Stockholm, Sweden, July 18, 2018 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B). As previously announced, the BAN2401 Phase 2b clinical study results will be presented in an oral session at the 2018 Alzheimer’s Association International Conference (AAIC) on July 25, 2018 at 3:30 p.m. CDT in Chicago, IL, as part of Session DT-01: “Recent Developments in Therapeutics” (2:00 p.m. to 4:00 p.m. CDT).
The oral presentation will focus on the results of Phase 2b clinical study (ClinicalTrials.gov identifier: NCT01767311) in 856 patients with early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia).
The presentation will be webcast live. To access the live webcast, please visit the Investors section of Eisai’s website on July 25th at 3:30 p.m. CDT at https://www.eisai.com/ir/index.html.
BioArctic announced on July 6 that BAN2401 Phase 2b study achieved statistical significance at 18 months based on key predefined endpoints evaluating the efficacy on slowing progression in the Alzheimer’s Disease Composite Score (ADCOMS) and the reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography). This study marks the first time that late-stage study data has successfully demonstrated potential disease-modifying effects on both clinical function and amyloid beta accumulation in the brain. The most common treatment emergent adverse events reported were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA).
This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.
For more information, please contact
Gunilla Osswald, PhD, CEO, BioArctic AB
Telephone: + 46 8 695 69 30
Christina Astrén, IR & Communications Director, BioArctic AB
Telephone: + 46 70 835 43 36
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of the contact persons above, on July 18, 2018, at 10.00 p.m. CET.
Notes to editors
Please note AAIC embargo policy: All materials submitted to AAIC are embargoed for publication and broadcast until the officially scheduled date and time of presentation.
The Alzheimer’s Association International Conference (AAIC) is the world’s largest conference for the latest scientific research and clinical developments for Alzheimer’s disease. AAIC 2018 will be held in Chicago, IL at McCormick Place July 22-26. For more information about AAIC, please visit www.alz.org/aaic.
BAN2401 is a humanized monoclonal antibody for Alzheimer’s disease that is the result of a strategic research alliance between BioArctic and Eisai. BAN2401 selectively binds to, neutralize and eliminate soluble, toxic Aβ aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArctic in December 2007.
Eisai is responsible for the Phase 2b study and the development of BAN2401 for Alzheimer’s disease. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.
About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most important agreements are the development and commercialization agreement on the BAN2401 antibody, which was signed in December 2007, and the development and commercialization agreement on the antibody BAN2401 back-up for Alzheimer’s disease, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. The company also develops a potential treatment for Complete Spinal Cord Injury. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with our strategically important global partners in the Alzheimer (Eisai) and Parkinson (AbbVie) projects. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. BioArctic’s B-share is listed on Nasdaq Stockholm Mid Cap (STO:BIOA B). www.bioarctic.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of Aricept®, a treatment for Alzheimer’s disease and dementia with Lewy bodies, Eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. As a pioneer in the field of dementia treatment, Eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.
For more information about Eisai Co., Ltd., please visit www.eisai.com.