatibility with the reimbursement model for prefilled insulin pens, but the convenience of a pump.
  • While Unilife has not disclosed potential launch timeframes, we estimate a potential launch is about two to three years away. The Imperium has yet to secure approval in the US or EU, since this will be done under a collaboration with the relevant insulin partner.

In a surprise move, Unilife announced yesterday the debut of a new patch pump, the Imperium, for insulin-dependent type 2 patients on basal-bolus therapy. The disposable device is designed for multi-day wear, comes pre-filled and pre-assembled (no priming required),and has the capability to be Bluetooth-paired to a smartphone app that can provide patient reminders and track insulin delivery data – in our view, pre-filled and Bluetooth capability would be distinct advantages over the V-Go, PaQ, Finesse, and OmniPod if this vision could be realized and payers would reimburse. Imperium’s rectangular on-body form factor resembles the Valeritas V-Go (see pictures here), features on-demand bolus delivery via the push of a button, and will be customizable in multiple versions with different reservoir sizes and preset basal and bolus rates (no specifics disclosed). Unilife’s ambitious goal is compatibility with the reimbursement model for prefilled insulin pens – the aim is for patients to get the pre-filled device just like a pen through existing distribution channels, paying a similar co-pay. It’s a tall order given the integration of Bluetooth, but perhaps with enough volume this is possible. We assume a launch in ~2017-2018 is feasible, though this is highly dependent on securing one or more insulin partners, and gaining regulatory approval.  

Partnership is mission critical for Unilife, who has long pursued a business model based on the production and supply of its products to pharmaceutical companies ready for filling and packaging with injectable drugs – Imperium is designed (presumably theoretically) to be supplied to an insulin manufacturer, who will fill the device with their insulin and take the finalized drug-device combination product through regulatory approval (likely a standard 10-month NDA) and commercialization. Sanofi is likely to be in the mix, considering the companies' 15-year agreement for Unilife to be the sole provider of cartridge based wearable injectors for all of Sanofi's large dose volume drugs – this original deal excluded insulin. This product could fit well with Afrezza’s broad aim to simplify insulin delivery. Of course, Novo Nordisk and Lilly are certainly strong targets as well, and Unilife is not necessarily looking for exclusivity. The press release makes specific mention of the device’s high precision that enables compatibility with U-500 insulin, making us wonder if Lilly would be particularly eager to jump on board.

Ultimately, it is very tough to speculate on the technology’s potential given Unilife’s stealth progress, small size (market cap: $245 million), and the need to secure an insulin partner. The device’s two key features –pre-filled and potential Bluetooth capability – are advantages over competitive offerings in our opinion, though this will come to market much later than those devices. Will one of the insulin players sign on? How long will regulatory take? How expensive is manufacturing and what will patients pay out of pocket? How will Imperium fit in the existing reimbursement model for pre-filled disposable insulin pens? Below, we include details on the company’s competition along with background on Unilife.

  • Who is Unilife? The company is a small (market cap: $245 million), US-based supplier of injectable drug delivery systems. Unilife has been listed on the NASDAQ stock exchange since 2010. Unilife has historically specialized in multiple sectors of the injectable drug delivery market, such as prefilled syringes, ocular delivery and auto-injectors. Within the diabetes market, the company signed a 15-year supply agreement with Biodel in June 2013 for a customized dual-chamber auto-reconstitution device for its in-development glucagon product. The company does not have any other disclosed projects in the diabetes space. However, we understand that senior leadership has some experience in the field, such as Senior Vice President Mr. Ian Hanson, who previously worked at Medtronic where he was involved in the commercialization of multiple insulin pumps.  
  • The patch pump market is a relatively underpenetrated ecosystem, despite what we see as a very positive ROI. Unilife estimates that the number of type 2 patients in the US and Europe injecting multiple times per day that remain uncontrolled will increase from four million today to nine million patients by 2035 – we aren’t sure about the source of their estimates and while we agree the population of uncontrolled patients is growing, we do also think GLP-1/basal insulin mixes will help. That said – the area needs a LOT of help and there is a lot of room for good products.  According to Unilife, the revenue opportunity will consequently grow to ~$600 million in 2020 (assuming 10% penetration among type 2s) and ~$1.9 billion in 2025 (assuming 25% penetration) – the 25%, even of type 2s who are on MDI that are uncontrolled, sounds bit high to us but of course for great products that are reimbursed, anything is possible.
  • With Bluetooth and pre-filled insulin, Unilife’s Imperium has some points of  differentiation from existing (and soon-to-be) competitive offerings in type 2 diabetes. Of course, a developed device announced on a conference call vs. a commercialized product are two very different things, and getting the economics to work out is not easy. Note that this list of patch devices excludes devices that are not focused on the type 2 space – e.g., Roche's Solo MicroPump and Cellnovo’s patch pump.

Patch Delivery Device Competitive Landscape

Company/Pump

Details

Status

Valeritas V-Go

-24-hour wear
-Fully disposable
-20, 30, 40-unit basal rate
-2-unit boluses (36 units max)
-Reservoir max: 76 units

- Manual fill, though pre-filled is in the pipeline

Commercially available in the US; IPO was postponed in March

CeQur PaQ

-Three-day wear
-Combination disposable/reusable
-16, 20, 24, 32, 40, 50, 60-unit basal options
-2-unit boluses
-Reservoir max: 330 units

- Manual fill

EU launch in 2016.

 

FDA 510(k) submission expected in 2015, with potential 2016 launch

J&J/Calibra Finesse

-Three-day wear
-Fully disposable

-Very low profile design
-Bolus-only (1 or 2 units)
-Reservoir max: 200 units
- Manual fill

Launch in 2016

BD

Interest in smaller patch devices targeting MDIs.

Opened advanced diabetes care facility earlier this month to develop products

 

 

Full Featured Patch Pumps Targeted at Type 2 Diabetes

Insulet OmniPod for use with Lilly’s U500 insulin

-Three day wear
-Disposable pod, reusable PDM controller
-Customizable basal/bolus

-Redesigned handheld interface for use with U500 insulin
-Reservoir max: 200 units

Clinical study was slated to commence in 2015, though no updates for some time

Debiotech JewelPump2

-Three-day wear
-Disposable patch pump, reusable smartphone controller
-Customizable basal/bolus
-Reservoir max: 800 units

Debuted JewelPump2 at ATTD 2014

SFC Fluidics

-Small on-body footprint,
-350-unit reservoir,
-Basal/bolus delivery via a wireless Bluetooth-enabled controller
-Dosing in 1/100 of a unit using microfluidics technology

FDA submission expected in early 2016 and US launch could occur by the end of 2016.

   

               -- by Varun Iyengar, Adam Brown, and Kelly Close