Nexium

AstraZeneca PLC
29 November 2004




    NEXIUM RECEIVES FDA APPROVAL FOR RISK REDUCTION OF NSAID-ASSOCIATED 
                                 STOMACH ULCERS


AstraZeneca today announced that a new indication for its prescription proton
pump inhibitor Nexium(R) (esomeprazole magnesium) has been approved by the US
Food and Drug Administration (FDA).  Nexium is now also indicated for reducing
the risk of gastric (stomach) ulcers developing among at risk patients on
continuous therapy with non-steroidal anti-inflammatory drugs (NSAIDs). The FDA
also issued an approvable letter for the indication of the healing of gastric
ulcers associated with therapy.


NSAIDs play a crucial role in providing relief to many pain sufferers.  However
potentially serious gastrointestinal side effects are often a deterrent to
continue long-term treatment.  Health care professionals now can offer their
patients on NSAID therapy, who may be at risk for developing gastric ulcers, a
therapeutic option that may lessen possibility of such stomach injury occurring.


A total of 1,429 patients, ranging in age from 19 to 89 were evaluated in two
separate multi-center, double-blind, placebo-controlled clinical studies.
Patients included in both studies had a chronic condition requiring daily NSAID
treatment (including COX-2 selective NSAIDs). They were randomised to treatment
with Nexium, 40 mg or 20 mg once daily, or placebo for up to 6 months. Nexium 20
mg and 40 mg demonstrated comparable benefits in providing risk reduction with
the proportion of NSAID patients remaining free of gastric ulcers ranging from
95.4 percent to 96.7 percent in one study and 94.7 percent to 95.3 percent in
the second study.


It is estimated that over 100 million prescriptions are written for NSAIDs each
year in the United States.  Everyday approximately 30 million people worldwide
take NSAIDs.  NSAIDs, which include such popular pain medications as aspirin,
ibuprofen and naproxen, are a common cause of stomach ulcers and have been
associated with side effects ranging from stomach upset to potentially life
threatening stomach bleeding.  In fact, NSAID use leads to more than 103,000
hospitalizations and 16,500 deaths each year in the United States.






Beyond its newest indication in the US for the reduction in the occurrence of
gastric ulcers associated with continuous NSAIDs therapy in patients at risk for
developing gastric ulcers, Nexium is also approved for healing erosive
esophagitis.  Studies show that up to 94 percent of patients were healed with
Nexium.  Most erosions heal in 4 to 8 weeks. Individual results may vary, and
only a doctor using endoscopy can determine if erosions to the esophagus have
occurred.  The drug is also indicated for treating heartburn and other symptoms
associated with acid reflux disease.


AstraZeneca announced that the European Union (Mutual Recognition Procedure
(MRP) for new indications for Nexium had been successfully finalized in
September this year. The new indications in the EU are for the healing of
gastric ulcers and, for patients at risk, the prevention of gastric and duodenal
ulcers, associated with NSAID therapy.  Nexium has been launched in 89 markets
and with strong continued growth in many large markets, is expected to become
the leading branded PPI by value in 2005.



                                     -Ends-

29th November 2004



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