First clinical study started with BAN2401, a novel antibody targeting the neurotoxin believed to cause Alzheimer’s disease
STOCKHOLM - Sweden and Tokyo, Japan, September 2nd, 2010. Swedish biopharmaceutical company BioArctic Neuroscience AB (Headquarters: Stockholm, CEO: Dr. Pär Gellerfors) and Japanese pharmaceutical company Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Hauro Naito), announce today the start of the first clinical study with BAN2401 in patients with Alzheimer’s disease. BAN2401 is an antibody that targets the toxic amyloid aggregates believed to cause degeneration of brain cells leading to Alzheimer’s disease. The new treatment approach is expected to halt progression of the disease
The primary goal of the study is to determine the safe dose range of BAN2401 and its effect on Alzheimer biomarkers. More than 80 Alzheimer's patients with mild to moderate forms of the disease will participate. BAN2401 is the first monoclonal antibody to selectively bind and efficiently eliminate amyloid-β protofibrils, the toxic protein believed to cause Alzheimer's disease.
The role of monoclonal antibody therapies in treating medical conditions has expanded tremendously since the first such therapy was developed in the 1970s, and their use in treating neurological conditions has only increased in the past few years.
"The commencement of the trial marks a huge step forward for both companies, and we hope the new antibody will slow down or halt the progression of the disease," said Dr. Pär Gellerfors, CEO of BioArctic Neuroscience. "We are very pleased to be working together with Eisai, the world-leading pharmaceutical company in Alzheimer's disease research and treatment. Our treatment concept of how to stop disease progression necessitates a strong partner as Eisai Ltd., that is fully committed to develop the project all the way to the market."
For more information, please contact:
BioArctic Neuroscience AB
Dr. Pär Gellerfors, CEO
Notes to editors
Current research suggests that an intermediate (Aβ protofibril) in the aggregation process of the amyloid-β peptide Aβ initiates and drives the neurodegenerative process in Alzheimer's disease. These Aβ protofibrils have been proven to be toxic elements of the disease in a number of studies 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 Aβ 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 use it for other medical indications.
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. Today, an estimated 15 million people worldwide are affected by Alzheimer's, and researchers estimate that this number could increase to around 70 million by 2050. In the United States, the annual cost for treatment, care, and loss to business as a result of Alzheimer's disease is estimated at €100 billion. This figure is expected to continue to grow as the average age of the population increases.
Alzheimer's disease represents an area of high unmet medical need, as there is currently no treatment that can cure or stop the disease. The world market for an effective Alzheimer's drug is estimated at €12 billion. 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 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 human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
Eisai concentrates its R&D activities in three key areas:
Integrative Neuroscience, including Alzheimer's disease, neuropathic pain and epilepsy.
Integrative Oncology, including anticancer therapies, tumor regression, tumor suppression and antibodies; supportive cancer therapies include nausea and vomiting.
Vascular/Immunological Reaction including acute coronary syndrome, atherothrombotic disease and sepsis.
Eisai Co., Ltd
Public Relations Department, Telephone: +81-3-3817-5120