AstraZeneca PLC
16 September 2004
NEW INDICATIONS FOR NEXIUM(R)
IN HEALING AND PREVENTION OF NSAID-ASSOCIATED ULCERS
AstraZeneca today announced that the Mutual Recognition Procedure (MRP) for new
indications for Nexium(R) (esomeprazole) has been successfully finalised. The
new indications are for the healing of gastric ulcers and, for patients at risk,
the prevention of gastric and duodenal ulcers, associated with non-steroidal
anti-inflammatory drug (NSAID) therapy. The company is now awaiting individual
national approvals.
Nexium(R) is proven to be fast and effective in healing gastric ulcers in
patients taking NSAIDs, including COX-2 selective NSAIDs. In addition, it is
proven to be effective in preventing gastric and duodenal ulcers associated with
all NSAIDs, including COX-2 selective NSAIDs.
Approximately 30 million people worldwide take NSAIDs on a daily basis to reduce
inflammation and alleviate pain and they are the gold standard treatment for the
majority of arthritic diseases and for treating chronic pain. However all
NSAIDs carry a risk of upper GI side-effects, placing a significant burden on
patients, the medical profession and the healthcare system.
It has been estimated that 15 to more than 40 per cent of NSAID users experience
upper GI symptoms such as dyspepsia, abdominal pain, heartburn and nausea and as
many as 15 to 30 per cent of long-term NSAID users develop peptic ulcers. A
major concern with NSAID use is the life-threatening risk of peptic ulcer
complications, such as bleeding and perforation.
Nexium(R) is an established treatment for gastroesophageal reflux disease
(GERD). GERD is a common condition that can significantly impair quality of
life. It is characterised by reflux of gastric acid from the stomach into the
esophagus, causing upper GI symptoms such as heartburn and acid reflux. Erosive
esophagitis (inflammation of the esophagus) is often present.
Nexium(R) belongs to the class of drugs, proton pump inhibitors (PPIs). PPIs
work by blocking the production of gastric acid which can irritate the lining of
your esophagus, stomach and duodenum (the top end of your small intestine).
Effective control of gastric acid secretion is a key factor in the management of
GERD and NSAID-associated upper GI side-effects. Nexium(R) has been shown to
provide more effective control of gastric acid secretion than all other PPIs.
It works by deactivating the proton (acid) pumps that produce stomach acid. This
reduces the amount of acid that is in the stomach, helping to treat heartburn
and other symptoms of GERD.
Regulatory applications 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, were submitted in the US and other global
markets earlier this year. Discussions with these regulatory authorities are
ongoing and further approvals are anticipated in the coming months.
During the first half of 2004, Nexium(R) worldwide sales increased by 20 per
cent to $1,826 million. Nexium(R) has been launched in 89 countries and in
sales terms, is the world's fastest growing PPI treatment on an annual basis.
16 September 2004
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
-Ends-
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.