New data support the efficacy and safety of the novel oral anticoagulant Exanta®

July 10, 2001

(Mölndal, Sweden, 10 July 2001) The presentation of a wide range of data at the 18th International Society on Thrombosis and Haemostasis meeting (ISTH) in Paris this week, provided new evidence to support the efficacy and safety of Exanta®, which is set to be the first new oral anticoagulant since warfarin was introduced over 50 years ago.

Exanta®, an oral direct thrombin inhibitor, is currently under investigation in an extensive phase III clinical trials programme in a number of key therapeutic areas. The programme, which involves more than 15,000 patients in 30 countries, includes European and US phase III studies in the prevention of blood clot formation in the leg veins of patients undergoing orthopaedic surgery, presented at the ISTH. These blood clots in leg veins, or deep vein thrombosis (DVT), can dislodge and travel to the lung causing pulmonary embolism (PE). DVT and PE together are known as venous thromboembolism (VTE).

Dr Ian Watts, Global Product Director, said: "Over 20 abstracts were selected for oral and poster presentation at the ISTH meeting, including the phase III results from US and European trials of VTE prophylaxis in orthopaedic surgery. These data show that Exanta® has efficacy and tolerability at least comparable to that of warfarin or a low molecular weight heparin compound, the standard anticoagulants in the US and Europe respectively."

The European phase III trial, one of the largest ever trials of VTE prophylaxis in orthopaedic surgery, included 2788 patients undergoing total hip or total knee replacement surgery, in centres across Europe. The study, which compared the efficacy and safety of Exanta® to the low molecular weight heparin, enoxaparin showed it to be effective and well tolerated for VTE prevention, with efficacy comparable to that of enoxaparin. The earlier phase II trial also showed Exanta® to be comparable to another low molecular weight heparin, dalteparin.

The US phase III trial, which included 680 patients in North American centres, also showed favourable results in patients undergoing total knee replacement surgery. This study which compared the efficacy and safety of Exanta® to warfarin in VTE prophylaxis showed that Exanta® is at least as effective as warfarin, and does not require routine coagulation monitoring or dose adjustment.

"There is no doubt that Exanta® works well and we are confident about its future" Dr Ian Watts continued. "We are currently committed to carrying out complementary phase III trials of VTE prophylaxis in orthopaedic surgery that will allow us to determine the optimal way of using Exanta® , as well as the ongoing phase III trials in the key indication of stroke prevention in atrial fibrillation. With a simple, fixed oral dosage and no need for routine coagulation monitoring, Exanta® offers the possibility of better anticoagulation for millions of patients."

Other data presented at the ISTH meeting included the results of important interaction studies. These studies, in conjunction with the wealth of clinical experience to date, confirm that there are no food or known drug-drug interactions with Exanta®.

The administration of Exanta® as a simple fixed oral dose, independent of age or ethnic origin, was also highlighted in comparison pharmacokinetic studies in young, old and ethnic origin groups (African, Asian and Caucasian). These data showed little variability in the pharmacokinetic profile within and between groups.

In addition to the positive Phase III trials of VTE prophylaxis in patients undergoing orthopaedic surgery, other promising data presented at the ISTH included data on the use of Exanta® in abdominal surgery and in DVT treatment. These studies both showed the efficacy of Exanta® to be comparable to the standard anticoagulant, dalteparin.

The key indication for Exanta® is stroke prevention in patients with the heart arrhythmia, atrial fibrillation. Three-month phase II, SPORTIF II, data on this major indication are to be presented at the 23rd European Society of Cardiology Meeting in Stockholm in September, and the longer-term phase II data, SPORTIF IV, should be presented later this year.

The phase III programme of research into the efficacy of Exanta® in stroke prevention in atrial fibrillation, comprising the SPORTIF III and V studies, is the largest-ever programme conducted in this indication with more than 6,200 patients enrolled.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales over $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

For further information please contact:

Jonathan Wilson
(T) 44-(0)- 207-611-3671
(M) 44-(0)-7968-799-349

Cathy Kernen
(T) 44- (0)-1625- 510-827

Ketchum UK

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