FDA grants priority review for lecanemab marketing application
Events during the second quarter 2022
Eisai completed the rolling submission of lecanemab for treatment of early Alzheimer's disease to theUS Food and Drug Administration (FDA) under the accelerated approval pathway-
AbbVie took a strategic business decision to terminate its collaboration with
BioArctic regarding its alpha-synuclein projects in Parkinson's disease.BioArctic is now working with AbbVie to bring back the projects with the intention of finding a new partner
Events after the second quarter
- The FDA accepted the Biologics License Application (BLA) and granted priority review of lecanemab for treatment of early Alzheimer's disease under the accelerated approval pathway, which entitles
BioArctic to a milestone of MEUR 15 fromEisai
Financial summary April -
- Net revenues for the period amounted to MSEK 4.2 (7.3)
- Operating profit amounted to MSEK -45.7 (-33.8)
-
Profit for the period amounted to MSEK -45.8 (-34.2) and earnings per share before and after dilution were
SEK -0.52 (-0.39) - Cash flow from operating activities amounted to MSEK -45.6 (-28.9)
- Cash and cash equivalents at the end of the period amounted to MSEK 752 (930)
Financial summary January -
- Net revenues for the period amounted to MSEK 8.0 (14.5)
- Operating profit amounted to MSEK -89.8 (-63.0)
-
Profit for the period amounted to MSEK -90.1 (-63.3) and earnings per share before and after dilution were
SEK -1.02 (-0.72) - Cash flow from operating activities amounted to MSEK -85.4 (-66.4)
- Cash and cash equivalents at the end of the period amounted to MSEK 752 (930)
Comments from the CEO
"Every day the patients can remain in the early stages of Alzheimer's disease is highly valuable. "
In early May, our partner
In parallel with the ongoing regulatory processes for lecanemab, the major confirmatory Phase 3 study Clarity AD is under way with 1,795 patients with early Alzheimer's disease. The study is making good progress, with a low share of patients discontinuing the study and with most patients continuing into the open-label extension study, which will also evaluate the subcutaneous formulation of lecanemab. Results from Clarity AD are expected this autumn and if these are positive,
The potential benefits for patients, their families and society when treated with lecanemab are significant. If patients reach the severe stages of the disease much later, fewer people will require resource-intensive elderly care. A recent published article in the scientific journal Neurology and Therapy presents the results of modeling based on clinical data generated thus far for lecanemab. The modeling showed that lecanemab could prolong the time patients remain in the early stages of the disease by at least 2.5 years. In the early stages of Alzheimer's disease, individuals often function well and can continue to live an active life together with friends and family. Every day, week and month the patients can remain in the early stages is therefore highly valuable. The modeling also indicates that treatment with lecanemab reduces the likelihood of patients needing institutional care in the later phases of the disease.
In Parkinson's disease, we are working actively with AbbVie to bring back BAN0805 and our other antibodies against alpha-synuclein from AbbVie, which during the quarter, for strategic reasons, chose to terminate our collaboration. We look forward to intensifying the discussions with new potential partners as soon as the projects have been transferred from AbbVie. During the quarter, a new drug substance patent for BAN0805 was granted in the US, which is valid until 2041, with a possible extension until 2046. Our preclinical data and results from the Phase 1 study are promising and we can already see interest in the project.
Our expanded in-house project portfolio is performing well and we are continuing to pursue these projects with full force. Our ALS project is progressing rapidly through the use of our unique technology platform and vast experience in developing antibodies and we have already begun humanization of some of our antibodies.
We are now looking forward to a number of exciting events during the remainder of the year, both for
I would like to end by wishing you all a great summer and I look forward to an exciting autumn together with you all!
CEO,
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