Regulatory Approval

AstraZeneca PLC 12 July 2000 'NEXIUM' GAINS FULL EUROPEAN UNION MUTUAL RECOGNITION APPROVAL WITH WIDE RANGE OF INDICATIONS AstraZeneca today announced full European Union (EU) approval of 'Nexium' (esomeprazole), through the Mutual Recognition Procedure. 'Nexium' the first proton pump inhibitor (PPI) developed as an isomer, is approved across a broad range of indications including two new treatment approaches. 'Nexium' will soon be available in 15 EU Member States, in addition to Norway and Iceland, subject to local licensing, pricing and reimbursement approvals. Sweden acted as the Reference Member State for the European Mutual Recognition Procedure and obtained fast clearance approval of 'Nexium' in March 2000. Launches in a number of European countries, including the UK and Germany, are planned before the end of 2000, starting in Sweden next month (August). AstraZeneca is awaiting 'Nexium' approval in the USA and in other major markets, such as Canada, Australia, New Zealand and Switzerland. 'Nexium' has shown superior acid-control that is greater, faster and more sustained compared with other PPIs. 'Nexium' has also demonstrated superior clinical efficacy over omeprazole, the current unsurpassed gold standard treatment and has been approved across a wide range of acid-related diseases. 'Nexium' is indicated for gastroesophageal reflux disease (GERD) including: - Treatment of erosive reflux esophagitis - Long-term management of patients with healed esophagitis to prevent relapse - Symptomatic treatment of GERD. And 'Nexium' in combination with an appropriate antibacterial therapeutic regimen for the eradication of H. pylori for: - Healing of H. pylori-associated duodenal ulcer - Prevention of relapse of peptic ulcers in patients with H. pylori-associated ulcers. This broad indication base includes a whole new treatment approach unique to 'Nexium' across Europe. On-demand treatment allows doctors to prescribe 'Nexium' to patients, who then take a single dose of medication as and when needed, to control their recurrent symptoms. Results from clinical trials suggest that after six months' treatment, up to 90 percent of patients are able to control symptoms effectively by taking 'Nexium' on-demand. This is a new, highly convenient, approach to the long-term control of the symptoms of GERD that is likely to be cost-effective. Another treatment approach is one-week 'Nexium' triple-therapy in treating H. pylori-associated duodenal ulcers, a regimen that has been shown to be as effective as one-week triple-therapy with omeprazole followed by three additional weeks of omeprazole monotherapy (the currently recommended regimen). 'Nexium' provides superior acid control compared with the standard therapeutic dose of omeprazole 20 mg as well as omeprazole 40 mg, and standard doses of other drugs in this class such as pantoprazole 40 mg and lansoprazole 30 mg. 'Nexium' is also the first drug that has ever shown significant clinical advantages over omeprazole. Further enquires to: Elizabeth Sutton: Tel. +44 (0)20 7304 5101 Michael Olsson: Tel +44 (0)20 7304 5087 Ed Seage: Tel. +1 302 886 4065 Jorgen Winroth: Tel. +1 609 896 4148 or +44(0)7715 011140

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