SOURCE: Novo Nordisk A/S

November 18, 2008 12:44 ET

Novo Nordisk A/S - Research Update

BAGSVAERD, DENMARK--(Marketwire - November 18, 2008) - 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

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