Update on FDA Advisory Committee meeting on liraglutide for the 
treatment of type 2 diabetes 
 
 
Novo Nordisk today announced that the Endocrinologic and Metabolic 
Drugs Advisory Committee of the United States Food and Drug 
Administration (FDA) has finalised its discussions of questions 
related to liraglutide, a once-daily human GLP-1 analogue. 
 
The Advisory Committee voted on questions related to the risk profile 
of liraglutide. 
 
*        A majority of Advisory Committee members supported that 
  appropriate evidence of cardiovascular safety had been provided to 
  rule out excess cardiovascular risk of liraglutide relative to 
  comparators. 
 
*        While a majority of Advisory Committee members did not find 
  that Novo Nordisk based on the available data had ruled out that 
  the finding of C-cell tumours in rodents was not relevant to 
  humans, the Advisory Committee was split on the FDA question 
  related to whether the available data on C-cell tumours permitted 
  approvability. 
 
*        Finally, the Advisory Committee unanimously supported 
  approvability of liraglutide with regard to risk of papillary 
  thyroid cancer. 
 
"We remain convinced that liraglutide has a positive benefit:risk 
profile and represents an important advance for people with type 2 
diabetes. We will work closely with the FDA as it completes its 
review of our application to address the concerns expressed by 
members of the Advisory Committee," said Mads Krogsgaard Thomsen, 
executive vice president and chief science officer of Novo Nordisk. 
 
The Advisory Committee reviewed data from 40 clinical studies 
involving more than 6,800 people with type 2 diabetes of which more 
than 4,600 were treated with liraglutide. 
 
The timing of US launch of liraglutide will be determined after 
completion of the FDA's review of the application. 
The outcome of the FDA Advisory Committee is not expected to 
significantly impact Novo Nordisk's expectations for the company's 
financial results for 2009, which were provided on 29 January in 
connection with the release of the financial results for 2008. Novo 
Nordisk will update the expectations for the company's financial 
results for 2009 on 30 April 2009 in connection with the release of 
the financial results for the first quarter of 2009. 
 
FDA advisory committees are panels of independent experts who advise 
the FDA as they consider regulatory decisions. The FDA is not bound 
by the committee's recommendation, but it takes its advice into 
consideration when reviewing new drug applications. 
 
Conference call 
On 3 April at 8am CET, corresponding to 2am EDT, a conference call 
for investors will be held. Investors will be able to listen in via a 
link on the investor section of novonordisk.com. 
 
About liraglutide 
Liraglutide is the first once-daily human Glucagon-Like Peptide-1 
(GLP-1) analogue developed for the treatment of type 2 diabetes. 
Liraglutide works by stimulating the release of insulin only when 
glucose levels become too high and by inhibiting appetite. 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 liraglutide for the treatment of people with type 2 
diabetes. A New Drug Application was also submitted for approval in 
Japan on 15 July 2008. 
 
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 27,000 
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. 
 
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 20 / 2009 
 
 
This announcement was originally distributed by Hugin. The issuer is 
solely responsible for the content of this announcement. 
 
http://hugin.info/2013/R/1302907/298491.pdf 
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