2005-10-21

BOLDER II Study Confirms Therapeutic Potential of SEROQUEL in Bipolar Depression


Alderley Park, England (ots/PRNewswire) -

- For Health Professional Press and Non-UK Journalists Only

Newly released top-line results from the BOLDER II (BipOLarDEpRession) study have underlined the potential for SEROQUEL(quetiapine fumarate) in the treatment of patients with majordepressive episodes associated with bipolar disorder. In BOLDER II,SEROQUEL 300mg and 600mg doses achieved a statistically significantreduction in levels of bipolar depression compared with placebo(p<0.001), as measured by the change from baseline in MADRS* totalscore(1).

BOLDER II, an eight week, multi-centre, placebo-controlled study,reinforces the findings of the landmark BOLDER I study(2) publishedin American Journal of Psychiatry in July 2005, which firstindicated a significant effect for SEROQUEL in treating majordepressive episodes associated with bipolar disorder.

In BOLDER II, the significant reduction in MADRS total score wasseen both in patients with bipolar I and bipolar II disorder, inpatients with or without a rapid cycling course of illness, and asearly as week one after randomisation. Significant improvements werealso seen compared with placebo in the various secondary studyendpoints among SEROQUEL-treated patients, including reduction ofanxiety symptoms. In addition, more than half (53%) of patientsreceiving SEROQUEL achieved remission** from their bipolar depressionsymptoms.

Importantly, SEROQUEL was shown to be well tolerated in BOLDER IIwith a similar safety profile seen to that in BOLDER I. The rate ofserious adverse events was low and comparable in all treated groups.The most common adverse events reported in the trial were dry mouth,sedation, somnolence, dizziness and constipation, and there was a lowincidence of treatment-emergent mania in the SEROQUEL-treated groups.

As in BOLDER I, there was a low incidence of EPS (extrapyramidalsymptoms) and minimal weight change reported in the study.

Professor Joseph Calabrese, co-director of the National Instituteof Mental Health Bipolar Research Center at University Hospitals ofCleveland and Case Western Reserve University says: "Patients withbipolar depression are underserved and understudied. The findingsfrom the BOLDER II study are very encouraging and support thefindings of BOLDER I, in showing the potential of SEROQUEL, asmonotherapy, for the acute treatment for bipolar depression. Each ofthese two studies represent the largest placebo-controlled short-termstudies ever conducted in bipolar depression. The beneficialrisk:benefit profile of Seroquel seen in both studies could offer animportant therapeutic value for both patients and physicians as wecurrently have only one FDA-approved therapy to treat depressiveepisodes associated with bipolar disorder."

Bipolar disorder is a serious mental illness that affectsapproximately 3-4% of the adult population and is the sixth leadingcause of disability in the world(3,4,5,6). Patients with bipolardisorder are symptomatic almost half of their lives, andapproximately two-thirds of that time is spent in the depressedphase of the illness(7). Currently SEROQUEL is only approved for thetreatment of mania associated with bipolar disorder.

"BOLDER II shows that SEROQUEL may provide substantial clinicalbenefits to patients with bipolar disorder", commented CarolynFitzsimons, Seroquel Commercial VP. "Based on prior discussions withthe FDA and the results of BOLDER II, AstraZeneca plans to file for aUS licence extension for SEROQUEL in the treatment of depressiveepisodes associated with bipolar disorder around the end of this year(2005)."

SEROQUEL has been licensed for the treatment of schizophreniasince 1997 and is available in 85 countries for the treatment of thiscondition. SEROQUEL is also licensed in 73 countries for thetreatment of mania associated with bipolar disorder.

* MADRS (Montgomery- Asberg Depression Rating Scale) measures theseverity of a number of depressive symptoms including mood andsadness, tension, sleep, appetite, energy, concentration, suicidalideation and restlessness. The MADRS score decreases as depressionsymptoms improve.

** Remission defined as a score of less than 12 on the MADRS scale(Montgomery-Asberg Depression Rating Scale) at any point in timeduring the study

Notes to Editors

All product names appear in upper case. SEROQUEL is a trademark ofthe AstraZeneca group of companies.

SEROQUEL is currently not licensed for the treatment of bipolardepression.

BOLDER II was an eight week, multi-centre, placebo-controlledtrial conducted in the US which evaluated the efficacy of SEROQUEL(quetiapine) treatment at doses of 300 or 600mg in over 500 patientswith bipolar disorder experiencing major depressive episodes. InBOLDER, the primary endpoint for bipolar depression was change inbaseline on the MADRS (Montgomery- Asberg Depression Rating Scale).Bipolar depression and anxiety symptoms were assessed using theMADRS, HAM-D (Hamilton Rating Scale for Depression) and HAM-A(Hamilton Rating Scale for Anxiety Scale).

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the world's leading pharmaceutical companies withhealthcare sales of over $21.4 billion and leading positions in salesof gastrointestinal, cardiovascular, respiratory, oncology andneuroscience products. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index.

In Neuroscience, AstraZeneca is dedicated to providing medicinesthat have the potential to change patients' lives. The companyalready markets several products including SEROQUEL and ZOMIG.SEROQUEL, which has proven efficacy and a very favourable side effectprofile, is the fastest growing of the leading atypicalantipsychotics and the number one prescribed atypical in the UnitedStates with global sales of $2 billion in 2004; ZOMIG is a reliablemigraine therapy and a leader within the triptan market. TheNeuroscience pipeline includes leading approaches for the treatmentof depression and anxiety, overactive bladder, dementia, stroke, paincontrol and anaesthesia.

Further Information:

For further information, please go towww.astrazenecapressoffice.com

References:

1. BOLDER II study. AstraZeneca Data on File.

2. Calabrese JR et al. Am J Psychiatry 2005;162:1351-60.

3. American Psychiatric Association: Diagnostic and StatisticalManual of Mental Disorders, Fourth Edition, Text Revision. WashingtonDC, American Psychiatric Association, 2000:385;395.

4. Hirschfield et al. Screening for bipolar disorder in thecommunity J Clin Psychiatry. 2003:64;53-59

5. Lish JD, Dime-Meenan S, Whybrow PC et al. The NationalDepressive and Manic-Depressive Association (DMDA) survey of bipolarmembers. J Affect Disord. 1994:31;281-294.

6. World Health Organization and the World Bank. The Global Burdenof Disease: Summary. Cambridge, Mass: The Harvard School of PublicHealth Harvard University Press, 1996.

7. Judd, Lll, Akiskal, HS, Schettler, PJ, et al. The long-termnatural history of the weekly symptomatic status of bipolar disorder.Arch Gen Psychiatry. 2002;59:530-537

ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:Louise Marland at AstraZeneca, Tel: +44-(0)-1625-510782, Mobile +44-(0)7900-607-794, louise.marland@astrazeneca.com; Julie Saunders at AstraZeneca, Tel: +44-(0)-1625-231319, Mobile: +44-(0)-7810-528-368, lucy.turvill@hillandknowlton.com

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