UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
November 21, 2007
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NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
NOVO ALLE
DK-2880, BAGSVAERD
DENMARK
(Address of principal executive offices)
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Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g-32(b):82-_____________________
RESEARCH UPDATE
NEW PHASE 2 STUDY SHOWS THAT LIRAGLUTIDE LEADS TO SIGNIFICANT WEIGHT LOSS IN
OBESE PEOPLE
Novo Nordisk today announced clinical results from a double-blind,
placebo-controlled phase 2 study comparing liraglutide, the once-daily human
GLP-1 analogue, with orlistat, a lipase inhibitor, for treatment of obesity in
people who do not have diabetes.
The study demonstrated that liraglutide given once daily over 20 weeks at the
highest dose led to a weight loss from baseline of just above 7 kg in comparison
to a weight loss of just below 3 kg in the placebo group and a weight loss of
just above 4 kg in the orlistat-treated group. All doses of liraglutide reduced
body weight. More than 75% of the people treated with the highest dose
experienced a weight loss larger than 5%, and more than 25% experienced a weight
loss larger than 10% relative to their body weight at randomisation. Finally,
the study revealed a beneficial effect on systolic blood pressure after
treatment with liraglutide.
Approximately 30% of the 564 participants in the study showed signs of
prediabetes at randomisation. Following 20 weeks of treatment with any dose of
liraglutide, between 80% and 90% of these participants no longer showed any sign
of prediabetes, as opposed to around 40% in the placebo- and orlistat-treated
groups.
Liraglutide was generally well tolerated. The overall withdrawal rate across the
study was around 20%, and no more than 10% of the people who were treated with
liraglutide withdrew from the trial due to adverse events. Consistent with all
previous trials, the most common adverse events were related to the
gastrointestinal systems and mainly rated as mild to moderate. The most
frequently reported individual adverse event was nausea. The frequency of events
was dose dependent and in the range of 20% to 50%. Nausea was most frequently
observed at the beginning of the study.
In order to study the long-term weight reduction of liraglutide treatment,
around 85% of all participants in the study volunteered to continue into an open
label extension phase of the study.
Mads Krogsgaard Thomsen, chief science officer, said: "We are very encouraged by
these new results. They give us reason to believe that liraglutide has the
potential to become a new and important treatment option in the fight against
serious obesity."
The results of the phase 2 trial do not change Novo Nordisk's expectations for
the company's financial results for 2007, which were provided on 31 October in
connection with the release of the financial results for the first nine months
of 2007.
CONFERENCE CALL
At 15.00 CET today, corresponding to 9.00 am New York time, a conference call
for investors will be held. Investors will be able to listen in via a link on
novonordisk.com, which can be found under 'Investors - Download centre'.
ABOUT THE STUDY DESIGN
After an initial run-in period of two weeks with dietary advice and daily
injections of placebo, study participants were randomised to either placebo, to
increasing doses of liraglutide or to an open-labelled control arm with orlistat
for a treatment period of 20 weeks. 564 people with an average baseline weight
at randomisation of just below 100 kg entered the study.
ABOUT PREDIABETES
People with prediabetes are characterised by having either levels of fasting
glucose (Impaired Fasting Glucose) or levels of glucose in a glucose tolerance
test (Impaired Glucose Tolerance) that are too high to be considered normal, but
not high enough to meet the criteria for diagnosis of diabetes. People with
prediabetes are at a higher risk of developing both cardiovascular disease and
actual diabetes. Prediabetes is often associated with the so-called metabolic
syndrome which in addition to high blood glucose levels includes obesity,
abnormal blood lipid levels and elevated blood pressure.
ABOUT TREATMENT OF OBESITY WITH LIRAGLUTIDE
Obesity is an increasing global problem, which is associated with increased risk
of developing type 2 diabetes and other serious conditions. It is generally
agreed that the best way to tackle obesity is through exercise and healthy
diets. It is, however, also recognised that for some it is difficult to achieve
and maintain the needed weight reduction even with substantial efforts. Thus, in
people who are at high risk of getting obesity-related complications, for
example patients with additional risk factors such as osteoarthritis,
hypertension or cardiovascular disease, adjunctive treatment with medicine may
be needed to reduce the risk of complications and improve quality of life.
ABOUT LIRAGLUTIDE
Liraglutide is Novo Nordisk's once-daily GLP-1 analogue, currently in phase 3
development for treatment of type 2 diabetes and phase 2 development for
treatment of obesity. Results from four of five phase 3 studies in people with
type 2 diabetes have been reported. The last study will be reported on around
the turn of the year, and submission for regulatory approval for treatment of
type 2 diabetes is expected mid 2008.
Novo Nordisk is a healthcare company and a world leader in diabetes care. The
company has the broadest diabetes product portfolio in the industry, including
the most advanced products within the area of insulin delivery systems. 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 approximately 25,800 employees in
79 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.
FURTHER INFORMATION:
Media: Investors:
Outside North America: Outside North America:
Elin K Hansen Mads Veggerby Lausten
Tel: (+45) 4442 3450 Tel: (+45) 4443 7919
ekh@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel (direct): (+45) 4442
4765
hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel: (+1) 609 902 9164 Tel: (+1) 609 919 7937
secl@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 32 / 2007
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf of the
undersigned, thereunto duly authorized.
Date: November 21, 2007 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer