Based on extensive clinical studies involving more than 15,000 patient treatments, Nexium® has received approval for both initial and long-term management of gastro-esophageal reflux disease (GERD), healing of H. pylori-associated duodenal ulcers and prevention of relapse of peptic ulcer disease.

This is based on studies showing:

Nexium® demonstrates advanced clinical efficacy and predictability beyond that achieved by omeprazole, the current gold standard of treatment, and is a significant advance in the management of acid-related disease.

Dr Tom McKillop, Chief Executive Officer of AstraZeneca, said: "We are delighted to have received the first approval of Nexium® in such a fast time. It is a major milestone for the company, but more importantly, Nexium® will provide unsurpassed benefits to patients around the world and is the first major advance in acid-related disease treatment in more than a decade.”

The Swedish MPA will act as rapporteur for the European Mutual Recognition Procedure to obtain approval in 14 other member states in the EU with launches in a number of these countries anticipated before the end of the year. Launch plans are developed for Nexium® and sales in Sweden will start in the second half of this year (2000). Nexium® is also awaiting approval in the USA (launch expected early 2001), and in other markets.

Patient benefits achieved with Nexium® include greater predictability of response, improved symptom control and healing. Studies have also shown that acid control with Nexium® is greater, faster and more sustained compared to other proton pump inhibitors (PPIs). Nexium® is metabolised in such a way that more of the drug is delivered to the site of action, leading to superior acid control.

Clinical studies in patients with heartburn and reflux esophagitis show that the healing rates achieved by Nexium® in four weeks match those attained by omeprazole in eight weeks, demonstrating potential for health economic benefits.

The broad indication base includes two new treatment approaches for Nexium® - the healing of H. pylori-associated duodenal ulcer, with one week treatment, without the need for subsequent monotherapy and the symptom-driven 'on-demand' treatment for management of recurrent heartburn and other symptoms of GERD.

'On-demand' treatment allows doctors to prescribe Nexium® to patients, who then take the medication once daily, 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. Clinical studies have demonstrated that after six months' treatment, 90 per cent of patients can control symptoms effectively by taking Nexium®, on-demand. Nexium® is the first and only PPI to gain approval for this new treatment of symptomatic GERD.

Dr Martin Nicklasson, Executive Vice President GI Franchise, AstraZeneca, said: "Physicians will soon have the opportunity to provide their patients with Nexium®, the best treatment for acid related diseases. Many patients do not even realise that their condition is treatable. Nexium® offers sufferers the best chance of acid related disease control which will restore quality of life for many patients”.