- CeQur announced that its PaQ Insulin Delivery Device received CE Mark. No details have been shared on the product’s launch timeline.
- Clinical data on the device (including CGM data!) will be presented at ATTD 2013 and ADA 2013.
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.
|Company||Device||Description||FDA Clearance||CE Mark|
|CeQur||PaQ||Simple basal-bolus||?||Approved in November 2012 for use with Novolog; not yet launched.|
|Valeritas||V-Go||Simple basal-bolus||Approved in December 2010 for use with Humalog; approved in March 2011 for use with Novolog; launched in US in Spring 2012||Approved in July 2011 for use with Novolog and Humalog; not yet launched|
|J&J (Calibra Medical)||Finesse||Bolus only||Approved in February 2010 for insulin delivery; approved in April 2012 with expanded indication (for "clinician-prescribed medications"); launch timeline unclear||?|
|Roche (Medingo)||SOLO Micropump||Full-featured||Requires new 510(k) clearance since last 2009 approval given modifications (e.g., integrated Accu-Chek BGM)||Initiating studies in the EU in 2H13 to support approval (studies have been delayed)|
|Insulet||OmniPod (second-generation)||Full-featured||As of Insulet 3Q12, FDA 510(k) clearance is expected "soon" (submitted to FDA in May 2011).||Approved in August 2011 and recently launched in the Netherlands and the UK; launch expected in Germany, Switzerland, and Austria by end of 2012.|
|Cellnovo||Cellnovo System||Full-featured||As of ADA, targeting late 2012 submission, with hopes to launch in 2013||Approved in September 2011. A 100-patient usability study began in the UK in February 2012. As of EASD 2012, launch is expected in the UK "soon-ish."|
|Debiotech||JewelPUMP||Full-featured (control via smartphone application)||Initiating studies in 2013 to support approval||Initiating studies in 2013 to support approval|
|D. Medical||Spring Hybrid||Full Featured (can revert to wear as a tubed pump)||D. Medical was delisted from the NASDAQ on July 17, 2012. According to a Form 6-K filed with the SEC on November 8, 2012, D. Medical was "negotiating with a foreign international company that is engaged in the development and manufacture of devices used for treatment of diabetes, for the purpose of selling the intellecutal property owned by Spring Health Solutions Ltd. and Spring-Set Health Solutions Ltd... The entire of the aforesaid transaction's terms have not yet been agreed upon."|
|Medtronic||Patch Pump||We speculate the pump is full featured but have not heard recent updates on the design.||Targeting May 2014 - April 2016||Targeting May 2014 - April 2016|
-- by Adam Brown, Kira Maker, and Kelly Close