EMA Grants Marketing Authorisation of mylife' YpsoPump for Use with NovoRapid PumpCart, Marking the Start of a Collaboration Between Novo Nordisk and Ypsomed

BAGSVÆRD, Denmark, June 28, 2016 /PRNewswire/ --

This material is intended for global medical media only.

For journalistic assessment and preparation before publication.

Novo Nordisk today announces the European Medicines Agency (EMA) marketing approval of the mylife' YpsoPump^® insulin pump for use with prefilled pump cartridge NovoRapid^® PumpCart^®. The approval is a key milestone for the collaboration between Novo Nordisk and Ypsomed and their goal to deliver innovative care solutions that improve the lives of people with diabetes.

With its icon-based touch screen, mylife' YpsoPump^® by Ypsomed is an insulin pump, designed to simplify therapy, which is fully compatible with NovoRapid^® PumpCart^® by Novo Nordisk, the first prefilled pump cartridge with an insulin analogue that has been specifically designed for insulin pumps.

"Insulin pump therapy can be an effective option for helping some people with diabetes, particularly those living with type 1 diabetes, however, operating a traditional insulin pump, and manually filling the insulin reservoir, can be complex and time-consuming," says Dr Mark Evans, lecturer and honorary consultant in medicine at the University of Cambridge. "Given these factors, and the burden put upon health systems to train patients to use traditional pumps, efforts to simplify the process are truly welcomed."

NovoRapid^® PumpCart^® contains NovoRapid^® (insulin aspart), a rapid-acting insulin from Novo Nordisk, and is a 1.6 ml prefilled pump cartridge specifically designed to make insulin pump therapy more convenient for some people with diabetes and the healthcare professionals caring for them. It is compatible with insulin pump mylife' YpsoPump^® by Ypsomed and has also been available with Roche Diabetes Care's Accu-Chek^® Insight insulin pump since November 2014 in select EU markets.

"Our partnerships with Ypsomed and Roche Diabetes Care enable us to offer new options designed to simplify insulin pump therapy for people living with diabetes and the healthcare professionals who manage their care," said Christian Kanstrup, senior vice president, marketing, medical affairs and stakeholder engagement at Novo Nordisk.

NovoRapid^® PumpCart^® is currently available in the following EU markets for use with the Accu-Chek^® Insight pump: United Kingdom, Sweden, Austria, Denmark, Netherlands, Germany, France, Czech Republic and Italy.

mylife' YpsoPump^® received authorisation for use with prefilled pump cartridge NovoRapid^® PumpCart^® on 24 June 2016. Healthcare professionals interested in knowing in which countries mylife' YpsoPump^® will be made available should contact Ypsomed directly.

About insulin pump therapy

An insulin pump delivers insulin from a reservoir inside the pump to a patient's body using an infusion set and a tiny cannula. Insulin pumps use bolus insulin, such as insulin aspart. The insulin is delivered using continuous infusion and is often used by people with type 1 diabetes who receive intensified insulin therapy and test their blood glucose levels on a regular basis. An insulin pump is suitable for certain patients and provides more flexibility, with the potential to improve glycaemic control and quality of life^[1],[2]. In Europe, use of insulin pumps among people with type 1 diabetes varies, with less than 5% using a pump in some countries and more than 15% in other countries. In the US, 40% use a pump^[3],[4].

About NovoRapid^®

NovoRapid^® (insulin aspart) is a mealtime insulin analogue indicated for the treatment of diabetes mellitus in adults, adolescents, children aged 2 years and above and can be used in pregnancy. NovoRapid^® has been available for use in Europe since 1999 and has launched in more than 120 countries.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

Further information

Media:
Katrine Sperling
[phone]
[e-mail]

Åsa Josefsson
[phone]
[e-mail]

Investors:
Peter Hugreffe Ankersen
[phone]
[e-mail]

Melanie Raouzeos
[phone]
[e-mail]

Kasper Veje (US)
[phone]
[e-mail]

For information about mylife' YpsoPump®, please contact Ypsomed directly:

Benjamin Overney
[phone]
[e-mail]

All trademarks used or mentioned in this release are legally protected.

References:

1. Cohen ND, et al. Long-Term Metabolic Effects of Continuous Subcutaneous Insulin Infusion Therapy in Type 1 Diabetes. Diabetes Technology & Therapeutics 2013; 15(7):544-549.
2. Pickup JC. Management of diabetes mellitus: is the pump mightier than the pen? Nature Reviews Endocrinology 2012; 8:425-433.
3. Clinical Audit and Registries Management Service. National Diabetes Insulin Pump Audit 2013-15. Version 1. Health & Social Care Information Centre. 1 April 2016. Available at: http://www.hqip.org.uk/public/cms/253/625/19/520/National%20Diabetes%20Insulin%20Pump%20Audit%20report%202013-15.pdf?realName=hOfPw8.pdf?v=0 (Last accessed: 20 June 2016).
4. Pickup JC. Insulin pumps. International Journal of Clinical Practice (Supplement) 2011; 170:16-19.

Internet: http://www.novonordisk.com
CVR no: 24 25 67 90
ZINC: HQMMA/NR/0616/0165
Date of preparation: June 2016