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
April 24, 2009
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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 RECEIVES POSITIVE OPINION ON VICTOZA(R) (LIRAGLUTIDE) FROM
THE EUROPEAN REGULATORY AUTHORITIES
Novo Nordisk today announced that the Committee for Medicinal Products for Human
Use (CHMP) under the European Medicines Agency (EMEA) adopted a positive
opinion, recommending marketing authorisation, for Victoza(R) for treatment of
type 2 diabetes.
Victoza(R) is the brand name for liraglutide, the first once-daily human
Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2
diabetes. The positive opinion for Victoza(R) covers:
o combination treatment with metformin or a sulphonylurea in patients with
insufficient glycaemic control despite maximal tolerated dose of
monotherapy with metformin or sulphonylurea, and
o combination treatment with metformin and a sulphonylurea or metformin and a
thiazolidinedione in patients with insufficient glycaemic control despite
dual therapy.
Novo Nordisk expects to receive final marketing authorisation from the European
Commission within approximately two months. Subject to the Commission's
approval, Novo Nordisk expects to launch Victoza(R) in a number of European
markets during this summer.
"We are very pleased with the positive opinion from the CHMP, which gives us
confidence that Victoza(R) will soon become available to many people with type 2
diabetes in Europe," says Mads Krogsgaard Thomsen, executive vice president and
chief science officer of Novo Nordisk. "In clinical studies involving more than
6,500 patients, Victoza(R) has been shown to have a significant blood glucose
lowering effect and lead to weight loss, while having a low risk of
hypoglycaemia. On this background, we are convinced that Victoza(R) will offer
people with type 2 diabetes a valuable new treatment option."
The positive opinion from the CHMP does not change Novo Nordisk's expectations
for the company's financial results for 2009, which were provided on 29 January
in connection with the release of the financial results for 2008. Novo Nordisk
will provide an update on the expectations for the company's financial results
for 2009 on 30 April 2009 in connection with the release of the financial
results for the first quarter of 2009.
ABOUT VICTOZA(R)
Victoza(R) is the first once-daily human Glucagon-Like Peptide-1 (GLP-1)
analogue developed for the treatment of type 2 diabetes. Victoza(R) works both
by stimulating the release of insulin when glucose levels become too high, and
by reducing appetite. On 23 May 2008, Novo Nordisk submitted a New Drug
Application to the Food and Drug Administration in the US as well as a marketing
authorisation application to the European Medicines Agency in Europe, for the
approval of Victoza(R) for the treatment of people with type 2 diabetes. A New
Drug Application was also submitted for approval in Japan on 14 July 2008.
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 27,000 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:
An Phan Hans Rommer
Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937
anph@novonordisk.com hrmm@novonordisk.com
Company Announcement no 23 / 2009
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: April 24, 2009 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer