Regulatory Approval

 
TIDMNVOB 
 
Novo Nordisk receives approval for Victoza ® in Japan 
 
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and 
Welfare has approved Victoza ® for the treatment of type 2 diabetes. 
 
Victoza ® is the brand name for liraglutide, the first Glucagon-Like Peptide-1 
(GLP-1) analogue approved in Japan, developed for the treatment of type 2 
diabetes. Victoza ® is indicated as monotherapy or as an add-on to sulphonylurea 
(SU) in people with type 2 diabetes. 
 
"The Japanese approval of Victoza ® represents a major advancement in the 
treatment of type 2 diabetes and an important milestone for Novo Nordisk." says 
Mads Krogsgaard Thomsen, executive vice president and chief science officer of 
Novo Nordisk. "We are excited to pioneer the GLP-1 market in Japan, where we are 
convinced Victoza ® will prove to be a valuable treatment option for people with 
type 2 diabetes. The clinical studies conducted in Japan showed Victoza ® to 
provide superior glucose control with a low risk of hypoglycaemia." 
 
Novo Nordisk expects to launch Victoza ® in Japan in the first half of 2010 upon 
completion of price negotiations. 
 
About Victoza ® 
 
Once-daily Victoza ® is the first human Glucagon-Like Peptide-1 (GLP-1) analogue 
developed for the treatment of type 2 diabetes. Victoza ® works by stimulating 
the release of insulin from the pancreatic beta cells only when blood sugar 
levels are high. Weight loss with Victoza ® is attributed to the fact that it 
leads to increased satiety after meals in part by slowing gastric emptying and, 
in part, by other mechanisms. Victoza ® is broken down naturally in the body and 
does not depend upon renal excretion. 
 
In Europe, Novo Nordisk received marketing authorisation for Victoza ® on 30 June 
and Victoza ® has subsequently been launched in several countries. A New Drug 
Application was submitted for regulatory approval in the US in May 2008 and in 
China in August 2009, respectively, and regulatory decisions are 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 29,000 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. 
 
Further information: 
 
 
 Media:                                  Investors: 
 
 
 
 Mike Rulis                              Klaus Bülow Davidsen 
 
 Tel: [phone]                    Tel: [phone] 
 
 [e-mail]                    [e-mail] 
 <mailto:[e-mail]>            <mailto:[e-mail]> 
 
 
                                         Kasper Roseeuw Poulsen 
 
                                         Tel: [phone] 
 
                                         [e-mail] 
                                         <mailto:[e-mail]> 
 
 
 In North America:                       In North America: 
 
 An Phan                                 Hans Rommer 
 
 Tel: [phone]                  Tel: [phone] 
 
 [e-mail]                    [e-mail] 
 <mailto:[e-mail]>            <mailto:[e-mail]> 
 
 
Company Announcement no 2 / 2010 
 
 
 
[HUG#1375094] 
 
 
 
 
 
    Company Announcement no 2 2009: http://hugin.info/2013/R/1375094/337282.pdf