Oskar Bosson, Investor Relations & Communications at BioArctic, talks about BioArctic's impressive progress, the partnership with Eisai and the great interest in the drug candidate Lecanemab.
Who is BioArctic and can you briefly tell us about your business?
BioArctic is a Swedish biopharmaceutical company that focuses on developing new medicines for patients with diseases of the central nervous system through groundbreaking research. The goal is to create future treatments on a global market that can stop or delay the progression of Alzheimer's disease, Parkinson's disease and other neurological diseases. The company was founded in 2003 based on innovative research at Uppsala University.
Can you tell us what BioArctic's collaboration with the Japanese player Eisai looks like?
BioArctic has had a long-term collaboration with Eisai since 2005 on the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the development and commercialization agreement for the antibody Lecanemab, which was entered into in December 2007, and the development and commercialization agreement for the antibody BAN2401 back-up for Alzheimer's disease, which was entered into in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize Lecanemab in the Nordic countries under certain conditions and is currently preparing commercialization in the Nordic countries together with Eisai. BioArctic has no development costs for Lecanemab in Alzheimer's disease and is entitled to compensation in connection with submission of applications to regulatory authorities, approvals and sales milestones, as well as on global sales.
How does your drug candidate Lecanemab affect Alzheimer's disease?
Lecanemab selectively binds to, neutralizes and eliminates the soluble toxic aggregates of Aβ (protofibrils) that are thought to be involved in the neurodegenerative process of Alzheimer's disease. Lecanemab therefore has the potential to have an effect on the pathology of the disease and slow the progression of the disease.
After this positive study result - what is the next step towards market approval?
Lecanemab is currently under FDA review under an accelerated procedure. Notification of such approval from the FDA will be made no later than January 6, 2023. If approved, Lecanemab would become available on the US market, but without a drug subsidy. This is a first step in the US and will be followed by Eisai applying for full approval in the US. Such an application is expected to be submitted no later than the first quarter of 2023.
Eisai initiated a submission of application data for Lecanemab to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in March 2022 under the “prior assessment consultation” process. The goal is to accelerate the approval process so that people with early Alzheimer’s disease can access the treatment as soon as possible. Eisai aims to submit marketing authorization applications in Japan and the EU by the first quarter of 2023.
In what ways have you primarily noticed the great interest in Lecanemab after the latest study results?
There has been an incredible amount of pressure from investors, media and other pharmaceutical companies who have all shown interest in us as a company, in our project portfolio and of course in Lecanemab. In recent weeks we have met with more than 100 investors and had countless interviews. Incredibly happy that our research and the work our partner Eisai has done.
What effect does the medication have on Alzheimer's patients?
In patients treated with Lecanemab, clinical deterioration was slowed by 27 percent compared to placebo after 18 months of treatment, and this effect increased over time. According to modeling published by Eisai earlier this year based on the Phase 2b results, such a change could mean that the progression of the disease can be delayed by several years, which is of course enormously valuable, not only for patients but also for relatives and society. The results of the Phase 3 study met all our expectations, and more. The solid and consistent results represent a major step towards fundamentally improving the treatment of this severely vulnerable patient group.
What are your expectations for the additional data that Eisai will present at the Alzheimer's Conference in San Francisco on November 29?
We are very much looking forward to seeing more data on November 29th at the CTAD international congress, but we have no specific expectations. It is a large amount of material that Eisai has collected during the course of the study and there will be material to present at many congresses in the future. Regardless of what happens this time, it will be interesting data to see.
We thank BioArctic and Oskar Bosson for the interview and wish the company great success in the future!
Disclaimer: Impala Nordic, or the people behind Impala Nordic, do not own any shares in the company.
