Eisai

Biogen and Eisai Announce ADUHELM™ (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021

Monday, July 26, 2021 - 9:10pm

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Key Points: 
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.
  • Leveraging the experience gained from the development and marketing of a treatment for Alzheimers disease, Eisai aims to establish the Eisai Dementia Platform.
  • Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Friday, July 23, 2021 - 1:17am

Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.

Key Points: 
  • Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued.
  • Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to a pregnant woman.
  • Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate.
  • "Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of KEYTRUDA plus LENVIMA in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."

Eisai to Present Latest Data on Pipeline Assets in The Area of Alzheimer's Disease and Dementia at AAIC 2021

Wednesday, July 21, 2021 - 2:34am
Key Points: 
  • A poster presentation will also be given on the results of an in vivo study of E2511, Eisai's in-house discovered and developed investigational novel oral synapse regenerant.
  • Additionally, Eisai and Biogen Inc. (Nasdaq: BIIB) will hold a virtual symposium, "Defining the next-generation clinical care pathway for Alzheimer's disease: biological, technological, and healthcare perspectives," focusing on the AD treatment landscape.
  • Eisai serves as the lead in the co-development of lecanemab, an anti-Aβ protofibril antibody, which is being jointly developed by Eisai and Biogen.
  • Eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of AD and dementia.

Eisai Launchs Bile Acid Transporter Inhibitor Goofice in Thailand

Monday, July 19, 2021 - 1:03am

TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.

Key Points: 
  • TOKYO, July 19, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced that its Thailand subsidiary Eisai (Thailand) Marketing Co., Ltd. has launched the bile acid transporter inhibitor Goofice (generic name: elobixibat hydrate) in Thailand.
  • Goofice inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon.
  • In Asia (Thailand, Indonesia, Philippines, Malaysia, and Singapore), Eisai is responsible for the commercialization and marketing of this product under a contract with EA Pharma.
  • Eisai will continue to make a further contribution to improve QOL for patients with chronic constipation in Thailand and other Asian countries, through maximization of the product value of Goofice.

Eisai Launches In-house Developed Anti-insomnia Drug Dayvigo (Lemborexant) In Hong Kong

Thursday, July 1, 2021 - 3:43am

TOKYO, July 1, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has launched the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Key Points: 
  • TOKYO, July 1, 2021 - (JCN Newswire) - Eisai Co., Ltd. announced today that its Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. has launched the in-house-discovered and developed orexin receptor antagonist DAYVIGO (generic name: lemborexant) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  • Eisai received approval for DAYVIGO in Hong Kong on February 28, 2021, and this launch is the first for DAYVIGO in Asia outside of Japan.
  • (10)
    The anti-insomnia drug market in Hong Kong as of 2020 valued at approximately 8.4 million USD, comprising nearly 9% of the insomnia drug market in Asia (Hong Kong, India, Indonesia, Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand).
  • Sleep.

Eisai Inc. Announces the Appointment of Dr. Andree Amelsberg as Vice President, U.S. Medical Affairs, Oncology Business Group

Monday, June 28, 2021 - 12:55pm

WOODCLIFF LAKE, N.J., June 28, 2021 /PRNewswire/ --Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Andree Amelsberg, M.D., MBA, as Vice President, U.S. Medical Affairs, Oncology Business Group.

Key Points: 
  • WOODCLIFF LAKE, N.J., June 28, 2021 /PRNewswire/ --Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced the immediate appointment of Andree Amelsberg, M.D., MBA, as Vice President, U.S. Medical Affairs, Oncology Business Group.
  • He will also oversee Eisai Oncology's Medical Directors, Medical Science Liaisons (MSL) and Medical Information & Education teams in the U.S.
    "We are delighted to welcome Dr. Amelsberg to Eisai, and look forward to collaborating with him as he leads our U.S. Oncology Medical Affairs team," said Dr. Kirk Shepard, Senior Vice President, Chief Medical Officer and Head of Global Medical Affairs for the Oncology Business Group.
  • He joins Eisai from HUTCHMED, where, as the Senior Vice President of Medical Affairs, he led the organizational strategy on near-term launches and pipeline products.
  • Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases).

Eisai and Biogen Inc. Announce U.S. FDA Grants Breakthough Therapy Designation for Lecanemab (BAN2401)

Thursday, June 24, 2021 - 4:00am

TOKYO, June 24, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer's disease (AD).

Key Points: 
  • TOKYO, June 24, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of Alzheimer's disease (AD).
  • Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.
  • The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
  • In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the the Phase 3 Clarity AD study.

FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer's disease

Thursday, June 24, 2021 - 12:41am

STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.

Key Points: 
  • STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.
  • Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.
  • The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
  • In March 2021, the enrollment of 1,795 patients with early Alzheimer's disease in the Phase 3 study of lecanemab, Clarity AD, was completed.

FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer's disease

Thursday, June 24, 2021 - 12:38am

STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.

Key Points: 
  • STOCKHOLM, June 23, 2021 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A) protofibril antibody for the treatment of Alzheimer's disease.
  • Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions.
  • The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.
  • In March 2021, the enrollment of 1,795 patients with early Alzheimer's disease in the Phase 3 study of lecanemab, Clarity AD, was completed.

Eisai and Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate

Thursday, June 17, 2021 - 11:30pm

Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).

Key Points: 
  • Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).
  • MORAb-202 is Eisais first ADC and combines Eisais in house developed anti-folate receptor alpha (FR) antibody, and Eisais anticancer agent eribulin, using an enzyme cleavable linker.
  • Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.
  • The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories.