Novo Nordisk announces ‘disappointing’ NovoSeven phase III trial results

Novo Nordisk has announced the results of a phase III clinical trial of NovoSeven, its recombinant activated factor VII treatment for patients with intracerebral haemorrhage (ICH).

Patients administered with the drug displayed reduced bleeding in the brain when compared to those receiving a placebo, though while improvement in clinical outcomes were seen after 15 days, reduction in mortality and severe disability were not seen at the end of the 90-day study period.

NovoSeven is licensed for the prevision of bleeding during surgery and the treatment of bleeding episodes in patients with congenital haemophilia that have inhibitors to treatment with factors VIII or IX.

Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk, said: “These results are disappointing, particularly given the encouraging results we saw in the phase II trial.”

He added that the company had previously hoped that NovoSeven could be indicated as a treatment for the currently unmet need of patients with ICH.

Novo Nordisk commented that these results had not altered its forecast of its financial results for the 2007 fiscal year announced last month.

In 2005, the company set up the Novo Nordisk Haemophilia Foundation in Zurich, Switzerland to address the need of patients with haemophilia in the developing world.

The programme includes development projects for patient education, training of medical staff, the creation of patient registries and diagnostic facilities, and a number of awards and fellowships.