Exanta

RNS Number:6113T
AstraZeneca PLC
23 December 2003



EXANTATM (XIMELAGATRAN) REGULATORY FILINGS SUBMITTED IN UNITED STATES (US) AND
                EUROPEAN UNION (EU) FOR KEY CHRONIC INDICATIONS



AstraZeneca has submitted ExantaTM the first oral direct thrombin inhibitor,
for regulatory review in the EU and US in key chronic-use indications. In the
US, submissions have been made to the Food and Drug Administration (FDA) for
Exanta in the prevention of stroke and other thromboembolic complications
associated with atrial fibrillation (AF) and long-term secondary prevention of
venous thromboembolism (VTE), after standard treatment for an episode of acute
VTE.  In Europe, regulatory submissions have been made to the Reference Member
State, France, as part of the Mutual Recognition Procedure for use of Exanta in
prevention of stroke and other thromboembolic complications associated with AF
and the treatment of VTE.



Exanta is the first oral treatment in a new World Health Organisation class of
direct thrombin inhibitors (DTIs) and is the first new oral anticoagulant to
reach regulatory review since the introduction of warfarin almost 60 years ago.
These submissions collectively comprise one of the largest-ever regulatory
filings and are based on an extensive clinical study programme involving around
30,000 patients.



Exanta has the potential to meet an important unmet medical need in these
long-term chronic indications involving prevention or treatment of venous
thromboembolic events.  For example, in the prevention of stroke in patients
with AF, studies have shown that the risk of stroke can be reduced by 62 per
cent in patients taking oral anticoagulant therapy, and that around 50 per cent
of eligible patients do not currently receive optimal treatment.



Exanta benefits from administration as a fixed oral dose, has a rapid onset and
offset of action and shows low potential for food and drug interactions.
Importantly, coagulation monitoring and dose titration are also not necessary in
treatment with Exanta.  Although existing anticoagulant treatments are
effective, they are also associated with many limitations. While some require
subcutaneous or intravenous administration, the current standard oral treatment,
warfarin, is limited by extensive drug and food interactions and the need for
routine coagulation monitoring and dose titration.



A submission for the prevention of venous thromboembolic events in major
elective orthopaedic (knee replacement) surgery has also been submitted in the
US to the FDA this month.





23 December 2003



Media Enquiries

Chris Major, [phone]



Investor Enquiries:

Mina Blair-Robinson, [phone]

Jonathan Hunt, [phone]



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