Decision on marketing approval for lecanemab is approaching
Events during the first quarter 2022
- Eisai commenced submission of lecanemab data in Japan for a prior assessment consultation, with the objective of obtaining faster regulatory marketing approval.
Events after the first quarter
- AbbVie took a strategic business decision to end its collaboration with BioArctic regarding its alpha-synuclein portfolio, including ABBV-0805. BioArctic will now, in accordance with the license agreement, take back the project and evaluate the best way forward.
- A recently published article in Neurology and Therapy based on disease modeling suggests that lecanemab could delay the progression to Alzheimer’s dementia by several years.
Financial summary January – March 2022
- Net revenues for the period amounted to MSEK 3.7 (7.2)
- Operating profit amounted to MSEK -44.1 (-29.1)
- Profit for the period amounted to MSEK -44.1 (-29.1) and earnings per share before and after dilution were SEK -0.50 (-0.33)
- Cash flow from operating activities amounted to MSEK -39.7 (-37.5)
- Cash and cash equivalents at the end of the period amounted to MSEK 801 (960)
Comments from the CEO
“Our partner Eisai states that there is potential for full marketing approvals of lecanemab in the US, the EU and Japan as early as 2023. “
A new, disease-modifying treatment for Alzheimer’s disease could give patients and their families better lives. We look forward with excitement to the Clarity AD Phase 3 results expected in September, while we can state that a decision on marketing approval of lecanemab for early Alzheimer’s disease is approaching. Our partner Eisai has already submitted two thirds of its rolling application to the US Food and Drug Administration (FDA) under the Accelerated Approval program. Submission of the final part is expected during the second quarter of the year, and a decision on accelerated approval in the US could thus come as early as this year. Both a completed application and potential approval would mean that BioArctic is entitled to milestone payments from Eisai.
At the same time, the regulatory processes in the rest of the world are progressing at a rapid pace. In early March, Eisai announced that, with the help of BioArctic’s employees, it had commenced submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) under a process called prior assessment consultation. This allows the agency to preview available data before the application for marketing approval is submitted with the aim to shorten application review time.
Our partner Eisai plans to submit applications for full marketing approval to relevant authorities in the US, the EU and Japan at the latest in the first quarter of 2023, pending Phase 3 topline data. There is thus potential that lecanemab will be first to receive full marketing approvals in all these markets already next year. Full marketing approval is important for broader patient access and reimbursement in the US. In China as well, the developments are positive, with more than 100 patients included in the Clarity AD Phase 3 study, which will meet the requirements for a future application for marketing approval.
If lecanemab is approved in Europe, BioArctic will have the right to market and sell the product in the Nordic region. In preparation for potential marketing approval, we are building our commercial organization, and it is gratifying to see the broad experience represented in this new organization.
At this year’s AD/PDTM congress several presentations about lecanemab generated significant interest among participants and our co-founder, Professor Lars Lannfelt, held a highly appreciated presentation on lecanemab’s unique binding profile that also promoted greater understanding of the drug candidate’s mechanism of action. Eisai gave an update on the development of lecanemab including a new dosage form. The goal is to be able to offer patients a weekly subcutaneous treatment instead of a biweekly infusion. The new possibility for administering the treatment will be evaluated in the open-label extension study that follows the large Phase 3 study, Clarity AD. Eisai also plans to evaluate longer time intervals, up to three months, between maintenance doses of lecanemab.
Moreover, a recently published article in Neurology and Therapy based on disease modeling suggests that lecanemab could delay the progression to Alzheimer’s dementia by several years. Analyses such as these are important to understand the potential and long-term effects for patients, families and society offered by lecanemab treatment.
It is also gratifying to see that both our blood-brain barrier technology and our drug candidate TDP-43 against amyotrophic lateral sclerosis (ALS) have developed so well that they can now be combined and together become a new project in our project portfolio.
We are disappointed about AbbVie’s strategic decision to terminate its collaboration with BioArctic regarding our alpha-synuclein portfolio. Our preclinical data and the Phase 1 study supports progression to Phase 2. We are convinced that ABBV-0805 has the potential to become a disease-modifying treatment for patients with Parkinson’s disease. We will now, in accordance with the license agreement, take back the project and evaluate the best way forward.
In conclusion, I look with great confidence forward to the results from the Clarity AD study in the autumn, which will be of great significance for BioArctic and patients with Alzheimer’s disease. Furthermore, I am pleased with the positive developments in several of our projects, and I see how our advances can be combined to strengthen our projects. I am proud to lead a strong organization that can keep focus both on what is happening here and now and on the breakthroughs in disorders of the central nervous system that are just around the corner.
CEO, BioArctic AB
Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, April 28, at 9:30–10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson will present BioArctic, comment on the interim report and answer questions.
To participate in the conference, please call:
Sweden: +46 8 505 583 56
Denmark: +45 823 331 94
Netherlands: +31 107 129 162
Norway: +47 235 002 36
Switzerland: +41 225 805 976
UK: +44 333 300 08 04
Germany: +49 692 222 391 66
USA: +1 631 913 1422
The webcast will afterwards also be available on demand at BioArctic’s corporate website https://www.bioarctic.se/en/section/investors/presentations/
For more information, please contact
Gunilla Osswald, CEO, firstname.lastname@example.org, phone +46 8 695 69 30
Jan Mattsson, CFO, email@example.com, phone + 46 70 352 27 72
Oskar Bosson, VP Communications & Investor Relations, firstname.lastname@example.org, phone +46 70 410 71 80
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the Swedish Securities Market Act. The information was submitted for publication, though the agency of the named contact persons, at 08:00 a.m. CET on April 28, 2022.
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. 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 its 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 Class B share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.