AstraZeneca's Nexium receives fast first approval

® ASTRAZENECA'S NEXIUM RECEIVES FAST FIRST APPROVAL IN SWEDEN WITH WIDE RANGE OF INDICATIONS Treatment breakthrough offers acid-related disease sufferers greater, faster healing and more sustained symptom freedom ® AstraZeneca today announced the initial approval of Nexium (esomeprazole) with fast clearance given by the Swedish Medical Product Agency (MPA) for a broad range of indications, including two new treatment approaches. 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: - fast healing of reflux esophagitis - fast symptom relief - a new approach to long term management of symptomatic GERD - a new approach to H. pylori treatment ® 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 in Sweden and sales 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". - Ends - For further enquires: Steve Brown, tel +44 171 304 5033 Lucy Williams, tel +44 171 304 5034 Mikael Widell, tel +44 171 304 5030 NOTE TO NEWS EDITORS: ® AstraZeneca, invented the PPI drug class with Losec (omeprazole), currently the world's top selling branded pharmaceutical product. With ® Nexium , AstraZeneca has achieved an evolution in the management of acid- related diseases and has underscored the company's commitment to optimising treatment in the field of gastroenterology. ® Nexium will enter a global market worth $12.6bn in 1999 with an estimated 10 per cent of the population thought to suffer from peptic ulcer disease and an even higher proportion with acid-related reflux ® disease. Further clinical data on Nexium will be published at the Digestive Diseases Week conference in San Diego, USA, in May. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (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 $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/03/13/20000313BIT00040/bit0001.doc http://www.bit.se/bitonline/2000/03/13/20000313BIT00040/bit0002.pdf