CeQur’s PaQ Insulin Delivery Device for type 2 diabetes receives CE Mark – November 29, 2012

Switzerland-based CeQur announced yesterday that its flagship product, the PaQ Insulin Delivery Device, received CE Mark. The review process took a little over four months, and we understand it was more thorough and detailed than the company expected. While FDA submission is certainly a future goal for CeQur, the US focus on A1c may mean additional clinical support will be required to support submission. To our knowledge, the company’s focus in the coming 24 months will be on increasing manufacturing capacity to support a widespread launch in the coming years and conducting additional clinical trials. We expect to see data on the CeQur device at ATTD 2013 in February and ADA 2013 in June. We are especially looking forward to CGM and glycemic variability data from the recently completed clinical trial in 20 people with type 2 diabetes.

As a reminder, PaQ is an insulin delivery patch device that delivers a preset 24-hour basal rate along with on-demand bolus insulin over three days of wear (330-unit reservoir). The device, which is targeted at patients with type 2 diabetes and designed with simplicity and ease of use as priorities, consists of a disposable insulin reservoir attached to a reusable electronic messenger, which lasts six to 12 months. The messenger is the only battery-powered component of the device. Boluses (two unit) are administered by pressing a button on the device and the PaQ will be available in multiple basal rates: 16, 20, 24, 32, 40, 50, and 60 units per day. As we understand it, the trials were conducted with Novolog (Novo Nordisk), and the company also intends to pursue approval for Humalog (Lilly). We are very glad to see a continued drive to develop new and innovative insulin delivery technologies that can address the adherence barriers and stigma surrounding insulin therapy in type 2 diabetes.

The approval comes 16 months after the CE Marking for Valeritas’ V-Go, which received CE Mark in July 2011 (V-Go is also FDA approved and has since launched in the US). Like PaQ, the basal-bolus V-Go device targets insulin-dependent patients with type 2 diabetes and is designed with an emphasis on simplicity and convenience. The two devices, while similar in many ways, have some key differences: 1) V-Go has no electronics, while PaQ has an electronic messenger; 2) V-Go has three basal increments (20, 30, or 40 units per day) vs. PaQ’s multiple basal rates (see above) – this could allow CeQur to target a broader number of type 2s than Valeritas (more insulin sensitive or resistant patients); 3) the V-Go is worn for 24 hours vs. PaQ’s 72 hours; 4) there is no limit on bolus capacity for the PaQ until the t reservoir is empty (vs. 36 units per day for V-Go). We expect that V-Go’s average wholesale price of $8.10/day will likely set a loose precedent for PaQ pricing, though we expect PaQ would come in a bit higher (in addition to monthly supplies of the disposable insulin reservoir [10 reservoirs], PaQ wear would also require a six-month to yearly purchase of the electronic messenger). Certainly, having more options available for type 2 insulin delivery is a major win for patients, and the market is certainly big enough to support more options. We hope that payors will be quick to appreciate the value that these devices can provide people who are struggling to gain control with insulin injections.

• As a reminder, CeQur recently completed a clinical study evaluating its PaQ insulin delivery patch in 20 people with type 2 diabetes; results are expected at ATTD 2013 in February and ADA 2013 in June. The study's primary endpoint was ability to assemble, fill, prime, apply, and use the PaQ device, with secondary endpoints that included insulin usage, seven-point glucose profiles, glucose variability as measured by CGM (yes!), hypoglycemia, and patients' self-reported quality of life. For a deeper delve into the study’s design, please see our June 7 Closer Look at http://www.closeconcerns.com/knowledgebase/r/f59c6fee.
• While Valeritas’ V-Go is the most direct competitor to CeQur, J&J’s (Calibra Medical) Finesse is another key competitor in the simple, disposable insulin delivery space. Insulet’s OmniPod is the biggest current player in the patch-pump arena, though its patch pump is more full featured than either the Finesse or PaQ, and thus, less of a direct competitor. Several other companies also have patch-pumps in development. The table below is informed by our coverage of the field, and may not reflect a comprehensive listing.

-- by Adam Brown, Kira Maker, and Kelly Close