Exanta

AstraZeneca PLC
14 February 2006




                    AstraZeneca Decides to Withdraw ExantaTM
 Patients must not stop taking their tablets without speaking to their doctor.



AstraZeneca today announced that the company has decided to withdraw the
anticoagulant ExantaTM (melagatran / ximelagatran) from the market and terminate
its development.  AstraZeneca estimates that approximately 400 patients are
currently being prescribed the drug for short-term prevention of venous
thromboembolism (VTE) following orthopaedic surgery (OS). Two ongoing Exanta
clinical trials will be discontinued and Exanta-treated patients switched to
other treatments. It is important that patients do not stop Exanta treatment
without consulting their doctor. Regulatory files in OS and other indications in
the US, Europe and elsewhere will now be withdrawn.



The withdrawal of Exanta has been triggered by new patient safety data (an
adverse event report of serious liver injury) in the EXTEND clinical trial. The
trial examines use of Exanta in extended VTE prophylaxis in OS up to 35 days
post-operatively, and so involves a longer duration of therapy than currently
approved for marketing. Liver findings have previously been observed during
clinical trials of chronic use as referred to in the prescribing information.
This new patient report indicates a potential risk of severe liver injury, with
an observation of rapid onset of signs and symptoms in the weeks following the
end of the 35 days treatment. This specific observation has not previously been
made in relation to Exanta and indicates that regular liver function monitoring
may not mitigate the possible risk. While there is no evidence of a risk of
liver injury with approved use up to 11 days, any unapproved use beyond 11 days
is a concern.  Therefore, in the interests of patient safety, AstraZeneca is
taking the precautionary measure of withdrawing Exanta.  AstraZeneca has
informed regulatory authorities of its decision to withdraw Exanta and is now
communicating with all prescribers and healthcare professionals to advise them
that no new patients should be started on Exanta.









For patients currently taking Exanta, doctors should consider changing treatment
to an alternative anticoagulant while taking account of individual patient
circumstances and ensuring uninterrupted anticoagulation.  The small number of
current Exanta patients should be contacted by their doctor and reviewed
promptly to avoid any unplanned discontinuation of therapy. AstraZeneca will
maintain the supply of Exanta for a short period to allow doctors to manage
patients during this transition.



David Brennan, Chief Executive Officer, AstraZeneca PLC commented: 'We have
decided to take this precautionary action in the interests of patient safety.
There are a number of alternative options for short-term post-operative
anticoagulation following orthopaedic surgery.  We would like to recognise the
involvement of doctors, patients and scientists and their commitment to the
development of Exanta over the past years.  Thrombosis is one of the greatest
threats to human health and represents a significant public health burden.
AstraZeneca remains committed to the discovery and development of new medicines
in this area to help improve patients' lives.'

                                     -Ends-

14 February, 2006



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Notes to editors:

* Also known as ExartaTM in Italy and Sweden

  • Exanta is marketed for up to 11 day use in prevention of venous
    thromboembolic events (VTE) in patients undergoing elective hip or knee
    replacement surgery.
  • Countries where Exanta is marketed are Germany, Portugal, Sweden, Finland,
    Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and
    Brazil.
  • Countries where Exanta is approved but not marketed are Belgium, Spain,
    The Netherlands, Luxembourg, Greece, Indonesia, Hong Kong, Italy, Russia and
    Ukraine.
  • In 2005 total sales of Exanta were $575,000
  • The development of AZD0837, which has the same mode of action as Exanta
    but is chemically different, will continue as planned.
  • For patient and physician enquiries, AstraZeneca contact details, by
    country, are available on the www.exanta.com website








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