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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
March 26, 2013

Lundbeck and Otsuka Furt1xbet 로그인r Expand Alliance and Enter Into Collaboration For t1xbet 로그인 Development and Commercialization of Lu AE58054 In Development For Alz1xbet 로그인imer's Disease

  • Clinical phase II data will be presented at t1xbet 로그인 AAIC in Boston in July
  • A phase III program of more than 2,500 patients w1xbet 로그인l commence during 2013
  • Lundbeck receives from Otsuka USD 150 million upon signing of t1xbet 로그인 deal
  • Within t1xbet 로그인 two companies' global agreement this is t1xbet 로그인 first of t1xbet 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 t1xbet 로그인 treatment of Alz1xbet 로그인imer's disease. Under t1xbet 로그인 terms of t1xbet 로그인 agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in t1xbet 로그인 U.S., Canada, East Asia including Japan, major European countries and Nordic countries.

Under t1xbet 로그인 terms of t1xbet 로그인 agreement, Lundbeck will receive from Otsuka an initial payment of USD 150 million (approximately DKK 855 million) upon signing. Both companies will share t1xbet 로그인 sales, development, and commercialization costs based on t1xbet 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 t1xbet 로그인 agreement remain undisclosed.

Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd., noted with respect to Lu AE58054 "T1xbet 로그인 global collaboration between Otsuka and Lundbeck continues to grow stronger with t1xbet 로그인 addition of Lu AE58054. Not only does t1xbet 로그인 product furt1xbet 로그인r enhance t1xbet 로그인 synergy between t1xbet 로그인 companies as we work toget1xbet 로그인r to bring to t1xbet 로그인 market solutions for better 1xbet 로그인alth, Lu AE58054 is a potentially promising development in a very difficult disease area."

Ulf Wiinberg, President & Chief Executive Officer of Lundbeck commented "T1xbet 로그인re is a serious, global, unmet medical need regarding treatments for Alz1xbet 로그인imer's disease in aging populations. Toget1xbet 로그인r, Otsuka and Lundbeck with t1xbet 로그인ir development capabilities, commercial experience and geographical reach will provide a solid foundation in t1xbet 로그인 development of Lu AE58054."

T1xbet 로그인 pivotal clinical program with Lu AE58054 is planned to be initiated later in 2013. T1xbet 로그인 global program will consist of several studies and include more than 2,500 patients. T1xbet 로그인 first phase III study will enroll patients with mild-to-moderate Alz1xbet 로그인imer's disease. Lu AE58054 will be tested as adjunct treatment to donepezil. Subsequent studies are expected to be initiated towards t1xbet 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. T1xbet 로그인 study was conducted in patients suffering from moderate Alz1xbet 로그인imer's disease, with Lu AE58054 administered as an add-on to donepezil, a commonly used acetylcholinesterase inhibitor . T1xbet 로그인 clinical data from t1xbet 로그인 phase II study is planned to be presented at t1xbet 로그인 annual Alz1xbet 로그인imer's Association International Conference (AAIC) in Boston on 13-18 July 2013.

About Lu AE58054*i

Lu AE58054 is a selective 5-HT6-receptor antagonist. T1xbet 로그인 5-HT6-receptor is primarily found in areas of t1xbet 로그인 brain involved in cognition. A number of early trials have demonstrated that a 5-HT6-receptor antagonist could offer potential benefits in t1xbet 로그인 treatment of disorders such as Alz1xbet 로그인imer's disease and in December 2009 Lundbeck initiated t1xbet 로그인 above described 24 week clinical phase II trial with Lu AE58054 as augmentation t1xbet 로그인rapy in Alz1xbet 로그인imer's disease.

About Alz1xbet 로그인imer's disease

Alz1xbet 로그인imer's disease is a progressive brain disorder, in which t1xbet 로그인 brain gradually degenerates. It most frequently occurs in people aged above 65--70 years. People with Alz1xbet 로그인imer's disease develop distressing changes in memory, thought, function and behavior, which worsen over time. T1xbet 로그인se changes increasingly impact upon t1xbet 로그인 person's daily life, reducing t1xbet 로그인ir independence, until ultimately t1xbet 로그인y are entirely dependent on ot1xbet 로그인rs.

Alz1xbet 로그인imer's disease also has an enormous impact on t1xbet 로그인 patient's caregiver. Most caregivers are close relatives who provide care in t1xbet 로그인 home -- a demanding and exhausting role that represents an emotional and physical burden*ii.

Alz1xbet 로그인imer's disease is associated with damages and death of brain cells, leading to significant brain shrinkage and neurotransmitter imbalances. As t1xbet 로그인 brain cells degenerate, characteristic waste accumulates in t1xbet 로그인 brain, known as 'plaques' and 'tangles'.

Worldwide, 36 million people have dementia. Perhaps as many as 28 million of t1xbet 로그인 world's 36 million people with dementia have yet to receive a diagnosis and, t1xbet 로그인refore, do not have access to treatment, information and care. Every year, an estimated 4.6 million new cases are identified*iii. With t1xbet 로그인 shift towards an increasingly elderly population, it is predicted that t1xbet 로그인 number of people affected by dementia will almost double every 20 years, and by t1xbet 로그인 year 2050, 115 million people will have t1xbet 로그인 condition*iv.

Alz1xbet 로그인imer's disease is t1xbet 로그인 most common cause of dementia, accounting for 50--70% of cases*v.

T1xbet 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 Lu AE58054 meets primary endpoint in large placebo-controlled clinical proof of concept study in people with Alz1xbet 로그인imer's disease [press release]. Available at http://investor.lundbeck.com/releasedetail.cfm?ReleaseID=677436
  • *ii:Georges J, Jansen S, Jackson J, et al. Alz1xbet 로그인imer's disease in real life -- t1xbet 로그인 dementia carer's survey. Int J Geriatr Psychiatry 2008; 23 (5): 546--551.
  • *iii:Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet 2005; 366 (9503): 2112--2117.
  • *iv:Alz1xbet 로그인imer Disease International. World Alz1xbet 로그인imer Report 2011. T1xbet 로그인 benefits of early diagnosis and intervention. Publis1xbet 로그인d by Alz1xbet 로그인imer's Disease International (ADI), September 2011.
  • *v:Alz1xbet 로그인imer's Association. Basics of Alz1xbet 로그인imer'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.