Breakthrough for NovoSeven(R): New Study Shows Significant Reduction in Blood Transfusion Needed in Trauma Patients
BAGSVAERD, Denmark, Dec. 19 /PRNewswire-FirstCall/ -- Novo Nordisk A/S
(NYSE: NVO) today announced the first results from its phase 2 studies of the
safety and efficacy of NovoSeven(R) in trauma patients. The study shows that
patients receiving treatment with NovoSeven needed significantly less red
blood cell transfusion than patients receiving conventional treatment.
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Furthermore, results indicate that patients treated with NovoSeven had
fewer complications and spent less time in intensive care units than patients
receiving conventional treatment and, further, that overall mortality was
lower in the group treated with NovoSeven. However, as the study was not
designed to show differences in these parameters, these findings need to be
investigated further in a subsequent study.
Equally important, in terms of safety, the study revealed no difference
between the two treatment groups in the number or types of serious adverse
events, including thrombo-embolic events.
Lars Rebien Sorensen, president and chief executive officer of Novo
Nordisk, said, "The proof of concept for the use of NovoSeven is a major
breakthrough in the treatment of patients with trauma and one of the most
important events in Novo Nordisk's R&D pipeline in recent years."
The trauma study involved 280 patients in five continents, with critical
bleeding related to either blunt or penetrating trauma. Patients that had
been hospitalized with life-threatening bleeding, and who had already received
transfusion of approximately 8 units of blood, were randomized to receive
either NovoSeven or placebo, in addition to conventional treatment.
In the patients whose bleeding was caused by a blunt trauma, for example
victims of traffic accidents, the effect of NovoSeven in reducing bleeding was
statistically significant. In patients whose bleeding was caused by
penetrating trauma, for example gunshots, there was a strong trend towards
reduction of bleeding. In most countries blunt trauma is responsible for 75-
95% of the total number of traumatic injuries.
UPDATE ON OTHER NOVOSEVEN(R) STUDIES
Novo Nordisk has also finalized a study of the effect of NovoSeven on
bleeding in patients undergoing stem cell transplantation. In this study 100
patients suffering from moderate to severe bleeding episodes were treated with
various doses of NovoSeven or placebo, in addition to standard treatment.
Although a statistically significant dose-response was not seen, results
indicated a clinical effect at a relevant dose. The effect of NovoSeven for
patients undergoing stem call transplantation will be investigated further in
an already ongoing study.
As announced in Novo Nordisk's financial statement for the first nine
month of 2003 on October 29, 2003, Novo Nordisk also expects to be able to
report the conclusions from a study of the use of NovoSeven in connection with
liver transplantation in the first quarter of 2004.
The above scientific results do not change Novo Nordisk's expectations for
the financial results for 2003.
ABOUT TRAUMA
Serious bleeding is the leading cause of death in traumatic injury related
among others to traffic accidents, falls and use of weapons. Approximately
1.5 million people experience a major traumatic event per year in the Western
world, and approximately 20% of those need blood transfusion.
In general traumatic injuries can be classified in one of two broad
categories according to the injury, namely blunt and penetrating trauma. In
the United States the distribution between the two major trauma categories is
around 80% being blunt trauma and around 20% being penetrating trauma. Blunt
trauma refers to injuries resulting from non-penetrating forces such as
traffic accidents or falls. Penetrating injuries result from a piercing of the
skin and damage to the deeper tissues or organs of the body. Penetrating
injuries typically result from gunshot wounds or stabbing.
Usually a combination of surgical management, non-operative management and
intravascular interventions is used in the treatment of trauma. Most patients
with severe trauma experience acute hemorrhage. The significant reduction in
intravascular blood volume resulting from severe trauma can lead to clinical
shock and often cause death.
However, transfusions are associated with increased mortality and
morbidity. Although blood transfusion is a crucial component in the
management of trauma patients, recent studies have shown that infection and
mortality rates in patients who receive blood transfusion are higher compared
to those who do not. Reduction in blood loss, and a reduction in the level of
blood transfusion, is therefore an increasingly important management
objective.
ABOUT NOVOSEVEN(R)
NovoSeven is a recombinant hemostatic agent (recombinant activated factor
VII). The product is currently registered for treatment of bleeding episodes
in hemophilia patients with congenital or acquired inhibitors against the
clotting factors VIII or IX. Its unique mechanism of action induces hemostasis
independently of FVIII and FIX. By stimulating a burst of thrombin production
on the surface of activated platelets, rFVIIa is able to accelerate and
strengthen the body's own clotting process. Factor Xa, in complex with other
factors, then converts prothrombin to thrombin, which leads to the formation
of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing
local hemostasis.
FORWARD-LOOKING STATEMENT
The above sections contain forward-looking statements as the term is
defined in the US Private Securities Litigation Reform Act of 1995. Forward-
looking statements provide current expectations or forecasts of events such as
new product introductions, product approvals and financial performance.
Such forward-looking statements are subject to risks, uncertainties and
inaccurate assumptions. This may cause actual results to differ materially
from expectations. Factors that may affect future results include interest
rate and currency exchange rate fluctuations, delay or failure of development
projects, production problems, unexpected contract breaches or terminations,
government-mandated or market-driven price decreases for Novo Nordisk's
products, introduction of competing products, Novo Nordisk's ability to
successfully market both new and existing products, exposure to product
liability and other lawsuits, changes in reimbursement rules and governmental
laws and related interpretation thereof, unexpected growth in costs and
expenses.
Risks and uncertainties are further described in reports filed by Novo
Nordisk with the US Securities and Exchange Commission (SEC) including the
company's Form 20-F, which was filed on March 27, 2003. Please also refer to
the section "Financial Risk Factors" in the Annual Financial Report 2002.
Novo Nordisk is under no duty to update any of the forward-looking statements
or to conform such statements to actual results, unless required by law.
Novo Nordisk is a focused healthcare company. With the broadest diabetes
product portfolio in the industry, including the most advanced products within
the area of insulin delivery systems, Novo Nordisk is a world leader in
diabetes care. In addition, Novo Nordisk has a leading position within areas
such as hemostasis 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 18,700 people in 68 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 further company information visit
http://www.novonordisk.com, or in the US at
http://www.novonordisk-us.com.
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