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 19, 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
FDA RESCHEDULES ADVISORY COMMITTEE MEETING FOR LIRAGLUTIDE - NO CHANGE OF REVIEW
TIMELINE ANTICIPATED
The US Food and Drug Administration (FDA) has informed Novo Nordisk that the
planned Advisory Committee meeting for liraglutide on 2 March 2009 has been
rescheduled to 2 or 3 April 2009.
Novo Nordisk submitted the New Drug Application (NDA) to the FDA on 23 May 2008,
meaning that an action letter from the agency to the NDA could be expected on 23
March 2009 following a standard 10-month review period. In September, the agency
indicated that it would most likely have to extend the date of completing its
assessment by a couple of months. The FDA has informed Novo Nordisk that this is
still the timeline it is targeting.
FDA advisory committees are panels of independent experts who advise the FDA as
they consider regulatory decisions. The advisory committee meetings are open to
the public and are common for major pharmaceutical drugs under review.
Once-daily liraglutide is a 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.
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 26,550 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:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 3079 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
hrmm@novonordisk.com
In North America:
An Phan Kasper Roseeuw Poulsen
Tel: (+1) 609 558 0420 Tel: (+45) 44427741
anph@novonordisk.com krop@novonordisk.com
Company Announcement no 76 / 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: November 19, 2008 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer