Exanta

RNS Number:9306R
AstraZeneca PLC
11 November 2003





NEW STUDY CONFIRMS POTENTIAL FOR EXANTATM (ximelagatran) IN PREVENTION OF STROKE
                             IN ATRIAL FIBRILLATION



AstraZeneca today announced the results from the SPORTIF V study at the American
Heart Association (AHA) Scientific Sessions 2003, in Orlando, US. The data
supports the potential for ExantaTM (ximelagatran), the first oral treatment in
a new class of direct thrombin inhibitors (DTIs), to be an effective and
predictable replacement for warfarin in the prevention of stroke and systemic
embolic events (SEE) in patients with atrial fibrillation (AF), without the
limitations of warfarin treatment.



SPORTIF V, together with the recently presented SPORTIF III, is the largest
study programme to date for stroke prevention in AF, involving 7,329 patients in
total.  The SPORTIF programme will represent the key element of regulatory
submissions to support use of Exanta for the prevention of stroke in AF
patients, an important area of unmet medical need. These regulatory submissions
are planned to take place in the US and Europe by the end of 2003.



SPORTIF V compares oral Exanta with the current standard treatment,
dose-adjusted warfarin in preventing stroke and SEE in patients with AF and was
designed to demonstrate the non-inferiority of Exanta with the comparator.  The
results support the findings of the SPORTIF III study. The primary efficacy
endpoint was met, showing that fixed dose, twice daily 36mg oral Exanta is
non-inferior to dose-adjusted warfarin in preventing stroke and SEE: (51 Exanta
patients with events (1.6 per cent/yr) vs 37 for warfarin (1.2 per cent/yr)).
Importantly, this result was seen despite excellent control of warfarin
treatment in the study: patients were within the INR range of 2.0-3.0 for 68 per
cent of time.   The design of SPORTIF III and V allowed for a pooled analysis of
the results.  In the combined studies, a total of 91 patients with events were
seen for Exanta compared with 93 for warfarin (1.6 per cent/yr vs 1.6 per cent/
yr), supporting the efficacy of Exanta in prevention of strokes and
thromboembolic events in patients with AF.



Patients were treated for an average of 20 months in SPORTIF V, providing
further long-term data to support the emerging benefit-risk profile for Exanta.
Despite no coagulation monitoring or dose titration in the Exanta group, a lower
number of patients in SPORTIF V experienced major bleeding (2.4 per cent Exanta
vs 3.1 per cent warfarin; p=n.s.). Warfarin was well controlled in this study
with careful ongoing coagulation monitoring, dose adjustment and dose titration,
yet Exanta demonstrated significantly less total (major and/or minor) bleeding
rates than well-controlled warfarin (37 per cent Exanta vs 47 per cent warfarin
p3XULN) was observed in six per cent of
patients treated with Exanta in SPORTIF V, a consistent level to that seen in
other long-term Exanta studies.  An incidence of elevated bilirubin > 2XULN
following ALAT > 3XULN was seen in nine Exanta patients vs one warfarin patient.
  When assessed alongside SPORTIF III as pooled data, the overall incidence of
liver enzymes for Exanta in the SPORTIF programme is 6.1 per cent, compared with
0.8 per cent of patients in the warfarin group.  These elevations are typically
transient (occurring within first 2-6 months), decrease towards baseline with
treatment continuation or discontinuation and are not associated with specific
clinical symptoms in the SPORTIF programme overall.



Overall, a statistically significant net clinical benefit is seen for Exanta
from the pooled data of both the SPORTIF V and SPORTIF III studies.  In an
assessment of the combined rates of deaths, primary events and major bleeding
while on treatment, 5.2 per cent events were seen with Exanta compared with 6.2
per cent with warfarin (p=0.038).  This finding demonstrates that patients can
benefit from a predictable and effective treatment to prevent morbidity and
mortality, whilst avoiding the limitations that are associated with warfarin.



The overall clinical programme for Exanta, involving around 30,000 patients, is
the most extensive to date and supports a positive risk/benefit profile for the
treatment, which is the first oral anticoagulant to reach late stage clinical
development in almost 60 years.  The current worldwide market for
antithrombotics is $9.6 billion.



11 November 2003



Media Enquiries
Steve Brown, ++44 (0) 207 304 5033
Edel McCaffrey, ++44 (0) 207 304 5034



Investor Enquiries:
Mina Blair-Robinson, ++44 207 304 5084
Jonathan Hunt, ++44 207 304 5087



A webcast of the SPORTIF V late breaking clinical presentation, will go live on
the AHA website www.scientificsessions.org, from 10:45 EST / 1545 GMT, Wednesday
12th November.



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