SODERTALJE, Sweden, Feb. 7 /CNW/ - AstraZeneca announced today that it has submitted an application to the 14 European Member States involved in the Mutual Recognition Procedure for Seroquel (quetiapine) to be granted a license for the treatment of manic episodes associated with bipolar disorder (manic- depressive illness). The Type II license variation application to Seroquel's existing schizophrenia marketing authorization means that the drug is now currently under regulatory review for bipolar mania both in Europe and the United States(1).

   "We are delighted to be submitting our application to the European Health
Authorities so soon after our submission to the FDA" commented Geoff Birkett, Global Vice President, CNS, Pain and Infection. "Seroquel is a truly unique compound and its profile is ideal for the treatment of manic episodes associated with bipolar disorder. Use of Seroquel has been growing at a tremendous rate in Europe and feedback from patients and clinicians continues to be very positive. With its expanded indication range we are sure of further strong growth in 2003 and beyond."

   The application to the European Health Authorities follows the completion
of a comprehensive clinical trial programme in bipolar disorder undertaken
by AstraZeneca, involving almost 1000 patients in 28 countries. The trials
examined the efficacy and tolerability of quetiapine in the treatment of
manic episodes on two levels: as monotherapy (i.e to be prescribed on its
own) and as adjunctive therapy with standard mood stabilising medication.
These clinical trials have delivered strong and positive results in both
the monotherapy and adjunctive therapy studies, which confirm quetiapine
to be an ideal first line therapy for the treatment of manic episodes associated
with bipolar disorder.

   "Seroquel as a treatment for bipolar disorder will offer significant
benefits to European clinicians and patients" commented Dr. Eduard Vieta,
Director of Research, Department of Psychiatry, University of Barcelona.
"Throughout the duration of the studies, Seroquel was shown to provide
a substantial resolution of the various symptoms associated with manic
episodes, while keeping side effects to a minimum. This is particularly
critical in bipolar disorder since patients may lead full and productive
lives when stable while a relapse in symptoms can cause real difficulties."

   The results from one of the adjunctive therapy studies were presented
in September, 2002, at the 3rd European Stanley Foundation Conference in
Bipolar Disorder, in Germany(2). The results from this trial showed that
quetiapine, in combination with standard mood stabilising medication (lithium
or divalproex), is significantly more effective at treating the manic episodes
associated with bipolar disorder than mood stabilisers alone. Importantly,
the results also showed that quetiapine in combination with mood stabilisers
is well tolerated - a major consideration in the treatment of this disorder.
The results from the remaining monotherapy studies will be presented at
major psychiatry conferences in 2003.

   Seroquel has been simultaneously submitted to the 14 European Member
States participating in the Mutual Recognition Procedure. Further submissions in other markets worldwide are progressing.

   Seroquel is manufactured by AstraZeneca and is currently approved in
over 75 markets. Seroquel combines broad-based efficacy in the treatment
of positive, negative, cognitive and affective symptoms of schizophrenia,
while offering excellent tolerability. Seroquel is associated with an incidence
of EPS and prolactin elevation no different to placebo across the full
dosage range, a favourable weight profile, and no clinically important
effects on QT interval in most patients. To date, over 4 million people
have been treated with Seroquel worldwide.

   AstraZeneca is a major international healthcare business engaged in
the research, development, manufacture and marketing of 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  $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

In CNS, AstraZeneca is dedicated to providing medicines that
offer the potential to change patients' lives. The company already markets
Seroquel, one of the fastest growing global antipsychotics with proven
efficacy and a very favourable side effect profile; and Zomig, a reliable
migraine therapy and a leader in the triptan market. AstraZeneca's R&D
pipeline also includes leading approaches for the treatment of depression
and anxiety, overactive bladder, dementia and stroke.

   'Seroquel' is a trade mark property of AstraZeneca.

   For an electronic and downloadable version of this press release, please
visit the psychiatry resource internet site at:www.psychiatry- in-practice.com.

   This psychiatry resource features educational materials relating to
severe mental illness, including background information on schizophrenia
as well as epidemiological data and treatment issues clinicians face in
everyday practice.

   References:

   1.  AstraZeneca submitted an application to the U.S. Food and Drug
   Administration (FDA) for quetiapine (Seroquel) to be granted a
   license for the treatment of acute mania associated with bipolar
   disorder (manic-depressive illness) on December 30th, 2002.

   2.  Sachs G, Mullen JA, Devine NA. Quetiapine vs Placebo as Adjunct
   to  Mood Stabilizer for the treatment of acute mania. Stanley Foundation
   Bipolar Conference, 2002, abs.





 

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