“We are delighted to submit 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 continued growth for SEROQUEL in 2003 and beyond.”
The proposed new indication is expected to expand the market for SEROQUEL, which is currently indicated for the treatment of schizophrenia in adults. Analysts estimate that bipolar disorder alone constitutes a multibillion-dollar market. The illness affects over two percent of the population worldwide and is also ranked as the second leading cause of disability worldwide among the neuro-psychiatric disorders. To date, over 4 million people have been treated with Seroquel worldwide. SEROQUEL is the fastest-growing atypical antipsychotic on the market, with sales of $1.1 billion in 2002.
The trial programme consisted of four studies involving approximately 1000 patients in 28 countries. The results from one of the combination therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany. The results from this trial showed that SEROQUEL, in combination with standard mood stabilizing medication (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilizers alone. Importantly, the results also showed that SEROQUEL 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.
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-® (zolmitriptan), 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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Note to News Editors:
- Bipolar disorder, also known as manic depression or manic-depressive disorder, is characterized by recurring cycles of depression and mania.
- Bipolar disorder is classified as manic and depressive episodes that last for a certain length of time, from days to months, marked by changes in a person’s mood and behaviour. Episodes can last anywhere from days to months and generally have a beginning phase when symptoms emerge, an active phase during which symptoms are at their worst, and a recovery phase during which symptoms gradually abate. Symptoms of bipolar disorder can include:
- Manic Symptoms
- Pressured speech
- Racing thoughts
- Risk taking / impulsive behaviour
- Decreased need for sleep
- Depressive Symptoms
- Depressed mood
- Diminished interest or pleasure in all, or almost all, activities
- Feelings of worthlessness
- Changes in sleep/appetite
