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 | Japan: the customer is more than king |
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Small drug - large potential
NovoSeven® for inhibitor patients |
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Financial statement
for the first nine months of 1997 Financial statement |
| Financial highlights Summary of the Group |
| Nuvera™ in Europe and the US |
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Novo Nordisk forging ahead in Russia The market for health care products in Russia has recovered |
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Education as a strategic tool in India The growth rate of Novo Nordisk’s Health Care products in India is expected to increase up to twice as fast as that of the general world market |
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On 11 November 1997, Novo Nordisk submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of a new hormone replacement therapy (HRT) product, Nuvera™.
Nuvera™ is a continuous combined HRT product consisting of plant-derived oestradiol and norethindrone acetate, for the treatment of symptoms associated with menopause. This is the first time Novo Nordisk has submitted an NDA for regulatory approval of a product for the US HRT market. Some 2,000 women have participated in the clinical studies. The world market for HRT products in 1996 was DKK 11.8 billion, of which the US market alone accounted for DKK 6.4 billion.
The product was submitted for European approval in September 1997. Novo Nordisk intends to develop the product further with a view to obtaining approval for its use for the prevention of osteoporosis. Novo Nordisk expects to be ready to file for approval of this indication next year.
Novo Nordisk was the first company to introduce continuous combined HRT with another product, Kliogest®, which is available in Europe, Asia, Australia and other parts of the world.
Novo Nordisk and Rhône-Poulenc Rorer have formed a global alliance to market hormone replacement products. This alliance combines the complementary strengths of Novo Nordisk in oral hormone replacement therapies and Rhône-Poulenc Rorer in transdermal patches to offer a greater choice to physicians and women.
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