AstraZeneca: New Intravenous -I.V.- Formulation of Nexium-R- Provides Faster and More Effective Acid Control Than Pantoprazole I.V.

Business Editors/Health/Medical Writers

MADRID, Spain--(BUSINESS WIRE)--Nov. 4, 2003

Today, data presented at the 11th United European Gastroenterology Week shows that the new i.v. formulation of Nexium(R) provides faster and more effective acid control than pantoprazole i.v.(1) Nexium(R) i.v. will provide patients with Gastroesophageal reflux disease (GERD), unable to take an oral acid suppressive therapy, with an alternative treatment option.

The greater effectiveness of acid control with Nexium(R) i.v. compared with pantoprazole i.v. has been demonstrated in a single-centre, open, randomised, crossover study in healthy volunteers comparing the effect on intragastric pH on day 1 (first 4h and 24h) and day 5 (24h). Nexium(R) i.v. showed to be more effective in both number of hours with the pH(more than)4 and the level of pH control during all the time periods (e.g. Nexium(R) i.v: median pH 4.3, pantoprazole i.v: median pH 3.2 on day 5). The greater effectiveness of acid control with Nexium i.v. compared with pantoprazole i.v. already became apparent during the first 4 hours after dosing on day 1, demonstrating its fast action.

Commenting on the study, lead investigator, Dr Clive Wilder-Smith, Head of the Gastrointestinal Physiology Laboratory in Bern, Switzerland, said "It is critical that hospital physicians have the means to treat patients who are unable to take oral medication. Nexium(R) i.v. provides physicians with the PPI treatment choice most likely to quickly and effectively control intragastric pH in their GERD patients."

In a previous study, Nexium(R) administered intravenously demonstrated similar efficacy in acid control as oral Nexium(R)(2) - the first PPI to have shown more effective control of gastric acid secretion compared with all other PPIs.(3)

Nexium(R) i.v. is available in a single vial containing 40 mg for both infusion and injection. This convenient presentation means nurses and physicians can administer 20 or 40 mg from one single vial for either infusion or injection and it is also convenient for hospitals and pharmacists to stock.

The intravenous formulation of Nexium(R) has already been launched in Sweden and AstraZeneca plans to launch the intravenous formulation of Nexium(R) in the remaining EU markets, following the conclusion of a Mutual Recognition Procedure in which Sweden will act as the reference member state. An application for approval in the US has been submitted and further launches in the rest of the world will follow in 2004.

Nexium(R) i.v. is indicated in GERD patients who are unable to take oral therapy.

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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

To learn more about Nexium(R), please visit our interactive website: www.astrazenecapressoffice.com.

References:

(1) Wilder-Smith, C et al. Esomeprazole 40 mg intravenous provides faster and more effective acid control then pantoprazole 40 mg intravenous after first dose and 5 days. Presented at the United European Gastroenterology Week Congress, 1-5 November 2003, Madrid, Spain.

(2) Rohss K et al. Esomeprazole 40 mg administered as a 30-minute intravenous infusion provides the same effective acid control as oral administration in healthy subjects. Gastroenterology 2003;124 Suppl 1:A231.

(3) Miner P et al. Esomeprazole 40 mg provides more effective intragastric acid suppression at steady state than standard doses of other proton pump inhibitors. Gastroenterology 2003;124 Suppl 1:A229.