Novo-7.
New Breakthrough for NovoSeven(R); NovoSeven(R) Effective in Treatment of Intracerebral Hemorrhage
Tuesday June 22, 10:04 am ET
BAGSVAERD, Denmark, June 22 /PRNewswire-FirstCall/ -- Novo Nordisk A/S (NYSE: NVO - News) today announced the first results from the largest clinical trial ever conducted with a pharmaceutical agent in the treatment of intracerebral hemorrhage (ICH). The phase 2b study demonstrated that treatment with NovoSeven® of ICH patients led to a significant reduction in hematoma growth compared to the placebo group.
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Importantly, results demonstrated that patients treated with NovoSeven® had significantly improved neurological and functional outcome, implying a lasting patient benefit in terms of reduced disability and dependency on help. This is the first time such encouraging results have been observed in any ICH trial.
The study showed that treatment with NovoSeven® for ICH was associated with a minor, non-significant increase in thromboembolic events that was vastly outweighed by highly significant clinical benefits across the trial.
Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk, said: "The proof of concept for the use of NovoSeven® in the treatment of intracerebral hemorrhage represents a pioneering breakthrough. It is a major step forward in our aspiration to develop NovoSeven® as a general treatment of critical bleedings. This is an extraordinary extension of the positive results obtained in the treatment of trauma victims late last year."
Based on the data, Novo Nordisk will immediately liaise with regulatory agencies in the effort to achieve approval for the use of NovoSeven® as the first pharmaceutical treatment of ICH.
The ICH study involved 400 patients in 20 countries, in a multi-centre, randomized, double-blind, placebo-controlled dose-response study. Patients who all had spontaneous ICH confirmed by Computed Tomography (CT) scan within three hours of symptom onset, were randomized to receive either NovoSeven® or placebo, in addition to conventional treatment.
The above scientific results do not change Novo Nordisk's expectations for the financial results for 2004.
PRESENTATION OF THE KEY RESULTS
On Saturday, June 26, 2004 the key results from the study will be presented at the 5th World Stroke Congress in Vancouver, Canada. For further information with regard to the conference, please visit kenes.com. A short summary of the presentation will be made available on novonordisk.com under 'Investors' on Monday, June 28, 2004. |
