FDA APPROVES INTRAVENOUS FORMULATION FOR NEXIUM®
AstraZeneca today announced that a new administration formulation for its prescription proton pump inhibitor NEXIUM® (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). NEXIUM I.V. is now approved as an intravenous infusion or injection for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) patients, with a history of erosive esophagitis, who are unable to take capsules. NEXIUM® I.V. (esomeprazole sodium) for injection is administered once daily as either a 10 to 30 minute intravenous infusion or by intravenous injection (no less than 3 minutes). Treatment is given for up to 10 days and does not require an in-line filter. "Hospitalised patients with GERD are often unable to take their oral medication," said David C. Metz, M.D., Professor of Medicine in the Division of Gastroenterology at the Hospital of the University of Pennsylvania. "The availability of NEXIUM in an intravenous formulation provides these patients with an effective alternative route of administration that they can tolerate easily." About NEXIUM® I.V. (esomeprazole sodium) for injection The approval of NEXIUM I.V. was based, in part, on the findings of four multi-centre, open-label, two-period crossover studies. These studies compared the pharmacodynamic efficacy of the intravenous formulation with NEXIUM delayed-release capsules at corresponding doses of 20 mg and 40 mg in GERD patients with or without a history of erosive esophagitis. They demonstrated that, after 10 days of once-daily administration, NEXIUM I.V. 20 mg and 40 mg are similar in their ability to suppress acid to the corresponding oral dosage form of NEXIUM. There were no relevant changes in acid suppression when switching between intravenous and oral dosage forms. About NEXIUM® (esomeprazole magnesium) delayed-release capsules NEXIUM (delayed release capsules) is indicated for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease. The drug was recently approved for reducing the risk of gastric (stomach) ulcers developing among at risk patients on continuous NSAID therapy. It also is 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. NEXIUM I.V. formulation was first approved via the European Mutual Recognition Process in August 2003 and launches in Europe are ongoing. NEXIUM capsules have been launched in 89 countries. Worldwide NEXIUM sales totalled $3.9 billion in 2004, with US sales reaching $2.7 billion. 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 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 $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. Media Enquiries: Staffan Ternby, 08-553 261 07 Edel McCaffrey, +44 (0) 207 304 5034 Steve Brown, +44 (0) 207 304 5033 Investor Relations: Staffan Ternby, 08-553 261 07 Jonathan Hunt, +44 (0) 207 304 5087