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 3, 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 FDA ADVISORY COMMITTEE MEETING ON LIRAGLUTIDE FOR THE TREATMENT OF
TYPE 2 DIABETES
Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs
Advisory Committee of the United States Food and Drug Administration (FDA) has
finalised its discussions of questions related to liraglutide, a once-daily
human GLP-1 analogue.
The Advisory Committee voted on questions related to the risk profile of
liraglutide.
o A majority of Advisory Committee members supported that appropriate
evidence of cardiovascular safety had been provided to rule out excess
cardiovascular risk of liraglutide relative to comparators.
o While a majority of Advisory Committee members did not find that Novo
Nordisk based on the available data had ruled out that the finding of
C-cell tumours in rodents was not relevant to humans, the Advisory
Committee was split on the FDA question related to whether the available
data on C-cell tumours permitted approvability.
o Finally, the Advisory Committee unanimously supported approvability of
liraglutide with regard to risk of papillary thyroid cancer.
"We remain convinced that liraglutide has a positive benefit:risk profile and
represents an important advance for people with type 2 diabetes. We will work
closely with the FDA as it completes its review of our application to address
the concerns expressed by members of the Advisory Committee," said Mads
Krogsgaard Thomsen, executive vice president and chief science officer of Novo
Nordisk.
The Advisory Committee reviewed data from 40 clinical studies involving more
than 6,800 people with type 2 diabetes of which more than 4,600 were treated
with liraglutide.
The timing of US launch of liraglutide will be determined after completion of
the FDA's review of the application.
The outcome of the FDA Advisory Committee is not expected to significantly
impact 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 update 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.
FDA advisory committees are panels of independent experts who advise the FDA as
they consider regulatory decisions. The FDA is not bound by the committee's
recommendation, but it takes its advice into consideration when reviewing new
drug applications.
CONFERENCE CALL
On 3 April at 8am CET, corresponding to 2am EDT, a conference call for investors
will be held. Investors will be able to listen in via a link on the investor
section of novonordisk.com.
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 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 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 20 / 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 3, 2009 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer