BioArctic continues to strengthen its sales organization | News

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STOCKHOLM, February 18, 2022 /PRNewswire/ — BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) continues to develop the Nordic commercial organization in anticipation of a potential launch of the Company’s lead drug candidate, lecanemab, in the Nordic region. During the spring of 2022, several key roles will be added to the organization.

Since 2005, BioArctic has had a long-standing cooperation with the global pharmaceutical company Eisai regarding the development and commercialization of the drug candidate lecanemab (BAN2401) for the treatment of early-onset Alzheimer’s disease. Development of lecanemab is being led by Eisai, which also owns the marketing rights. Lecanemab is currently being evaluated in a global Phase 3 trial, Clarity AD, with a primary readout planned in September 2022. The results of the Clarity AD study will be used to apply for marketing authorization in Europe and other markets around the world.

Under the agreement with Eisai, BioArctic has certain rights to market and sell lecanemab in the Nordic region. In order to prepare for a potential launch, BioArctic has begun building a Nordic market organization. Anna-Kaija Grönblad, who was previously Chief Executive Officer of Sanofi in Sweden and has over 25 years of experience in leadership positions in the pharmaceutical industry in Sweden and the Nordics, has already taken on the position of Commercial Director to lead these efforts.

The organization is now expanded with Frida Lekander as marketing manager. Frida Lekander comes from Oncopeptides where she worked as Director of Global Medical Strategy and Excellence. She has extensive experience in life sciences and previously worked at Siemens-Elema, Biotage, Johnson & Johnson and Janssen. Frida Lekander holds a master’s degree in molecular biotechnology from Uppsala University.

Sven Erickson will join the company on 1st of March as Chief Medical Officer. Sven has so far held the position of Medical Officer for Alzheimer’s disease at Biogen Sweden and has previously worked at companies such as Roche, Novartis, Medivir and Isofol AB. He holds a PhD in Experimental Oncology from Karolinska Institutet.

Mats Ekelund assumes the role of Market Access Manager and will join the company on 8 March. He joins the company from Biogen, where he was responsible for value and access in the Nordics. He previously worked at Wyeth and Pfizer. Mats holds a doctorate in economics from Stockholm School of Economics.

Harald Borgeke takes up his post as head of public affairs at the end of April. He has extensive experience in various commercial and market access roles from MSD, Novo Nordisk, Lilly and Celgene and currently works as a Head of Health Technology Assessment and Health Economics and CAR-T results at Bristol-Myers Squibb in the Nordics. Harald holds an MBA from the Gothenburg School of Economics as well as an MBA.

The department is also strengthened by the appointment of Professor Hans Basun as Senior Advisor Medical Affairs. Hans Basun has extensive clinical experience with patients with Alzheimer’s disease and previously served as Senior Director of Clinical Development and Medical Director at BioArctic. Prior to joining BioArctic, Hans Basun held senior management positions at AstraZeneca.

“Regulatory approval of lecanemab would give BioArctic the opportunity to offer healthcare providers in the Nordic region an entirely new way to treat patients with early-stage Alzheimer’s disease. The medical need is enormous, but any introduction of new drugs requires thorough and careful preparation to ensure that the right patients have access to treatment. With the recruitment of these experienced employees, we have a good basis to start this work”, says Anna-Kaija Grönblad, Commercial Director of BioArctic.

“BioArctic is now taking the first step to establish itself as an integrated biopharmaceutical company with a strong position in the Nordic market. If approved, we see great potential in lecanemab, and in the long term also in our development projects. These advances mean that now is the time to move from being a pure research and development company to also having structures to support the ability of healthcare providers to best integrate innovative and effective treatments. for patients with Alzheimer’s disease,” says Gunilla OsswaldCEO, BioArctic.

This release discusses experimental uses of an agent under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any experimental use of such a product will successfully complete clinical development or obtain approval from health authorities.

For more information, please contact:

Gunilla OsswaldCEO

Email: [email protected]

Telephone: +46 8 695 69 30

Oskar BossonVP Communications and IR

Email: [email protected]

Telephone: +46 70 410 71 80

The information has been released for public disclosure, through the above contact persons, the February 18, 2022at 08:00 CET.

Note to Editors

About Lecanemab (BAN2401)

Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds, neutralizes and eliminates soluble toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may affect disease pathology and slow disease progression. Eisai has been granted worldwide rights to study, develop, manufacture and commercialize lecanemab for the treatment of AD pursuant to an agreement entered into with BioArctic in December 2007. In March 2014, Eisai and Biogen have entered into a joint development and commercialization agreement for lecanemab. Currently, lecanemab is undergoing a pivotal phase 3 clinical study in symptomatic early AD (Clarity AD), following the results of the phase study 2b clinical study (Study 201). The results are expected in September 2022. Another Phase 3 clinical study, AHEAD 3-45, is currently underway for people with preclinical (asymptomatic) AD, meaning they are clinically normal and have intermediate or high levels of brain amyloid. AHEAD 3-45 is being conducted through a public-private partnership between the Alzheimer’s Clinical Trial Consortium, funded by the National Institute on Aging, part of the National Institutes of Health, and Eisai. In June 2021the FDA granted Breakthrough Therapy Designation to lecanemab and in September 2021, Eisai has launched a continuing submission for the US FDA Biologics license application of lecanemab for the early treatment of Alzheimer’s disease under the accelerated approval pathway. In December 2021, the FDA has granted fast track designation to lecanemab and the second part of the continuing application has been submitted. Eisai expects the continued submission to be completed in the first half of 2022.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer’s disease. The most significant agreements are the lecanemab antibody development and commercialization agreement, which was signed in December 2007and the development and commercialization agreement for the Alzheimer’s disease rescue antibody BAN2401, which was signed in May 2015. Eisai is responsible for the clinical development, marketing authorization application and commercialization of products for Alzheimer’s disease. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments related to regulatory filings, approvals and sales milestones.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharmaceutical company focused on disease-modifying therapies and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease. 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 as well as its strategically important global partners in the Alzheimer’s (Eisai) and Parkinson’s (AbbVie) projects. The project portfolio is a combination of fully funded projects managed in partnership with global pharmaceutical companies and innovative internal projects with significant market and licensing potential. BioArctic’s class B stock is listed on the Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information on BioArctic, please visit www.bioarctic.com.

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