AstraZeneca PLC
13 October 2003
ASTRAZENECA RECEIVES EUROPEAN APPROVAL FOR SEROQUEL(TM) IN BIPOLAR MANIA
AstraZeneca announced today that it has successfully completed the Mutual
Recognition Procedure (MRP) involving 14 European countries to extend the use of
SEROQUEL (quetiapine) to the treatment of mania associated with bipolar disorder
(manic-depressive illness). SEROQUEL is also under review for bipolar mania in
the United States with the Food and Drug Administration (FDA) and in the UK with
the Medicines and Healthcare products Regulatory Agency (MHRA).
In 2002, worldwide sales of SEROQUEL grew 67 per cent to $1.14 billion.
Bipolar disorder is a serious mental illness that affects approximately 3-4 per
cent of the adult population and is the sixth leading cause of disability in the
world. More than half of those with bipolar disorder stop taking their
medication at some point during their illness, subjecting themselves to a high
risk of relapse and an increased risk of suicide. This lack of compliance is
strongly associated with the occurrence of side effects, therefore, a well
tolerated and effective treatment is pivotal to the successful treatment of this
condition.
Health authorities involved in the MRP reviewed data from a comprehensive
clinical trial programme in bipolar disorder undertaken by AstraZeneca,
involving almost 1000 patients in 28 countries. The trials have delivered
compelling results, which confirm SEROQUEL to be an excellent first line therapy
for the treatment of manic episodes associated with bipolar disorder.
Individual licenses in the 14 European countries involved in the MRP will follow
from the completion of this procedure. Health Authority approvals also have
been received in Mexico and New Zealand.
Data from two trials from the clinical trial programme, which examined the
efficacy of SEROQUEL as a monotherapy for the treatment of bipolar mania, were
presented in May this year at the International Conference on Bipolar Disorder
(ICBD), Pittsburgh, USA. The results confirmed that SEROQUEL monotherapy is as
effective as current treatments for bipolar disorder and offers improved
tolerability benefits. Data from another trial examining SEROQUEL as an
adjunctive therapy to mood stabilisers in the treatment of bipolar mania were
presented at the 3rd European Stanley Foundation Conference on Bipolar Disorder
in Freiburg, Germany, in September 2002. The results found that SEROQUEL is
significantly more effective than mood stabilizers alone in the treatment of
bipolar mania.
The MRP involves Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland,
Ireland, Luxembourg, The Netherlands, Norway, Portugal, Spain, and Sweden.
13 October 2003
Media Enquiries:
Steve Brown, +44 (0) 207 304 5033
Chris Major, +44 (0) 207 304 5028
Investor Enquiries:
Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
-Ends-
This information is provided by RNS
The company news service from the London Stock Exchange
*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.