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: (+45) 4442 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com
In North America: In North America:
Sean Clements Hans Rommer
Tel: (+1 609-514-8316 Tel: (+1) 609 919 7937
secl@novonordisk.com hrmm@novonordisk.com
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.
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