OTC:ESALY

Eisai's Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria and Commitment for Funding to the 3rd Phase of Global Health Innovative Technology Fund Activities

Retrieved on: 
Thursday, May 25, 2023
Vaccine, Infection, Partnership, Neglected tropical diseases, University, Anxiety, Research, Global Health Innovative Technology Fund, Drugs for Neglected Diseases Initiative, Filariasis, Organization, Mycetoma, Patient, Risk, Bill, Diagnosis, Health, Malaria, Pharmaceutical industry, Eisai

Eisai has provided a total of 1 billion yen to the first phase (FY2013 - FY2017) and the second phase (FY2018 - FY2022) of the GHIT Fund.

Key Points: 
  • Eisai has provided a total of 1 billion yen to the first phase (FY2013 - FY2017) and the second phase (FY2018 - FY2022) of the GHIT Fund.
  • In order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (NTDs) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome.
  • Eisai considers making efforts to resolve the global issue of access to medicines to be its duty.
  • Eisai is also conducting a Phase II clinical trial of antimalarial agent SJ733 in collaboration with the University of Kentucky.

Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023

Retrieved on: 
Wednesday, May 24, 2023
MSD, CREB-binding protein, Apoptosis, Carcinoma, Abstract, Senior, CBP, FR, Pembrolizumab, Cancer, Fallopian tube cancer, Bristol Myers Squibb, Research, Lung cancer, Trial of the century, ASCO, LEAP, Endometrial cancer, American Society of Clinical Oncology, Patient, Physician, Sorafenib, Oncology nursing, Annual general meeting, ADC, Merck, Poster, Merck & Co., FDA, Survival analysis, Ovarian cancer, Society, HCC, Safety, Nivolumab, Pharmaceutical industry, Eisai

Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.

Key Points: 
  • Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.
  • A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • Eisai and Merck are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types across more than multiple clinical trials.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain

Retrieved on: 
Saturday, May 20, 2023
Health care, Lecanemab, Brain, Marketing, Clarity, Eisai, Co-promotion, MAA, Innovation, AD, Neurotoxicity, Alzheimer's disease, Disease, MHRA, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • As such, lecanemab may have the potential to have an effect on disease pathology and the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Eisai Enters Into Joint Development Agreement with Blissbio for Antibody Drug Conjugate BB-1701 with Option Rights for Strategic Collaboration

Retrieved on: 
Monday, May 8, 2023
Eribulin, Senior, Hangzhou, HER2, Breast, Antibody, USD, Lung, Patient, ADC, Spacecraft, Phase, Breast cancer, Pharmaceutical industry, Eisai

TOKYO, May 8, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.

Key Points: 
  • TOKYO, May 8, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into a joint development agreement with Bliss Biopharmaceutical (Hangzhou) Co., Ltd., for BB-1701, an antibody-drug conjugate (ADC) with option rights for a strategic collaboration.
  • Under a license agreement signed by the two companies in 2018, Eisai has granted BlissBio global exclusive development rights for several ADCs to use eribulin as the payload.
  • Under the terms of the joint development agreement, Eisai will make upfront and development milestone payments to BlissBio, conduct a Phase II clinical trial in breast cancer, and obtain option rights to develop and commercialize BB-1701 globally, excluding Greater China (China, Hong Kong, Macau, Taiwan).
  • If all development, regulatory and sales milestones are achieved, up to a total of $2 billion USD will be paid.