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
September 23, 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
UPDATE ON TIMELINE FOR FORMAL FEEDBACK ON LIRAGLUTIDE FROM THE FDA
Novo Nordisk today announced that formal feedback from the United States Food
and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1
analogue, has been deferred until the fourth quarter of 2009. Novo Nordisk
continues the constructive dialogue with the FDA regarding the regulatory
process for liraglutide.
Novo Nordisk expects to provide an update on the regulatory process for
liraglutide in connection with the announcement of the financial results for the
first nine months of 2009, on 29 October 2009, if formal feedback is not
received before then.
This update on the timeline for formal feedback on liraglutide from the FDA does
not change Novo Nordisk's expectations for the company's financial results for
2009, which were provided on 6 August in connection with the release of the
financial results for the first six months of 2009.
ABOUT LIRAGLUTIDE
Liraglutide is the first once-daily human Glucagon-Like Peptide-1 (GLP-1)
analogue developed for the treatment of type 2 diabetes. Liraglutide works by
stimulating the release of insulin only when glucose levels become too high and
by inhibiting appetite. On 23 May 2008, Novo Nordisk submitted a New Drug
Application to the Food and Drug Administration (FDA) in the US for the approval
of liraglutide for the treatment of people with type 2 diabetes. In Europe, Novo
Nordisk received marketing authorization for liraglutide under the brand name
Victoza(R) on 3 July and Victoza(R) has subsequently been launched. 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 28,500 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.
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
Company Announcement no 56 / 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: September 23, 2009 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer