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Newly Published Data Demonstrates Superiority of Cipralex Over,Duloxetine for Acute Treatment of Depression

COPENHAGEN, Denmark, June 04, 2007 /PRNewswire/ --

- Cipralex Better Tolerated and at Least as Effective in Long-Term Treatment

H. Lundbeck A/S announces new study data published today in the journal Current Medical Research and Opinion, demonstrating that Cipralex(R) (escitalopram) was superior to duloxetine in the acute treatment of patients with major depressive disorder (MDD) and was at least as efficacious in long-term treatment(1). The study directly compared Cipralex(R) (an allosteric serotonin reuptake inhibitor - ASRI) to duloxetine (the most recently introduced serotonin and noradrenaline reuptake inhibitor - SNRI) and these findings support the growing body of evidence that Cipralex(R) offers important treatment advantages over SNRI antidepressants such as duloxetine(2-6).

Depression is a serious illness that results in significant disability and is associated with both increased morbidity and the risk of suicide(7). Affecting around 121 million people globally(8,) the World Health Organization lists depression as the leading cause of disability worldwide(8). At present, there is no simple universal treatment effective for all patients and it is therefore relevant that treatments are directly compared in order to provide clinicians with information on the efficacy and tolerability benefits of the currently available treatments.

"The study demonstrates that Cipralex(R) was superior to duloxetine during acute treatment and at least as effective in long-term treatment with the added benefit of significantly better tolerability," said Dr Alan Wade, lead investigator and medical director of CPS Research, Glasgow, Scotland. "Data that compares antidepressants in this way is an important tool for physicians and allows them to make informed decisions about the best treatments for their patients."

Important key findings from the study:

The 24-week study investigated t he efficacy and tolerability of Cipralex(R) compared to duloxetine and its key findings include(1):

- Patients taking Cipralex(R) demonstrated significantly greater improvement in depression symptoms at week eight (acute treatment) than patients taking duloxetine. This superiority was evident after the first week of treatment and was maintained at all time points until week 16 (p<0.05)(1)

- Cipralex(R) was at least as effective as duloxetine at 24 weeks of treatment, the primary endpoint of the study (p=0.055)(1).

- Patients treated with Cipralex showed significantly better functioning in their work, family and social life at week 8 and week 24, compared to duloxetine(1)

- Cipralex(R) was better tolerated than duloxetine. Significantly more duloxetine patients withdrew from the study due to adverse events than those treated with Cipralex(R) (17 percent versus nine percent respectively)(1)

"Since current guidelines urge the long-term treatment of depression, it is vital that treatments offer the required efficacy coupled with acceptable tolerability," continued Dr Wade. "These new data add to the increasing evidence that Cipralex(R) may have a significant clinical advantage in this respect."

Notes to Editors

About the clinical study

The study was designed to look at the efficacy and tolerability of Cipralex(R) compared to duloxetine in patients with moderate to severe MDD over 24 weeks, with a secondary endpoint at eight weeks (acute treatment). The double-blind, fixed-dose, comparative study included 294 patients with MDD from 35 centres in nine countries. Patients were randomised to either Cipralex(R) (n=143) or duloxetine (n=151), at dosing regimens recommended in the package inserts in participating countries (Cipralex(R) 20mg, duloxetine 60mg)(1).

Efficacy (using the MADRS rating scale as the primary scale) and tolerability were assessed at baseline and after 1, 2, 4, 8, 12, 16, 20 and 24 weeks; a sa fety follow-up visit was performed at 28 weeks(1).

This superiority was evident after the first week of treatment and was maintained at all time points until week 16 (p<0.05). At the primary endpoint at 24 weeks, Cipralex(R) was at least as effective as duloxetine (p=0.055)(1).

At the end of the secondary pre-defined endpoint at week 8, patients taking Cipralex(R) demonstrated significantly greater improvement than patients taking duloxetine as determined by MADRS and other predefined secondary endpoints such as the Clinical Global Impression - Improvement (CGI-I) and the Sheehan Disability Scale (SDS) scores(1).

Significantly more people taking duloxetine withdrew from the study compared to those taking Cipralex(R) (17% vs 9% respectively, p<0.05)(1).

A post-hoc analysis of the present study revealed a significant advantage for Cipralex(R) (68.8% early responders) versus duloxetine (54.8%)(1).

About depression

Depression is a very common, debilitating illness affecting around 121 million people worldwide(8). The symptoms of depression can be chronic or recurrent, and impact patients both mentally and physically. Depression has a significant impact on patient quality of life and imposes a considerable burden on society, yet it is still underrecognised and undertreated with less than 25 percent of those affected having access to effective treatment(8).

Symptoms include feelings of hopelessness, sadness, guilt, loss of interest in activities, decreased energy, poor concentration, persistent physical symptoms such as headache and digestive disorders, and in more severe cases, suicidal thoughts and suicide attempts(9).

About Lundbeck

H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. In 2006, the company's revenue was DKK 9.2 billion (approximately EUR 1.2 bill ion or USD 1.6 billion). The number of employees is approximately 5,300 globally. For further information, please visit www.lundbeck.com.

References

(1) Wade et al. Current Medical Research and Opinion. Vol. 23, No 7, 2007,1605-1614 DOI: 10.1185/030079907X210732

(2) Jonas J, Bose A, Alexopoulos G, et al. Double-blind comparison of escitalopram and duloxetine in the acute treatment of major depressive disorder. Poster presented at of Neuropsychopharmacology Congress, October 11-15 2006, Orlando, Florida, USA

(3) Bielski RJ, Ventura D. Chang CC. A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder. J Clin Psychiatry. 2004; 65:1190-1196

(4) Montgomery SA, Andersen HF. Escitalopram versus venlafaxine XR in the treatment of depression. Int Clin Psychopharmacol 2006; 21:297-309

(5) Montgomery SA, Huusom AK, Rothmer J. A randomised study comparing escitalopram with venlafaxine XR in primary care patients with major depressive disorder. J Neuropsychology. 2004; 50:57-64

(6) Nierenberg A, Greist J, Mallickrodt C, et al. Onset of antidepressant action and acute efficacy and safety of duloxetine versus escitalopram and placebo in the treatment of major depressive disorder. Neuropsychopharmacol 2005; 30(Suppl 1): S142

(7) Bostwick JM, Pakratz VS. Affective disorders and suicide risk: a reexamination. Am J Psychiatry. 2000; 157:1925-1932

(8) Depression. World Health Organisation. Last accessed on 06.11.06 from http://www.who.int/mental_health/management/depression/definition/en/

(9) Depression. National Institute for Mental Health. Last accessed on 09.11.06 from http://www.nimh.nih.gov/publicat/depression.cf m#ptdep3

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CONTACT: Media contacts: For more information, please contact: PaulGittins, Ruder Finn UK Ltd, Tel: +44-(0)207-462-8922, Mobile:+44-7958-533462, Email: pgittins@ruderfinn.co.uk

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