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NiaStase (rFVIIa) Shows Promise as First Effective Treatment for Intracerebral Hemorrhage

New potential treatment for the deadliest form of stroke

VANCOUVER, BC -- July 12, 2004 -- Novo Nordisk announced at the 5th World Stroke Congress that NiaStase® (recombinant Factor VIIa, rFVIIa) has been demonstrated to have a positive effect upon treatment outcome when administered to intracerebral hemorrhage (ICH) patients at an early stage after onset.

ICH is the most deadly and least treatable form of stroke. ICH patients face the highest rates of mortality or severe disability of all stroke victims, and until now no proven ICH treatment has been identified. Those patients who survive an ICH are left with more severe disabilities and complications than survivors of other forms of stroke, including - often total - loss of movement, speech and mental capability.

"We are extremely encouraged by this trial data for NiaStase, which confirms there is at last a proven, safe treatment for this most deadly type of stroke," said Lars Rebien Sørensen, president and CEO of Novo Nordisk. "NiaStase may finally offer a much-needed lifeline to ICH patients. This study of the use of NiaStase in ICH is a major breakthrough for ICH patients and specialists."

"It is also an extraordinary extension of the positive results obtained in the treatment of trauma victims late last year and an important development for Novo Nordisk's R&D pipeline and our NiaStase expansion program. At present we are also exploring the potential for this versatile product in other critical bleeding scenarios such as surgery and gastrointestinal bleeding."


A non-invasive, direct treatment
By travelling to the ICH site through the circulatory system, rFVIIa reaches ruptured vessels in the brain without invasive surgery, and can accelerate the coagulation process from within. In this way, rFVIIa can limit the hematoma (blood leakage) size, which is a vital predictor of outcome for ICH patients. Smaller hematomas are less damaging to the brain, and are related to better clinical outcomes for patients2.

Promising results
The results show that NiaStase can reduce hemorrhage growth when administered early and has impact on the major functional neurological and disability measures.

Importantly, results demonstrated that patients treated with NiaStase had significantly better neurological and functional outcome after treatment, implying a lasting patient benefit in terms of reduced disability and dependency on help, as compared to placebo. This is the first time such encouraging results have been observed in any ICH trial.

The study showed that treatment with NiaStase for ICH was associated with a minor non-significant increase in thromboembolic events that was outweighed by significant clinical benefits across the trial.

This is the largest ICH study performed to date and represents a significant advance in Novo Nordisk's knowledge of ICH evolution and ability to improve its management strategies around this clinical setting.

"There is no question that NiaStase is a major advance in the field of ICH research," said Dr. Andrew Woolfenden, Assistant Director of Stroke, Vancouver General Hospital, Vancouver, British Columbia. "This trial data, which suggests the wait for a recognized ICH treatment may soon be at an end, will be welcomed worldwide. This could benefit many thousands of lives a year."

Next steps
Novo Nordisk will immediately liaise with regulatory agencies in the effort to achieve approval for the use of NiaStase as the first treatment of ICH.
NiaStase® has been successfully treating people with hemophilia with inhibitors since 1996, when it was first approved. NiaStase is approved in this indication in the US, Canada and the EU. In the EU NiaStase is also indicated for the treatment of bleeding episodes in people undergoing surgery or invasive procedures with congenital FVII deficiency or with Glanzmann's thrombasthenia with antibodies to GPIIb-IIa and/or HLA, and with past or present refractoriness to platelet transfusions.


About ICH:
·Intracerebral Hemorrhage (ICH) is bleeding within the brain which starts spontaneously rather than from external factors such as head trauma. During ICH, blood accumulates in the brain, creating a reservoir of blood called a hematoma. Larger hematomas are more likely to create permanent brain damage which can cause severe permanent physical and mental disability, and in many cases death.

·Stroke is estimated to occur in over 700,000 patients a year of which approximately 10-15% will be ICH (the US only). This represents over 80,000 patients. Mortality occurs in approximately 35-52% of these patients within one month, and only 20% of the remaining patients are likely to be living independently.


About the trial:
·This large international ICH trial began in August 2002. 400 patients were involved in a multi-centre (20 countries worldwide), randomized, double-blind, placebo-controlled trial. Patients were divided into four groups of 100 patients, comparing 3 doses of rFVIIa (40, 80, and 160 µg/kg) with placebo. Patients all had spontaneous ICH confirmed by Computed Tomography (CT) scan within 3 hours of onset, and were treated within 1 hour of the admission CT scan.

·The outcome measures were change in ICH volume between admission and 24 hour CT scans, the proportion of patients who were dead or severely disabled at 90 days, and overall adverse effects over the study period.
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SOURCE: National PharmaCom

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