The notion of "peel and stick" just got a new meaning in the Diabetes World with the advent of Imperium, a unique new prefilled patch insulin pump being developed by Pennsylvania medical device company Unilife Corp, which makes injectable medication delivery systems. The company announced its plan for this new device on July 30.
Through an OEM-type business model, Imperium will not be marketed and sold as its own brand, but rather by the insulin companies themselves -- similar to the way they license insulin pen devices and sell them as their own products.
Imperium's design is in many ways similar to the V-Go patch pump by Valeritas and the CeQur PaQ device. While it appears largely aimed at the type 2 audience, Unilife does seem to be pitching this as a "game-changer" for all of the diabetes world, including those of us with type 1 who often use more nuanced basal-bolus commands than what these patch pumps allow.
Here are some key specs on this new Imperium:
- Design - similar to other patch pumps including the OmniPod, it has an adhesive on the back that you peel the paper off to reveal the sticky part. You just stick it on your skin and push a button, which inserts the cannula.
- Wear - you can keep it on for 2 or 3 days.
- Capacity - it holds up to 150 units of typical U-100 insulin. (Higher concentration insulins would pack more power in that capacity, of course).
- Bolusing - you push a button to deliver two units at a time.
- Product - as noted, Unilife 's business-to-business model means insulin manufacturers like Lilly, Novo, or Sanofi would pre-fill the Imperium, package and sell it directly to distributors, providers or patients with their own brand name.
We were a bit unclear about the basal / bolus capabilities here, and had many more questions for Unilife, so we reached out to Stephen Allan, Unilife's Senior Vice President of Strategic Planning. Here's what he tells us:
DM) First, tell us about the Imperium and how that name came to be?
SA) In Latin, the word "imperium" means "command" and that was inspired by the company's desire to help empower patients to achieve better diabetes health using this device.
Does it work like a traditional pump, delivering a continuous basal stream and also allowing bolus doses for meals and higher blood sugars?
It will be pre-set to a customer, insulin and target patient product requirement for continuous infusion. Likely a few different preset rates will be available. The user will control bolus delivery on an on-demand basis via the push button user interface.
What's the setup for getting started with Imperium, or changing it out?
Once Imperium is removed from its packaging, only three simple steps are required to initiate continuous subcutaneous insulin infusion. We call these three steps Peel, Stick and Click. All you have to do is peel off the liner from the device, apply it onto the body, and then push the button once to start basal therapy. There are no filling or priming steps required by the user.
How do bolus doses work?
On-demand bolus delivery occurs via the simple push of the button on Imperium. The user presses and holds the button to enter the bolus mode. They then click the button for two units of insulin bolus infusion. Once insulin delivery is complete, the patient will be alerted with an audible tone and light providing visual indication.
How many actual units of insulin does it hold? Like the OmniPod and other insulin pumps have cartridges or reservoirs that hold up to 180, 200 or 300 units...?
If U-100 insulin is chosen, then it's current base model format will hold 150 units of insulin. However it is likely that our appointed insulin partners will leverage the prefilled, preassembled design of Imperium to allow the safe delivery of concentrated insulins up to U-500. If a U-200 insulin is filled into Imperium for example, it would hold 300 units while still maintaining the same compact form factor. Because Imperium is a high-precision device, designed to accurately deliver concentrated insulins up to U-500, up to 750 Units of insulin would be possible.
Can you refill it?
No, it comes with a single dose at a preset rate for infusion, and it’s disposed after use.
How do you view data from this device?
The fundamental architecture of Imperium is designed to leverage robust communication protocols to simplify data transfer and to allow patients to quickly retrieve data. For example, a user of Imperium could receive alerts for when it is time to attach a new 3-day wearable device, as well as the current status and history of insulin administration. Our hope is that the insulin providers that utilize this technology will continue to follow the lead of other developers and enable open source solutions like Tidepool to give patients control over their data.
And will it communicate with meters or CGMs?
Imperium has the capability to have integrated data connectivity features such as Bluetooth LE. A range of data options regarding insulin delivery would be available. The decision regarding what data is available to be shared to authorized parties, and the form factor that is used, will be based on the existing infrastructure of our appointed insulin partners.
How would pricing work, if each insulin maker is responsible for selling it individually?
It’s designed to fit into a price structure that would fit into the same model for reimbursement as prefilled disposable pen therapies -- and also the same sales and distribution channels as per insulin pen therapies. The insulin provider will be responsible for setting final prices.
Why is Unilife getting into the insulin pump business?
This was precipitated by our market success with other wearable injection systems. Several years ago, we started developing simple-to-use wearable solutions for the delivery of larger-dose volume biologics. The clear unmet need in that market was a device solution that would enable patients who are not as familiar with injections as those with diabetes to safely and simply administer their therapy at home or wherever else they are during a normal day.
We created a lot of knowledge and IP during this process that we knew could add value within other under-served markets, including diabetes. In addition to our team members having led the development of several durable insulin pumps that are now on the market, we also know first-hand the challenges faced by many friends and family with diabetes.
Did you consult people with diabetes in designing this?
Yes, we consulted with people with diabetes and other industry thought leaders through a number of channels.
First, when developing Unilife’s wearable solutions, including Imperium, we studied the way in which patients respond and interact with devices for the purpose of self-administration. What we quickly found, regardless of the disease state, was that the device needed to be as safe, simple and convenient as possible. One area where patients had difficulty was in the set-up of devices, which led to our insight that neither the patient nor their healthcare provider should need to fill the device with the drug before use.
One of the unique and rewarding parts about this kind of human factors analysis and market research was our interaction with patients. Not surprisingly, people with diabetes have, on average, significantly more experience with medical devices than many other patient populations. They were able to more easily express the ways in which a device would unburden their daily lives – this type of interaction was critical in developing the Imperium product.
Second, the Imperium design team is built around some of the best and brightest engineers with decades of industry experience from diabetes leaders, such as Medtronic and Animas. Their experience with the diabetes device market, and years of first-hand interactions with patients, endocrinologists and other diabetes industry leaders, was crucial in our ability to efficiently identify the key elements that would make living with diabetes more manageable.
It's great that you see a need, but this is a tough market -- as you can see from the recent closure of Asante Solutions that made the Snap pump. How can you compete?
There are several important things necessary to ensure an insulin patch pump solution is widely embraced within the type 2 diabetes market. Ultimately, we believe this device category needs to combine the therapeutic advantages of an insulin pump with the low cost and convenience of prefilled, disposable pens.
The current generation of insulin pumps has not been widely embraced within the type 2 market in particular due to device complexity, reimbursement constraints and high out-of-pocket cost for patients. With Imperium, we’ve made it simple for patients to commence insulin therapy.
We also recognize that it’s not efficient for an insulin pump company to have to go out and create its own team to sell and market the device. It’s better to use existing sales and marketing channels established by insulin providers, such as those that are used today with insulin pens. Unilife intends to partner with one or more established diabetes market leaders who will supply Imperium, prefilled with their insulin brand under one prescription. That means we can leverage the established channels of our partner, and also minimize our own costs. Because Imperium is prefilled and preassembled with insulin, it represents the only patch pump technology to our knowledge that allows insulin providers to leverage their own established diabetes sales and marketing channels.
Because of these and other factors, we believe Imperium is well-positioned to allow a selected insulin partner or partners to supply a complete basal-bolus insulin therapy directly to the patient under a single prescription at a price that is as attractive for reimbursement as prefilled pens.
Where are you in development, and getting this to the FDA for regulatory review?
The Imperium platform has been developed, and we are working with prospective pharmaceutical partners to customize it to best meet the needs of their target markets. By and large, it is our pharmaceutical customers who are responsible for shepherding the regulatory approval process for drug-device combination products. For the majority of our customer collaborations, we expect the regulatory pathway for our devices and their drugs will be intertwined. Therefore, it is likely that you will first hear about regulatory milestones when our customers provide this information. Regardless, we are working very hard to ensure this technology reaches the market in an efficient manner to ensure it can have the broadest impact possible.
Wait... the insulin makers develop insulin. Wouldn't it be your responsibility to get any device you're developing approved by the FDA?
Unilife supplies injectable drug delivery systems that fit seamlessly into the filling, packaging and regulatory processes used by pharmaceutical customers for their drug-device combination products. Specifically, our products are supplied to customers as sub-assembly components, with the device only becoming complete once it has been filled and packaged with the injectable drug.
Unilife does not supply rigid products under a one-size fits all model. All of our products are customized to the specific drug, patient and commercial requirements of the customer. During our regulatory review process, the primary mode of action is determined based on the risk characteristic of the individual “system” that is being provided to a customer for a target therapy and patient population. The primary mode of action and label claims for a combination product using Imperium will be reviewed in collaboration by Unilife, our pharmaceutical partner and the FDA to determine which center will be the lead reviewer. This process will ultimately define the classification and FDA review pathway for each system utilizing Imperium with a target insulin product.
What about clinical trials, which are standard in getting any device or medication approved for patients?
With respect to clinical trials, Unilife believes it is unlikely that additional clinical trials will be required prior to regulatory approval because there are existing cleared predicate pumps on the market. However, our pharmaceutical partners may consider the use of Imperium in their own clinical studies to develop specific claims and demonstrate other potential improved outcomes.
It's an interesting proposition to help the Big Insulin Makers quickly create and market their own prefilled patch pumps. What kind of response are you getting so far, as you work with these customers to approach FDA?
This approach is consistent with the combination product submission approach that we are taking with other pre-filled products in our portfolio. Unilife has a number of products that are in various stages of combination product review with agencies as part of the combination filing. We cannot provide information with regards to the regulatory progress of our partners. In most cases, we expect they are the ones whom would first provide an update on achievement of any regulatory milestones.
Unilife is confident, we'll give them that. They truly believe their system will entice Big Pharma companies like Lilly, Novo and Sanofi to invest not only in their product, but in regulatory review, and yet that won't require clinical studies.
In our opinion, this is either a brilliant strategy or one doomed to crash and burn, depending on the quality of the product and how anxious the insulin makers are to get into the patch pump business. This is one to watch, for sure.