4523.T

Eisai: Supplementary New Drug Applications for Anti-Epileptic Drug Fycompa as Monotherapy for Partial-Onset Seizures

Friday, October 16, 2020 - 5:44am

Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data.

Key Points: 
  • Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data.
  • The submission covering partial-onset seizures in pediatric patients was based on the results of a Phase III clinical study (Study 311) of Fycompa as adjunctive therapy conducted globally on pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
  • As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs1, this is a disease with significant unmet medical needs.
  • Fycompa has been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

The University of Tokyo and Eisai Announce Research Collaboration for the Development and Drug Discovery of Targeted Protein Degradation Technology

Thursday, October 8, 2020 - 6:18am

TOKYO, Oct 8, 2020 - (JCN Newswire) - The University of Tokyo and Eisai Co., Ltd. announced today a collaboration aiming for the development and drug discovery of targeted protein degradation technology has been created, with the establishment of a social cooperation program, "Protein Degradation Drug Discovery".

Key Points: 
  • TOKYO, Oct 8, 2020 - (JCN Newswire) - The University of Tokyo and Eisai Co., Ltd. announced today a collaboration aiming for the development and drug discovery of targeted protein degradation technology has been created, with the establishment of a social cooperation program, "Protein Degradation Drug Discovery".
  • The "Protein Degradation Drug Discovery" course is to be established within the Graduate School of Pharmaceutical Sciences, the University of Tokyo.
  • This research will combine the world's most advanced ubiquitin-proteasome research as conducted in the graduate school with drug discovery knowledge fostered by Eisai, for the development of new protein degradation technology towards proteins targeted by drugs and the promotion of drug discovery research based on this technology.
  • Through the development of this technology and drug discovery, the University of Tokyo and Eisai aim to provide new treatment options to patients for which treatment options were previously limited.

Eisai: Joint Development Agreement Aiming for Drug Discovery for COVID-19 Utilizing Eritoran and E6011 Concluded

Tuesday, October 6, 2020 - 4:07am

The involvement of the formation and exacerbation of vasculopathy as well as the cytokine storm* in the process of aggravation are assumed.

Key Points: 
  • The involvement of the formation and exacerbation of vasculopathy as well as the cytokine storm* in the process of aggravation are assumed.
  • However, at this time, the mechanism of aggravation based on the SARS-CoV-2 infection is not fully understood.
  • Additionally, TLR (Toll-Like Receptor) 4 antagonist eritoran, discovered by Eisai, and an anti-FKN (fractalkine) antibody E6011, discovered by Eisai's research subsidiary KAN Research Institute, will be evaluated.
  • Eritoran has been selected as the therapeutic drug candidate in the international trial REMAP-COVID for hospitalized patients with moderate COVID-19.

Eisai and Seikagaku Enter into Agreement for the Marketing Alliance of SI-613, a Treatment of Osteoarthritis, in South Korea

Wednesday, September 30, 2020 - 7:06am

Eisai and Seikagaku signed an agreement for the co-development and marketing alliance in China of SI-613 on April 1, 2020.

Key Points: 
  • Eisai and Seikagaku signed an agreement for the co-development and marketing alliance in China of SI-613 on April 1, 2020.
  • On the basis of this agreement, Eisai Korea Inc., Eisai's subsidiary in South Korea, will acquire exclusive marketing rights for SI-613 in South Korea and apply for the manufacturing and marketing approval thereof.
  • Seikagaku will seek to maximize the value of SI-613 in South Korea by leveraging Eisai's business base in South Korea.
  • Eisai and Seikagaku signed an agreement for the co-development and marketing alliance of SI-613 in China on April 1, 2020.

Eisai: Jyseleca (Filgotinib) Approved in Japan for Rheumatoid Arthritis

Monday, September 28, 2020 - 1:04am

(Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.

Key Points: 
  • (Tokyo, Japan) regulatory approval of Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 preferential inhibitor for the treatment of rheumatoid arthritis (RA) in patients who have had an inadequate response to conventional therapies, including the prevention of structural joint damage.
  • Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for the product supply of Jyseleca in Japan, while Eisai will be responsible for product distribution of Jyseleca in Japan in RA.
  • The companies will jointly commercialize the medicine to make it available to physicians and patients across Japan.
  • The approval in Japan is based on robust clinical trial results from the global FINCH Phase 3 and DARWIN Phase 2 programs.