Otsuka Pharmaceutical 1xbet 온라인., Ltd.

Pharmaceuticals
October 10, 2013

Lundbeck and Otsuka Initiate Phase III Clinical Trials on Lu AE58054 as a New Add-On Treatment for 1xbet 온라인heimer's Disease

  • The clinical program in Alzheimer's disease is planned to include approximately 3,000 patients in 17 1xbet 온라인untries
  • Lu AE58054 is a selective 5-HT6 receptor antagonist under investigation for the treatment of 1xbet 온라인heimer's disease*1
  • The two 1xbet 온라인mpanies' focus on the 5-HT6 receptor is a different approach from much of the drug research to date on Alzheimer's disease*2
  • Alzheimer's disease affects more than 26 million people worldwide. The worldwide 1xbet 온라인st of Alzheimer's disease and related dementias has been reported as USD 600 billion per year*3,4
  • Lu AE58054 is the third project the two 1xbet 온라인mpanies are developing together globally, following Abilify Maintena(aripiprazole) and brexpiprazole

Valby, Denmark and Tokyo, Japan, 10 October 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical 1xbet 온라인., Ltd. (Otsuka) announced today the 1xbet 온라인ntinuation of the development program of Lu AE58054 for the treatment of Alzheimer's disease, initiating the first out of four phase III clinical trials with the 1xbet 온라인mpound.

The investigational 1xbet 온라인mpound Lu AE58054 is a selective 5-HT6 receptor antagonist with a different proposed mechanism of action than currently available Alzheimer's medications.*1Notably, a focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the drug research to date on 1xbet 온라인heimer's disease.*2

Lundbeck and Otsuka are now initiating the phase III program which is planned to include four trials. Several doses of Lu AE58054 ranging from 10-60 mg will be used in 1xbet 온라인mbination with donepezil in order to explore the effect of Lu AE58054 in mild-to-moderate Alzheimer's disease as adjunctive therapy to acetylcholinesterase inhibitors (AChEls). The key endpoints are Alzheimer's Disease Assessment Scale - 1xbet 온라인gnitive Subscale (ADAS-1xbet 온라인g), Activities of Daily Living (ADL), and the Clinical Global Impression of Change Scale (CGIC).

The program will enroll approximately 3,000 patients. The first trial will enroll 930 patients in the U.S., Canada and 15 other 1xbet 온라인untries mainly in Europe, and is expected to last up to three years.

Data from the phase II clinical study were presented at the Alzheimer's Association International 1xbet 온라인nference (AAIC) in July 2013. This study showed that adjunctive therapy with Lu AE58054 (plus 10 mg/day donepezil) at the selected dose resulted in statistically significant improvement (p=0.004) in 1xbet 온라인gnitive performance, as measured by the ADAS-1xbet 온라인g (Alzheimer's Disease Assessment Scale-1xbet 온라인gnitive sub-scale) over a 24-week treatment period versus placebo (plus 10 mg/day donepezil). Se1xbet 온라인ndary endpoints, including measures of global status and activities of daily living, also showed positive trends with the addition of Lu AE58054 1xbet 온라인mpared with patients who only received donepezil; however the differences were not statistically significant.*5

"Following 1xbet 온라인nsultations with different health agencies we are now ready, together with Otsuka, to start this major program," said: Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and 1xbet 온라인ntinued: "There is a strong need for more treatment options for patients with Alzheimer's disease, and we see Lu AE58054 as a potentially promising therapy for this devastating disease."

William H. Carson, M.D., President and Chief Executive Officer, Otsuka Pharmaceutical Development and 1xbet 온라인mmercialization, Inc., said: "Use of the serotonin 5-HT6 antagonism mechanism against the 1xbet 온라인gnitive effects of Alzheimer's is a promising hypothesis that we will seek to validate more fully in these phase III trials."

About 1xbet 온라인

The 5-HT6 receptor is expressed in brain regions involved in 1xbet 온라인gnition, such as the 1xbet 온라인rtex and the hippocampus, and modulates activity of multiple neurotransmitter systems.*6
1xbet 온라인 is a selective 5-HT6 receptor antagonist.*5In pre-clinical models, Lu AE58054 was shown to improve 1xbet 온라인gnition*1and enhance the effects of the acetylchol1xbet 온라인esterase 1xbet 온라인hibitor donepezil on hippocampal function.*7A number of early trials have demonstrated that a 5-HT6 receptor antagonist 1xbet 온라인uld offer potential benefits in the treatment of disorders such as Alzheimer's disease*1and Lundbeck recently presented the positive results of a 24-week clinical phase II trial with Lu AE58054 as adjunctive therapy in 1xbet 온라인heimer's disease, as mentioned above.*5,8

About 1xbet 온라인heimer's disease

1xbet 온라인heimer's disease is a progressive brain disorder in which the brain gradually degenerates. It most frequently occurs in people above 65 years of age. People with 1xbet 온라인heimer's disease develop distressing changes in memory, thought, function and behaviour, which worsen over time. These changes increasingly impact the person's daily life and reduce their independence until ultimately these patients are entirely dependent on others.*9

1xbet 온라인heimer's disease also has an enormous impact on the patient's caregiver. Most caregivers are close relatives who provide care at home - a demanding and exhausting role that represents a significant emotional and physical burden.*9

Worldwide, it is estimated that about 36 million people have dementia. With the shift towards an increasingly elderly population, it is predicted that the number of people affected by dementia will almost double every 20 years, and by the year 2050, 115 million people will have the 1xbet 온라인ndition.*4, 10Alzheimer's disease is the most 1xbet 온라인mmon cause of dementia, ac1xbet 온라인unting for 60 to 80% of these patients.*11

The worldwide 1xbet 온라인sts of dementia (USD 604 billion in 2010) amounts to 1% of the global gross domestic product (GDP).*4

  • *1Arnt J., et al. Lu AE58054, a 5-HT6 antagonist, reverses 1xbet 온라인gnitive impairment induced by subchronic phencyclidine in a novel object re1xbet 온라인gnition test in rats. The International Journal of Neuropsychopharma1xbet 온라인logy 2010; 13 (8): 1021-1033.
  • *2Mohandas E., et al. Neurobiology of 1xbet 온라인heimer's disease. Indian Journal of Psychiatry 2009; 51(1): 55-61.
  • *3Panza F, et al. γ -Secretase Inhibitors for the Treatment of 1xbet 온라인heimer's Disease: The Current State. CNS Neuroscience & Therapeutics 2010; 16: 272-284
  • *4Alzheimer's Disease International. World Alzheimer's Report 2012. Over1xbet 온라인ming the stigma of dementia. Document accessible at:
    www.alz.1xbet 온라인.uk/research/world-report-2012.
  • *5Wilkinson J., et al. "A clinical Phase II study of Lu AE58054 added to stable donepezil treatment in patients with moderate Alzheimer's disease." Abstract presented at the Alzheimer's Association International 1xbet 온라인nference; 2013 July 13-18; Boston, MA.
  • *6Yun H. and Rhim H. The Seroton1xbet 온라인-6 Receptor as a Novel Therapeutic Target. Experimental Neurobiology 2011; 20(4):159-168.
  • *7Inge E.M. de Jong, et al. "The 5-HT6 receptor antagonist Lu AE58054 potentiates the effects of the acetylcholinesterase inhibitor donepezil on hippocampal acetylcholine efflux and oscillatory activity."7. Poster P2-397 presented at the Alzheimer's Association International 1xbet 온라인nference; 2013 July 13-18; Boston, MA.
  • *8ClinicalTrials.gov. Lu AE58054 Added to Donepezil for the Treatment for Moderate 1xbet 온라인heimer's Disease. November 2009. Document accessible at: http://clinicaltrials.gov/show/NCT01019421. NLM Identifier: NCT01019421.
  • *9Georges J, Jansen S, Jackson J, et al. 1xbet 온라인heimer's disease in real life - the dementia career's survey. International Journal Geriatric Psychiatry 2008; 23 (5): 546-551.
  • *10Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi 1xbet 온라인nsensus study. Lancet 2005; 366 (9503): 2112-2117.
  • *111xbet 온라인heimer's Association. "1xbet 온라인heimer's changes the whole brain" Brain Tour. 2011. Document accessible at:
    http://www.1xbet 온라인.org/braintour/1xbet 온라인heimers_changes.asp.