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1 April 2003
ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM® IN THE FIRST OF FOUR INDICATIONS FOR THE MANAGEMENT OF NSAID*-ASSOCIATED GI SIDE EFFECTS

AstraZeneca today announced the submission of a regulatory application to the United States Food and Drug Agency (FDA) for the first of four indications within the NSAID-associated gastrointestinal (GI) side effect programme for NEXIUM®. This first indication is for the use of NEXIUM® for the treatment of upper GI symptoms in patients taking NSAIDs. Applications for the indication are also currently being filed in Europe and Canada.

The file for the treatment of acute NSAID-associated symptoms is supported by two clinical trials, which show that NEXIUM® provides effective control of NSAID-associated upper GI symptoms and improves quality of life in ulcer-free patients. Abstracts for both studies have been submitted to the annual congress of Digestive Disease Week (DDW), in May, 2003, in Orlando and will be presented as oral presentations.

The other three indications within the NSAID-associated GI side effect programme will be filed next year (2004), namely:

  • Prevention of NSAID-associated symptoms
  • Healing of NSAID-associated ulcers
  • Prevention of NSAID-associated ulcers in patients at risk

These new indications for NSAID-associated conditions are key elements in the life cycle management plan for NEXIUM®, 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, which are accountable for 20-25 per cent of all reported adverse events in the UK and US. In 2002, NEXIUM® had sales of $1,978m worldwide.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Further enquires to:

Media Enquiries

Emily Denney
+44 (0)20 7304 5034

Steve Brown
+44 (0)20 7304 5033

Asa Pehrsson Global PR Manager GI AstraZeneca
+46 (0) 31 706 55 20


Investor Relations

Mina Blair-Robinson
+44 (0)20 7304 5084

Jonathan Hunt
+44 (0)20 7304 5087


Note to News Editors:

  • * 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 gastro-intestinal side effects such as peptic and duodenal ulceration.

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