30 1 月, 2023

Lecanemab Receives Priority Review Status in Japan

TOKYO and CAMBRIDGE, Mass., Jan 30, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Abeta 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. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal. In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023 and accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) in December 2022. 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. *Protofibrils are large Abeta aggregated soluble species of 75-500 Kd. (1),(2)For more information, visit www.eisai.com/news/2023/news202312.html. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

16 1 月, 2023

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer’s Disease in Japan

TOKYO and CAMBRIDGE, Mass., Jan 16, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA).This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab. In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB(2): Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at 3 months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL(3). The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of Clarity AD study were presented at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal the New England Journal of Medicine(New Window).In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022.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.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2023/news202307.html.MEDIA CONTACT:Eisai Co., Ltd.Public Relations DepartmentTEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman+ 1-201-753-1945Libby_Holman@eisai.com INVESTOR CONTACT:Eisai Co., Ltd.Investor Relations DepartmentTEL: +81-(0)03-3817-5122 Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

11 1 月, 2023

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease in Europe

TOKYO, Jan 11, 2023 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) to the European Medicines Agency (EMA). This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD, and is subject to a validation to determine whether the EMA accepts the application for review.The Clarity AD study met its primary endpoint (CDR-SB(1): Clinical Dementia Rating-Sum of Boxes) and all key secondary endpoints with highly statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine, peer-reviewed medical journals.In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day. In China, Eisai has initiated submission of data for BLA to the National Medical Products Administration (NMPA) of China in December 2022. In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.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.(1) CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD.Media Contacts:Eisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)EMEA Communications Department+44 (0) 786 601 1272EMEA-comms@eisai.netBiogen Inc.Natacha Gassenbach+ 1-857-777-6573public.affairs@biogen.comInvestor Contacts: Eisai Co., Ltd. Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Biogen Inc.Mike Hencke+ 1-781-464-2442IR@biogen.com Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)

30 11 月, 2022

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, in San Francisco, California and virtually.Figure 1: CDR-SB as Primary endpoint change (18 months)Summary of Presentations in the Scientific Session featuring Lecanemab at CTADDesign of Clarity AD StudyEisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia. The participants were randomized 1:1 to receive either placebo or lecanemab 10-mg/kg IV biweekly, and the randomization was stratified according to clinical subgroup (MCI due to AD or mild AD), presence or absence of concomitant approved AD symptomatic medication at baseline (e.g., acetylcholinesterase inhibitors, memantine, or both), ApoE4 status and geographical region. Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants. As a result of Eisai's recruitment strategy of diversity in the Clarity AD study, 4.5% and 22.5% of the randomized participants in the U.S. were Black and Hispanic, respectively.The primary endpoint was change from baseline at 18 months in the CDR-SB1 (Clinical Dementia Rating Sum of Boxes), the global cognitive and functional scale, and key secondary endpoints were the change from baseline at 18 months in amyloid Positron Emission Tomography (PET) using Centiloids, AD Assessment Scale - Cognitive Subscale 14 (ADAS-Cog142), AD Composite Score (ADCOMS3) and AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL4). In addition, longitudinal changes in brain tau pathology as measured by tau PET (n=257) and cerebrospinal fluid (CSF) biomarkers of AD pathology (n=281) were evaluated in optional sub-studies.Efficacy Results of Clarity ADMean change of CDR-SB from baseline at 18 months as the primary endpoint was 1.21 and 1.66 for lecanemab and placebo groups, respectively. Lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale, compared with placebo at 18 months by -0.45 (95% Confidence Interval (CI): -0.67, -0.23; P=0.00005), representing a 27% slowing of decline. Starting as early as six months (difference: -0.17 [95% CI: -0.29, -0.05]; PAll key secondary endpoints also showed highly statistically significant results compared with placebo (PFor more information, visit www.eisai.com/news/2022/pdf/enews202285pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

30 11 月, 2022

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

21 11 月, 2022

Eisai to Present Full Findings from Lecanemab Confirmatory Phase 3 Clinical Trial (Clarity AD) and Other Alzheimer’s Disease Research at The 15th Clinical Trials on Alzheimer’s Disease (CTAD) Conference

TOKYO, Nov 21, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. will present the efficacy, safety and biomarker findings from the company's Phase 3 confirmatory Clarity AD clinical trial for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the potential treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain, at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference. At the meeting, which will be held in San Francisco, CA and virtually from November 29 to December 2, Eisai and esteemed faculty will present the full data in a scientific session on the first day of the meeting (November 29 at 4:50 p.m. PT). Additionally, other important research from the lecanemab clinical development program and Eisai's AD pipeline, including the company's investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations.Topline results from Clarity AD were announced in late September and showed that lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was within expectations.Key Eisai Lecanemab CTAD Presentations- Clarity AD: Full results from the Phase 3 confirmatory Clarity AD clinical trial of lecanemab in patients with early AD will be presented in a scientific session on November 29 at 4:50 p.m. PT. Eisai will host a live webcast of presentations in the session and can be viewed live on the investors section of the Eisai Co., Ltd. website.- Abeta Protofibrils Binding Properties: Research studying the characterization of Aβ protofibrils and theunique binding properties and mechanisms of Aβ clearance of lecanemab (Poster #P029)- AHEAD 3-45 Study:o An evaluation of tau PET screening data from the Phase 3 AHEAD 3-45 study of lecanemab for associations with plasma p-tau217 and cognitive testing (Late Breaker Oral #LB1)o A study exploring increased accuracy of amyloid PET prediction in preclinical AD using plasma levels for Abeta42/40 and p-tau217 ratios from the Phase 3 screening data from the AHEAD 3-45 study (Late Breaker Oral #LB2)"Based on the Clarity AD results, the investigational anti-amyloid beta protofibril antibody lecanemab has the potential to make a clinically meaningful difference for people living with the early stages of Alzheimer's disease and their families by slowing cognitive and functional decline," said Lynn Kramer, M.D., Chief Clinical Officer, Alzheimer's Disease and Brain Health at Eisai Co., Ltd. "Eisai is excited to share the results of the company's confirmatory Phase 3 Clarity AD clinical study at CTAD and present important data exploring lecanemab's potential efficacy, safety and use in a variety of early AD patient sub-populations."Eisai aims to file for traditional approval in the U.S. and for marketing authorization applications in Japan and Europe by the end of Eisai's FY2022, which ends March 31, 2023. In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted it Priority Review. The Prescription Drug User Fee Act (PDUFA) action date is January 6, 2023. The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. In an effort to secure traditional FDA approval for lecanemab as soon as possible, Eisai submitted the BLA through the FDA's Accelerated Approval Pathway so that the agency could complete its review of all lecanemab data with the exception of the data from the confirmatory Clarity AD study. In March 2022, Eisai began submitting application data, with the exception of Clarity AD data, to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system, with the aim of obtaining early approval for lecanemab so that people living with early AD may have access to the therapy as soon as possible.For more information, visit www.eisai.com/news/2022/pdf/enews202279pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

28 9 月, 2022

Eisai’s Lecanemab Confirmatory Phase 3 Clarity AD Study Met Primary Endpoint

TOKYO, Sep 28, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced positive topline results from Eisai's large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai's FY2022, which ends March 31, 2023. Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer's Congress (CTAD), and publish the findings in a peer-reviewed medical journal.Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat (ITT) population. Starting as early as six months, across all time points, the treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo (all p-values are less than 0.01). All key secondary endpoints were also met with highly statistically significant results compared with placebo (pThe incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group and 1.7% in the placebo group. The incidence of symptomatic ARIA-E was 2.8% in the lecanemab group and 0.0% in the placebo group. The ARIA-H (ARIA cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) rate was 17.0% in the lecanemab group and 8.7% in the placebo group. The incidence of symptomatic ARIA-H was 0.7% in the lecanemab group and 0.2% in the placebo group. There was no imbalance in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) between lecanemab (8.8%) and placebo (7.6%). The total incidence of ARIA (ARIA-E and/or ARIA-H) was 21.3% in the lecanemab group and 9.3% in the placebo group. Overall, lecanemab's ARIA incidence profile was within expectations. Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD. The treatment group was administered a dosage of 10 mg/kg bi-weekly of lecanemab, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab. The baseline characteristics of both placebo and lecanemab groups are similar and well balanced. Eligibility criteria allowed patients with a broad range of comorbidities/comedications: hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants, etc. Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic and African American persons living with early AD. Due to the inclusive eligibility criteria and the successful recruitment of diverse ethnic and racial populations in the U.S., Clarity AD's population is generally comparable to the country's Medicare population. "Since Eisai launched Aricept in the U.S. and Japan in the late 1990s and obtained its approval in over 100 countries, Eisai has provided the drug to people living with dementia while building empathy for them and their families through disease education efforts and community involvement. The positive result of the lecanemab, an anti-Abeta protofibril antibody, pivotal study after almost 25 years since Aricept's launch is an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer's disease community. Alzheimer's disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole," said Haruo Naito, Chief Executive Officer at Eisai. "Additionally, the lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of Alzheimer's disease, when targeted with a protofibril-binding therapy. Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer's disease as well as further activate innovation for new treatment options. The successful results of the Clarity AD clinical trial would not be possible without the truly inspiring dedication of the study's participants, their families and caregivers and the clinical investigators around the world. We thank all the people involved in the study for their invaluable contributions.""Today's announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer's disease, and provide a clinically meaningful impact on cognition and function," said Michel Vounatsos, Chief Executive Officer at Biogen. "Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease. We want to thank the many patients who participated in this groundbreaking global study and want to acknowledge the clinical investigators who worked tirelessly to increase the enrollment of traditionally underrepresented populations. As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities."In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and granted Priority Review. The Prescription Drugs User Fee Act action date (PDUFA) is set for January 6, 2023. The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. In an effort to secure traditional FDA approval for lecanemab as soon as possible, Eisai submitted the BLA through the FDA's Accelerated Approval Pathway so that the agency could complete its review of all lecanemab data with the exception of the data from the confirmatory Clarity AD study.In March 2022, Eisai began submitting application data, with the exception of Clarity AD data, to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab so that people living with early AD may have access to the therapy as soon as possible.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.*CDR-SB is a numeric scale used to quantify the various severity of symptoms of dementia. Based on interviews of people living with AD and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The total score of the six areas is the score of CDR-SB, and CDR-SB is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of AD. For more information, visit www.eisai.com/news/2022/news202271.html. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

4 8 月, 2022

Eisai Presents New Findings on Lecanemab’s Investigational Subcutaneous Formulation and Modeling Simulation of ApoE4 Genotype on Aria-E Incidence at AAIC 2022

TOKYO and CAMBRIDGE, Mass., Aug 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced that Eisai presented new findings on a subcutaneous formulation of lecanemab (BAN2401) and the modeling simulation of the impact of ApoE4 genotype on the incidence of amyloid-related imaging abnormalities - edema/effusion (ARIA-E) - in subjects treated with lecanemab, an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. The data were shared at the Alzheimer's Association International Conference (AAIC) in San Diego, CA.Key Eisai presentations include:Eisai Abstract #69438: Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Lecanemab in Healthy SubjectsThis Phase 1 study was an open-label, parallel-group study conducted in healthy subjects: 30 subjects were randomized into a 10 mg/kg intravenous (IV) dose group and 29 subjects (5 of which were Japanese) were randomized into a single fixed 700mg SC dose group. The absolute bioavailability of lecanemab following a single SC injection was 49.7% (90% CI: 43.54 - 56.83). After SC dosing, the Cmax was observed 72 hours post-dose and was 4-fold lower compared to IV infusion, which reflects the relatively long absorption phase following SC dose administration compared with 1-hour IV infusion. Lecanemab's half-life (~7 days) was similar following SC and IV administrations. The incidence of adverse events was similar between SC and IV administrations. No positive results for neutralizing antibodies (NAb) were recorded in this study. Lecanemab PK for the 5 Japanese subjects was similar to that of the non-Japanese subjects following a single subcutaneous dose administration.Eisai Abstract #69429: Subcutaneous Dose Selection of Lecanemab for Treatment of Subjects with Early Alzheimer's DiseaseIn this analysis, modeling and simulation was conducted to evaluate the equivalence of a fixed weekly SC dose to a body weight-based 10 mg/kg IV bi-weekly dose with regard to lecanemab exposure. The analysis showed that a fixed lecanemab SC dose of 720 mg administered weekly may potentially result in comparable exposure (AUC) and efficacy as measured by reduction in amyloid PET SUVr to 10mg/kg IV dose administered bi-weekly. The exposure-response model is based on the established correlation between ARIA-E and Cmax. SC lecanemab dose is predicted to have a lower incidence of ARIA-E compared to IV lecanemab due to lower Cmax following SC administration.Eisai Virtual Developing Topics Presentation Abstract #69402 / Session VDT-4-29: Modeled Impact of ApoE4 Genotype on ARIA-E Incidence in Patients Treated with LecanemabIn this analysis, the results of the Phase 2 (Study 201) core study were used to explore the effect of ApoE4 genotype on ARIA-E incidence by modeling and simulation. The model predictions were compared to the ARIA-E incidence observed in subjects newly initiated on lecanemab 10 mg/kg bi- weekly in the Phase 2 (Study 201) open-label long-term study (OLE study). The effect of the ApoE4 genotype was analyzed in the exposure-ARIA-E model with three categorical covariates (homozygous carriers, heterozygous carriers, and noncarriers) using the results of the Phase 2 (Study 201) core study. ApoE4 genotype (homozygous) was a significant covariate in the exposure-ARIA-E model, and the incidence of ARIA-E correlated best with Cmax at steady state. On the other hand, there was no statistically significant difference in ARIA-E incidence between ApoE4 noncarriers and heterozygous carriers. The predicted incidence of ARIA-E when lecanemab was dosed at 10 mg/kg bi-weekly was 22.5% in ApoE4 homozygous carriers, 6.8% in heterozygous carriers, and 5.4% in ApoE4 noncarriers. In the OLE study, the incidence of ARIA-E observed in ApoE4 homozygotes newly initiated on lecanemab 10 mg/kg bi-weekly treatment was 25% (1 out of 4), comparable to the model prediction of 22.5%. Amyloid-related imaging abnormalities (ARIA) are an adverse event associated with amyloid-lowering therapies, and it is important to monitor for and manage during treatment."In an effort to simplify the patient journey and fulfill our human health care mission, Eisai is developing a subcutaneous formulation of lecanemab that patients may be able to use at home," said Michael Irizarry, M.D., Senior Vice President, Deputy Chief Clinical Officer, Alzheimer's Disease and Brain Health, Eisai Inc. "The new data Eisai presented today about the bioavailability of subcutaneous dosing, and comparability with intravenous dosing, was used by Eisai to define the appropriate subcutaneous dosing that is currently being tested in the Phase 3 Clarity AD open-label extension. In addition, Eisai has expanded on the previous modeling that explored the effect of the ApoE4 genotype on ARIA-E to further our understanding of patient populations who are most impacted by ARIA-E in the lecanemab clinical trials. The modeling will be updated with data from Eisai's Phase 3 Clarity AD confirmatory study reading out in fall 2022.""We will continue to inform the treatment of patients with Alzheimer's disease and further our development of new therapies," said Dominic Walsh, Head of Neurodegenerative Research Unit at Biogen. "Subcutaneous administration may provide a convenient option for patients and their caregivers in the future, and we look forward to a continued co-development with Eisai on this formulation."On July 5, 2022, Eisai announced the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lecanemab under the accelerated approval pathway and was granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023. The readout of the primary endpoint data of Clarity AD will occur in the fall of 2022. The FDA has agreed that the results of Clarity AD when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit www.eisai.com/news/2022/pdf/enews202260pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

22 6 月, 2022

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

TOKYO, Jun 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (Abeta) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using a validated disease simulation model, AD Archimedes Condition Event (AD ACE) model1,2,3 from the healthcare payer and societal perspectives in the United States, in the peer-reviewed journal Neurology and Therapy. This is the second publication of lecanemab's potential value. It follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in Neurology and Therapy in April 2022.4 While the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). As reported in the previous publication, it was suggested that compared to standard of care* (SoC), individuals treated with lecanemab in addition to SoC (lecanemab+SoC) may potentially experience slower disease progression to mild, moderate and severe AD from baseline by 2.51, 3.13 and 2.34 years on average, respectively. The preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (QALY**) and reduction in the formal and informal care costs***. Additionally, the AD ACE model framework used in this study allowed assessment of the potential value of lecanemab in different scenarios and sensitivity analyses, including the impact of patient subsets, alternative treatment stopping rules**** and potential dosing regimens as well as major sources of uncertainty. Eisai is committed to conducting and sharing these types of clinical and socioeconomic analyses to establish trust as we work to potentially bring lecanemab to people living with early AD who have confirmed presence of amyloid pathology in the brain. To that end, Eisai would like to provide a common foundation for stakeholders' discourse regarding the potential clinical and socioeconomic value of lecanemab from the societal perspective, not to assign a price for lecanemab at this time. This model-based simulation was conducted using the results of a Phase 2b clinical trial (Study 201) evaluating the efficacy and safety of lecanemab for early AD with confirmed amyloid pathology as well as published literature. It also estimated the potential economic value of lecanemab+SoC over a broad range of willingness-to-pay thresholds from $50,000 to $200,000 per QALY gained as recommended by the Institute for Clinical and Economic Review (ICER)*****. Lecanemab+SoC was predicted to result in a gain of 0.61 QALYs and a decrease in total non-treatment costs of $8,707 per person from the healthcare payer perspective (Societal perspective: 0.64 QALYs gain and $11,214 decrease) compared to the SoC for patients with early AD who have confirmed presence of amyloid pathology. The potential annual value-based price (VBP) of lecanemab was estimated at $9,249 to $35,605 (Societal perspective: $10,400 to $38,053) based on this early economic assessment. ICER's value framework5 indicates that value cannot be wholly derived from measures of clinical and cost-effectiveness, so contextual considerations and an examination of other benefits and disadvantages are also added into the framework when assessing long-term value. This may lead to using the societal perspective and higher end of the broad range of willingness-to-pay threshold in estimating the justifiable price of lecanemab, given the large societal burden of AD relative to direct healthcare costs. Many people living with AD received informal care from their family and friends totaling more than 16 billion hours of unpaid care valued at $271.6 billion in the U.S. in 2021.6 These predicted and simulated findings suggest that early treatment with lecanemab may reduce these costs and economic burdens, and provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. The Phase 3 lecanemab Clarity AD data will soon be available to inform the model inputs and refine the findings. In the event that lecanemab receives the U.S. Food and Drug Administration's (FDA) approval, Eisai may determine a VBP using this framework along with other considerations, such as affordability, health system sustainability, etc. "Eisai's goal is to create therapies, such as our investigational anti-amyloid beta protofibril antibody lecanemab, that may help impact the anxieties of people living with Alzheimer's disease and their families. For Alzheimer's disease, it is important to evaluate the holistic value of therapies taking into account not only medical costs but also the immense societal costs," said Ivan Cheung, Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd., Chairman and CEO, Eisai Inc. "As part of Eisai's commitment to our human health care mission, trust and transparency, we will continue to publish data and information about lecanemab and look forward to sharing the results of the lecanemab confirmatory Phase 3 Clarity AD clinical trial this fall." Eisai completed lecanemab's rolling submission of a Biologics License Application (BLA) for the treatment of early AD to the FDA under the accelerated approval pathway in May 2022. The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends in March2023. In Japan, in March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the goal of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval. * Standard of Care (SoC) for AD currently consists of lifestyle modifications and pharmacologic treatment of symptoms.** The quality-adjusted life year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life (i.e., quantity) and quality of life (QOL), the QALY was developed as an attempt to combine the value of these attributes into a single index number. One QALY equates to one year in perfect health. QALY scores range from 1 (full health) to 0 (dead). For example, a new intervention may increase length of life by 3 years and improve quality of life by 70% (QALY score of 2.1) compared to an existing intervention that may increase length of life by 3 years and only improve QOL by 50% (QALY score of 1.5), the incremental QALY for this new intervention will be 0.6 QALYs.*** Formal and informal care costs do not include lecanemab drug cost.**** Alternative treatment stopping rules were explored in scenario analyses where treatment with lecanemab was stopped after a fixed duration of 1.5, 3 and 5 years.***** ICER is a non-profit research organization in the U.S. that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations. 1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001.2) Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018. bit.ly/3NgEeDD(3) Tafazzoli A, Weng J, Sutton K, et al. Validating simulated cognition trajectories based on ADNI against 436 trajectories from the National Alzheimer's Coordinating Center (NACC) dataset. 11th edition of Clinical Trials on 437 Alzheimer's Disease (CTAD); Barcelona, Spain: 2018.(4) Tahami Monfared AA, Tafazzoli A, Ye W, Chavan A, Zhang Q. Long-Term Health Outcomes of Lecanemab in Patients with Early Alzheimer's Disease Using Simulation Modeling. Neurol Ther 11, 863-880 (2022). https://link.springer.com/article/10.1007/s40120-022-00350-y.(5) ICER Value Framework 2020-2023. 2022. bit.ly/39HjYO3(6) Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures 2022 Available from: bit.ly/3bkCR9VMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Eisai Inc. USLibby HolmanLibby_Holman@Eisai.com201-753-1945 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

10 5 月, 2022

Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

TOKYO and CAMBRIDGE, Mass., May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during fiscal year 2022.The BLA submission for lecanemab is based on clinical, biomarker and safety data from the proof-of-concept Phase 2b (Study 201 Core) in 856 people with early AD with confirmed presence of amyloid pathology, biomarker and safety data from the Study 201 OLE (open-label extension study, 180 subjects), and blinded safety data from the confirmatory Clarity AD Phase 3 study (1,795 subjects). The large number of participants across these studies provides the FDA with extensive safety data. Study 201 explored the impact of treatment with lecanemab on reducing amyloid plaque and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. In the Core study, the overall rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with anti-amyloid beta antibodies therapies was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients. The results from Study 201 were published in a peer-reviewed journal Alzheimer's Research and Therapy in April 2021."We would like to thank the people living with early AD and the healthcare professionals who participated in the lecanemab 201 study for their cooperation allowing completion of this BLA to the U.S. FDA. Alzheimer's disease is a progressive and devastating disease with few treatment options," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "Eisai employees have spent time with people living with Alzheimer's disease and their families to truly understand their feelings and challenges and have been working to create new treatments for many years. Our comprehensive medicine creation approach along the Alzheimer's disease continuum reflects Eisai's long-term commitment to providing innovative treatments to the people living with AD, their families and healthcare professionals who urgently need new treatment options.""With Alzheimer's disease, patients and their loved ones don't have the luxury of time. There is an enormous unmet need in this space, and we continue to make progress in advancing additional treatment options for people living with this devastating disease," said Michel Vounatsos, Chief Executive Officer at Biogen. "Anti-amyloid antibodies are a new wave of important medicines, which could provide patients and their physicians more options in addressing this complex disease."Lecanemab was granted Breakthrough Therapy and Fast Track designations by the FDA in June and December 2021, respectively. In March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system in Japan with the aim of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022.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.About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Abeta) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process 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. Currently, lecanemab is being developed as the only anti-Abeta antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. * Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD. About Eisai Co., Ltd.Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com. About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities. The company routinely posts information that may be important to investors on our website at www.biogen.com.MEDIA CONTACT: Eisai Co., Ltd.Public Relations Department+81-(0)3-3817-5120Biogen Inc.Ashleigh Koss+ 1-908-205-2572public.affairs@biogen.com Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

22 3 月, 2022

Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting

CAMBRIDGE, Mass., and TOKYO, Mar 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.Four key symposium presentations explored how lecanemab's clinical efficacy data, overall amyloid-related imaging abnormality (ARIA) rates, biomarker relationships to clinical outcomes, potential dosing regimens, and administration have the potential to benefit people living with early AD.1. Science of the Amyloid Cascade and Distinct Mechanism of Action (MoA) of Lecanemab- BioArctic's Professor Lars Lannfelt presented the science of the amyloid cascade and studies evaluating lecanemab's distinct binding profile to antibodies created from patented sequences of two other clinical antibodies, aducanumab and gantenerumab. The three antibodies have different binding profiles to Abeta species. All three antibodies bind to fibrils, but with different selectivity. Lecanemab was the strongest Abeta binder and prefers protofibrils. Lecanemab's binding profile is critical to enriching our understanding of the features in clinical outcomes and safety. BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD.2. Key Trial Design Aspects and Clinical Outcomes of the Lecanemab Phase 2b (Study 201) Trial and Open-Label Extension (OLE) in Early AD- Innovative Bayesian Adaptive Randomization Design and Dose Regimen-Finding Study with OLE - Study 201 (published by Eisai in Alz Res Therapy 13;21) was prospectively designed as a blinded 18-month study. To accelerate the development program, Eisai used a Bayesian adaptive design with a prespecified 12-month Bayesian primary endpoint in addition to the prespecified traditional analysis at the end of the 18-month treatment period. The OLE evaluated the long-term safety and tolerability of lecanemab and the effect of lecanemab on amyloid PET over 12 months of treatment, which looked at treatment naive patients (those on placebo during the core study) and those patients who had previously been treated with lecanemab, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). Eisai's study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.- Rapid and Thorough Amyloid Clearance Correlates with Clinical Benefit - By using the Bayesian study design across a broad range of doses, researchers were able to efficiently and effectively identify the most effective dose, 10 mg/kg biweekly, to produce rapid and thorough amyloid clearance and potential clinical efficacy. Of the approximately 12 treatment-naive patients in the OLE (those who received placebo in the Core study), more than 40 percent were amyloid negative as early as 3 months and more than 80% were amyloid negative by 12 months as measured by PET image (visual read).(1) The OLE results are consistent with core phase results in which 65% were amyloid negative at 12 months(1) and 81% of participants were amyloid negative at 18 months as measured by PET image (visual read) in 161 subjects treated with 10 mg/kg biweekly dose. Robust amyloid reduction in those receiving lecanemab in the Core study was maintained while off-treatment over the Gap period. Despite the small number of participants in the OLE, findings help confirm the results from the Core study: lecanemab rapidly and thoroughly cleared amyloid plaque from the brain. Study 201 established 10 mg/kg biweekly as the most effective dose of lecanemab based on ADCOMS. Lecanemab could potentially be administered at 10mg/kg on the first day of treatment and continue at biweekly intervals without titration.ARIA Incidence, Frequency, Severity and ModelingARIA-E is an important adverse event of amyloid-lowering therapies that is critical to monitor and manage during treatment.Study 201 Core ARIA-E RatesARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: overall ApoE4 carriers 14.3% (7/49), ApoE4 carriers homozygous 50.0% (5/10), ApoE4 carriers heterozygous 5.1% (2/39) and ApoE4 non-carriers 8.0% (9/112). The overall ARIA-E rate in the Core study was 9.9% (16/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 0.8% (2/245) of placebo patients.Study 201 OLE ARIA-E RatesAlthough ApoE carriers were underrepresented in the 10 mg/kg biweekly group in Study 201 Core, all participants entering Study 201 OLE (69.4% of whom were ApoE4 carriers) were treated with 10 mg/kg biweekly, and ARIA rates were consistent with those in the Core study. Forty-five participants who received placebo in the Core study joined the OLE. ARIA-E was observed in allele groups newly treated with 10 mg/kg biweekly in the OLE at the following rates: overall ApoE4 carriers 12.9% (4/31), ApE4 carriers homozygous 25.0% (1/4), ApoE4 carriers heterozygous 11.1% (3/27) and ApoE4 negative 0.0% (0/14). In the OLE study, overall ARIA-E rates were as follows: ApoE4 carriers 10.4% (13/125), ApoE4 carriers homozygous 14.3% (4/28), ApoE4 carriers heterozygous 9.3% (9/97) and ApoE4 non-carriers 1.8% (1/55).Study 201 Core and OLE Pooled ARIA-E RatesIn the Core and the OLE, ARIA-E was observed in allele groups administered 10 mg/kg biweekly at the following rates: ApoE4 carriers 13.8% (11/80), ApoE4 carriers homozygous 42.9% (6/14), ApoE4 carriers heterozygous 7.6% (5/66) and ApoE non-carriers 7.1% (9/126). The overall ARIA- E rate was 9.7% (20/206) of patients treated with lecanemab 10 mg/kg biweekly.ARIA-E Rates Frequency and SeverityIn the Core study and OLE, the majority of ARIA-E events occurred within the first 3 months of treatment (75% [12/16]) and resolved within 4 months of onset. For the majority of patients, the radiographic severity was mild or moderate; severe radiographic severity was reported in 1.2% (2/161) of patients. The majority of ARIA-E was asymptomatic; with symptomatic ARIA-E reported in 1.9% (3/161) of patients. Symptoms reported in association with ARIA-E included headache, visual disturbance, confusion, aphasia. There has been a single case of ARIA-E associated with seizure in the Core study and OLE to date. Exposure-Response Model Predicted and Observed ARIA-E vs. Cmax for APOE 4The PK/PD exposure-ARIA-E model was developed from the Core study utilizing data from all doses and demonstrated that ARIA-E is driven primarily by Cmax. The ApoE4 genotype is a significant covariate in the model. The PK/PD model predicted ARIA-E by Cmax at the 10 mg/kg biweekly dose in the Core study by allele group as follows: ApoE4 carriers homozygous 22.5%, ApoE4 carriers heterozygous 6.8% and ApoE4 non-carriers 5.4%. In addition to the modeling predicting ARIA-E by Cmax in the Core study, it confirmed the observed ARIA-E in the OLE. Given the small data set for ApoE4 homozygous patients, this will be evaluated in Eisai's Phase 3 Clarity AD clinical trial.ARIA-H RatesIn the Core study, the incidence was higher in ApoE4 homozygous carriers than in ApoE4 heterozygous carriers and non-carriers. ARIA-H was observed in 6.2% (10/161) of patients treated with lecanemab 10 mg/kg biweekly compared with 4.9% (12/245) of placebo patients. The rate of ARIA-H was higher in ApoE4 carriers (12.2% [6/49] vs placebo 5.2% [9/174]), than in ApoE 4 non- carriers (3.6% [4/112] vs placebo 4.2% [3/71]). All patients with microhemorrhage or superficial siderosis were asymptomatic. There has been one report of symptomatic cerebral macrohemorrhage. These data are hypothesis-generating and will be further evaluated in Clarity AD.3. Phase 2b (Study 201) Lecanemab Early AD Study Biomarker Results, Correlations with Clinical Outcomes and Potential Less-Frequent Maintenance Dosing- Abeta42/40 and P-Tau181 are plasma biomarkers that signal sequential changes in AD progression. Lecanemab has an effect on these plasma biomarkers as amyloid plaque reduction is related to soluble amyloid and P-Tau. Lecanemab has a dose- and time-dependent reduction of amyloid plaques with a correlated increase in plasma Abeta42/40 and a decrease in plasma P-Tau181. Changes in plasma Abeta42/40 and P-Tau18 also correlate with change from baseline Clinical Dementia Rating scale Sum of Boxes (CDR-SB). In the Core study, a correlation in change from baseline in amyloid PET SUVR and plasma Abeta42/40 ratio and plasma P-tau181 was observed at 18 months, indicating that plasma biomarkers could potentially help with measuring clinical changes.- When lecanemab treatment was discontinued at the end of the Core study, changes in the plasma Abeta42/40 (47%), P-Tau18 (24%), and amyloid PET SUVR (21%), gradually began to reverse, suggesting stopping therapy prematurely may potentially allow re-accumulation of pathology. Less frequent maintenance treatment to prevent re-accumulation may be possible based on data and modeling. Eisai will further explore maintenance dosing in the subcutaneous substudy of the Study 201 OLE, which will evaluate alternative dosing every 4 weeks or every 12 weeks.- Increasing strong evidence highlights the role of amyloid plaques in triggering tau dysregulation and researchers optimize tau therapeutics by removing a key driver of tau dyshomeostasis (amyloid). For this reason, the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, selected lecanemab as the backbone anti-amyloid therapy for anti-tau combination for the ongoing component of the Tau NexGen clinical study, which continues enrollment efforts. 4. Update on Lecanemab Clinical Development, Including New Subcutaneous FormulationEisai's Dr. Michael Irizarry Senior VP of Clinical Research and Deputy Chief Clinical Officer presented updates on key lecanemab clinical trials.- Clarity AD Phase 3: The innovative Bayesian design of lecanemab's robust dose-ranging Phase 2b study allowed Eisai to design the Phase 3 confirmatory Clarity AD clinical trial to verify lecanemab's clinical efficacy and safety in early AD. Enrollment is complete with 1,795 participants globally. Additionally, Eisai's recruitment strategy for the Clarity AD clinical trial ensured greater inclusion of ethnic and racial populations in the U.S., resulting in approximately 25% of the total U.S. enrollment including Hispanic (22.5%) and African American (4.5%) persons living with early AD, which mirrors the U.S. Medicare population. The readout will occur in Fall 2022.- AHEAD3-45 Phase 3 Study in Preclinical AD: As of March 2022, there were over 2,900 people screened, resulting in 287 participants enrolled.- Clarity AD Subcutaneous Substudy: Eisai is developing a subcutaneous formulation of lecanemab with the potential to be administered at home by the patient or caregiver via an auto-injector with a more rapid administration than the IV formulation ("The invited lecanemab presentations at AD/PD provide new and exciting insights into how the mechanism of action of late-stage anti-amyloid antibodies differ and how that may help simplify the patient journey by offering a less frequent dosing regimen while providing long-term benefit," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "Eisai aims to bring these potential innovations to people living with early AD and healthcare providers as quickly as possible as we work to fulfill our human health care mission."Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab's rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway. Eisai expects to complete this rolling submission in the first quarter of our fiscal year 2022, which begins April 1, 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.(1) Swanson C.et all, November, 9-12, 2021, Clinical Trials On Alzheimer's Disease Annual Meeting, Lecanemab: An Assessment of the Clinical Effects, the Correlation of Plasma Abeta 42/40 Ratio With Changes in Brain Amyloid PET SUVr, and Safety from the Core and Open Label Extension of the Phase 2 Proof-of- Concept Study, BAN2401-G000-201, in Subjects With Early Alzheimer's Disease. Contacts:MEDIA CONTACT:Eisai Co., Ltd.Public Relations Department+81-(0)3-3817-5120Eisai Inc. (U.S.) Libby Holman+ 1-201-753-1945Libby_Holman@eisai.comINVESTOR CONTACT:Eisai Co., Ltd.Investor Relations Department+81-(0)70-8688-9685MEDIA CONTACT:Biogen Inc. Ashleigh Koss+ 1-908-205-2572public.affairs@biogen.comINVESTOR CONTACT:Biogen Inc. Mike Hencke+ 1-781-464-2442IR@biogen.comFor more information, visit https://www.eisai.com/news/2022/pdf/enews202221pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

15 3 月, 2022

Biogen and Eisai Amend Collaboration Agreements on Alzheimer’s Disease Treatments

CAMBRIDGE, Mass., and TOKYO, Mar 15, 2022 - (JCN Newswire via SEAPRWire.com) - Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa). Effective as of January 1, 2023, Eisai will receive a tiered royalty based on net sales of ADUHELM rather than sharing global profits and losses. The royalty rate starts at 2% and reaches 8% when annual sales exceed $1 billion. Effective immediately Biogen's existing final decision-making rights on ADUHELM have converted to sole decision making and commercialization rights worldwide. Overall, economic arrangements for both companies in 2022 are expected to remain materially unchanged with Eisai's share of expenses capped at an agreed amount for the costs related to development, commercialization and manufacturing of ADUHELM for the period from January 1, 2022, to December 31, 2022. Once the tiered royalty model commences on January 1, 2023, Eisai will not participate in ADUHELM's economics beyond these royalties. The companies will continue to jointly develop and commercialize the investigational therapy lecanemab. Eisai continues to serve as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product, and Eisai having final decision-making authority. Both companies share economics equally with Eisai booking all sales for lecanemab and Biogen reflecting its 50% share of profits and losses. The supply agreement related to lecanemab has been extended from five to 10 years. Biogen will manufacture the lecanemab drug substance in its Solothurn, Switzerland facility with the goal of providing reliable commercial supply worldwide. "This amended collaboration agreement will increase operational efficiency and agility in addressing market developments, including the final determination of CMS on coverage of ADUHELM," said Michel Vounatsos, Chief Executive Officer at Biogen. "In addition we are pleased to be expanding our agreement with Eisai through a new long-term manufacturing contract." "The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. as the first treatment to address a defining pathology of Alzheimer's disease, which is a significant step into a new chapter of Alzheimer's therapy," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both ADUHELM and lecanemab. Eisai will increase its focus on lecanemab and remains committed to bringing a new treatment option expeditiously to patients in need worldwide." About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities. The company routinely posts information that may be important to investors on its website at www.biogen.com.About EisaiEisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com. Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of ADUHELM and lecanemab; the potential benefits, safety and efficacy of ADUHELM and lecanemab; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; clinical development programs, the anticipated benefits and potential of Biogen's manufacturing of lecanemab, clinical trials and data readouts and presentations; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.MEDIA CONTACTS:Biogen Inc.Ashleigh Koss+1-908-205-2572public.affairs@biogen.com Eisai Inc. (U.S. Media)Public Relations Department+1-201-753-1945 Eisai Co., Ltd. (Media Outside the U.S.)Public Relations DepartmentTEL: +81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

4 3 月, 2022

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

TOKYO, Mar 4, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) is ongoing.The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time. Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022. In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.About the Prior Assessment Consultation SystemThe prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time. About Lecanemab (BAN2401)Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process 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. Currently, lecanemab is being developed as the only anti- Aβ antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017. * Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo. About the Collaboration between Eisai and Biogen for Alzheimer's DiseaseEisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab. About the Collaboration between Eisai and BioArctic for Alzheimer's DiseaseSince 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD. About Eisai Co., Ltd.Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com. About BiogenAs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.Biogen Safe HarborThis news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

12 11 月, 2021

Eisai Presents New Analysis of Lecanemab Clinical Efficacy Results from Phase 2b Study at Clinical Trials On Alzheimer’s Disease (CTAD) Conference

TOKYO and CAMBRIDGE, Mass., Nov 12, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). This presentation was made by Eisai at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021 in Boston, Massachusetts and virtually. In September 2021, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early AD, to the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway. Study 201, a multicenter, double-blind, placebo-controlled, Phase 2b trial conducted in 856 patients with early AD, evaluated key efficacy assessments, including clinical change on the Alzheimer's Disease Composite Score (ADCOMS) at the primary endpoint of 12 months and at select key secondary endpoints, Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months. The primary endpoint was Bayesian analysis of 12-month clinical change on ADCOMS with the goal to identify the most efficacious dose (ED90 dose). Primary analysis was super-superiority over placebo by ≥25%: goal was 80% probability of >/=25% reduction in decline versus placebo. Study achieved the goal of identifying smallest dose that achieved ≥90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. At 12 months, ED90 dose had 64% probability of being super-superior to placebo by 25% reduction. At 12 months, ED90 dose had 98% probability superior to placebo. Consistent treatment effect was observed at 18 months for ADCOMS (29% to 37%), CDR-SB (26.5% to 35%), and ADAS-Cog (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses. "In Study 201, lecanemab showed robust clearance of brain amyloid and slowing of clinical decline across several clinical and biomarker endpoints. This sensitivity analysis shows lecanemab clinical efficacy results across statistical models are consistent, reliable and further enhances our confidence in the clinical potential of this investigational therapy," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "Through our comprehensive research program, we will continue to advance the understanding of how this anti-amyloid beta protofibril antibody may play a role in the treatment of early and preclinical AD. In March 2021, Eisai completed enrollment of 1,795 patients with early Alzheimer's disease in our confirmatory Phase 3 Clarity AD clinical study. The Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab's safety and efficacy in individuals with preclinical AD." This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit https://www.eisai.com/news/2021/news202187.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

11 11 月, 2021

Eisai Presents Late-Breaker Updates on Lecanemab Clinical, Biomarker and Safety Data from Phase 2b Study Core and Open-Label Extension

TOKYO, Nov 11, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. 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.OLE Study Explores Biomarkers and Clinical Effects Across Five YearsAn OLE with 10 mg/kg IV biweekly lecanemab dosing was implemented after analysis of the 18-month, core phase (Study 201, Alz Res Therapy 13;21) with an intervening off-treatment period (gap period) ranging from 9-59 months (mean 24 months). The OLE phase evaluated the effect of lecanemab on amyloid PET over 12 months of treatment, including earlier time points (3 and 6 months) than in the core phase (12 and 18 months). This study design provided the opportunity to explore the biomarker and clinical effects of stopping and restarting lecanemab across five years of disease trajectory.Amyloid Reduction Correlates with Clinical BenefitThe updated assessment of the OLE phase showed that treatment with lecanemab resulted in reduction of brain amyloid levels in as early as 3 months based on OLE data and robust clearance of amyloid plaque with more than 80% of participants (10/12) achieving amyloid negative status by 12-18 months of treatment as measured by PET (visual read). These results are consistent with core phase results. The 201 study core data suggested that clinical efficacy (ADCOMS) is correlated with amyloid reduction (PET SUVr) at both the population (correlation coefficients=0.832, p-value=0.080) and subject levels (correlation coefficients=0.201, slope=0.199, p=0.036). Amyloid PET levels were significantly reduced by quantitative assessment in newly treated OLE subjects in as early as 3 months after initiation of treatment. Additionally, the core data suggested that clinical efficacy is correlated with plasma Aβ at both the population (correlation coefficients=-0.306, not significant) and subject levels (correlation coefficients=-0.208, slope=-3.957, p- value=0.050).Potential Slowing of Cognitive Decline May Suggest Disease-Modifying EffectThe clinical treatment difference in study participants between lecanemab treatment and placebo at the end of core period is maintained after discontinued dosing over the 24-month Gap period. The reduction of clinical decline of participants receiving the highest dose of lecanemab relative to placebo at the end of the 18-month, core period showed a difference of 0.05 in ADCOMS (placebo 0.19, lecanemab 0.14). This treatment difference of 0.10 in subjects who entered OLE was maintained while off-treatment during the gap period up to the beginning of the OLE (placebo 0.28, lecanemab 0.18). Similar findings were observed for CDR-SB and ADAS-Cog, although both groups continued to progress. This pattern of sustained treatment effect after stopping lecanemab, reflected in biomarkers as well amyloid PET, plasma Aβ42/40 and ptau181 is consistent with a disease-modifying effect. Blood Tests May be Able to Monitor Lecanemab Treatment EffectsNew results were presented for two new blood tests that were measured in the Phase 2b and OLE studies: Plasma Aβ42/40 ratio and Plasma p-tau181. Plasma Aβ42/40 ratio changes suggested an inverse correlation with amyloid PET changes. Both amyloid PET and blood Aβ show correlation with ADCOMS at the population and individual levels in the core phase (PET correlation coefficients=0.832 population, 0.201 subject level and Aβ plasma correlations coefficients:-0.306 population, -0.208 subject level). Monitoring of treatment effects using plasma biomarkers may allow simple dose modification following robust amyloid removal (e.g., less frequent and/or lower dose).Safety Profile with Low Incidence of ARIA-E and Symptomatic ARIA Rate in Core and OLEConsistent with the safety findings in the core period, lecanemab was well-tolerated with "The latest lecanemab findings provide greater insight into the time course and extent of amyloid reduction observed with lecanemab, and the relationship to clinical outcomes and blood-based biomarkers," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "The Clarity AD Phase 3 Study in Early AD, which completed enrollment of 1795 subjects in March, aims to verify these findings."The presentation video and slides will be available on the investors' section of the Eisai Co., Ltd. Website by 10:00 p.m. U.S. EST on November 11.This release discusses the investigational use of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.For more information, visit https://www.eisai.com/news/2021/pdf/enews202185pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

4 11 月, 2021

Eisai Presents New Data on the Relationship Between Clinical, Biomarker and Safety Outcomes from the Lecanemab Phase 2B Study

TOKYO, Nov 4, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. 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 (Abeta) 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 findings Eisai will present at CTAD provide scientific insights into the potential role of lecanemab in the treatment of early Alzheimer's disease as well as the relationship between clearance of amyloid-beta plaque from the brain, changes in blood-based biomarkers and clinical outcomes," said Michael Irizarry, M.D., Vice President, Deputy Chief Clinical Officer, Neurology Business Group, Eisai Inc. "We are working to advance lecanemab and our other targeted investigational compounds as quickly as possible in our commitment to bringing solutions to patients and their families."The focus on AD has historically been on alleviating cognitive, functional, and behavioral symptoms, but there has been significant progress in understanding the biological mechanisms of the disease and Eisai's investigational pipeline aims to treat the range of underlying pathophysiology, including amyloid, tau and neurodegeneration."With lecanemab's rolling BLA submission to the FDA under the accelerated approval pathway, completion of enrollment of 1,795 patients in the confirmatory Phase 3 Clarity AD clinical trial, initiation of a lecanemab subcutaneous dosing Phase 1 study and the ongoing Phase 3 AHEAD 3-45 study in people with pre- clinical Alzheimer's disease, it is an exciting time for lecanemab and Eisai's AD franchise," said Ivan Cheung, Chairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd. "We are optimistic about the promise lecanemab and other investigational compounds in our robust pipeline may have for people living with Alzheimer's disease."For more information, visit https://www.eisai.com/news/2021/pdf/enews202182pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

28 9 月, 2021

Eisai Initiates Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab (BAN2401) for Early Alzheimer’s Disease Under the Accelerated Approval Pathway

TOKYO, Sep 28, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer's disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. The lecanemab Phase 2b trial results demonstrated a high degree of Abeta plaque lowering and consistent reduction of clinical decline across several clinical endpoints. The correlation between the extent of Abeta plaque reduction and effect on clinical endpoints in Study 201 further supports Abeta as a surrogate endpoint that is reasonably likely to predict clinical benefit. AD is a serious, progressive and devastating disease with few treatment options. Eisai is utilizing the accelerated approval pathway after discussion with the FDA and aims to bring a new treatment option to people living with early AD, their families and healthcare professionals.In June, 2021, lecanemab was granted Breakthrough Therapy designation, which is an FDA program intended to expedite the development and review of medicines for serious or life threatening conditions. Eisai has an agreement with the FDA to submit the BLA for lecanemab as a rolling submission. This agreement allows completed portions of the application to be submitted to the FDA for review on an ongoing basis. After all portions are submitted to the FDA and the agency accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set.The BLA submission for lecanemab is primarily based on the results of the proof-of-concept Study 201 in 856 patients with mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology. The results were published in a peer-reviewed journal in April 2021.1 Study 201 explored the impact of treatment with lecanemab on reducing brain Abeta and clinical decline. At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. Furthermore, the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer's Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with amyloid targeted therapies, for the 10 mg/kg biweekly dosing was 9.9%.After completion of the Core period and a Gap period off treatment (average of 24 months), all 180 patients in the Study 201 open-label extension study received 10 mg/kg biweekly lecanemab dosing. The data confirmed lecanemab produces reductions of amyloid PET SUVr, with significant reduction occurring as early as 3 months, and >80% of subjects achieved amyloid negative status by visual read in as early as 12 months [https://www.eisai.co.jp/ir/library/presentations/pdf/e4523_210730.pdf]. Significant amyloid reduction relative to placebo in those exposed to lecanemab in the Core period was maintained while off-treatment over the Gap period. The rate of ARIA-E was consistent with the Core study at around 10%.The lecanemab Clarity AD Phase 3 clinical trial in early AD is ongoing and completed enrollment in March 2021 with 1,795 patients. The U.S. FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Blinded safety data from Clarity AD will be included to support the BLA."With the worldwide population growing and aging, the number of people living with AD is on the rise. AD imposes an enormous burden on not only people living with AD and their families but also for society. We recognize the strong and urgent expectations from stakeholders to further advance a treatment system for this disease. For many years, Eisai has endeavored to understand the anxieties of people living with AD and has been conducting research and development of novel therapies," said Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. "The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD. As part of our human health care mission, we are committed to bringing new medicines to people living with AD and their families as early as possible.""The Alzheimer's community welcomes scientific innovation that creates more treatment options for people living with this terrible neurodegenerative disease," said Jeffrey Cummings, M.D., ScD, lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas. "Based on the efficacy and safety results of the Phase 2b study and preliminary results from the open-label extension study, I am optimistic about the potential lecanemab may have as a treatment choice for patients with early Alzheimer's to ameliorate the otherwise inevitable decline they face.""It is our vision that patients and their families have choice and access to multiple treatment options for Alzheimer's disease. The rolling submission of lecanemab for FDA review under the accelerated pathway is a positive step toward that goal," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe that treatments directed at amyloid beta reduction in the brain have the potential to transform diagnosis and treatment of Alzheimer's disease. We look forward to continuing to work with Eisai to pioneer science, advance knowledge, and serve the needs of Alzheimer's patients."MEDIA CONTACT:Eisai Co., Ltd.Public Relations Department TEL: +81-(0)3-3817-5120Eisai Inc. (U.S.)Libby Holman +1-201-753-1945 Libby_Holman@eisai.comINVESTOR CONTACT:Eisai Co., Ltd.Investor Relations Department TEL: +81-(0)70-8688-9685MEDIA CONTACT: Biogen Inc.Allison Parks +1-781-464-3260public.affairs@biogen.comINVESTOR CONTACT: Biogen Inc.Mike Hencke +1-781-464-2442 IR@biogen.comFor more information, visit https://www.eisai.com/news/2021/pdf/enews202177pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

30 7 月, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab (BAN2401)

TOKYO, Jul 30, 2021 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. today announced results of a longitudinal preliminary assessment of the clinical effects of lecanemab (development code: BAN2401) -- granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in June 2021 -- following 18 months of treatment in the open-label extension (OLE) of the Phase 2b proof-of-concept study in subjects with early Alzheimer's disease (AD) (Mild Cognitive Impairment [MCI] due to AD and mild AD) at the Alzheimer's Association International Conference (AAIC) held in Denver, Colo., United States and virtually from July 26 to 30, 2021 (Presentation No.: 57780).Lecanemab Study 201 and OLELecanemab is an investigational humanized monoclonal antibody that preferentially binds to soluble amyloid- beta (Aβ) aggregates (protofibrils). Lecanemab reduced brain Aβ and slowed clinical decline in an 18-month Phase 2b proof of concept study (Study 201, n=856) in early AD (Alz Res Therapy 13; 2021). After analysis of the core study, there was an off-treatment gap period of 9-59 months (period of time between the last dose of lecanemab in the core and the OLE baseline; average of 24 months). After this off-treatment gap, the OLE evaluating the 10 mg/kg IV biweekly lecanemab dosing was implemented (n=180 from core study enrolled). The clinical effect of treatment with lecanemab was assessed via the adjusted mean change of the AD Composite Score (ADCOMS), the primary clinical endpoint of the core study. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment. Additional clinical endpoints included Clinical Dementia Rating-Sum of Boxes (CDR-SB) and AD Assessment Scale - Cognitive Subscale (ADAS- Cog).May suggest a potential disease-modifying effectFor subjects with early AD at Study 201 OLE baseline, the dose-dependent clinical treatment effect of lecanemab administration relative to placebo during the core phase was maintained. While off-treatment during the gap period, people who received 10 mg/kg IV in the core continued to perform better than those who received placebo on ADCOMS. While off-treatment during the gap period, subjects declined at the same rate on key clinical measures in all core treatment groups. The increase in adjusted mean change between the three month follow up after the core 18-month and OLE baseline for lecanemab bi-weekly, lecanemab monthly and placebo dosing respectively were 0.11 (0.07 to 0.18 ), 0.10 (0.12 to 0.22) and 0.09 (0.19 to 0.28) for ADCOMS. Similar results were observed for CDR-SB and ADAS-Cog. This may suggest a potential disease-modifying effect of lecanemab.Potential relationship between the plasma Aβ42/40 ratio, brain amyloid by PET and treatmentLow values of plasma Aβ42/40 ratio is recognized as an indicator of elevated amyloid in the brain, and was assessed in a subset of participants in Study 201.1 The plasma Aβ42/40 ratio increased during the core phase and OLE in those treated with lecanemab and decreased during the gap period, potentially demonstrating the relationship between the plasma Aβ42/40 ratio and treatment with lecanemab. The lecanemab treatment related increases in plasma Aβ42/40 ratio were inversely correlated with treatment related reduction of brain amyloid in the core and OLE (Poster No. 57760).Assessing the long-term effect of continued treatment with lecanemabStudy participants with early AD at the OLE baseline who received placebo during the core phase and were treated for the first time with lecanemab during OLE, as well as those treated with lecanemab both during the core phase and during OLE, showed reduced clinical decline relative to natural disease progression (reference similar population from ADNI). The adjusted mean change from OLE baseline at the end of the 18-month OLE study period for core 10 mg/kg bi-weekly dosing, 10 mg/kg monthly dosing, and placebo groups respectively were 0.102, 0.165 and 0.07 for ADCOMS, all of which showed a slower rate of progression as compared to ADNI (0.214). Similar results were observed for CDR-SB and ADAS-Cog. The results support the concept of increased long-term benefit of continued treatment with lecanemab when initiated in the early AD stage.These preliminary findings are based on limited data and are being further evaluated in the ongoing Phase 3 Clarity AD study for early AD."The findings from the lecanemab Phase 2b OLE study are encouraging as they supply further insights into outcomes with anti-amyloid therapies and we look forward to learning more in the Phase 3 studies, Clarity AD and AHEAD 3-45, currently underway," said Lynn Kramer, M.D., Chief Clinical Officer, Neurology Business Group, Eisai. "The unprecedented confluence of medical knowledge, data analytics, and technological advances make it an incredibly exciting time for Alzheimer's research. This combined with Eisai's precision research approach, which is a treatment paradigm based on a person's pathophysiological biomarker profile along the Alzheimer' disease continuum, makes our company uniquely positioned to research and develop new solutions for patients and their families."Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen, said, "The findings from the Open-Label Extension further strengthen our belief in the potential of addressing amyloid beta pathology in Alzheimer's disease. We look forward to our ongoing collaboration with Eisai to study lecanemab and continuing to pioneer to address the high unmet need for Alzheimer's disease patients."The enrollment of 1,795 patients with early AD in the Phase 3 Clarity AD clinical study was completed in March 2021. The study's primary endpoint is expected to be completed by the end of September 2022. The Phase 3 clinical study, AHEAD 3-45, is currently evaluating lecanemab in individuals with preclinical AD.For more information, visit https://www.eisai.com/news/2021/pdf/enews202165pdf.pdf. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)

24 6 月, 2021

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

TOKYO, Jun 24, 2021 - (JCN Newswire via SEAPRWire.com) - 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. The FDA's Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.1 The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Abeta) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses.In March 2021 Eisai and Biogen completed enrollment of 1,795 patients with early AD in the the Phase 3 Clarity AD study. The study's primary endpoint is expected to be completed by the end of September 2022. Additionally, the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Study 201 confirmed time-dependent reduction of brain Abeta in individuals newly treated with lecanemab and was presented at the 2021 Alzheimer's Disease and Parkinson's Disease Conference. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.For more information, visit: https://www.eisai.com/news/2021/news202151.html. Copyright 2021 JCN Newswire. All rights reserved. (via SEAPRWire)