Phase 3 Stroke Trial Shows That Novoseven Reduces Bleeding in the Brain, but Does Not Improve Long-term Clinical Outcomes
COPENHAGEN, Feb. 26, 2007-Novo Nordisk today announced the
initial results of a phase 3 clinical trial investigating
NovoSeven® (recombinant activated factor VII) for the treatment
of people suffering from bleeding in the brain, also known as
intracerebral haemorrhage, or ICH.
The trial showed that treatment with NovoSeven® significantly
reduced intracerebral bleeding compared to 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 ICH. Novo Nordisk's other
research and development activities within the management of
critical bleedings will continue as planned.
Lars Rebien Sørensen, president and chief executive officer
of Novo Nordisk, said: "These results are disappointing,
particularly given the encouraging results we saw in the phase 2
trial. We hoped that NovoSeven® could become a treatment for
the people who suffer from ICH, and for whom no effective medical
treatment exists."
The phase 3 trial in ICH involved 821 patients from 22 countries in
a multi-centre, randomised, double-blind, placebo-controlled
efficacy and safety study. People suffering from spontaneous ICH
confirmed by a CT (Computed Tomography) scan were randomised to
receive either NovoSeven® or placebo within four hours of
symptom onset, in addition to conventional treatment.
Further details from the phase 3 trial results are expected to be
communicated at the 59th Annual Meeting of the American Academy of
Neurology held in Boston from 28 April to 5 May 2007, and at the
European Stroke Congress in Glasgow from 29 May to 1 June
2007.
The results of the phase 3 trial do not change Novo Nordisk's
expectations for the company's financial results for 2007, which
were provided on 31 January in Novo Nordisk's financial statement
for 2006.
Conference call
At 10.00 am CET today, corresponding to 4.00 am New York time, a
conference call for investors will be held. Investors will be able
to listen in via a link on novonordisk.com, which can be found
under 'Investors - Download centre'.
About NovoSeven®
Factor VIIa is a naturally occurring protein found in the blood. It
plays a crucial role in the coagulation process. NovoSeven®
(recombinant human coagulation factor VIIa) has been developed by
Novo Nordisk. It is licensed for the treatment of bleeding episodes
and for the prevention of bleeding during surgery or invasive
procedures in patients with congenital haemophilia with inhibitors
to coagulation factors VIII or IX. It is also licensed for
treatment of bleeding in patients with acquired haemophilia and
congenital factor VII deficiency, two very rare but serious
coagulation factor deficiencies. In Europe, NovoSeven® is
furthermore licensed for treatment of bleeding in patients with
Glanzmann's thrombasthenia with antibodies to GP IIb-IIIa and/or
HLA, and with past or present refractoriness to platelet
transfusions.
Novo Nordisk is a healthcare company and a world leader in
diabetes care. The company has the broadest diabetes product
portfolio in the industry, including the most advanced products
within the area of insulin delivery systems. In addition, Novo
Nordisk has a leading position within areas such as haemostasis
management, growth hormone therapy and hormone replacement therapy.
Novo Nordisk manufactures and markets pharmaceutical products and
services that make a significant difference to patients, the
medical profession and society. With headquarters in Denmark, Novo
Nordisk employs more than 23,600 employees in 79 countries, and
markets its products in 179 countries. Novo Nordisk's B shares are
listed on the stock exchanges in Copenhagen and London. Its ADRs
are listed on the New York Stock Exchange under the symbol 'NVO'.
For more information, visit novonordisk.com.
Contacts for further information:
Media: Investors:
Outside North America: Outside North America:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 4442 3573 Tel: (+45) 4443 7919
E-mail: mike@novonordisk.com
E-mail: mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
E-mail: hrmm@novonordisk.com
In North America: In North America:
Susan T Jackson Christian Qvist Frandsen
Tel: (+1) 609 919 7776 Tel: (+1) 609 919 7937
E-mail: stja@novonordisk.com E-mail:
cqfr@novonordisk.com
Posted: February 2007
