Novo Nordisk files for regulatory approval of liraglutide in Japan
Novo Nordisk today announced the submission of a new drug application
to the Ministry of Health, Labour and Welfare in Japan for the
approval of liraglutide, a once-daily human GLP-1 analogue, for the
treatment of people with type 2 diabetes.
The Japanese phase 3 programme, which included 678 patients with type
2 diabetes, was designed to obtain the indication for use of
liraglutide to treat type 2 diabetes as an adjunct to diet and
exercise, both as monotherapy and in combination with sulfonylurea.
The submission of liraglutide in Japan does not impact Novo Nordisk's
expectations for the company's financial results for 2008, which were
provided on 30 April in connection with the release of the financial
results for the first quarter of 2008.
About liraglutide
Liraglutide is a once-daily human analogue of the naturally occurring
hormone Glucagon-Like Peptide-1 (GLP-1). Liraglutide works by
stimulating the release of insulin only when glucose levels become
too high and by inhibiting appetite. In contrast to most other
antidiabetic treatments, liraglutide also leads to weight loss
instead of weight increase.
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:
Outside North America: Outside North America:
Elin K Hansen Mads Veggerby Lausten
Tel: (+45) 4442 3450 Tel: (+45) 4443 7919
ekh@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel: (+1) 609 514 8316 Tel: (+1) 609 919 7937
secl@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 45 / 2008