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
May 27, 2008
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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
NOVO NORDISK FILES FOR REGULATORY APPROVAL OF LIRAGLUTIDE IN BOTH THE US AND
EUROPE
Novo Nordisk today announced the submission of a New Drug Application (NDA) to
the Food and Drug Administration (FDA) in the US as well as a marketing
authorisation application to the European Medicines Agency (EMEA) in Europe, for
the approval of liraglutide, a once-daily human GLP-1 analogue, for the
treatment of people with type 2 diabetes.
Both the US and the European applications contain documentation from an
extensive clinical development programme that included around 6,500 people of
which approximately 4,200 received liraglutide. The programme was designed to
obtain the indication for use of liraglutide to treat type 2 diabetes as an
adjunct to diet and exercise, both as monotherapy and in combination with
commonly used antidiabetic medications. The majority of people were included in
the phase 3 trials constituting the LEAD(TM) (Liraglutide Effect and Action in
Diabetes) programme. The LEAD(TM) programme has compared liraglutide with three
widely used classes of antidiabetic drugs - sulfonylurea, glitazone or basal
insulin - and the programme confirmed a statistically significant benefit of
liraglutide on the primary endpoint, lowering of blood glucose (HbA1c), as well
as on the secondary endpoint, weight loss.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at
Novo Nordisk, said: "This is a major achievement for Novo Nordisk and it
represents a huge amount of work done by Novo Nordisk employees and our
collaborators across the world. We are very pleased with the results from the
programme demonstrating that liraglutide will be able to offer benefits to
people with type 2 diabetes. We are enthusiastic about the prospect of bringing
liraglutide to market after completion of the regulatory process."
Novo Nordisk still expects to file for marketing approval of liraglutide in
Japan in the third quarter of 2008.
The submission of liraglutide in the US and Europe does not impact Novo
Nordisk's expectations for the company's financial results for 2008, which were
provided on 30 April in connection with the release of the financial results for
the first quarter of 2008.
ABOUT LIRAGLUTIDE, LEAD(TM) AND HBA1C
Liraglutide is a once-daily human analogue of the naturally occurring hormone
Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by stimulating the release of
insulin only when glucose levels become too high and by inhibiting appetite. In
contrast to most other antidiabetic treatments, liraglutide also leads to weight
loss instead of weight increase.
The portfolio of LEAD(TM) studies for liraglutide included around 4,000 patients
with type 2 diabetes whose blood glucose is inadequately controlled. The
programme was comprised of five randomised, controlled, double-blind studies
conducted in more than 40 countries.
o The LEAD(TM) 1 and LEAD(TM) 2 studies investigated the effect of different
doses of liraglutide in combination with a single oral antidiabetic drug,
glimepiride and metformin respectively.
o The LEAD(TM) 3 study compared the effect of liraglutide with glimepiride
when used as monotherapy.
o The LEAD(TM) 4 study investigated the effect of different doses of
liraglutide in combination with metformin and rosiglitazone.
o The LEAD(TM) 5 study compared the effect of liraglutide with insulin
glargine when used as add-on therapy in patients inadequately controlled by
two of the most widely used oral antidiabetic drugs: metformin and a
sulfonylurea (glimepiride).
o At the annual meeting of the American Diabetes Association (ADA) to be held
in San Francisco on 6-10 June 2008, Novo Nordisk will present detailed
results from the LEAD(TM) phase 3 programme with liraglutide.
HbA1c is an abbreviation for glycated haemoglobin HbA1c. The level of HbA1c
reflects the average blood glucose level over the past two to three months and a
decrease is therefore a measure of treatment effect. The higher the blood
glucose the more glucose binds to haemoglobin (glycation).
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 approximately 26,300 employees in
80 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:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 3079 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
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Hans Rommer
Tel: (+45) 4442 4765
hrmm@novonordisk.com
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In North America: In North America:
An Phan Christian Qvist Frandsen
Tel: (+1) 609 987 4893 Tel: (+1) 609 919 7937
anph@novonordisk.com cqfr@novonordisk.com
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Stock Exchange Announcement no 29 / 2008
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: May 27, 2008 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer