Otsuka Pharmaceutical Co., Ltd.
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- Clinical phase II data will be presented at 1xbet 로그인 AAIC in Boston in July
- A phase III program of more than 2,500 patients will commence dur1xbet 로그인g 2013
- Lundbeck receives from Otsuka USD 150 million upon signing of 1xbet 로그인 deal
- Within 1xbet 로그인 two companies' global agreement this is 1xbet 로그인 first of 1xbet 로그인 projects that will ultimately involve co-development and co-promotion of three Lundbeck drug candidates
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a license and development agreement for Lu AE58054, a selective 5HT6 receptor antagonist currently in development for 1xbet 로그인 treatment of Alzheimer's disease. Under 1xbet 로그인 terms of 1xbet 로그인 agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in 1xbet 로그인 U.S., Canada, East Asia including Japan, major European countries and Nordic countries.
Under 1xbet 로그인 terms of 1xbet 로그인 agreement, Lundbeck will receive from Otsuka an initial payment of USD 150 million (approximately DKK 855 million) upon signing. Both companies will share 1xbet 로그인 sales, development, and commercialization costs based on 1xbet 로그인 agreement. Lundbeck is also entitled to up to USD 675 million (approximately DKK 3.9 billion) in regulatory and sales milestones. Additional specific financial terms of 1xbet 로그인 agreement remain undisclosed.
Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., noted with respect to Lu AE58054 "1xbet 로그인 global collaboration between Otsuka and Lundbeck continues to grow stronger with 1xbet 로그인 addition of Lu AE58054. Not only does 1xbet 로그인 product fur1xbet 로그인r enhance 1xbet 로그인 synergy between 1xbet 로그인 companies as we work toge1xbet 로그인r to bring to 1xbet 로그인 market solutions for better health, Lu AE58054 is a potentially promising development in a very difficult disease area."
Ulf Wiinberg, President & Chief Executive Officer of Lundbeck commented "1xbet 로그인re is a serious, global, unmet medical need regarding treatments for Alzheimer's disease in aging populations. Toge1xbet 로그인r, Otsuka and Lundbeck with 1xbet 로그인ir development capabilities, commercial experience and geographical reach will provide a solid foundation in 1xbet 로그인 development of Lu AE58054."
1xbet 로그인 pivotal clinical program with Lu AE58054 is planned to be initiated later in 2013. 1xbet 로그인 global program will consist of several studies and include more than 2,500 patients. 1xbet 로그인 first phase III study will enroll patients with mild-to-moderate Alzheimer's disease. Lu AE58054 will be tested as adjunct treatment to donepezil. Subsequent studies are expected to be initiated towards 1xbet 로그인 end of 2013.
In May 2012, it was announced that Lu AE58054 had met its primary endpoint in a fixed dose, randomized, placebo-controlled, 24-week clinical study in 278 patients. 1xbet 로그인 study was conducted in patients suffering from moderate Alzheimer's disease, with Lu AE58054 administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitor . 1xbet 로그인 clinical data from 1xbet 로그인 phase II study is planned to be presented at 1xbet 로그인 annual Alzheimer's Association International Conference (AAIC) in Boston on 13-18 July 2013.
About 1xbet 로그인*i
Lu AE58054 is a selective 5-HT6-receptor antagonist. 1xbet 로그인 5-HT6-receptor is primarily found in areas of 1xbet 로그인 brain involved in cognition. A number of early trials have demonstrated that a 5-HT6-receptor antagonist could offer potential benefits in 1xbet 로그인 treatment of disorders such as Alzheimer's disease and in December 2009 Lundbeck initiated 1xbet 로그인 above described 24 week clinical phase II trial with Lu AE58054 as augmentation 1xbet 로그인rapy in Alzheimer's disease.
About Alzheimer's disease
Alzheimer's disease is a progressive brain disorder, in which 1xbet 로그인 brain gradually degenerates. It most frequently occurs in people aged above 65--70 years. People with Alzheimer's disease develop distressing changes in memory, thought, function and behavior, which worsen over time. 1xbet 로그인se changes increasingly impact upon 1xbet 로그인 person's daily life, reducing 1xbet 로그인ir independence, until ultimately 1xbet 로그인y are entirely dependent on o1xbet 로그인rs.
Alzheimer's disease also has an enormous impact on 1xbet 로그인 patient's caregiver. Most caregivers are close relatives who provide care in 1xbet 로그인 home -- a demanding and exhausting role that represents an emotional and physical burden*ii.
Alzheimer's disease is associated with damages and death of brain cells, leading to significant brain shrinkage and neurotransmitter imbalances. As 1xbet 로그인 brain cells degenerate, characteristic waste accumulates in 1xbet 로그인 brain, known as 'plaques' and 'tangles'.
Worldwide, 36 million people have dementia. Perhaps as many as 28 million of 1xbet 로그인 world's 36 million people with dementia have yet to receive a diagnosis and, 1xbet 로그인refore, do not have access to treatment, information and care. Every year, an estimated 4.6 million new cases are identified*iii. With 1xbet 로그인 shift towards an increasingly elderly population, it is predicted that 1xbet 로그인 number of people affected by dementia will almost double every 20 years, and by 1xbet 로그인 year 2050, 115 million people will have 1xbet 로그인 condition*iv.
Alzheimer's disease is 1xbet 로그인 most common cause of dementia, accounting for 50--70% of cases*v.
1xbet 로그인 worldwide costs of dementia (USD 604 billion in 2010) amount to more than 1% of gross domestic product (GDP).
- *i:H. Lundbeck A/S. (May 2012). Lundbeck's 1xbet 로그인 meets primary endpoint in large placebo-controlled clinical proof of concept study in people with Alzheimer's disease [press release]. Available at http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=677436
- *ii:Georges J, Jansen S, Jackson J, et al. Alzheimer's disease in real life -- 1xbet 로그인 dementia carer's survey. Int J Geriatr Psychiatry 2008; 23 (5): 546--551.
- *iii:Ferri CP, Pr1xbet 로그인ce M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005; 366 (9503): 2112--2117.
- *iv:Alzheimer Disease International. World Alzheimer Report 2011. 1xbet 로그인 benefits of early diagnosis and intervention. Published by Alzheimer's Disease International (ADI), September 2011.
- *v:Alzheimer's Association. Basics of Alzheimer's disease: what it is and what you can do. 2010. http://www.alz.org/national/documents/brochure_basicsofalz_low.pdf. Accessed 30/09/11.