UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
June 12, 2008
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NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
NOVO ALLE
DK-2880, BAGSVAERD
DENMARK
(Address of principal executive offices)
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Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g-32(b):82-_____________________
RESEARCH UPDATE
NOVO NORDISK DISCONTINUES PHASE 3 CLINICAL TRIAL WITH NOVOSEVEN(R) IN TRAUMA
Novo Nordisk today announced the decision to discontinue the phase 3 clinical
trial with NovoSeven(R) 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(R) 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(R) 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(R) in
severely injured trauma patients with bleeding refractory to standard treatment.
Randomised patients received three single doses of NovoSeven(R) (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(R) compared to placebo in blunt trauma patients.
If not superior, the endpoint included an analysis to demonstrate
non-inferiority of NovoSeven(R) compared to placebo on all cause 30-day
mortality and superiority of NovoSeven(R) 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
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf of the
undersigned, thereunto duly authorized.
Date: June 12, 2008 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer