Home  Media Press releases 2004
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| 14 January 2004 | 2004-01-14T00:00:00.0000000-00:00 |
| SUCCESSFUL OUTCOME OF EUROPEAN MUTUAL RECOGNITION PROCEDURE FOR ASTRAZENECA’S NEXIUM I.V.
AstraZeneca today announced that the European Mutual Recognition Procedure (MRP) for the intravenous (i.v.) formulation of Nexium® has been successfully completed. | Oral Nexium®, which recorded an 86 per cent increase in sales to $2.5 billion for the first nine months of 2003, has shown more effective acid suppression compared with all other proton pump inhibitors (PPIs). Nexium® i.v. provides an opportunity for physicians to treat gastroesophageal reflux disease (GERD) in patients with esophagitis and/or severe symptoms of reflux and who are unable to take oral therapy.
Nexium® i.v. is already launched in Sweden, which was the reference member state for the MRP, and national marketing authorisations in an additional 16 countries will be issued in the coming months. An application for approval in the US has been submitted and further launches in the rest of the world will follow in 2004.
Nexium® administered intravenously demonstrates the same effective acid control as oral Nexium® – the first PPI to have shown more effective control of gastric acid secretion compared with all other oral PPIs. Nexium® i.v. has also shown to provide faster and more effective acid control than pantoprazole i.v.
For AstraZeneca, the new intravenous formulation will provide an additional opportunity to expand the use of Nexium® within the hospital setting, and help to establish Nexium® as the most effective PPI.
“Some patients, like those in intensive care units, are unable to take oral therapy due to their critical condition. The introduction of the Nexium® i.v. formulation provides these patients with a suitable alternative with similar efficacy to the oral formulation,” said Dr Ola Rönn, Vice President and Head of the Gastrointestinal Therapy Area, AstraZeneca. “Nexium® continues to gain market share worldwide, as more and more patients are able to experience the excellent acid control that it offers. The approval for this new formulation will ensure that new patient groups can get the beneficial treatment effects of Nexium®.”
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.
Media Enquiries:
Steve Brown , +44 (0) 207 304 5033
Edel McCaffrey, +44 (0) 207 304 5034
Investor Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
NOTE TO NEWS EDITORS
Nexium® administered intravenously has been shown to provide highly effective acid control, similar to oral Nexium® in a double-blind, randomised, two-way crossover study in healthy volunteers. The greater effectiveness of acid control with Nexium® i.v. compared with pantoprazole i.v. has been demonstrated in an open, randomised, two-way crossover study in healthy volunteers comparing the effect on intragastric pH on day 1 and day 5. The greater effectiveness with Nexium® i.v. already became apparent during the first four hours after dosing on day 1, demonstrating its fast action.
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