AstraZeneca PLC
28 October 2002
ASTRAZENECA'S NEW ORAL DIRECT THROMBIN INHIBITOR EXANTATM SUPERIOR IN REDUCING
RISK OF VENOUS THROMBOEMBOLISM (VTE) FOLLOWING TOTAL HIP OR KNEE REPLACEMENT
SURGERY
AstraZeneca announced today, from the 17th International Congress on Thrombosis
(ICT) in Bologna, results from the EXPRESS phase III clinical trial with
ExantaTM (oral ximelagatran and its active form, melagatran) that showed the
drug's superior efficacy in reducing risk of major venous thromboembolism (VTE)
compared with a routinely used prophylactic treatment, enoxaparin, in major
orthopaedic surgery.
Results showed a significant 63 per cent relative risk reduction (2.3% vs 6.3%:
p=0.0000018) in major venous thromboembolism (VTE) (proximal deep vein
thrombosis (DVT) and pulmonary embolism (PE)) when treated with 'Exanta',
compared to standard prophylaxis with enoxaparin (40mg od). A relative risk
reduction in major VTE of 67 per cent (1.8% vs 5.5%) was noted for total hip
replacement and a 60 per cent relative risk reduction (3.3% vs 8.2%) for total
knee replacement surgery. Additionally, there was a 24 per cent (20.3% vs
26.6%) reduction in the risk of total VTE (proximal and distal DVT and PE)
following prophylactic treatment (thromboprophylaxis) with 'Exanta', compared to
enoxaparin.
The 'Exanta' treatment regimen in EXPRESS shows a good balance between efficacy
and safety. A small increase in surgery-related bleeding was observed compared
to enoxaparin, although importantly, there were no differences between
treatments in clinically important bleeding events (defined as fatal, critical
organ or requiring re-operation).
Between 45-57 per cent of patients undergoing total hip replacement without
thromboprophylaxis develop DVT (deep vein thrombosis), a potentially fatal
condition. Similarly, the rate of DVT for patients undergoing total knee
replacement is 40-84 per cent. The market for anticoagulants is currently
valued at $3.1 billion.
'Exanta' is the first Oral DTI to be submitted for regulatory approval and works
by inhibiting thrombin, a key enzyme involved in the blood clotting
(coagulation) process. AstraZeneca submitted a filing for a European licence
for 'Exanta' (ximelagatran / melagatran) for the prevention of VTE following
major orthopaedic surgery in July 2002. This was the first regulatory
submission for 'Exanta'. In the United States, the parallel phase III clinical
trial programme in orthopaedic surgery, EXULT, remains on track.
Fifteen additional abstracts presented at the ICT highlighted the potential of '
Exanta' to meet a clear unmet medical need in the prevention and treatment of
thromboembolism and demonstrated its benefit in terms of efficacy, safety,
predictable pharmacokinetic results and tolerability across a wide patient
population.
Thrombosis is one of the largest causes of morbidity and mortality in the
Western world. There are nearly four million events of thromboembolic disease
(including stroke, deep vein thrombosis/pulmonary embolism and myocardial
infarction) each year throughout the EU and Japan.
EXPRESS is a randomised, double-blind study of 2,800 patients that compares the
efficacy and safety of 'Exanta', with that of commonly used prophylactic
treatment with subcutaneous enoxaparin (40mg od), for the prevention of venous
thromboembolism (VTE) following major hip and knee replacement surgery.
Patients received 2 mg subcutaneous 'Exanta' immediately before surgery,
followed by 3 mg subcutaneous 'Exanta' in the evening after surgery, and then 24
mg oral 'Exanta' as a fixed dose. EXPRESS was carried out in 12 European
countries and South Africa.
'Exanta' is a trademark of the AstraZeneca group of companies.
28 October 2002
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Chris Major, Tel: +44 (0) 207 304 5028
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
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.