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NVOB Novo-N.Dkk1'b'

0.00
0.00 (0.00%)
Share Name Share Symbol Market Type Share ISIN Share Description
Novo-N.Dkk1'b' LSE:NVOB London Ordinary Share DK0060102614 DKK1 SER'B'
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 0.00 -
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Research Update

18/11/2008 5:27pm

UK Regulatory


    Research Update
             
FDA reschedules Advisory Committee meeting for liraglutide - no
change of review timeline anticipated


The US Food and Drug Administration (FDA) has informed Novo Nordisk
that the planned Advisory Committee meeting for liraglutide on 2
March 2009 has been rescheduled to 2 or 3 April 2009.

Novo Nordisk submitted the New Drug Application (NDA) to the FDA on
23 May 2008, meaning that an action letter from the agency to the NDA
could be expected on 23 March 2009 following a standard 10-month
review period. In September, the agency indicated that it would most
likely have to extend the date of completing its assessment by a
couple of months. The FDA has informed Novo Nordisk that this is
still the timeline it is targeting.

FDA advisory committees are panels of independent experts who advise
the FDA as they consider regulatory decisions. The advisory committee
meetings are open to the public and are common for major
pharmaceutical drugs under review.

Once-daily liraglutide is a 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.

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 26,550
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:

Mike Rulis             Mads Veggerby Lausten
Tel: (+45) 3079 3573   Tel: (+45) 4443 7919
mike@novonordisk.com   mlau@novonordisk.com

                       Hans Rommer
                       Tel: (+45) 4442 4765
                       hrmm@novonordisk.com
In North America:
An Phan                Kasper Roseeuw Poulsen
Tel: (+1) 609 558 0420 Tel: (+45) 44427741
anph@novonordisk.com   krop@novonordisk.com


Company Announcement no 76 / 2008

http://hugin.info/2013/R/1271037/281707.pdf


This announcement was originally distributed by Hugin. The issuer is 
solely responsible for the content of this announcement.



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