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Biotech / Medical : New Brunswick Scientific Co., Inc. (NBSC) -- Ignore unavailable to you. Want to Upgrade?

To: richardred who wrote (567)	11/5/2002 12:00:52 PM
From: richardred	Read Replies (2) \| Respond to of 724

Not sure if there is a DGI tie here. DGICNW) Novo Nordisk Submits Marketing Authorization Application for NN304 (insulin detemir), a New Long-Acting Insulin Analog PR Newswire ~ November 5, 2002 ~ 9:16 am EST BAGSVAERD, Denmark, Nov. 5 /CNW/ -- Novo Nordisk A/S (NYSE: NVO) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for the approval of NN304 ( insulin detemir) for the treatment of diabetes mellitus. (Logo: newscom.com ) NN304 (insulin detemir) is a long-acting basal insulin analog 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 hypoglycemia 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, A1c 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 analog portfolio comprising rapid-acting, premixed, and long-acting insulin analog 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 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 hemostasis 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