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SECURITIES AND EXCHANGE COMMISSION
FORM 6-K
Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
November 5 2002
NOVO NORDISK A/S
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
| Form 20-F [X] | Form 40-F [ ] |
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
| Yes [ ] | No [X] |
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-________________
| SIGNATURES | ||||||||
| Stock Exchange Announcement | ||||||||
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.
| NOVO NORDISK A/S | ||
| Date: November 5 2002 | Lars Rebien Sørensen, President and Chief Executive Officer |
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Stock Exchange
Announcement
5 November 2002
Novo Nordisk submits Marketing Authorisation Application for
NN304 (insulin detemir), a new long-acting insulin analogue
Novo Nordisk A/S today announced that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the approval of NN304 (insulin detemir) for the treatment of diabetes mellitus.
NN304 (insulin detemir) is a long-acting basal insulin analogue with a unique mechanism of protraction that leads to a more predictable patient day-to-day profile of action compared to available basal insulin preparations. Insulin detemir has shown a lower risk of nocturnal hypoglycaemia and lower fasting plasma glucose compared to NPH insulin in long-term clinical trials, which is the expected clinical benefit of a more predictable insulin. In addition, HbA1c was overall comparable to NPH insulin, with superiority shown in a subset of the late development trials. NN304 (insulin detemir) also showed the added clinical benefit of no weight gain compared with NPH insulin.
Upon approval of NN304 (insulin detemir) by the regulatory authorities, Novo Nordisk will be the only diabetes company with a complete insulin analogue portfolio comprising rapid-acting, premixed, and long-acting insulin analogue products.
The filing of NN304 (insulin detemir) will not impact Novo Nordisk’s expectations for the financial results for 2002.
Forward-looking statement
The above sections contain forward-looking statements as the term is defined in
the US Private Securities Litigation Reform Act of 1995. Forward-looking
statements provide current expectations or forecasts of events such as new
product introductions, product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of
| Stock Exchange Announcement No 21 / 2002 | Page 1 of 2 |
| Novo Nordisk A/S | Novo Allé | Telephone: | Internet: | CVR Number: | ||||
| Corporate Communications | 2880 Bagsvaerd | +45 4444 8888 | www.novonordisk.com | 24256790 | ||||
| Denmark | Telefax: | |||||||
| +45 4444 2314 |
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development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk’s products, introduction of competing products, Novo Nordisk’s ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, unexpected growth in costs and expenses.
Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company’s Form 20-F, which was filed on 26 April 2002. Please also refer to the section ‘Financial Risk Factors’ in the Annual Financial Report 2001. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.
Novo Nordisk is a focused healthcare company and the 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 17,900 people in 68 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 further company information visit www.novonordisk.com
For further information please contact:
| Media: | Investors: | |
| Outside North America: | Outside North America: | |
| Karsten Madsen Phone (direct): (+45) 4442 4137 |
Peter Haahr Phone (direct): (+45) 4442 1207 |
|
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Palle Holm Olesen Phone (direct): (+45) 4442 6175 |
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| In North America: | In North America: | |
| Susan T Jackson Phone: (+1) 609 919 7776 |
Rasmus Jorgensen Phone (direct): (+1) 212 582 3676 |
| Stock Exchange Announcement No 21 / 2002 | Page 2 of 2 |
| Novo Nordisk A/S | Novo Allé | Telephone: | Internet: | CVR Number: | ||||
| Corporate Communications | 2880 Bagsvaerd | +45 4444 8888 | www.novonordisk.com | 24256790 | ||||
| Denmark | Telefax: | |||||||
| +45 4444 2314 |