AstraZeneca PLC
23 June 2003
Stock Exchange Announcement
ASTRAZENECA ANNOUNCES ABSTRACT PUBLISHED ON
EXANTA(TM) (ximelagatran) IN THE TREATMENT OF VENOUS THROMBOEMBOLISM (VTE)
AstraZeneca today announced the publication of an abstract, which details the
results from the phase III THRIVE Treatment study 1 for Exanta(TM)
(ximelagatran), the first of a new class of oral direct thrombin inhibitor (oral
DTI). The results of the THRIVE Treatment study will be presented at the XIX
Congress of the International Society on Thrombosis and Haemostasis, on Monday
14 July 2003. The abstract is available online at:
http://www.isth2003.co.uk/layersite/ indexbluelay.html. Top line results
include:
• In the study, designed to show non-inferiority 2, Exanta was shown to be as
effective as the current standard of care, enoxaparin/warfarin, in treatment
of acute VTE over six months in order to prevent recurrent VTE events (26
Exanta vs 24 enoxaparin/warfarin, ITT population).
• A favourable trend for Exanta over enoxaparin/warfarin was seen with
respect to risk of major bleeding (14 Exanta vs 25 enoxaparin/warfarin, OT
population) and mortality (28 Exanta vs 42 enoxaparin/warfarin, ITT
population).
• Laboratory blood tests showed transient liver enzyme elevations in 9.8% of
patients receiving Exanta, compared with 2% of patients receiving enoxaparin
/warfarin. These elevations spontaneously decreased with treatment
continuation or discontinuation and, as has been seen in previous studies,
were not typically associated with specific clinical symptoms.
THRIVE Treatment, together with THRIVE III, will form the basis for the
regulatory submission for Exanta in the treatment and long-term prevention of
VTE and contribute to the overall benefit-risk profile for the drug. This
submission remains on track to be submitted in Europe in the fourth quarter of
this year.
Exanta is the first of a new class of oral anticoagulants called direct thrombin
inhibitors (oral DTIs). The drug is currently under phase III investigation and
is the first oral anticoagulant to reach late clinical development in more than
50 years - since the development of warfarin.
23 June 2003
Investor Inquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
- Ends -
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.