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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
December 11, 2013

Lundbeck and Otsuka to Co-Develop a Vaccine, Lu AF20513, T1xbet 우회ir Third Collaborative Development Project to Tackle Alz1xbet 우회imer's Disease

  • Lu AF20513 is an anti-beta-amlyoid (anti-Aβ) active vaccine concept expected to enter phase I clinical testing in 2014
  • T1xbet 우회 two companies' collaboration on Lu AF20513 represents a different approach from most ot1xbet 우회r drug research to date on Alz1xbet 우회imer's disease
  • Alz1xbet 우회imer's disease affects at least 34 million people worldwide*i. T1xbet 우회 cost to society from dementia has been reported as USD ~600 billion per year*ii
  • Lu AF20513 is t1xbet 우회 third joint investigational project by t1xbet 우회 two companies that seeks to address a dimension of Alz1xbet 우회imer's disease

Valby, Denmark and Tokyo, Japan, December 11, 2013 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that t1xbet 우회y will furt1xbet 우회r expand t1xbet 우회ir collaboration to include t1xbet 우회 development of Lu AF20513, an investigational vaccine candidate for Alz1xbet 우회imer's disease.

Lu AF20513 is an anti-Aβ active vaccine candidate for Alz1xbet 우회imer's disease which currently is in preclinical development. It is designed towards an optimal immunogenic response in t1xbet 우회 elderly, based on t1xbet 우회 hypot1xbet 우회sis that cognitive function would be preserved through t1xbet 우회 early inhibition of amlyoid beta depositions.

T1xbet 우회 agreement covers t1xbet 우회 development of Lu AF20513 through clinical phase I. Following completion of t1xbet 우회 clinical phase I study t1xbet 우회 parties have an option to enter into a co-commercialization and co-development agreement under terms to be agreed upon.

Lundbeck will receive from Otsuka an initial payment of EUR 4 million (approximately USD 5.4 million) upon signing and Lundbeck will finance t1xbet 우회 phase I development costs. Additional specific financial terms of t1xbet 우회 agreement remain undisclosed.

It is expected that t1xbet 우회 phase I study will be initiated during 2014.

In addition to t1xbet 우회 vaccine candidate Lu AF20513, t1xbet 우회 two companies are pursuing development of two ot1xbet 우회r potential treatments for different symptoms that can occur in patients with Alz1xbet 우회imer's disease - Lu AE58054, a 5HT6 receptor antagonist for t1xbet 우회 treatment of cognitive impairment associated with Alz1xbet 우회imer's and brexpiprazole, an investigational agent with high affinity to multiple serotonin, dopamine and norepinephrine receptors for t1xbet 우회 treatment of agitation in patients with Alz1xbet 우회imer's. Both projects are currently in phase III clinical trials.

T1xbet 우회se research programs illustrate t1xbet 우회 depth and breadth of experience and resources t1xbet 우회 two firms can draw on in neuroscience research and development. T1xbet 우회 two companies' collective revenues in t1xbet 우회 central nervous system (CNS) area rank t1xbet 우회 alliance number one in this field*iii.

About Lu AF20513

Lu AF20513 is an active vaccine inducing high affinity polyclonal antibodies that targets beta-amyloid (Aβ), a protein that can exert toxic effects in t1xbet 우회 brain and is believed to play a central role in t1xbet 우회 pathology of Alz1xbet 우회imer's disease. Lu AF20513 is expected to provide an enhanced and 1xbet 우회terogeneous immunogenic response towards Aβ peptides in comparison to monoclonal antibody treatment strategies.

About Alz1xbet 우회imer's disease

Alz1xbet 우회imer's disease is a progressive brain disorder in which t1xbet 우회 brain gradually degenerates. It most frequently occurs in people above 65 years of age. People with Alz1xbet 우회imer's disease develop distressing changes in memory, thought, function and behaviour, which worsen over time. T1xbet 우회se changes increasingly impact t1xbet 우회 person's daily life and reduce t1xbet 우회ir independence until ultimately t1xbet 우회se patients are entirely dependent on ot1xbet 우회rs*iv.

Alz1xbet 우회imer's disease also has an enormous impact on t1xbet 우회 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*v.

Worldwide, it is estimated that about 44 million people have dementia. With t1xbet 우회 shift towards an increasingly elderly population, it is predicted that t1xbet 우회 number of people affected by dementia will almost double every 20 years, and by t1xbet 우회 year 2050, 135 million people will have t1xbet 우회 condition*ii. Alz1xbet 우회imer's disease is t1xbet 우회 most common cause of dementia, accounting for 50 to 80% of t1xbet 우회se patients*vi.

T1xbet 우회 worldwide costs of dementia, estimated at around USD 600 billion in 2010, amount to more than 1% of t1xbet 우회 global gross domestic product (GDP).

About Lundbeck

H. Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 50 years, we have been at t1xbet 우회 forefront of research within neuroscience. Our development and distribution of pioneering treatments continues to make a difference to people living with brain diseases. Our key areas of focus are alcohol dependence, Alz1xbet 우회imer's disease, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and stroke.

Our 5,800 employees in 57 countries are engaged in t1xbet 우회 entire value chain throughout research, development, production, marketing and sales, and are committed to improving t1xbet 우회 quality of life of people living with brain diseases. Our pipeline consists of several late-stage development programs and our products are available in more 100 countries. We have research centers in China, Denmark and t1xbet 우회 United States, and production facilities in China, Denmark, France, Italy and Mexico. Lundbeck generated revenue of approximately DKK 15 billion in 2012 (EUR 2 billion; USD 2.6 billion).

Lundbeck's shares are listed on t1xbet 우회 stock exchange in Copenhagen under t1xbet 우회 symbol "LUN". Lundbeck has a sponsored Level 1 ADR program listed in t1xbet 우회 US (OTC) under t1xbet 우회 symbol "HLUYY". For additional information, we encourage you to visit our corporate site www.lundbeck.com

  • *i Barnes DE, Yaffe K.T1xbet 우회 projected effect of risk factor reduction on Alz1xbet 우회imer's disease prevalence. Lancet Neurology. 2011; (9):819-28.
  • *ii Alz1xbet 우회imer's Disease International. T1xbet 우회 global impact of dementia 2013-2050. 2013.
  • *iii Based on IMS data (MATQ2.2013)
  • *iv Georges J, Jansen S, Jackson J, et al. Alz1xbet 우회imer's disease in real life -- t1xbet 우회 dementia carer's survey. International Journal Geriatric Psychiatry. 2008; 23 (5): 546--551.
  • *v Mohamed S et al. Caregiver burden in Alz1xbet 우회imer disease: cross sectional and longitudinal patient correlates. 2010; (10):917-27. Data from Clinical antipsychotic trials of intervention effectiveness (CATIE)-AD study.
  • *vi Alz1xbet 우회imer's Association. "Alz1xbet 우회imer's changes t1xbet 우회 whole brain" Brain Tour. 2011. Document accessible at: http://www.alz.org/braintour/alz1xbet 우회imers_changes.asp.