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:
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Media: |
Investors: |
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Outside North America: |
Outside North America: |
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Elin K Hansen |
Mads Veggerby Lausten |
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Tel: (+45) 4442 3450 |
Tel: (+45) 4443 7919 |
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Hans Rommer |
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Tel: (+45) 4442 4765 |
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In North America: |
In North America: |
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Sean Clements |
Christian Qvist Frandsen |
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Tel: (+1) 609 514 8316 |
Tel: (+1) 609 919 7937 |
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Stock Exchange Announcement no 45 / 2008