Lundbeck and Otsuka to Co-Develop a Vaccine, Lu AF20513, Their Third Collaborative Development Project to Tackle Alzheimer's Disease

• Lu AF20513 is an anti-beta-amlyoid (anti-Aβ) active vaccine concept expected to enter phase I clinical testing in 2014
• The two companies’ collaboration on Lu AF20513 represents a different approach from most other drug research to date on Alzheimer’s disease
• Alzheimer's disease affects at least 34 million people worldwideⁱ. The cost to society from dementia has been reported as USD ~600 billion per yearⁱⁱ
• Lu AF20513 is the third joint investigational project by the two companies that seeks to address a dimension of Alzheimer’s disease

VALBY, Denmark & TOKYO--(BUSINESS WIRE)--H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that they will further expand their collaboration to include the development of Lu AF20513, an investigational vaccine candidate for Alzheimer’s disease.

Lu AF20513 is an anti-Aβ active vaccine candidate for Alzheimer’s disease which currently is in preclinical development. It is designed towards an optimal immunogenic response in the elderly, based on the hypothesis that cognitive function would be preserved through the early inhibition of amlyoid beta depositions.

The agreement covers the development of Lu AF20513 through clinical phase I. Following completion of the clinical phase I study the 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 the phase I development costs. Additional specific financial terms of the agreement remain undisclosed.

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

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

These research programs illustrate the depth and breadth of experience and resources the two firms can draw on in neuroscience research and development. The two companies’ collective revenues in the central nervous system (CNS) area rank the alliance number one in this fieldⁱⁱⁱ.

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 the brain and is believed to play a central role in the pathology of Alzheimer’s disease. Lu AF20513 is expected to provide an enhanced and heterogeneous immunogenic response towards Aβ peptides in comparison to monoclonal antibody treatment strategies.

About Alzheimer's disease

Alzheimer'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 Alzheimer'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^iv.

Alzheimer'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^v.

Worldwide, it is estimated that about 44 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, 135 million people will have the conditionⁱⁱ. Alzheimer's disease is the most common cause of dementia, accounting for 50 to 80% of these patients^vi.

The worldwide costs of dementia, estimated at around USD 600 billion in 2010, amount to more than 1% of the 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 the 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, Alzheimer’s disease, depression/anxiety, epilepsy, Huntington’s disease, Parkinson’s disease, schizophrenia and stroke.

Our 5,800 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales, and are committed to improving the 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 the 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 the stock exchange in Copenhagen under the symbol ”LUN”. Lundbeck has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol ”HLUYY”. For additional information, we encourage you to visit our corporate site www.lundbeck.com.

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The chairman Akihiko Otsuka is the third generation of Otsuka family members to lead the business, whose origins date from 1921. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Consolidated sales were approximately USD 13 billion for fiscal year 2012 (4/1/2012-3/31/2013). Otsuka Pharmaceutical invites you to visit its global website at https://www.otsuka.co.jp/en/

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