Nexium gains full European Union mutual recognition approval with wide range of indications

® 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 pre-scribe ® Nexium to patients, who then take a single dose of medication as and when 1,2 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 symp-toms 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). Dr Tom McKillop, Chief Executive Officer of AstraZeneca, said: "The EU ® approval of Nexium is tremendous news and I am delighted that we can now offer the millions of sufferers of acid-related disease, many of whom are not yet managed, an optimal treatment. Physicians now have the option to use an evolutionary new PPI that defines a new level of acid-control, outperforming other drugs in this class, including omeprazole." ® Nexium provides superior acid control compared with the standard therapeutic 3 4 dose of omeprazole 20 mg as well as omeprazole 40 mg , and standard doses of 5 other drugs in this class such as pantoprazole 40 mg and lansoprazole 30 6 ® mg . Nexium is also the first drug that has ever shown significant clinical 7 advantages over omeprazole . ® Nexium has a tolerability profile similar to omeprazole, and the most common side effects observed are headache, abdominal pain, and diarrhoea. Further enquiries to: Steve Brown, tel +44 (0)20 7304 5033 Lucy Williams, tel +44 (0)20 7304 5034 References Talley NJ et al. Esomeprazole 20 mg maintains symptom control in endoscopy- negative GERD: a randomized placebo-controlled trial of on-demand therapy for six months. Gastroenterology 2000; 118: A21 Talley NJ et al. Esomeprazole 40 mg and 20 mg is efficacious in the long-term management of patients with endoscopy-negative GERD: a placebo-controlled on- demand therapy for six months. Gastroenterology 2000; 118: A658 Lind T et al. Esomeprazole provides improved acid control versus omeprazole in patients with symptoms of gastroesophageal reflux disease. Aliment Pharmacol Ther 2000; 14: 861-867 Röhss K et al. Esomeprazole 40 mg provides more effective acid control than omeprazole 40 mg. XXXII Nordic Meeting of Gastroenterology, Gothenburg, Sweden, 19-21 June 2000 (Abstract) Wilder-Smith C et al. Esomeprazole 40 mg provides more effective acid control than pantoprazole 40 mg. Gastroenterology 2000; 118: A22 Röhss K et al. Esomeprazole 40 mg provides more effective acid control than lansoprazole 30 mg. Gastroenterology 2000; 118: A20 Richter JE et al. Esomeprazole is superior to omeprazole for the healing of erosive esophagitis in GERD patients. Gastroenterology 2000; 118: A20 ------------------------------------------------------------ This informatin was brought to you by BIT http://www.bit.se The following files are available for download: http://www.bit.se/bitonline/2000/07/12/20000712BIT00240/bit0001.doc http://www.bit.se/bitonline/2000/07/12/20000712BIT00240/bit0002.pdf