Nexium - Replacement

AstraZeneca PLC 29 November 2004 Reference Announcement RNS 7666F CORRECTION to end of paragraph one : addition of the word 'NSAIDs' in the last sentence. 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 NSAIDs 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 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 This information is provided by RNS The company news service from the London Stock Exchange

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