Pharmaceutical study starts in Sweden with BAN2401 in early Alzheimer patients

The text below is a translation of a Swedish press release.

BioArctic Neuroscience AB today announced that the first patient in Sweden has been treated with BAN2401 in a clinical study aimed at patients with an early Alzheimer’s disease. BAN2401 is a monoclonal antibody, developed in Professor Lars Lannfelt’s laboratory at Uppsala University [1], Sweden. The clinical study is conducted by the Japanese drug company Eisai, a partner for the development of the drug.

BAN2401 is the first monoclonal antibody in clinical trial that selectively binds and eliminates beta-amyloid protofibrils [2]. These soluble toxic aggregates are believed to cause degeneration of brain cells leading to Alzheimer’s disease [1]. BAN2401 can hopefully prevent the ongoing cognitive impairment, which is typical of patients and most affected the natural course of the disease.

Three university hospitals in Sweden will participate in this global Phase II study, already initiated in the US and Canada. Further study centers in Europe will also participate. Up to 800 patients with early Alzheimer’s disease will be recruited and receive one of five different dosing alternatives of BAN2401 or placebo. A new adaptable study design will be used to evaluate the effect on cognition and markers that reflect disease progression. [3] Primarily, the effect will be investigated with ADCOMS, a new clinical measurement instrument, formulated specifically for use in early forms of Alzheimer’s disease by researchers at Eisai [4]. PET examination with an amyloid binding substance is used to visualize beta amyloid in the brain, thus identifying patients with Alzheimer’s pathology.

“The start of this study in Sweden represents an important step forward for BioArctic, and we hope this new antibody will affect the disease progression of early Alzheimer patients,” said Gunilla Osswald, CEO of BioArctic Neuroscience. “We are very pleased to work with Eisai, a world-leading pharmaceutical company in Alzheimer’s research, and we appreciate their new collaboration with Biogen Idec that includes Alzheimer’s disease.”

For more information, please contact

BioArctic Neuroscience AB
Gunilla Osswald, CEO
telephone + 46 (0)8-695 6933
e-mail gunilla.osswald@bioarctic.se

Notes to editors

Antibody BAN2401

Current research suggests that intermediates (A? protofibrils) in the aggregation process of the amyloid-? peptide initiate and drive the neurodegenerative process in Alzheimer’s disease[1]. A? protofibrils have been proven to be toxic elements of the disease in a number of studies in cell culture models and in transgenic animals with the Arctic and Swedish mutations (APParcswe), published by Prof. Lars Lannfelt, Uppsala University. BioArctic Neuroscience AB has developed a humanized monoclonal antibody (BAN2401) that selectively eliminates these toxic A? protofibrils. Eisai has obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease. BioArctic retains the rights to market the antibody in Nordic countries and to use it for other potential medical indications.

Alzheimer’s Disease

Alzheimer’s disease is a devastating neurodegenerative disease characterized by an insidious onset and progressive loss of memory and cognition. The disorder is also manifested by behavioural disturbances and functional impairment, and leads to premature death.

Alzheimer’s disease is a demographic time bomb. The disease is age-related and the number of patients doubles every five years beyond age 65, meaning that 30% of 85-year-olds are suffering from the disease. Current estimates indicate 35.6 million people worldwide are living with dementia and researchers estimate that this number could triple by 2050[5]. In Sweden alone, the costs of dementia were estimated in 2005 to exceed 50 billion SEK, with the figure anticipated to grow as the average age of the population increases [6].

Alzheimer’s disease represents an area of high unmet medical need, as there is currently no treatment that can cure or stop the disease. Despite this, the Alzheimer’s disease market already stands $5.8bn in the seven major markets in 2011, with the market predicted to more than double to $14.5bn by 2020 with the introduction of newer therapies [7]. Halting disease progression would lead to enormous benefits to patients and caregivers and cost savings for society given the huge cost of patient care.

BioArctic Neuroscience

BioArctic Neuroscience AB is a biopharmaceutical company with a proprietary technology for developing therapeutic monoclonal antibodies for the treatment of Alzheimer’s disease, Parkinson’s disease, and other disorders caused by misfolded proteins. www.bioarctic.se

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based pharmaceutical company that discovers, develops and markets products worldwide. Guided by its corporate mission of “giving first thought to patients and their families, and to increasing the benefits that health care provides,” all Eisai employees aspire to meet the various needs of global health care as representatives of a “human health care (hhc) company” that is capable of making a meaningful contribution under any health care system. For more information about Eisai Co., Ltd., please visit www.eisai.com

[1] Nat Neurosci. 2001 Sep;4(9):887-93.
[2] http://www.alzforum.org/therapeutics/ban2401
[3] http://www.alzforum.org/news/conference-coverage/ctad-adaptive-antibody-trial-try-bayesian-statistics
[4] http://www.alzforum.org/webinars/new-frontier-developing-outcome-measures-pre-dementia-trials
[5] WHO Report 2012: Dementia: A Public Health Priority. ISBN 978 92 4 156445 8
[6] Cost of dementia: Regional Patterns – Sweden Anders Wimo, Karolinska Institutet and Linus Jönsson, I3 Innovus. http://www.alzheimer-europe.org/Research/European-Collaboration-on-Dementia/Cost-of-dementia/Regional-Patterns-The-societal-costs-of-dementia-in-Sweden
[7] Reuters.com: Research and Markets: Alzheimer’s Market and Product Forecasts: Multi-Billion Dollar Potential in High-Risk Pipeline. Tue Jan 24, 2012 2:29