“We believe that SEROQUEL is an outstanding treatment which has benefited many patients who suffer from schizophrenia - and we are committed to further developing the product in the future. Bipolar disease represents a valuable element of lifecycle development for SEROQUEL,” commented Geoff Birkett, Vice President, Global Marketing Neuroscience, AstraZeneca. “Our belief is that the clinical profile of SEROQUEL in bipolar mania is extremely well suited to this new patient group who place high demands on their therapy and need a balance of strong efficacy with enhanced tolerability. We have very high expectations for SEROQUEL as we launch into this competitive market and have set our sights on raising treatment standards in the area.”
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.
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 $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including 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 within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.
All product names appear in upper case. SEROQUEL is a trade mark of the AstraZeneca group of companies
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The MRP involves Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, The Netherlands, Norway, Portugal, Spain, and Sweden.
Bipolar disorder, also known as manic-depressive illness, is a severe biological disorder that affects approximately 3 – 4 per cent of the adult population. As more patients are being accurately diagnosed this figure will increase. It is a chronic disease and approximately 90 per cent of patients will have multiple recurrences over the longer term with an average of nine episodes per lifetime. Bipolar disorder is characterised by recurrent, cyclical depressive and manic episodes, which can involve psychotic symptoms. The risk of suicide is high with about 15 to 20 per cent of people with untreated or inadequately treated bipolar illness attempting suicide.