AstraZeneca PLC
01 April 2003
ASTRAZENECA SUBMITS REGULATORY APPLICATIONS FOR NEXIUM(R) 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 Administration (FDA) for the first of four
indications within the NSAID-associated gastrointestinal (GI) side effect
programme for NEXIUM(R). This first indication is for the use of NEXIUM(R) 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(R) 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(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, which are
accountable for 20-25 per cent of all reported adverse events in the UK and US.
In 2002, NEXIUM(R) 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.
1 April 2003
For further enquires please contact:
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Asa Pehrsson, Global PR Manager GI, AstraZeneca
Tel: +46 (0) 31 706 55 20, email: Asa.C.Pehrsson@astrazeneca.com
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 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.
- Ends -
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