Novo Nordisk discontinues phase 3 clinical trial with NovoSeven® in
trauma
Novo Nordisk today announced the decision to discontinue the phase 3
clinical trial with NovoSeven® for the treatment of bleeding in
patients with severe trauma. The decision was made based on the
results of an analysis for futility conducted by the independent Data
Monitoring Committee. The phase 3 trial was evaluating the efficacy
and safety of NovoSeven® in severely injured trauma patients with
bleeding refractory to standard treatment. The primary efficacy
endpoint of the study was mortality and morbidity.
Due to an observed lower mortality than anticipated in the overall
study group (around 10% in the phase 3 trial in total compared to
more than 25% in the phase 2 trial), a futility analysis was
conducted to assess the likelihood of reaching a successful outcome
on the primary endpoint. The analysis predicted a low likelihood of
obtaining a positive trial outcome with the planned study population,
and as a consequence, Novo Nordisk has decided to discontinue the
trial.
The decision is not due to safety concerns. In its latest review on
safety data of 31 March 2008, the independent Data Monitoring
Committee recommended continuation of the study.
Mads Krogsgaard Thomsen, executive vice president and chief science
officer said: "It is regrettable that this trial is coming to an end.
It has, however, already now provided a lot of important data on the
treatment of severely injured patients. We will share these findings
with the medical community as soon as the full clinical analysis has
been completed."
The decision to discontinue the phase 3 clinical study with
NovoSeven® for the treatment of bleeding in patients with severe
trauma does not impact Novo Nordisk's expectations for the company's
financial results for 2008, which were provided on 30 April in
connection with the release of the financial results for the first
quarter of 2008.
About the study
The study had enrolled more than 550 patients of the planned 1,502 in
24 countries. It was a multicentre, randomised, double-blind,
parallel group, placebo-controlled trial to evaluate the efficacy and
safety of NovoSeven® in severely injured trauma patients with
bleeding refractory to standard treatment. Randomised patients
received three single doses of NovoSeven® (200 mcg/kg + 100 mcg/kg +
100 mcg/kg) or placebo after the transfusion of the fourth unit of
red blood cells)
The study has the primary endpoint of all cause 30-day mortality
designed to show superiority of NovoSeven® compared to placebo in
blunt trauma patients. If not superior, the endpoint included an
analysis to demonstrate non-inferiority of NovoSeven® compared to
placebo on all cause 30-day mortality and superiority of NovoSeven®
compared to placebo on pulmonary and/or renal dysfunction requiring
ongoing medical intervention at day 30 in blunt trauma patients.
(ClinicalTrials.gov. Identifier: NCT00184548).
Novo Nordisk is a healthcare company and a world leader in diabetes
care. 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 approximately 26,300
employees in 80 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
mike@novonordisk.com mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
hrmm@novonordisk.com
In North America: In North America:
Sean Clements Christian Qvist Frandsen
Tel: (+1) 609 514 8316 Tel: (+1) 609 919 7937
secl@novonordisk.com cqfr@novonordisk.com
Stock Exchange Announcement no 34 / 2008