Exanta

AstraZeneca PLC
23 December 2003





                EXANTATM (XIMELAGATRAN) RECEIVES FIRST APPROVAL



    First indication for prevention of venous thromboembolic events in major
                              orthopaedic surgery



AstraZeneca has received its first regulatory approval for ExantaTM
(ximelagatran) in France for the prevention of venous thromboembolic events in
major orthopaedic (hip or knee replacement) surgery.  France is the Reference
Member State for the European Union (EU) Mutual Recognition Procedure for
Exanta.  Subject to approval, launches of Exanta in this first 'proof of
principle' indication are expected to take place later in 2004.



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
approved since the introduction of warfarin almost 60 years ago.  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 is also not necessary in treatment with Exanta.



The approval of Exanta for this first indication in France is based on the
METHRO study programme, involving an early postoperative start of Exanta
treatment, with initial injectable dosing administered at least four hours after
the completion of surgery, followed by oral Exanta 24mg twice daily for up to 11
days.  This approval reflects clinical practice that is becoming increasingly
common in Europe and allows use in conjunction with spinal anaesthesia with the
oral dosing route enabling treatment to be easily continued following discharge
from hospital.  More than half of patients undergoing major orthopaedic surgery
develop VTE in the absence of preventative anticoagulant treatment, and while
effective treatments are available, no treatment regimen to date has
successfully balanced efficacy and bleeding risk with oral dosing.



Regulatory submissions for Exanta in key chronic treatment indications, for
prevention of stroke in atrial fibrillation and treatment of VTE, have already
been filed in France as part of the EU Mutual Recognition Procedure.  In the US,
the Food and Drug Administration (FDA) submissions for use of Exanta in stroke
prevention in patients with atrial fibrillation and long-term secondary
prevention of VTE have also been filed alongside the orthopaedic surgery file
for use of Exanta in prevention of VTE in total knee replacement.



23 December 2003





Media Enquiries

Chris Major, [phone]



Investor Enquiries:

Mina Blair-Robinson, [phone]

Jonathan Hunt, [phone]

- Ends -


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