Public Release: 

Study results offer new hope for people with manic depression

Shire Health International

Alderley Park, UK - Results from a clinical trial presented for the first time today at Europe's largest Conference on Bipolar Disorder, reveal that Seroquel (quetiapine), a medication currently used to treat patients with schizophrenia, could offer a more effective therapy for the millions of people worldwide suffering from bipolar disorder.

The results show that quetiapine, a new generation antipsychotic made by AstraZeneca, when taken in combination with mood stabilizers (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilizers alone. Critically, the results also show that quetiapine is well tolerated - a major consideration in the treatment of this disorder1.

"Current treatment options for patients with bipolar disorder are limited. Commonly used therapies involving mood stabilizers are not effective for all patients and can be associated with troublesome side effects, such as distressing movement disorder side effects known as EPS, as well as weight gain and sexual dysfunction," commented Professor Gary Sachs, from Harvard Medical School, Boston, USA, and study leader. "As a result patient compliance with treatment can be a real challenge. This is particularly critical in bipolar disorder since patients typically lead full lives, with jobs to hold down and valuable relationships to maintain. This is where the true value of a treatment such as quetiapine lies - in its ability to improve the symptoms of the disease while keeping side effects to a minimum making compliance with the medication more likely."

The quetiapine trial, known as Study 99, is the first ever large-scale trial to study the efficacy, tolerability and safety of quetiapine in combination with mood stabilizers in the treatment of bipolar mania. The trial forms part of a comprehensive bipolar disorder clinical trial programme being undertaken to examine the efficacy of quetiapine in treating bipolar disorder.

"The results from this trial have been highly anticipated within the psychiatric community and I am pleased to be able to confirm that they show quetiapine to be an effective and well tolerated treatment for patients with bipolar disorder, when prescribed in combination with mood stabilizers" continued Professor Sachs. "Importantly, the results show not only that quetiapine is effective in treating bipolar disorder and the manic symptoms often associated with it, but also that more patients treated with quetiapine experienced a full resolution of their manic symptoms compared to patients taking mood stabilizers alone. This impressive efficacy, combined with the excellent tolerability profile that quetiapine exhibited throughout the trial, suggest that it is an important and valuable new weapon in our fight against this problematic disease."

Bipolar disorder, also known as manic depressive illness, is a severe mental illness that affects more than 1% of the adult population. As more patients are being accurately diagnosed this figure will increase2. The mortality rate for untreated bipolar disorder is higher than for most types of heart disease and some types of cancer, with about 15% to 20% of people with untreated or inadequately treated bipolar illness attempting suicide3.

Seroquel (quetiapine) 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 neutral effect on weight in long-term treatment, and no clinically important effects on QT interval. 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.

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Embargo: 14.00hours BST, September 13th, 2002

'Seroquel' is a trade mark property of AstraZeneca. For further information please contact:

Jim Minnick at AstraZeneca
Tel: 302-886-5135
jim.minnick@astrazeneca.com

Antonia Betts or Ellie Goss at Shire Health International
Tel. 44-207-471-1500
antonia.betts@shirehealthinternational.com
ellie.goss@shirehealthinternational.com

References:
1. 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
2. Sachs G, Printz DJ, Kahn DA et al. The Expert Consensus Guideline Series: Medication Treatment Of Bipolar Disorder 2000. Postgrad Med Special Report. 2000 (April): 1 - 104
3. Vestergaard P, Aagaard J. Five year mortality in lithium-treated manic-depressive patients. J Affect Discord, 1991, 21:33-38

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