Lundbeck initiates clinical phase II trials with Lu AE58054 as
augmentation treatment in Alzheimer's
(Thomson Reuters ONE) - H. Lundbeck A/S today announced the initiation of a multi-centre,placebo-controlled, fixed-dose study of Lu AE58054 as add-on todonepezil in patients with moderate Alzheimer's disease. The clinicalphase II study is planned to enrol approximately 270 patients. Thepurpose of this study is to investigate if Lu AE58054 after 24 weeksimproves cognition and functional outcomes in patients with moderateAlzheimer's disease that are already in treatment with donepezil."Alzheimer's disease is one of the most complex and challenging areasof research and development, but also an area with huge unmet medicalneeds," says Executive Vice President Anders Gersel Pedersen, Head ofDrug Development at Lundbeck. "We are very pleased that Lundbeck cancontinue to deliver projects that potentially can alter the course ofthis debilitating neurological disease and radically change the livesof patients."About Lu AE58054Lu AE58054 is a potent and selective 5-HT6-receptor antagonist. The5-HT6-receptor is primarily found in areas of the brain involved incognition. A number of early trials have demonstrated that a5-HT6-receptor antagonist could offer potential in the treatment ofdisorders such as Alzheimer's disease and schizophrenia and inNovember 2008 Lundbeck initiated a 12 week clinical phase II trial inschizophrenia. The present study examines the possible benefit of LuAE58054 over a much longer period in Alzheimer's disease.About Alzheimer's diseaseAlzheimer's disease is a neurodegenerative disease characterised byprogressive cognitive impairment such as memory loss, reducedperception ability and language disruptions, eventually preventingthe patient from taking care of him-/herself. Anxiety, confusion andanger may occur in the later stages of the disease.Alzheimer's disease affects 5% of the population over the age of 65and more than 30% of those aged over 85. Today, about 60% ofAlzheimer's patients are diagnosed, and of these about 80% arediagnosed with either moderate or severe Alzheimer's disease. It isestimated that there are between 5-6 million people with dementia inEurope. The total costs to society are estimated to amount to EUR 55billion making dementia the most costly brain disorder[1]. The agingpopulation in Europe will make dementia an even bigger burden tosociety in the years to come. Studies have shown that even relativelysmall delays in disease progression will have huge impact on medicalcosts.Financial guidanceThe content of this release will have no influence on the LundbeckGroup's financial result for 2009.Lundbeck contactsInvestors: Media:Jacob Tolstrup Mads KronborgDirector, IR & Communication Media Relations+45 36 43 30 79 +45 36 43 28 51Palle Holm Olesen Kasper RiisHead of Investor Relations Media Relations+45 36 43 24 26 +45 36 43 28 33Magnus Thorstholm JensenInvestor Relations Officer+45 36 43 38 16About LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an internationalpharmaceutical company highly committed to improve the quality oflife for people suffering from central nervous system (CNS)disorders. For this purpose Lundbeck is engaged in the research anddevelopment, production, marketing and sale of pharmaceuticals acrossthe world, targeted at disorders like depression and anxiety,schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson'sdiseases.Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,and employs today over 5,500 people worldwide. Lundbeck is one of theworld's leading pharmaceutical companies working with CNS disorders.In 2008, the company's revenue was DKK 11.3 billion (approximatelyEUR 1.5 billion or USD 2.2 billion). For more information, pleasevisit www.lundbeck.com.[1] Costs of Disorders of the Brain in Europe; European Journal ofNeurology; Volume 12, Supplement 1, June 2005http://hugin.info/130085/R/1357623/330329.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 27.11.2009 - 10:06 Uhr
Sprache: Deutsch
News-ID 8938
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