New Drug May Reduce Side Effects Of NSAIDs

Ed. Note: The following is a press release from AstraZeneca.

16 Sep 2004

AstraZeneca today announced that the Mutual Recognition Procedure (MRP) for new indications for Nexium® (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® 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.

Professor Chris Hawkey, University Hospital, Nottingham and lead investigator of the worldwide Nexium® NSAID programme said that the results of Nexium® research into the treatment of NSAID-associated upper GI side-effects showed that Nexium® is effective in substantially reducing NSAID-associated damage and ulcers.

"The good news is these innovative studies show Nexium® can effectively heal gastric ulcers and prevent gastric and duodenal ulcers, associated with long-term NSAID therapy, as well as relieve other painful upper GI symptoms such as epigastric pain, heartburn and acid reflux."

Nexium® 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® 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® 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® 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® worldwide sales increased by 20 per cent to $1,826 million. Nexium® has been launched in 89 countries and in sales terms, is the world's fastest growing PPI treatment on an annual basis.

Further enquiries to:

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

Notes to editors:
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 world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. Nexium® is a trademark of the AstraZeneca group of companies.