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
JULY 6, 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-_____________________
REGULATORY APPROVAL
NOVO NORDISK'S VICTOZA(R) (LIRAGLUTIDE) RECEIVES MARKETING AUTHORISATION IN
EUROPE
Novo Nordisk announced today that the European Commission has granted marketing
authorisation for Victoza(R) for the treatment of type 2 diabetes in adults. The
authorisation covers all 27 European Union member states.
Victoza(R) is the brand name approved in Europe for liraglutide, the first
once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the
treatment of type 2 diabetes. The marketing authorisation 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.
"This is an important milestone for Novo Nordisk and for the treatment of type 2
diabetes," says Mads Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. "In clinical studies involving more than 6,500
people with type 2 diabetes, 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) is a
valuable new treatment option for people with type 2 diabetes."
Novo Nordisk will launch Victoza(R) in the UK, Germany and Denmark during the
summer and in other European markets during the second half of 2009 and
throughout 2010.
The marketing approval in Europe does not change Novo Nordisk's expectations for
the company's financial results for 2009. Novo Nordisk will provide an update on
the expectations for the company's financial results for 2009 on 6 August 2009
in connection with the release of the financial results for the first six months
of 2009.
ABOUT VICTOZA(R)
Once-daily Victoza(R) is the first human Glucagon-Like Peptide-1 (GLP-1)
analogue developed for the treatment of type 2 diabetes. Victoza(R) works by
stimulating the release of insulin only when blood sugar levels are high. Weight
loss with Victoza(R) is attributed to the fact that it slows gastric emptying
and leads to increased satiety after meals. Victoza(R) is naturally broken down
in the body and does not require renal excretion.
Throughout the clinical development programme, which involved more than 6,500
patients, Victoza(R) has demonstrated a favourable benefit:risk profile and has
been compared to widely used diabetes treatments such as sulphonylureas (SUs) ,
thiazolidinediones (TZDs), insulin glargine and exenatide.
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.
In both the US and Japan, a regulatory decision is pending.
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 27,900 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 40 / 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: JULY 6, 2009 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer