Animas Closes Operations and Exits Insulin Pump Market

By Adam Brown and Kelly Close

What are the options for approximately 90,000 Animas pumpers worldwide and for others considering a new pump? What does it mean for the pump market and patient choice?

On October 5, Johnson & Johnson (J&J) announced in disappointing news that Animas is closing operations and exiting the insulin pump market, affecting approximately 90,000 Animas pumpers worldwide.

Click to Jump to FAQs:

• I’m an Animas user – what does this mean for me?

• My warranty hasn’t expired yet. What can I do?

• My Animas pump warranty expires after September 30, 2019 (i.e., pump is 0-2 years old). What can I do?

• What pumps are currently available in the US? What is coming soon, especially with automated insulin delivery?

Effective immediately in the US and Canada, Animas will no longer manufacture and sell the Vibe and OneTouch Ping insulin pumps, and will continue to offer supplies, customer service, training, and warranty support through a transition period. “Partner-of-choice” Medtronic will take over Animas supply reordering and support in the “next few months.” The companies will send an email with more details soon. We’d assume Animas’ exit is also coming very soon in other countries besides the US and Canada. 

For now, Animas pumpers can stay on their Animas pumps and continue to access supplies, and will need to decide what pump to move to next – see below for the different options between Medtronic, Insulet, and Tandem in the US, depending on preferences and warranty timing. For those who acquired an Animas pump in the last two years, a free upgrade is only available to Medtronic's less advanced MiniMed 630G pump. Read an open letter from The diaTribe Foundation about this decision here.

Although the closing of the business is not unexpected – J&J has been considering a sale or partnership of the Animas business since at least January— whenever a diabetes company exits the market, patient choice and competition both decline. This news continues a string of challenges for insulin pump companies in the US, including Asante closing operations in 2015 (quickly purchased by Bigfoot just days later) and Roche halting new pump sales in the US in January.

Why did Animas decide to exit the market? The insulin pump market is fragile at present, with many companies competing for business, a rising bar for innovation, and very high expenses to offer all the necessary support. Unfortunately, Animas found it difficult to improve the One Touch Ping and Vibe pumps, and it lagged behind on automated insulin delivery, pump design, and connectivity.

J&J acquired Animas in 2005, a very exciting acquisition at the time. Animas actually could have been first to market with a hybrid closed loop, as it signed an automated insulin delivery partnership with JDRF way back in 2010; unfortunately, it did not move quickly enough and Medtronic’s MiniMed 670G came out ahead. Other companies are following at a faster pace than Animas was moving – see the pipeline below. For the approximately 410 Animas employees worldwide, we all salute your commitment to serving people with diabetes. Let's hope that other pump companies remain strong and keep the market competitive – innovation can only thrive when many players compete to offer the best products in a flourishing market.

FAQs

• I’m an Animas User – What Does This Mean for Me?

• My warranty hasn’t expired yet. What can I do?

• My Animas pump warranty expires after September 30, 2019 (i.e., pump is 0-2 years old). What can I do?

• What pumps are currently available in the US? What is coming soon, especially with automated insulin delivery?

1. I’m an Animas User – What Does This Mean for Me?

As noted above, your Animas supply reordering and customer support will move over to Medtronic in the next few months; expect an email with more details. The bigger question is your pump’s warranty expiration and what pump to move to. Here’s what you need to know:

• When did you acquire your pump? Pumps have a four-year warranty, meaning the “warranty expires” when four years have elapsed since you first got your pump. This will determine what options you have and how much you’ll have to pay to get a new pump.

• If your Animas pump is more than four years old now (or will be soon), you can shop the open market, evaluate ALL pumps currently available, pick the one you like, and get it billed through insurance. Contact each company for the insurance details and costs. Below, we include current products and key pipeline plans for Medtronic, Insulet, and Tandem. 

• If your Animas pump warranty expires before September 30, 2019 (i.e., your pump is 2-4 years old): Animas will honor your warranty until it expires, meaning if your pump breaks, it will be replaced with another Animas pump. Once the warranty expires, you can transition to whatever new pump you’d like (see above).

2. My warranty hasn’t expired yet. What can I do? If you want to change pumps before your Animas warranty expires, you can:

• Move to a Medtronic pump using the Switch2System program – cost depends on your circumstances.

• Move to Insulet’s Omnipod for no upfront cost using the Omnipod welcome program.

• If your Animas pump warranty expires on or before September 30, 2019, move to Tandem’s t:slim X2 for a one-time payment of $999, which can be credited to a new pump or might be refunded. More details on the Touch Simplicity Program are here.

3. My Animas pump warranty expires after September 30, 2019 (i.e., pump is 0-2 years old). What can I do? You can:

• Transition to a Medtronic MiniMed 630G for free beginning in May 2018. Note, this pump only offers threshold suspend (low glucose suspend). If you want to get the newer MiniMed 670G hybrid closed loop, you’ll need to explore your options by calling Medtronic.

• Transition to the Insulet Omnipod for no upfront cost using the Omnipod welcome program. 

4. I’m not sure if I want to change right now. What pumps are currently available in the US? What is coming soon, especially with automated insulin delivery?

Medtronic

• Currently offers the leading technology MiniMed 670G/Guardian Sensor 3 hybrid closed loop (automated basal insulin delivery to reduce highs and lows) – read more on it here. The MiniMed 630G is also available, but only includes threshold (low glucose) suspend. In the Spring, Medtronic plans to update the 630G from using the current Enlite sensor to the improved Guardian Sensor 3.

• Medtronic is also working on Bluetooth-enabled pumps and a future system that can deliver automatic correction boluses; there is no timing to report on either product.

Insulet 

• Currently offers the tubeless Omnipod, which has been growing in popularity with pumpers for years.

• The new touchscreen Dash handheld will be submitted to the FDA before the end of this year, enabling a possible launch in 2018. This has the look and feel of an Android phone, communicates with the Omnipod via Bluetooth, and will also relay data to a user’s own smartphone. Read more here.

• The Horizon automated glucose control (hybrid closed loop) system remains in studies, and as of the most recent update, is expected to launch in the US in 2019.

Tandem 

• Currently offers the attractively designed t:slim X2, which also can communicate with the Dexcom G5 CGM.

• A predictive low glucose suspend (PLGS) device is expected to launch next summer (2018), using the t:slim X2, Dexcom G5, and an algorithm to predictively suspend/resume insulin delivery (i.e., to avoid/minimize hypoglycemia). The pivotal PLGS study just started.

• A second-generation hybrid closed loop device with TypeZero is in development, with plans to launch by the end of next year (2018). 

Bigfoot

• Plans to enter pivotal trials in 2018 for its automated insulin delivery service with an insulin pump (the basis of which was acquired from Asante), a next-gen version of Abbott’s FreeStyle Libre CGM sensor, and a smartphone app. Launch timing for this pump-based system, pending FDA approval, is planned for 2020. Separately, Bigfoot also has a connected smart pen solution in development that uses a mobile app and the FreeStyle Libre sensor.

Beta Bionics

• A pivotal trial testing the integrated iLet bionic pancreas device (with Dexcom CGM) in an insulin-only version is expected to start in the beginning of 2019, enabling a possible US launch in the first half of 2020.

• A pivotal trial testing the insulin plus glucagon (bihormonal) configuration is also expected to start in the beginning of 2019. Timing of FDA submission and launch depend on a stable glucagon, among other things. Partner Zealand has recently reported positive results from phase 2a clinical studies testing their stable, pumpable glucagon.

In Europe:

• Diabeloop expects to complete its CE Mark pivotal trial using Dexcom CGM and a Cellnovo pump in November 2017. A European regulatory filing and possible launch are expected in 2018.

• Roche/Senseonics/TypeZero hope to begin a pivotal trial in Europe in early 2018. The system will use Senseonics’ 180-day CGM sensor, a notable change from other systems. There is no launch timing to report.

• Cellnovo hopes to launch its own automated insulin delivery system in 2018, though no pivotal trial or product details have been shared.