PRESS RELEASE: Novo Nordisk: Research Update

Novo Nordisk insulin analogues have proven safety profiles 
 
 
On Friday 26 June, Diabetologia, the journal of the European 
Association for the Study of Diabetes (EASD) published online data 
from four studies relating to a possible link between a long-acting 
insulin analogue, insulin glargine, and cancer1. As a basis for such 
a possible link, an accompanying editorial explains that certain 
insulin analogues have a structure making them more likely to bind to 
the IGF-1 receptor which is known to be involved in promoting tumour 
growth2. 
 
Novo Nordisk markets three insulin analogues, Levemir® (insulin 
detemir), a long-acting basal insulin analogue, NovoRapid®/NovoLog® 
(insulin aspart), a short-acting insulin analogue, and 
NovoMix®/NovoLog® Mix 70/30 (biphasic insulin aspart). To avoid 
unnecessary speculation about whether Novo Nordisk insulin analogues 
may be associated with an increased risk of cancer, the company 
wishes to highlight the following: 
 
  * For the past 20 years, all Novo Nordisk insulin analogues have 
    been tested for IGF-1 receptor binding in the early research 
    phase and only insulins with a binding ratio between the insulin 
    and IGF-1 receptors similar to, or better than, that of human 
    insulin have been accepted for further development3. 
  * Studies on receptor binding and cell growth together show that 
    insulin aspart, the insulin analogue present in 
    NovoRapid®/NovoLog® and NovoMix®/NovoLog® Mix 70/30 has an in 
    vitro safety profile that is identical to that of human 
    insulin3,4. 
  * Studies on receptor binding have shown that Levemir® in 
    comparison to human insulin has a relative affinity to the IGF-1 
    receptor which is equal to or slightly lower than to the insulin 
    receptor.4,5. Levemir® distinguishes itself from insulin 
    glargine, which has been shown to have increased affinity for the 
    IGF-1 receptor compared to human insulin4,5,6 . 
  * All Novo Nordisk insulin analogues on the market have been 
    studied in many randomised, controlled trials, in observational 
    studies and are furthermore monitored for any safety signals 
    through rigorous post-marketing safety surveillance. Novo Nordisk 
    has not identified any cancer signals for any of the three 
    insulin analogues. 
  * Novo Nordisk has over the last 20 years discovered and developed 
    insulin analogues to improve the treatment success rate for 
    people with diabetes. Extensive clinical testing has provided 
    evidence that Levemir®, NovoRapid®/NovoLog® and NovoMix®/NovoLog® 
    Mix 70/30 possess clinical advantages for many patients with 
    diabetes compared to human insulin. 
 
Mads Krogsgaard Thomsen, executive vice president and chief science 
officer of Novo Nordisk, says: "Our science-driven approach to the 
discovery and development of safe, improved insulin analogues, 
together with the existence of comprehensive insulin safety 
databases, convinces us that our insulin analogues improve treatment 
outcomes in diabetes patients relative to human insulin." 
 
Conference call 
On 29 June at 8 am CET, corresponding to 2 am EDT, a conference call 
for investors will be held. Investors will be able to listen in via a 
link on the investor section of novonordisk.com. Presentation 
material for the conference call will be made available approximately 
one hour before on the same page. 
 
About insulin and IGF-1 receptors 
Insulin can bind to two different receptors: insulin and IGF-1 
(insulin-like growth factor-1) receptors. The former mainly causes 
glucose lowering whereas the latter mainly induces cell 
proliferation. Insulin binds much stronger (more than 500-fold) to 
the insulin receptor than to the IGF-1 receptor and it is if this 
binding profile is unfavourably changed due to alterations in the 
insulin molecule that an insulin analogue can increase the risk of 
cell proliferation via the IGF-1 receptor. 
 
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. 
 
Contacts for further information 
 
 
Media:                Investors: 
 
Mike Rulis            Mads Veggerby Lausten 
Tel: [phone]  Tel: [phone] 
[e-mail]  [e-mail] 
 
                      Kasper Roseeuw Poulsen 
                      Tel: [phone] 
                      [e-mail] 
 
In North America:     In North America: 
Sean Clements         Hans Rommer 
Tel: [phone] Tel: [phone] 
[e-mail]  [e-mail] 
 
 
 
 
References: 
1 www.diabetologia-journal.org/ 
2 Baserga R, Peruzzi F, Reiss K (2003): The IGF-1 receptor in cancer 
biology. Int J Cancer 107: 873-877 
3 Gammeltoft S, Hansen BF, Dideriksen L, Lindholm A, Schäffer L, Trüb 
T, Dayan A, Kurtzhals P (1999): Insulin aspart, a novel rapid-acting 
human insulin analogue. Exp Opin Invest Drugs 8 (9): 1431-1442 
4 Kurtzhals P, Schäffer L, Sørensen A, Kristensen C, Jonassen I, 
Schmid C, Trüb T (2000): Correlations of receptor binding and 
metabolic and mitogenic potenticies of insulin analogs designed for 
clinical use. Diabetes 49: 999-1005 
5 Center for Drug Evaluation and Research, FDA. Application number 
21-536: Pharmacology review of insulin detemir 
6 Shukla A, Grisouard J, Ehemann V, Hermani A, Ensmann H, Mayer D 
(2009) Analysis of signalling pathways related to cell proliferation 
stimulated by insulin analogs in human mammary epithelial cell lines. 
Endocrine-Related Cancer 16: 429-441 
 
Company Announcement no 36 / 2009 
 
 
This announcement was originally distributed by Hugin. The issuer is 
solely responsible for the content of this announcement. 
 
http://hugin.info/2013/R/1325510/311775.pdf 
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