Nexium NSAID

AstraZeneca PLC
29 January 2004


           ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM(R)
     IN US AND EUROPE FOR HEALING AND PREVENTION OF NSAID-ASSOCIATED ULCERS

AstraZeneca today announced the submission of regulatory applications to the
United States Food and Drug Administration (FDA), the European Union (EU) and
other global markets for two indications related to the Non-steroidal
anti-inflammatory drugs (NSAID)-associated gastrointestinal (GI) side effect
programme for NEXIUM(R).  These indications are for the use of NEXIUM(R) for the
healing of NSAID-associated gastric ulcers and prevention of NSAID-associated
gastric and duodenal ulcers in patients at risk, in patients requiring continued
NSAID therapy.

In addition, AstraZeneca has reached agreement with European authorities
regarding the application for treatment of NSAID associated upper GI symptoms
submitted in March 2003. The European regulatory authorities concluded that the
current product labeling for NEXIUM(R) covers the medical need for all patients
with symptomatic disease, regardless of the etiology. Regulatory submissions for
NSAID-associated upper GI symptoms have also been submitted to other agencies
including the FDA.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat pain and
inflammation associated with diseases such as arthritis. Their use is associated
with gastrointestinal side effects such as gastric and duodenal ulceration, and
they are accountable for 20-25 per cent of all reported adverse events in the UK
and US.

Acid in the stomach plays an important role in NSAID-associated gastroduodenal
damage and NEXIUM(R) has been shown to provide more effective acid suppression
compared with all other PPIs.  In clinical trials, NEXIUM(R) has demonstrated
that it is effective in preventing the development of gastric and duodenal
ulcers in long-term users of NSAIDs, including COX-2-selective NSAIDs, who are
at risk of ulcer development.   Clinical trials also demonstrate that NEXIUM(R)
is effective in healing gastric ulcers in patients who require continuous NSAID
treatment, including COX-2 selective NSAIDs.  Abstracts have been submitted to
the Digestive Disease Week (DDW), taking place in May 2004, in New Orleans.

These new indications for NSAID-associated (upper) GI disorders are key elements
in the life cycle management plan for NEXIUM(R), as they will bring the benefits
of the product to a significant, new population of patients.  It is estimated
that approximately 30 million people worldwide take NSAIDs daily and between 20
and 30 per cent of patients taking NSAIDs suffer from duodenal and gastric
ulcers.

29 January 2004


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