CEO comments on April 28, 2022 (Interim Report for the period January – March 2022):
“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