EISAI CO

ADDF leads roundtable on combination therapy at 2024 CTAD conference, highlighting the evolution of Alzheimer's treatments towards precision medicine. The panel, moderated by Jeffrey Cummings, features Howard Fillit and other experts discussing the future of Alzheimer's treatments, including novel approaches beyond amyloid and tau targets.

The immunoglobulin market, valued at US$ 13.36 billion in 2023, is projected to reach US$ 28.70 billion by 2034, driven by its use in treating immunodeficiency and other applications. Key growth factors include immunodeficiency disorders, infections, and thrombocytopenia. North America leads with a 46% share, while Asia-Pacific is expected to grow fastest due to increased health spending and prevalence of autoimmune diseases. Recent advancements include subcutaneous injection therapies and acquisitions by major pharmaceutical companies.

E. Heath reports advisory/consulting, steering committee, honoraria/paid travel, speaker’s bureau, and research support from various companies. J.R. Ribeiro, K. Poorman, and J. Xiu report personal fees and other support from Caris Life Sciences. H. Mamdani reports other support and grants from Daiichi Sankyo, AstraZeneca, and Genentech. A.F. Shields reports personal fees from Caris Life Sciences. G.L. Lopes reports stock ownership, honoraria, consulting, research funding, travel, and other relationships with multiple companies. S.A. Kareff reports personal fees and travel grants from various organizations. M. Radovich and G.W. Sledge report other support from Caris Life Sciences. G.A. Vidal reports relationships with Guardant360, Gilead, BillionToOne, Genentech/Roche, GSK, and AstraZeneca. J.L. Marshall reports personal fees from Caris. No other disclosures were reported by the other authors.

The FDA's approval of Cobenfy (KarXT) marks a significant milestone in psychopharmacology as the first antipsychotic not targeting dopamine 2 receptors. The drug's journey began with xanomeline, synthesized by Novo Nordisk in the 1980s, showing promise in Alzheimer's and schizophrenia studies but shelved by Eli Lilly. Resurrected by Steven M. Paul, MD, who combined it with trospium at Karuna, the drug's approval highlights the industry's potential lapses in foresight and unnecessary delays in bringing effective treatments to market.

Eisai Co., Ltd. announces the start of operations at Eisai Saudi Arabia, a wholly-owned subsidiary in Riyadh, focusing on pharmaceutical sales. Established in April 2024, it aims to build an in-house sales system, taking over commercial rights from local partners. The company plans to expand its product portfolio, including Methycobal, Fycompa, Lenvima, and Halaven, and has submitted an application for Alzheimer’s treatment lecanemab. Saudi Arabia’s pharmaceutical market, the largest in the Middle East, grew at an average rate of 7% from 2019 to 2023.

The European Medicines Agency's human medicines committee is re-examining the marketing authorisation application for Alzheimer's drug lecanemab, which has shown to slow cognitive decline. Lecanemab was approved in the US and UK but was rejected by the EMA's Committee for Medicinal Products for Human Use (CHMP) in July. Eisai, the drug's developer, requested a re-examination to make lecanemab available in the EU. The EMA cited risks of serious adverse events as a concern, but proponents argue for patient autonomy in treatment choices.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

August 2024 biopharma deals highlight trends in bispecific T-cell engagers, CD-19 targeting in autoimmune diseases, and Chinese biopharma innovation. Merck's $1.3B acquisition of Curon's CD3xCD19 BiTE CN201 reflects confidence in early trial outcomes and market enthusiasm for BiTEs. JPMorgan reports a 50% reduction in upfront payments since 2020, indicating a more back-loaded deal structure.

MP Nigdelis received honoraria from RG Ärztefortbildung GmbH and travel grants from Organon and Gedeon Richter. M Doerk received travel grants from Gedeon Richter, Organon, and Eisai, and is a member of DGGG, AGE, and Deutsche Gesellschaft für Senologie. S Burghaus received honoraria from FOMF and is a member of DGGG, AGEM, AGE, Stiftung Endometriose Forschung, AGUB, AGO, and DKK. M Sillem, CEO of EuroEndoCert Gmbh, received payments from Bayer, Gedeon Richter, Hologic, and EndoHealth. B Haj Hamoud received travel grants from Gedeon Richter, Astrazeneca, Johnson & Johnson, and Storz, and is a member of DGGG, AGE, and Stiftung Endometriose Forschung. EF Solomayer receives grants from the University of Saarland, Storz, and Erbe, and fees from Roche, Pfizer, Celgene, Amgen, Astra Zeneca, Esai, Johnson & Johnson, Novartis, Tesaro, Teva, Medac GmbH, MSD, Vifor, Gedeon Richter, Takeda, and AGE, among others. GL Olmes received grants from AstraZeneca, Universitätsklinikum Freiburg, and RG Ärztefortbildung GmbH, and is a member of DGGG, AGE, and AGEM, with scientific collaboration with Karl Stotz.