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 8, 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 SCHEDULES ADVISORY COMMITTEE MEETING FOR LIRAGLUTIDE
Novo Nordisk today announced that the Food and Drug Administration (FDA) has
informed the company that an FDA Advisory Committee meeting is scheduled to be
held on 2 March 2009 to discuss the New Drug Application (NDA) for liraglutide,
a once-daily human GLP-1 analogue. 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.
Novo Nordisk submitted the 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. Since the Advisory Committee meeting is held
shortly before this date, the agency has indicated that it will most likely have
to extend the date of completing their assessment by a couple of months.
ABOUT LIRAGLUTIDE
Once-daily liraglutide is the first 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 in the US as well as a marketing
authorisation application to the European Medicines Agency in Europe, for the
approval of liraglutide for the treatment of people with type 2 diabetes. A New
Drug Application was also submitted for approval in Japan on 15 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 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:
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
Tel: (+1) 609 558 0420
anph@novonordisk.com
Company Announcement no 56 / 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: September 8, 2008 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer