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
JUNE 17 2005
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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 RECEIVES US APPROVAL OF LEVEMIR(R) AND BECOMES THE FIRST COMPANY
WITH A FULL RANGE OF INSULIN ANALOGUES IN THE US
Novo Nordisk announced today that the US Food and Drug Administration (FDA) has
granted marketing authorisation for Levemir(R), the company's long-acting
insulin analogue for the treatment of diabetes. With the US approval of
Levemir(R), Novo Nordisk is the only company in the US with a complete range of
insulin analogues, encompassing rapid-acting NovoLog(R), premixed NovoLog(R) Mix
70/30 and now also the long-acting analogue Levemir(R).
"The US approval of Levemir(R) is an important event for Novo Nordisk in the US
as it completes our portfolio of insulin analogues and thereby paves the way for
continued expansion of our US diabetes care franchise," says Kare Schultz,
executive vice president and chief operating officer.
In addition to the US approval, Levemir(R) has already been approved for use in
37 countries, including the countries in the European Union. The product has
been introduced in 11 European markets, with additional launches expected during
the second half of 2005.
Levemir(R) is a soluble, long-acting basal human insulin analogue with a
relatively flat action profile and prolonged duration of action of up to 24
hours. Levemir(R) is indicated for once or twice-daily subcutaneous
administration in the treatment of adult patients with diabetes mellitus who
require basal (long-acting) insulin for the control of hyperglycaemia.
Levemir(R) can be used as the basal component of basal-bolus therapy in type 1
and type 2 diabetes and as add-on therapy in people with type 2 diabetes who are
inadequately controlled on oral antidiabetic agents. The file on use in
paediatrics is under review with the FDA and a decision is expected before the
end of 2005.
Novo Nordisk expects to introduce Levemir(R) in the US market within the next 12
months. The approval of Levemir(R) does not change Novo Nordisk's expectations
for the financial results for 2005.
NOVO NORDISK is a healthcare company and a world leader in diabetes care. The
company has the broadest diabetes product portfolio in the industry, including
the most advanced products within the area of insulin delivery systems. 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 21,000 full-time
employees in 78 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.
For further information please contact:
Media: Investors:
Outside North America: Outside North America:
Mike Rulis Mogens Thorsager Jensen
Tel (direct): Tel (direct):
(+45) 4442 3573 (+45) 4442 7945
Mads Veggerby Lausten
Tel (direct):
(+45) 4443 7919
In North America: In North America:
Susan T Jackson Any of the above contacts
Tel (direct): or
(+1) 609 919 7776 tel (direct):
(+1) 609 919 7937
Stock Exchange Announcement no 18 / 2005
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: JUNE 17 2005 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer