AstraZeneca PLC
12 July 2000
'NEXIUM' GAINS FULL EUROPEAN UNION MUTUAL RECOGNITION APPROVAL WITH WIDE RANGE
OF INDICATIONS
AstraZeneca today announced full European Union (EU) approval of 'Nexium'
(esomeprazole), through the Mutual Recognition Procedure.
'Nexium' the first proton pump inhibitor (PPI) developed as an isomer, is
approved across a broad range of indications including two new treatment
approaches. 'Nexium' will soon be available in 15 EU Member States, in
addition to Norway and Iceland, subject to local licensing, pricing and
reimbursement approvals. Sweden acted as the Reference Member State for
the European Mutual Recognition Procedure and obtained fast clearance
approval of 'Nexium' in March 2000.
Launches in a number of European countries, including the UK and Germany,
are planned before the end of 2000, starting in Sweden next month (August).
AstraZeneca is awaiting 'Nexium' approval in the USA and in other major
markets, such as Canada, Australia, New Zealand and Switzerland.
'Nexium' has shown superior acid-control that is greater, faster and more
sustained compared with other PPIs. 'Nexium' has also demonstrated superior
clinical efficacy over omeprazole, the current unsurpassed gold standard
treatment and has been approved across a wide range of acid-related diseases.
'Nexium' is indicated for gastroesophageal reflux disease (GERD) including:
- Treatment of erosive reflux esophagitis
- Long-term management of patients with healed esophagitis to prevent relapse
- Symptomatic treatment of GERD.
And 'Nexium' in combination with an appropriate antibacterial therapeutic
regimen for the eradication of H. pylori for:
- Healing of H. pylori-associated duodenal ulcer
- Prevention of relapse of peptic ulcers in patients with H.
pylori-associated ulcers.
This broad indication base includes a whole new treatment approach unique to
'Nexium' across Europe. On-demand treatment allows doctors to prescribe
'Nexium' to patients, who then take a single dose of medication as and when
needed, to control their recurrent symptoms. Results from clinical trials
suggest that after six months' treatment, up to 90 percent of patients are
able to control symptoms effectively by taking 'Nexium' on-demand. This is a
new, highly convenient, approach to the long-term control of the symptoms of
GERD that is likely to be cost-effective.
Another treatment approach is one-week 'Nexium' triple-therapy in treating H.
pylori-associated duodenal ulcers, a regimen that has been shown to be as
effective as one-week triple-therapy with omeprazole followed by three
additional weeks of omeprazole monotherapy (the currently recommended
regimen).
'Nexium' provides superior acid control compared with the standard therapeutic
dose of omeprazole 20 mg as well as omeprazole 40 mg, and standard doses of
other drugs in this class such as pantoprazole 40 mg and lansoprazole 30 mg.
'Nexium' is also the first drug that has ever shown significant clinical
advantages over omeprazole.
Further enquires to:
Elizabeth Sutton: Tel. +44 (0)20 7304 5101
Michael Olsson: Tel +44 (0)20 7304 5087
Ed Seage: Tel. +1 302 886 4065
Jorgen Winroth: Tel. +1 609 896 4148 or +44(0)7715 011140
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.