Novo Nordisk A/S: New Study Directly Comparing Insulin Delivery Devices Shows That Next Generation FlexPen has a Significantly Lower Injection Force than SoloStar and KwikPen

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COPENHAGEN--(BUSINESS WIRE)--New data published this week in Expert Opinion Pharmacotherapy has revealed that Next Generation FlexPen®, Novo Nordisk’s prefilled insulin delivery device, has a significantly lower injection force than two other devices, SoloStar® and KwikPen®.1,2,3 Previous studies show that people with diabetes prefer a lower injection force.4,5

The study revealed that the injection (dose) force of Next Generation FlexPen® was 12–25% lower than SoloStar® and 35–41% lower than KwikPen®.1 In addition to the reduced injection force, this study and others have shown that Next Generation FlexPen® has advantages over SoloStar® and KwikPen® in providing improved accuracy.1,6,7

“Patients with diabetes generally prefer an insulin device with a lower injection force because it provides significantly less discomfort when injecting, especially for patients with impaired manual dexterity,” said Professor Andreas Pfützner, Institute for Clinical Research and Development, Mainz, Germany. “It is vitally important for the sake of compliance and individual satisfaction that patients with diabetes are comfortable with their insulin device as it is something they have to use on a daily basis.”

Next Generation FlexPen® has been available in some countries from late 2008 and is continuing to be launched in countries around the world. It has built upon the high standards set by FlexPen®. New features include 30% less force when injecting, coloured cartridge holders, labels and packaging to aid insulin type identification for patients and an innovative simple and easy needle attachment with a ‘Just twist’ mechanism which allows the NovoTwist™ needle to be attached (to be launched from June 2009).5 This makes the device the first pen to be designed for use with a new generation of needles, which have a patented state-of-the-art attachment interface. These features provide improved convenience and ease of use for people with diabetes.4,5

The study compared the dose forces of Next Generation FlexPen®, SoloStar® and KwikPen® by injecting 20U of insulin using two different gauge needles (NovoFine® 32G and BD Micro-fine™ 31G). Pens of each type were tested at injection speeds of 3.3, 5.0 and 8.3mm/sec. At all three injection speeds and with both needles, Next Generation FlexPen® had a significantly lower average injection force than either SoloStar® or KwikPen®, whilst KwikPen® had the highest mean injection force. Furthermore, the injection force with all three pens was lower when the NovoFine® 32G needle was used as opposed to the BD Micro-fine™ 31G.

About Next Generation FlexPen®

FlexPen® is the world’s most widely used prefilled insulin pen, trusted daily by more than three million people worldwide.8,9 Next Generation FlexPen® represents the latest advance in prefilled insulin pens from Novo Nordisk, designed to be simple and convenient to use, and helping to reduce the burden of living with diabetes.

Next Generation FlexPen® is a result of more than 25 years of research and development of insulin delivery systems undertaken since Novo Nordisk invented the insulin pen. Compared to other insulin delivery devices that have to be manually loaded with insulin cartridges, prefilled pens are ready to use, eliminating the step of loading insulin into the delivery device. Next Generation FlexPen® features a single-step dose-setting mechanism, portability and a discreet ‘non-medical’ appearance.

With Next Generation FlexPen® it is not possible to set a dose larger than that remaining in the pen. It permits dose corrections without loss of insulin, and provides doses in one-unit increments up to 60 units per injection (each pen contains 300 units in total). The dose scale on Next Generation FlexPen® automatically returns to zero after injection to allow visual confirmation of dose delivery.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 27,900 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit novonordisk.com.

References

1) Asakura T et al. Evaluation of injection force of three insulin delivery pens. Expert Opin Pharmcother. DOI 10.1517/14656560903018929. Posted online on 26 May 2009: http://www.informapharmascience.com/toc/eop/0/0

2) SoloStar®, a prefilled injection device, is a registered trademark of Sanofi-Aventis.

3) KwikPen®, a prefilled injection device, is a registered trademark of Humalog.

4) Sommavilla B et al. Safety, simplicity and convenience of a modified prefilled insulin pen. Expert Opin Pharmacother 2008; 9(13): 2223-32.

5) Pfützner A et al. Prefilled insulin device with reduced injection force: patient perception and accuracy. Curr Med Res Opin 2008; 24(9): 2545-2549.

6) Rissler J et al. Evaluation of the injection force dynamics of a modified prefilled insulin pen. Expert Opin. Pharmacother 2008; 9(13): 2217-2222.

7) Weise A et al. Comparison of the dose accuracy of prefilled insulin pens. J Diabetes Sci Tech 2009; 3(1): 149-53.

8) Estimated number of patients using FlexPen®, based on worldwide sales in number of packs sold, IMS worldwide data Q3’08 and Daily Defined Dosage (DDD) for insulin as issued by WHO.

9) Reimer T et al. Instruction time, Intuitiveness and Patient Acceptance of a Prefilled and a Reusable Insulin Delivery Device – The NovoMix® 30 FlexPen® and the HumaPen® Luxura™. Clin. Ther. 2008; 30(12):2252-62.

Contact:

Novo Nordisk A/S Media: Elin K Hansen Tel: (+45) 4442 3450 ekh@novonordisk.com or In North America: Ambre Morley Tel: (+1) 609 987 5898 abmo@novonordisk.com or Investors: Mads Veggerby Lausten Tel: (+45) 4443 7919 mlau@novonordisk.com or Kasper Roseeuw Poulsen Tel: (+45) 4442 4471 krop@novonordisk.com or Hans Rommer Tel: (+1) 609 919 7937 hrmm@novonordisk.com

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