EISAI CO

Biogen reported Q3 revenue and adjusted earnings exceeding expectations, raising full-year profit guidance to $16.10-$16.60 per share. Sales of Alzheimer's drug Leqembi, new rare disease and depression treatments offset declines in MS products, with Leqembi generating $67 million in Q3 sales.

Stanley Druckenmiller's Duquesne Family Office exited Eli Lilly, but the stock's potential remains high due to its Alzheimer's drug, eczema treatment, and AI initiatives.

Leqembi, an Alzheimer’s drug, reduces beta-amyloid plaques but doesn't halt cognitive decline; it may speed dementia by causing brain shrinkage. Eisai, the maker, kept genetic test results secret, violating informed consent. Despite modest trial results, FDA approved Leqembi in 2023; EU and Australia declined approval due to side effects. FDA has a history of bias towards drug approval, criticized for approving Aduhelm in 2021 against advisory committee's advice.

NICE not recommending Eli Lilly’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Kisunla (donanemab) for NHS use despite MHRA approval for mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD). This follows a similar NICE decision on Eisai/Biogen’s Leqembi (lecanemab) in 2024, due to cost-effectiveness and safety concerns. Both drugs, though representing a breakthrough, have modest efficacy and pose risks like amyloid-related imaging abnormalities (ARIAs). NICE decisions are not final, awaiting further evidence on drug effects and costs. GlobalData forecasts $3.5 billion and $2.0 billion sales for Leqembi and Kisunla, respectively, in the 8MM by 2030.

Drug shortages in Q4 2024 dropped to 277 from 323 in 2023, with 60% of reasons unknown. Alzheimer’s drug trial volunteers, identified through genetic tests as high-risk for brain injuries, were not informed of their increased risk by Eisai.

Eisai and Eli Lilly withheld genetic risk info from Alzheimer's drug trial volunteers, leading to brain injuries and deaths. FDA approved Leqembi in 2023 despite risks, raising concerns about patient safety and Alzheimer's research approach.

Eli Lilly’s Kisunla (donanemab) won’t be available to UK Alzheimer’s patients due to NICE’s assessment of poor value for NHS. MHRA approved it for mild cognitive impairment or dementia, but NICE cites uncertainties in benefits and safety concerns like brain swelling or bleeding. Cost-effectiveness estimates are 5-6 times higher than NICE’s acceptable threshold.

Biogen to present new Alzheimer's data at CTAD 2024 in Madrid, including lecanemab treatment, AHEAD 3-45 study, and AI-derived prognostic covariates.

The UK launches the Dementia Trials Accelerator (DTA) with £20 million funding to increase dementia trial participation from 61 to tens of thousands. Led by UK DRI and HDR UK, DTA aims to make the UK the top destination for pharma and industry to run late-phase clinical trials, leveraging world-class science and data infrastructure. The initiative addresses obstacles to commercial trials, including streamlined processes, and aims to offer patients access to potentially life-changing treatments through increased trial opportunities.

Biogen navigates the launch of Alzheimer's drug Leqembi amidst pipeline setbacks, with Leqembi's success crucial for future growth. The company faces competition from Eli Lilly's donanemab and recent pipeline failures, but potential for Leqembi's adoption and pipeline candidates like felzartamab offer growth opportunities.