Completely new approach to GERD treatment with Nexium

® STUDY HIGHLIGHTS COMPLETELY NEW APPROACH TO GERD TREATMENT WITH NEXIUM 'ON-DEMAND' TREATMENT FOR CONTROL OF ACID RELATED DISEASE NOW POSSIBLE 23 May 2000 -- London -- Data presented at Digestive Disease Week (DDW), San Diego, California, US, suggest that symptoms of gastroesophageal reflux disease (GERD), such as heartburn, may be effectively 1,2 3,4 controlled, and relapse after healing can be prevented, with ® 'on-demand' patient use of the new proton pump inhibitor (PPI) Nexium (esomeprazole, AstraZeneca). Results from trials discussed at the DDW suggest that after six months' treatment, up to 90 percent of patients may be able to control symptoms ® effectively by taking Nexium on-demand. Approved for use in Sweden, ® Nexium is the first and only PPI to gain approval for this new treatment of symptomatic GERD. 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. This is a new, highly convenient, and cost-effective approach to the long-term control of the symptoms of GERD. Professor Nicholas Talley, The Nepean Hospital, Penrith, New South Wales, Australia, presented the results of two trials of the new drug in GERD patients who had no physical damage to the surface of the esophagus (determined by endoscopy examination -'endoscopy-negative'). ® "Our results suggest that on-demand therapy with Nexium 20 mg is efficacious and well-tolerated in comparison with placebo in maintaining 1 symptom control in GERD patients without esophagitis. In one study ® involving 342 individuals, 86 percent continued with on-demand Nexium treatment over the six-month study period." GERD is a clinical condition in which reflux (backward flow) of stomach acid into the esophagus (gullet) is severe enough to cause recurrent symptoms that impact on patients' lives and/or to damage the esophagus. This condition, which is extremely widespread in the world's population, is both debilitating and can lead to significant reduction in quality of life for the sufferer. 2 A second study reported by Professor Talley, compared doses of 20 mg and ® 40 mg of Nexium on-demand, in a separate group of 721 GERD patients who were also endoscopy-negative. In this trial, more than 90 percent of patients continued with their treatment, taking an average of one dose every three days. There was no increase in clinical benefit at the higher dose. "The results of these trials demonstrate that on-demand treatment with ® Nexium , which patients can take as needed to control recurrent symptoms, provides both patients and physicians with a new symptom-driven approach to the long-term management of GERD, when esophagitis has been excluded," said Dr Martin Nicklasson, Executive Vice President GI Franchise, AstraZeneca. "This completely new treatment approach may result in a significant step forward in the management of acid-related digestive diseases," said Dr Nicklasson. Two further trials were also reported during the DDW, on the use of ® Nexium as maintenance therapy for GERD patients who had healed erosive 3,4 ® esophagitis. Both trials suggested that Nexium was significantly better than placebo in maintenance of healing of this condition, with 4 3 rates of more than 87 percent and 90 percent being observed among the patients. In addition, both trials indicate that the treatment was efficacious in control of heartburn. ® Nexium has a tolerability profile similar to omeprazole, and the most common side effects observed are headache, abdominal pain, and diarrhoea. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. # # # This press release contains forward-looking statements, which reflect AstraZeneca's current expectation regarding future events. The forward- looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the successful and timely completion of clinical studies, the uncertainties related to the regulatory process and the commercialisation of the drug thereafter. Investors should consult AstraZeneca's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. AstraZeneca disclaims any obligation to update these forward- looking statements. Further enquires to: Steve Brown, tel: +44 (0)20 7304 5033/Lucy Williams, tel: +44 (0)20 7304 5034 References 1. 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. Abstract / Study No 10 Gastroenterology 2000; 118: 3608, A658 2. 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 of on-demand therapy for six months. Abstract / Study No 22 Gastroenterology 2000; 118: 348, A21 3. Johnson DA et al. Efficacy and safety of esomeprazole as maintenance therapy in GERD patients with healed erosive esophagitis. Abstract / Study No 178 Gastroenterology 2000; 118: 330, A17 4. Vakil NB et al. Esomeprazole is effective as maintenance therapy in GERD patients with healed erosive esophagitis. Abstract / Study No 177 Gastroenterology 2000; 118: 350, A22 ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/23/20000523BIT00870/bit0001.doc http://www.bit.se/bitonline/2000/05/23/20000523BIT00870/bit0002.pdf