Novo Nordisk continues to make progress towards label expansion for NovoSeven® in Europe

| Source: Novo Nordisk A/S Novo Nordisk A/S

Novo Nordisk has now completed the compilation of the regulatory dossier related to the use of NovoSeven® in blunt trauma, and Novo Nordisk is in the process of filing for marketing approval with the European Medicines Agency, which will receive the filing by 7 January 2005. Furthermore, following consultations with the US regulatory authorities (FDA), Novo Nordisk now expects to initiate a US trauma trial in the second quarter of 2005.
 
Novo Nordisk still expects to file an application by mid-2005 for marketing approval in Europe for the use of NovoSeven® in connection with intracerebral haemorrhage (ICH).  
 
Following recent consultations with the FDA, Novo Nordisk is now in the process of preparing for a confirmatory clinical trial for the use of NovoSeven® in connection with ICH. The trial is expected to be initiated around mid-2005, involving around 450 patients. Novo Nordisk expects this trial to generate further clinical documentation for filing with the FDA for regulatory approval in the US of NovoSeven® in connection with ICH.
 
The confirmatory trial will be conducted in the US, Europe as well as in other countries, and will be designed as a randomised, double-blind and placebo-controlled clinical trial in patients with spontaneous ICH confirmed by Computed Tomography (CT) scan within three hours of symptom onset.
 
Lars Rebien Sørensen, president and CEO of Novo Nordisk, says: "We are excited about the filing of the trauma-related NovoSeven® data in Europe, and we look forward to the opportunity to generate the clinical documentation that is expected to allow Novo Nordisk to file in the US for label expansion of NovoSeven®."
 
The above information does not impact Novo Nordisk's expectations for the financial results for 2004. The financial results will be released on 28 January 2005 when the company will also announce its financial expectations for the year 2005.
 
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. 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 20,000 full-time employees in 69 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.
 
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Stock Exchange Announcement No 1 / 2005

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