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NOVO NORDISK'S NOVOSEVEN MISSES ENDPOINT IN BRAIN-BLEEDING TRIAL

February 26, 2007

Novo Nordisk has announced initial results from a Phase III clinical trial investigating NovoSeven (recombinant activated factor VII) for the treatment of people suffering from bleeding in the brain, also known as intracerebral hemorrhage.

The trial showed that treatment with NovoSeven significantly reduced intracerebral bleeding compared with placebo treatment. Improvement in clinical outcomes in terms of functional independence and neurological impairment was observed on day 15 after the bleeding, but mortality and severe disability was not improved at the end of the study period (day 90). With regard to safety, study results were in line with the established safety profile of NovoSeven.

As mortality and severe disability at day 90 was the primary endpoint of the study, Novo Nordisk has decided not to seek regulatory approval for NovoSeven in intracerebral hemorrhage. Novo Nordisk's other research and development activities within the management of critical bleedings will continue as planned.

"These results are disappointing, particularly given the encouraging results we saw in the Phase II trial," Lars Rebien Sorensen, president and CEO of Novo Nordisk, said.

The Phase III trial involved 821 patients from 22 countries in a randomized, double-blind, placebo-controlled efficacy and safety study. People suffering from spontaneous intracerebral hemorrhage confirmed by a computerized tomography scan were randomized to receive either NovoSeven or placebo within four hours of symptom onset, in addition to conventional treatment.

Factor VIIa plays a crucial role in the coagulation process. NovoSeven is approved for the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX. It is also approved for the treatment of bleeding in patients with acquired hemophilia and congenital factor VII deficiency.