Stockholm, Sweden, March 25, 2019 – BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announces that its partner Eisai will give poster presentations related to BAN2401 in early Alzheimer’s disease at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases (AD/PD) on March 27 in Lisbon, Portugal.
One poster presentation will highlight the study design for the Open Label Extension portion of the BAN2401 Phase 2b study in patients with early Alzheimer’s disease. Another poster presentation will cover pharmacokinetic and exposure-response analyses for efficacy and safety of BAN2401 in patients with early Alzheimer’s disease.
Eisai is responsible for the clinical development of BAN2401 in Alzheimer´s disease including the Phase 2b and Phase 3 studies.
Abstract ID: ADPD9-2329
Poster No.: 178
|Long-Term Safety and Tolerability of BAN2401 in Early Alzheimer’s Disease (EAD): An Open Label Extension (OLE) Study Design for BAN2401-G000-201
March 27, 2019
Abstract ID: ADPD9-2335
Poster No.: 177
|Population Pharmacokinetic (PK) and Exposure-Response (ER) Analyses for Efficacy and Safety of BAN2401 in Patients with Early Alzheimer’s Disease (AD)
March 27, 2019
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 agents 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 was submitted for publication at 08.00 a.m. CET on March 25, 2019.
Notes to editors
BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai. BAN2401 selectively binds to neutralize and eliminate soluble, toxic amyloid-beta aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 has the potential to have an effect on the 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 and Phase 3 studies of BAN2401 for Alzheimer’s disease. In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401. Currently, the open label extension phase of a Phase 2b clinical study targeting patients who were enrolled in the study is ongoing.
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 for Alzheimer’s disease.
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 (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. Eisai defines their corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which Eisai calls their human health care (hhc) philosophy. With approximately 10,000 employees working across the global network of R&D facilities, manufacturing sites and marketing subsidiaries, Eisai strives to realize their 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.