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INTRODUCTION OF FIRST-OF-A-KIND PLASMA-BASED BIOMARKER SCREENING TO FACILITATE IDENTIFICATION OF SUBJECTS FOR PHASE 3 AHEAD 3-45 TRIAL PRESENTED AT CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE

TOKYO and CAMBRIDGE, Mass., Nov.12, 2021 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) announced a presentation about exploring the use of plasma-based biomarkers in the Phase 3 AHEAD 3-45 study of lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody. AHEAD 3-45 is the first preclinical Alzheimer’s disease (AD) trial to use these biomarkers to detect AD pathology and potentially accelerate the screening process. This presentation was made by The Alzheimer’s Clinical Trial Consortium (ACTC) at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually.

EISAI PRESENTS LATE-BREAKER UPDATES ON LECANEMAB CLINICAL, BIOMARKER AND SAFETY DATA FROM PHASE 2B STUDY CORE AND OPEN-LABEL EXTENSION ACROSS FIVE YEARS AT CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE

TOKYO and CAMBRIDGE, Mass, Nov. 11, 2021 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) announced today results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer’s disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies. The findings were presented and discussed in a late-breaking roundtable session with esteemed clinical researchers at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually. Eisai recently initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway.

EISAI PRESENTS NEW DATA ON THE RELATIONSHIP BETWEEN CLINICAL, BIOMARKER AND SAFETY OUTCOMES FROM THE LECANEMAB PHASE 2B STUDY FOR EARLY ALZHEIMER’S DISEASE IN LATE-BREAKERS AND PIPELINE UPDATES AT THE 14TH CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the presentation of data from the company’s extensive Alzheimer’s disease (AD) pipeline, including six oral presentations that will provide deeper insights into lecanemab’s potential as a treatment for early AD. Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway in September 2021. The lecanemab data and additional research findings from Eisai’s robust AD pipeline will be featured in 10 presentations, including five late breaker oral presentations, at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference, November 9-12, 2021, in Boston, Massachusetts and virtually.

The CREB-binding protein (CBP)/β-catenin inhibitor E7386, co-created by Eisai and PRISM BioLab, achieved the clinical POC (Proof of Concept)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa, President and CEO: Dai Takehara, “PRISM”) announced today that the  CREB-binding protein (CBP) / β-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept).

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Positive EU CHMP Opinions for LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Two Different Types of Cancer

Positive Opinion Granted for Advanced Renal Cell Carcinoma Based on Significant Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Benefit Compared to Sunitinib in CLEAR/KEYNOTE-581 Trial
Positive Opinion Granted for Advanced Endometrial Carcinoma Based on Significant OS and PFS Benefit Compared to Chemotherapy in Study 309/KEYNOTE-775 Trial

EISAI TO PRESENT ABSTRACTS ON ONCOLOGY PRODUCTS AND PIPELINE AT ESMO VIRTUAL CONGRESS 2021

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that presentations on a series of abstracts highlighting updates on its oncology products and pipeline will be given at the European Society for Medical Oncology (ESMO) Virtual Congress 2021, from September 16 to 21, 2021, including its in-house discovered lenvatinib mesylate (product name: LENVIMA®, an orally available multi-kinase inhibitor, “lenvatinib”) and eribulin mesylate (product name: HALAVEN®, a halichondrin class microtubule dynamics inhibitor, “eribulin”).

EISAI RECEIVES AWARD FOR EXCELLENCE IN CORPORATE COMMUNICATIONS AT THE 37TH CORPORATE COMMUNICATIONS AWARDS

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received the Award for Excellence in Corporate Communications at the 37th annual Corporate Communications Awards, hosted by the Japan Institute for Social and Economic Affairs (Tokyo, Chairman: Masakazu Tokura), an affiliate of the Japanese Business Federation (Tokyo).

EISAI TO PRESENT LATEST DATA ON PIPELINE ASSETS IN THE AREA OF ALZHEIMER’S DISEASE AND DEMENTIA AT THE ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2021

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will conduct a total of 11 presentations, including the latest data of the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (development code: BAN2401) for which the U.S. Food and Drug Administration has granted Breakthrough Therapy designation, at the Alzheimer’s Association International Conference (AAIC) to be held in Denver, Colorado and virtually from July 26 to 30, 2021.

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

CAMBRIDGE, Mass. and TOKYO, JULY 8,2021(GLOBE NEWSWIRE) – Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution.