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Study boost for AstraZeneca's Nexium

Published on 01/08/06 at 05:01pm

AstraZeneca's blockbuster gastro-oesophageal reflux disease treatment Nexium has come out ahead of Wyeth's Zoton in a new study, which showed that it is better at preventing the return of gastric ulcers.

A clinical trial of more than 1,000 patients concluded Nexium gave better results than Zoton for preventing recurrences in patients with healed gastric ulcers and it was also equally effective at reducing the symptoms associated with gastric ulcers.

The study, published in Clinical Gastroenterology and Hepatology, confirms results from previous head-to-head trials demonstrating the efficacy of Nexium (esomeprazole) at maintaining the healing of erosive oesophagitis (EO).

Nexium is the third-biggest selling drug in the world and the only one in its proton pump inhibitor class to gain market share. The study should help AstraZeneca further consolidate Nexium's lead in the global market.

In the UK, the study results could help narrow the gap between Nexium and Zoton, which is one of the most prescribed drugs on the NHS.

Wyeth's drug outperforms that of AstraZeneca in terms of sales and, despite being off-patent, Zoton in its branded form accounted for 207 million pounds of GP prescribing in England and Wales in 2005 - ahead of Nexium which achieved 38.8 million pounds.

An estimated one in three people with acid reflux disease develop EO, when stomach acid begins to erode the inner lining of the oesophagus. Acid reflux disease is a condition in which the valve between the oesophagus and the stomach fails to fully close, allowing acid to leak back into the oesophagus.

Kenneth DeVault, director of gastrointestinal research at the Mayo Clinic College of Medicine, Jacksonville, Florida, and the lead study investigator, said: "The challenge in treating EO is that many patients who are successfully treated with an acid-suppressing medication will commonly relapse within a year if that medication is discontinued. Reflux symptoms are chronic in many patients, particularly those with EO."

The double-blind, randomised, double-dummy, parallel-group trial found that more patients who took Nexium 20mg once daily maintained healing of EO over six months compared with patients treated with Zoton (lansoprazole) 15mg once daily.

Launched in 2000 as the successor to AstraZeneca's Losec (omeprazole), sales of Nexium last year grew by 17% to $5.7 billion.

Losec lost US patent protection - and more than 70% of its sales in the country - in 2003, having already gone off-patent in the UK in 2002. Last year, it made sales of just $278 million.

Currently, AstraZeneca is fighting a US court battle against IVAX and its parent, Teva Pharmaceuticals USA, for wilful infringement of patents protecting Nexium.

The lawsuit is in response to an Abbreviated New Drug Application filed by IVAX with the FDA, regarding the company's intent to market a generic version of Nexium, prior to the expiry dates of the drugs various patents, which range from 2014 through to 2019.

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