EISAI CO

BioArctic announces EMA's CHMP positive recommendation for Eisai's MAA for lecanemab, a treatment for early Alzheimer's disease in ApoE ε4 heterozygotes or non-carriers. The recommendation follows Eisai's re-examination request after an initial negative recommendation. A European Commission decision is expected within 67 days.

Unusual activity detected; click box to confirm not a robot.

BioArctic's Q3 2024 report highlights Leqembi's launch in Hong Kong, Israel, UAE, and Great Britain, EMA's negative opinion on lecanemab, and positive lecanemab OLE data. Post-period events include TGA's initial lecanemab rejection, AHEAD 3-45 full recruitment, and Eisai's subcutaneous Leqembi application in the US. Financials show higher royalties, with CEO Gunilla Osswald emphasizing BrainTransporter technology's potential.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Liposarcoma, a common subtype of soft tissue sarcoma, includes dedifferentiated liposarcoma (DDLPS) with high MDM2 amplification. Brigimadlin, an MDM2-p53 antagonist, showed stable disease in 75% of patients in a phase 1a/1b study. A phase 2/3 Brightline-1 trial compares brigimadlin to doxorubicin in advanced DDLPS, aiming to identify optimal dosing and assess progression-free survival.

J.P.-G. consults for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead, MSD; receives travel compensation from Roche; employed by MEDSIR. G.A. receives honoraria from MEDSIR. M.G. receives travel support and honoraria from AstraZeneca, Gilead Sciences, Roche, Pfizer. A.L.-C. receives research support, consults, speaks, and travels for Roche, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, Daiichi Sankyo; owns MEDSIR, Initia-Research. J.C. consults, receives honoraria, research funding, stock, travel expenses, and patents for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies; holds patents for pharmaceutical combinations.

Alzheimer's researchers at the 2024 CTAD conference discussed the future of treatment, focusing on combination therapies, reducing ARIA risk, and novel approaches like gene therapy and stem cell treatment. Key topics included the potential of anti-amyloid antibodies in combination with other therapies, efforts to lower ARIA risk, and the presentation of promising data from gene therapy and stem cell studies.

Eisai Co., Ltd. reported Q2 2024 earnings with revenue up 3% YoY to JPY385 billion, driven by a 5% growth in the pharmaceutical business. Gross profit rose 3% YoY to 67%, with R&D expenses decreasing by 1 percentage point. The company emphasized proactive investment in the LEQEMBI business.

Trontinemab, a transferrin receptor-based antibody, rapidly removes amyloid plaques with few ARIA cases, but a participant's death from a macrohemorrhage prompts exclusion criteria expansion. Despite safety concerns, CTAD attendees remain optimistic about TfR-based therapies for safer brain delivery.