It's sad, but true: these days, Europe usually sees new diabetes technology before the U.S. With that in mind, Kelly Close and her team at the highly respected diabetes consultancy Close Concerns have put together a thorough round-up of some of the latest in diabetes technology, specifically regarding patch pumps, from across the pond. What Europe is up to is a taste of what we will see in America soon (hopefully)... Take it away, Kelly!
A Guest Post by Kelly Close
Valeritas announced last week that it has received CE mark approval for its V-Go disposable insulin delivery device. This clearly represents a key milestone for Bridgewater, NJ-based Valeritas, as far as commercialization of the V-Go outside of the United States is considered. We are excited to learn more about the company's plans for European distribution deals, about regulation across different parts of Europe, and launch timing. As a reminder, the company has targeted U.S. launch before the end of 2011 — it's getting exciting!
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We assume that the CE mark approval covers use of the V-Go with both Humalog and Novolog, which were separately approved by the FDA over the last six months. Valeritas becomes one of the first companies to receive CE mark approval for a disposable insulin delivery device.
The Valeritas V-Go is a non-electronic, mechanical device automatically administers insulin at a preset basal rate over 24 hours (at which point it must be replaced) and also allows users to deliver two-unit boluses by a two-step manual process that can be done through clothing. The V-Go will be available with reservoir sizes of 56, 66, or 76 units, which would provide basal delivery of 20, 30, or 40 units per day along with 36 units of bolus insulin that can be delivered in two-unit increments.
The company says this daily capacity covers roughly 70% of type 2 patients currently on insulin, given that insulin dosage is typically reduced when people move from multiple daily injections to continuous insulin delivery. Valeritas plans to market the V-Go primarily to patients with type 2 diabetes, and we believe the device will compete more with pens than with other pumps. Further, we believe it will expand the market to include type 2 patients who would benefit from mealtime insulin but are not using it currently.
In honor of Amy being in Germany for her annual summer break, we decided to take a closer look at what other companies in the pump/pen world are doing in Europe! Below is an update on the European and U.S. timelines of several other disposable and semi-disposable insulin devices in development. We note that these products differ in functionality and target audience — there's still a lot to learn!
- Calibra has received FDA approval for its "patch-pen," which allows people with type 1 and type 2 diabetes to deliver bolus insulin by pressing two buttons together, for three-day use with both Humalog (January 2010) and Novolog (July 2010). Calibra has not announced international plans to our knowledge. This one seems very cool to us because it is so small and easy to use.
- CeQur's insulin infuser PaQ is similar to the V-Go in that it lets people with type 2 diabetes deliver both basal and bolus insulin, although the device's disposable reservoir is designed for three days rather than one day of use. As we understand it, Cequr's insulin infuser will be in clinical trials in Europe later this year, with data available sometime in 2012; the company plans to seek CE mark by the end of 2012.
- Cellnovo's small, handheld-controlled pump has been filed for CE mark approval, and at ADA 2011 the company's representatives said that European launch is planned by the end of 2011, with American launch tentatively targeted for 2012.
- D. Medical plans that its Spring Hybrid semi-disposable patch pump will have regulatory clearance and a launch framework in place in Europe by "the beginning of 2012" and in Mexico, Brazil, Russia, India, and China by 2012, according to the company. Last year, management said they were targeting FDA submission of the Spring Hybrid for late 2011, and we have not heard an update on these plans since.
- Debiotech's JewelPUMP, a semi-disposable patch pump designed to be controlled by mobile phones, was filed with the FDA last year (as of ADA 2010). We are not aware of the company's European plans.
- Insulet is working with Abbott to address a final concern of the EU regulatory authorities about the second-generation OmniPod. During the company's first quarter 2011 call on May 9, CEO Duane DeSisto said he believed the second-generation product could obtain CE mark within 90 days (i.e., by early August). We look forward to an update when Insulet reports results on August 2, 2011. As a reminder, FDA filing of the second-generation OmniPod occurred in early May, and management looks for US clearance by the end of 2011 (see the May 10, 2011 Closer Look). We expect an update during the company's 2Q12 conference call, scheduled for tomorrow, Aug. 2.
- Medtronic is developing a disposable pump with the stated goal of expanding the type 2 pump market. The company has targeted this patch pump for the first half of its fiscal year 2013 (i.e., before November 2012), as of the company's update at the JP Morgan Healthcare Conference in January 2011. We are not sure whether this referred to plans for the U.S., international markets, or both.
- Roche (Medingo)'s Solo MicroPump, a full-featured semi-disposable pump designed for three-day use, is slated for a limited launch in the Netherlands in 2011 and worldwide release in 2012. As a reminder, the Solo has been cleared by the FDA since 2009. To our knowledge, the company has not announced an EU regulatory update since the receipt of ISO 13485 Quality Management System certification in 2009.
For more from Kelly and her team, check out their new report, Targeting a Cure for Type 1 Diabetes, which is available for free download online! It has received high praise from some of the leaders in the diabetes community, including JDRF's President Jeffrey Brewer and Medtronic Diabetes' Chief Medical Officer Dr. Francine Kaufman. Definitely worth a read!