FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

by codm | Jul 7, 2023 | Newsletter

The first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease
The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI

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TOKYO and CAMBRIDGE, Mass., July 6, 2023 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI^® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD. Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

LEQEMBI’s traditional approval is based on Phase 3 data from Eisai’s large, global Clarity AD clinical trial, in which LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of LEQEMBI. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. Additionally, the secondary endpoint of AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), as measured by people caring for patients with AD, noted a statistically significant benefit of 37%. This measures the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. Full results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2022 conference and simultaneously published in the peer-reviewed medical journal The New England Journal of Medicine on November 29, 2022.

Importantly, following FDA’s traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process. The CMS-facilitated registry is now available for healthcare professionals to submit required patient data to CMS. Eisai is pleased that Medicare will cover this important therapy for appropriate patients. This will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the United States.

“Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease. As a research and development-focused company based on our hhc (human health care) concept, we are proud that the results of Eisai’s AD research over the past 40 years have been recognized and delivered to people living with this disease in the United States,” said Haruo Naito, Chief Executive Officer at Eisai. “Alzheimer’s disease is a progressive, fatal disease that greatly impacts not only the people living with it, but also their loved ones, care partners and society. We continue to work to create broad and simple access to LEQEMBI for patients and to support diagnosis and treatment at the early stage of the disease. Eisai will diligently work to educate physicians on the safe and appropriate use of LEQEMBI to maximize its benefit to people living with early AD and their families.”

“Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable. We would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible,” said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen. “Our focus is now on the path forward, working alongside Eisai with the goal of making LEQEMBI accessible to eligible patients as soon as possible.”

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril*) and insoluble forms of amyloid beta (Aβ). Critically, LEQEMBI targets and clears the most neurotoxic form of Aβ that continuously accumulates as well as removes the existing plaques to treat this progressive, chronic disease. In June 2023, the FDA’s Peripheral and Central Nervous System Drugs (PCNS) advisory committee voted unanimously that the data from Eisai’s Clarity AD clinical trial confirmed the clinical benefit of LEQEMBI for the treatment of AD. Committee members also confirmed the overall risk-benefit of LEQEMBI. On January 6, 2023, LEQEMBI was approved by the FDA under the accelerated approval pathway.

Eisai has developed and deployed Understanding ARIA™, a multi-faceted educational initiative to further advance understanding in the AD healthcare community of the real-world management and monitoring of amyloid-related imaging abnormalities (ARIA). In collaboration with experts in the field of medical imaging as well as major professional societies, Understanding ARIA™ offers resources and programs that include peer-to-peer education, individual and group educational sessions and subject-matter-expert evaluation of historical case studies.

Eisai is committed to ensuring that appropriate patients have access to LEQEMBI and has established a Patient Assistance Program to provide LEQEMBI at no cost, for eligible uninsured and underinsured patients, including Medicare beneficiaries, who meet financial need and other program criteria. Additionally, Eisai offers patient support for improving access through LEQEMBI Patient Navigators, who will provide information about accessing LEQEMBI, help patients and their families understand their insurance coverage and options, and identify financial support programs for eligible patients. People in the U.S. can learn more about these services by visiting LEQEMBI.com, calling 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time or faxing an enrollment form to 1-833-770-7017.

Eisai serves as the lead of LEQEMBI 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 Aβ aggregated soluble species of 75-5000 Kd.^2,3.4

INDICATION
LEQEMBI is indicated for the treatment of Alzheimer’s disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION
LEQEMBI is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or to any of the excipients of LEQEMBI. Reactions have included angioedema and anaphylaxis.

WARNINGS AND PRECAUTIONS
AMYLOID RELATED IMAGING ABNORMALITIES

• LEQEMBI can cause ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. ARIA can occur spontaneously in patients with Alzheimer’s disease. ARIA-H associated with monoclonal antibodies directed against aggregated forms of beta amyloid generally occurs in association with an occurrence of ARIA-E. ARIA-H and ARIA-E can occur together.
• ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events, including seizure and status epilepticus, rarely can occur. Reported symptoms associated with ARIA may include headache, confusion, visual changes, dizziness, nausea, and gait difficulty. Focal neurologic deficits may also occur. Symptoms associated with ARIA usually resolve over time.

ARIA Monitoring and Dose Management Guidelines

• Obtain recent baseline brain magnetic resonance imaging (MRI) prior to initiating treatment with LEQEMBI. Obtain an MRI prior to the 5th, 7th and 14th infusions.
• Recommendations for dosing in patients with ARIA-E and ARIA-H depend on clinical symptoms and radiographic severity. Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
• Enhanced clinical vigilance for ARIA is recommended during the first 14 weeks of treatment with LEQEMBI. If a patient experiences symptoms suggestive of ARIA, clinical evaluation should be performed, including MRI if indicated. If ARIA is observed on MRI, careful clinical evaluation should be performed prior to continuing treatment.
• There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E. There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E. There are limited data in dosing patients who experienced recurrent ARIA-E.

Incidence of ARIA

• In Study 2, symptomatic ARIA occurred in 3% (29/898) of LEQEMBI-treated patients. Serious symptoms associated with ARIA were reported in 0.7% (6/898) of patients treated with LEQEMBI.  Clinical symptoms associated with ARIA resolved in 79% (23/29) of patients during the period of observation.
• Including asymptomatic radiographic events, ARIA was observed in LEQEMBI: 21% (191/898); placebo: 9% (84/897). ARIA-E was observed in LEQEMBI: 13% (113/898) placebo: 2% (15/897). ARIA-H was observed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There was no increase in isolated ARIA-H for LEQEMBI vs placebo.

ApoE ε4 Carrier Status and Risk of ARIA

• In Study 2, 16% (141/898) of patients in the LEQEMBI arm were ApoE ε4 homozygotes, 53% (479/898) were heterozygotes, and 31% (278/898) were noncarriers.
• The incidence of ARIA was higher in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among patients treated with LEQEMBI symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes compared with 2% of heterozygotes and 1% noncarriers. Serious events of ARIA occurred in 3% of ApoE ε4 homozygotes, and approximately 1% of heterozygotes and noncarriers.
• The recommendations on management of ARIA do not differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings

• The majority of ARIA-E radiographic events occurred early in treatment (within the first 7 doses), although ARIA can occur at any time and patients can have more than 1 episode. The maximum radiographic severity of ARIA-E in patients treated with LEQEMBI was mild in 4% (37/898), moderate in 7% (66/898), and severe in 1% (9/898). Resolution on MRI occurred in 52% of ARIA-E patients by 12 weeks, 81% by 17 weeks, and 100% overall after detection. The maximum radiographic severity of ARIA-H microhemorrhage in LEQEMBI-treated patients was mild in 9% (79/898), moderate in 2% (19/898), and severe in 3% (28/898) of patients; superficial siderosis was mild in 4% (38/898), moderate in 1% (8/898), and severe in 0.4% (4/898). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA-E was highest in ApoE ε4 homozygotes 5% (7/141), compared to heterozygotes 0.4% (2/479) or noncarriers 0% (0/278). Among LEQEMBI-treated patients, the rate of severe radiographic ARIA H was highest in ApoE ε4 homozygotes 13.5% (19/141), compared to heterozygotes 2.1% (10/479) or noncarriers 1.1% (3/278).

Intracerebral Hemorrhage

• Intracerebral hemorrhage >1 cm in diameter was reported in 0.7% (6/898) of patients in Study 2 after treatment with LEQEMBI compared to 0.1% (1/897) on placebo. Fatal events of intracerebral hemorrhage in patients taking LEQEMBI have been reported.
• Concomitant Antithrombotic Medication:
  • In Study 2, baseline use of antithrombotic medication (aspirin, other antiplatelets, or anticoagulants) was allowed if the patient was on a stable dose. The majority of exposures to antithrombotic medications were to aspirin. Antithrombotic medications did not increase the risk of ARIA with LEQEMBI. The incidence of intracerebral hemorrhage was 0.9% (3/328 patients) in patients taking LEQEMBI with a concomitant antithrombotic medication at the time of the event compared to 0.6% (3/545 patients) in those who did not receive an antithrombotic. Patients taking LEQEMBI with an anticoagulant alone or combined with an antiplatelet medication or aspirin had an incidence of intracerebral hemorrhage of 2.5% (2/79 patients) compared to none in patients who received placebo.
  • Because intracerebral hemorrhages >1 cm in diameter have been observed in patients taking LEQEMBI, additional caution should be exercised when considering the administration of anticoagulants or a thrombolytic agent (e.g., tissue plasminogen activator) to a patient already being treated with LEQEMBI.

Other Risk Factors for Intracerebral Hemorrhage:

• Patients were excluded from enrollment in Study 2 for findings on neuroimaging that indicated an increased risk for intracerebral hemorrhage. These included findings suggestive of cerebral amyloid angiopathy (prior cerebral hemorrhage >1 cm in greatest diameter, >4 microhemorrhages, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of intracerebral hemorrhage. The presence of an ApoE ε4 allele is also associated with cerebral amyloid angiopathy, which has an increased risk for intracerebral hemorrhage. Caution should be exercised when considering the use of LEQEMBI in patients with factors that indicate an increased risk for intracerebral hemorrhage and in particular for patients who need to be on anticoagulant therapy.

HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, including angioedema, bronchospasm, and anaphylaxis, have occurred in LEQEMBI-treated patients. Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction, and initiate appropriate therapy.

INFUSION-RELATED REACTIONS

• In Study 2, infusion-related reactions were observed in LEQEMBI: 26% (237/898); placebo: 7% (66/897), and the majority of cases in LEQEMBI-treated patients (75%, 178/237) occurred with the first infusion. Infusion-related reactions were mostly mild (69%) or moderate (28%) in severity. Infusion-related reactions resulted in discontinuations in 1% (12/898) of LEQEMBI-treated patients. Symptoms of infusion-related reactions included fever and flu-like symptoms (chills, generalized aches, feeling shaky, and joint pain), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.
• In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered.

ADVERSE REACTIONS

• In Study 2, the most common adverse reactions leading to discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in 2% (15/898) of patients treated with LEQEMBI compared to <1% (1/897) of patients on placebo.
• In Study 2, the most common adverse reactions reported in ≥5% of patients treated with LEQEMBI (N=898) and ≥2% higher than placebo (N=897) were infusion-related reactions (LEQEMBI: 26%; placebo: 7%), ARIA-H (LEQEMBI: 14%; placebo: 8%), ARIA-E (LEQEMBI: 13%; placebo: 2%), headache (LEQEMBI: 11%; placebo: 8%), superficial siderosis of central nervous system (LEQEMBI: 6%; placebo: 3%), rash (LEQEMBI: 6%; placebo: 4%), and nausea/vomiting (LEQEMBI: 6%; placebo: 4%). 

Please see full Prescribing Information for LEQEMBI, including Boxed WARNING. 

Media Contacts:

Investor Contacts:

Notes to Editors

1. About LEQEMBI^® (lecanemab-irmb)
LEQEMBI^® (lecanemab-irmb) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI accelerated approval on January 6, 2023, and Traditional Approval on July 6, 2023. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Eisai has also submitted applications for approval of lecanemab in Japan, EU, China, Canada, Great Britain and South Korea. In Japan and China, the applications have been designated for priority review, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201 as well as the Clarity AD (Study 301) OLE. Separate supplemental Biologics License Applications for subcutaneous dosing and a maintenance dosing regimen will be submitted to the FDA at the end of Eisai’s fiscal year.

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 AD (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.

2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015.

4. About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.

5. About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube.

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 lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; 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.

References

1. 1. The Centers for Medicare and Medicaid Fact Sheet: CMS announces new details of plan to cover new Alzheimer’s drugs. CMS announces new details of plan to cover new Alzheimer’s drugs | CMS. Accessed June 26, 2023.
   2. https://www.alzforum.org/news/conference-coverage/lecanemab-sweeps-toxic-av-protofibrils-catches-eyes-trialists
   3. Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. https://doi.org/10.1371/journal.pone.0032014 Epub 2012 Feb 15. PMID: 22355408; PMCID: PMC3280222.
   4. Söderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics. 2023;20:195-206. https://doi.org/10.1007/s13311-022-01308-6

EISAI TRANSFERS ALL FUTURE ECONOMIC RIGHTS FOR ELACESTRANT, A SELECTIVE ESTROGEN RECEPTOR DEGRADER, TO DRI HEALTHCARE

by codm | Jun 30, 2023 | Newsletter

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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to transfer all future economic rights for elacestrant (generic name), approved for the treatment for breast cancer in the United States, to DRI Healthcare Trust (Headquarters: Ontario, Canada, “DRI Healthcare”).

Elacestrant is a selective estrogen receptor degrader discovered by Eisai. In 2006, Eisai granted Radius Health, Inc (Headquarters: Massachusetts, United States) an exclusive worldwide license (with Japan included in 2015) concerning the research, development, manufacture and marketing of the given compound and, in return, had the rights to receive certain financial payments, including milestones, and royalties on net sales of elacestrant, etc.

In this agreement with DRI Healthcare, Eisai transfers to DRI Healthcare all of its future economic rights. Eisai will receive an upfront payment of 85 million U.S. dollars for the transfer. As a result of this transaction, Eisai anticipates no changes to its consolidated financial forecast for the period ended March 31, 2024.

Driven by our hhc concept, Eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: Neurology, Oncology and Global Health. As an hhceco company, Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120　

[Notes to editors]
1.  About Elacestrant
Elacestrant is a selective estrogen receptor degrader discovered by Eisai. Eisai has granted Radius Health, Inc. an exclusive worldwide license for elacestrant. In January 2023, Food and Drug Administration (FDA) approved elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The marketing authorization application (MAA) for the same indication is under review by the European Medicines Agency (EMA).

2.  About DRI Healthcare Trust
DRI Healthcare Trust is managed by DRI Capital Inc. (“DRI Capital”), the pioneer in global pharmaceutical royalty monetization with a more than 30-year history of accelerating innovation by providing capital to inventors, academic institutions and biopharma companies. Since its founding in 1989, DRI Capital has deployed more than US$2.5 billion, acquiring more than 70 royalties on 40-plus drugs, including Eylea, Spinraza, Zytiga, Remicade, Keytruda and Stelara. DRI Healthcare Trust’s units are listed and traded on the Toronto Stock Exchange in Canadian dollars under the symbol “DHT.UN” and in US dollars under the symbol “DHT.U”. To learn more, visit drihealthcare.com or follow us on LinkedIn

NEW NEURII RESEARCH COLLABORATION BETWEEN EISAI, GATES VENTURES, HEALTH DATA RESEARCH UK, LIFEARC AND THE UNIVERSITY OF EDINBURGH TO DEVELOP DIGITAL SOLUTIONS FOR DEMENTIA IS ANNOUNCED

by codm | Jun 29, 2023 | Newsletter

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• New research collaboration brings together world-leading institutions’ collective expertise in therapeutics, technology, health data, technology commercialisation and advanced analytics/data science in neurology.
• Two-year pilot provides a launch pad for translating scientific prototypes into practical solutions that demonstrate real-world impact.
• NEURii collaboration builds on Eisai’s extensive experience in delivering innovative treatments in neurology and supports ongoing contributions to the global digital health ecosystem.

TOKYO, HATFIELD, SEATTLE, LONDON, and EDINBURGH, 29 June, 2023 – Eisai, Gates Ventures, Health Data Research UK (HDR UK), LifeArc and The University of Edinburgh announced today a new two-year collaborative research agreement. The collaboration, named NEURii is a unique pioneering partnership that creates a powerhouse collaboration of collective expertise in therapeutics, technology development and commercialization, health data management and advanced analytics/data science to predict, protect and promote brain health.

NEURii will focus its initial efforts to develop data and digital solutions to complement approved treatment options for patients and solve issues related to the prediction, prevention, management, and treatment of dementia related disorders.

This groundbreaking collaboration will use high-quality individual data, Artificial Intelligence (AI), and Machine Learning (ML) to deliver patient-focused digital health solutions by developing initial pilot projects originated in highly recognized UK academic centres. These projects have been selected on the basis of their potential to make a meaningful difference to patients’ lives while maintaining data security and public trust. By combining diverse digital biomarkers that can be acquired non-invasively in real world clinical and non-clinical settings (e.g., speech from conversation) with the high-quality and abundant medical data accumulated in the UK, and analyzing them with tailored AI algorithms, NEURii will create innovative digital solutions. These will be deployed in the detection, monitoring and treatment of dementia patients in order to improve their lives as well as minimizing the impact of the disease burden on their carers and families.

This initial two-year pilot establishes a first-in-class launch pad underpinned by an innovative business model and scalable prototype for translating scientific prototypes that will enhance and improve public health demonstrating real world impact. It is envisaged that NEURii partners will explore further opportunities to scale up the program developing digital health solutions worldwide.

Dr. Teiji Kimura, Ph.D., Academia and Industry Alliance Officer, Deep Human Biology Learning (DHBL) Office of Eisai, commented, “Dementia is one of the major social and medical issues in an aging society, and Eisai’s mission is to contribute to solving these issues. We aim to create new digital solutions that will contribute to solving the challenges of dementia by combining the UK’s leadership in this field with our experience and track record of continuously creating innovative treatments in the field of dementia whilst staying true to our human health care concept of giving first thought to patients and the people in the daily living domain.”

It is estimated that more than 55 million are currently living with dementia in the world, and nearly one million people in the UK, and this number is expected to grow rapidly.^1,2 As well as having a significant impact on the lives of patients and those who care for them (52% of the UK public knows someone who has been diagnosed with a form of dementia), these conditions place significant pressure on health and social care systems. Providing data-driven solutions that complement existing treatments could help to improve earlier detection and diagnosis, evidence-based treatment decision-making, monitoring of disease progression and maintenance of quality of life.

“AI and other advanced technologies are beginning to play a powerful role in medical research,” said Dr. Niranjan Bose, Managing Director of Health & Life Sciences at Gates Ventures. “I’m excited about how the NEURii collaboration will apply these tools to diagnostics research and drug discovery, and contribute to breakthroughs that can improve life for millions of people suffering with dementia and dementia-related illnesses.”

“Identifying ways to prevent dementia and neurodegenerative disease is a key part of our multi-million-pound neurodegeneration program’ said Paul Wright, MND Translational Challenge Lead at LifeArc “‘This collaboration is one of many new innovative projects we are involved in to improve the diagnosis of dementia and a positive step towards predicting those who may develop the disease.”

The UK is a leader in digital technology investment and research across areas such as genomics, health data science, AI and ML, with rich and diverse health-related data. NEURii’s model will enable the identification of pioneering data and digital science, the mentoring of talented scientists and the translation of health prototypes into practical and accessible products. By bringing together the expertise and capabilities of the NEURii collaborators, it is hoped that the novel approach will provide an exciting launch-pad for new transformational digital products that can contribute to solving the ongoing challenges of dementia and neurodegenerative conditions.

Professor Andrew Morris, Director of HDR UK, said: “Almost one million people in the UK are living with dementia. This new public-private partnership aims to gain a deeper understanding of the disease through trustworthy use of large datasets of anonymised health data in secure environments. We will take forward a set of pilot projects and engage with the public. Our aim is to produce new data-driven products that will benefit patients and their families in detecting dementia, predicting its progress and better managing the disease.”

NEURii academic lead Professor Siddharthan Chandran, of the University of Edinburgh, said: “The University of Edinburgh is delighted to be part of this ambitious cross-sector digital partnership that has, as an explicit goal, the creation of low cost and globally scalable digital tools to predict and monitor dementia.”

Outputs from the NEURii collaboration will be shared quarterly internally and released externally when appropriate.

¹  World Health Organization. Fact sheets, Dementia https://www.who.int/news-room/fact-sheets/detail/dementia
² Alzheimer’s Research UK. Dementia Statistics Hub. Number of people in the UK. 2022. Available at: https://dementiastatistics.org/about-dementia/prevalence-and-incidence/

[Notes to editors]

1.  About NEURii
NEURii is a collaborative venture formed by Eisai, Gates Ventures, HDR UK, LifeArc and The University of Edinburgh. The partnership’s aim is to translate real-world data and digital science into solutions and products that predict, prevent and manage the treatment of dementia to help people live longer and better lives worldwide NEURii will operate within a strict governance framework and FAIR data principles (data which meet principles of findability, accessibility, interoperability, and reusability).

2.  About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook.
For more information about Eisai in the EMEA region, please visit www.eisai.eu.

3.  About Gates Ventures
Gates Ventures is the private office of Bill Gates. Gates Ventures’ programmatic investments in the Alzheimer’s field include the AD Diagnostics Accelerator, Dementia Discovery Fund (DDF), AD Data Initiative and the European Platform for Neurodegenerative Diseases (EPND).

4.  About Health Data Research UK
Health Data Research UK is the national institute for health data with a mission to unite the UK’s health data to enable discoveries that improve people’s lives. It is a charity funded by UK Research and Innovation, the Department of Health and Social Care in England and equivalents in Northern Ireland, Wales and Scotland, and leading medical research charities.
E: enquiries@hdruk.ac.uk
W: www.hdruk.org

5.  About LifeArc
LifeArc is a self-funded, non-profit medical research organisation. We take science ideas out of the lab and help turn them into medical breakthroughs that can be life-changing for patients. We have been doing this for more than 25 years and our work has resulted in five licensed medicines and a diagnostic for antibiotic resistance.
Our teams are experts in drug and diagnostics discovery, technology transfer, and intellectual property. Our work is in translational science – bridging the gap between academic research and clinical development, providing funding, research and expert knowledge, all with a clear and unwavering commitment to having a positive impact on patient lives.
LifeArc is committed to spending £1.3 billion by 2030 in areas of high unmet medical need. www.lifearc.org

6.  About the University of Edinburgh
The University of Edinburgh is a global university, rooted in Scotland. We are globally recognised for our research, development and innovation and we have provided world-class teaching to our students for more than 425 years. We are the largest university in Scotland, with more than 41,000 students and 15,000 staff. We are a founding member of the UK’s Russell Group of leading research universities and a member of the League of European Research Universities. Edinburgh Innovations is the University of Edinburgh’s commercialisation service. We bring University of Edinburgh research to industry, working to identify ideas with value, and facilitating the process of bringing them to life in real-world applications. We make ideas work for a better world.
Find out more on our website

Position and Policy Regarding Reduction of the Investment Unit of the Company’s Shares

by codm | Jun 29, 2023 | Newsletter

For Print (PDF)

Company Name: Eisai Co., Ltd.
Representative: Haruo Naito
Representative Corporate Officer and CEO
(Code 4523 Tokyo Stock Exchange Prime Market)

Inquiries: Sayoko Sasaki
Vice President, Corporate Communications
Phone +81-3-3817-5120

1.  Position Regarding Reduction in Trading Unit (Position to shift to the level of less than 500,000 yen)
Eisai Co., Ltd. (the Company) understands that a reduction in the trading unit of the Company’s shares is an effective way to promote liquidity in the equity market by encouraging a wider range of investors to participate in trading the Company’s shares.

2.  Policy Regarding Reduction in Trading Unit (Position to shift to the level of less than 500,000 yen)
Regarding a potential reduction in the trading unit, the Company will continue to comprehensively monitor a number of factors including the trends in its stock price level, number of shareholders, and shareholder composition, the liquidity of the Company’s shares as well as the costs and benefits, and carefully consider whether a reduction in trading unit is necessary or not, as well as the appropriate timing for reduction if warranted.

Note: This disclosure is in accordance with Rule 409 of the Tokyo Stock Exchange’s Securities Listing Regulations, “Disclosure of Lowering Investment Units.” The Company is subject to this rule because as of March 31, 2023, latest investment units of the Company were valued at a price of 500,000 yen per unit or more.

EISAI’S “NOUKNOW®” WILL CONTINUE TO BE UTILIZED FOR BRAIN HEALTH ASSESSMENT AS PART OF THE FY2023 DEMENTIA EXAMINATION PROJECT BY TOKYO BUNKYO CITY

by codm | Jun 22, 2023 | Newsletter

ACHIEVEMENT OF OUTCOME INDICATORS IN FY2022 PAY FOR SUCCESS CONTRACT

For Print (PDF)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that brain health checks utilizing “NouKNOW^®” (pronounced “NOH-NOH”), Eisai’s digital tool for self-assessment of cognitive function, will continue to be promoted as part of the FY2023 dementia examination project, conducted by Bunkyo City, Tokyo.

This project is designed to encourage approximately 12,300 Bunkyo City residents between the ages of 55 and 75, at a milestone of every 5 years, to have a brain health check using “NouKNOW”. Those who have undergone the assessment can receive medical advice based on the results directly from a physician on site, and depending on the results, referrals can be made for consultations at medical institutions and support from visiting nurses.

Eisai and Bunkyo City, concluded a “Community Building Partnership Agreement to Promote Local Dementia Support Initiatives For Dementia Patients and Their Families” in June 2015, co-promoting a variety of efforts, including the awareness activities regard to disease and health such as the dementia café, inviting medical doctors to give lectures to residents and operating a community center for intergenerational exchanges between residents.

The dementia examination project has been implemented since FY2021 as a priority policy of Bunkyo City, and Eisai has been providing “NouKNOW” and operational support for their public examinations. In FY2022, a Pay For Success (PFS) contract was introduced with the intention of further strengthening dementia awareness and early support, and the following outcome indicators were established. Eisai was commissioned for this project and achieved both outcome indicators through promotion measures such as the “NouKNOW” trial event and public lectures for residents on brain health.

• Outcome Indicator 1:        Increase brain health checks performed using “NouKNOW” at home, etc.
• Outcome Indicator 2:        Increase participation in lifestyle improvement programs

In FY2022, 430 people participated in on-site examinations (measurement using “NouKNOW” and medical interview), of which approximately 10% led to recommendations to see a medical institution. In FY2023, Eisai will continue to raise awareness of brain health among residents and contribute to early detection and support of dementia.

Eisai has concluded regional cooperation agreements with local governments, medical associations, and other organizations throughout Japan, and is promoting efforts to realize a Dementia-Inclusive Society (167 locations in 45 prefectures as of March 31, 2023). In addition, Eisai is collaborating with 46 other local governments including Bunkyo City (in FY2022) on dementia-related projects, providing opportunities for brain health assessments tailored to local issues and promoting initiatives to establish a pathway to subsequent medical care and support. Eisai will contribute to the creation of a community where citizens are aware of and check their brain health from the stage where they are in a healthy condition, and where early detection, diagnosis, and preparation for dementia are possible, aiming to realize a Dementia-Inclusive Society where people with dementia and the people in the daily living domain can live their lives how they would like.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

[Notes to Editors]
1. About “NouKNOW”
“NouKNOW” (non-medical device) is a self-assessment tool of brain performance (brain health) developed by Eisai based on the algorithm created by Cogstate, Ltd. (Headquarters: Australia) for which Eisai holds the rights for exclusive development and commercialization worldwide. It is conducted through a simple card test using a PC, tablet or smartphone device to quantitatively measure brain performance in four tests evaluating psychomotor function, attention, learning and memory, and working memory. This digital tool allows users to self-assess independently and in a short time frame (approx.15 minutes), enabling regular assessments in instances such as daily life and health checkups. On the results screen, a score (brain performance index (BPI)) – as a measurement of quantified brain performance aspects such as memorization, cognition, and decision – appears along with lifestyle advice for maintaining brain performance.

For additional information, please visit https://nouknow.jp/. (Japanese only)

2. About Pay For Success (PFS)
Pay For Success (PFS) is a new method of public-private partnership to set outcome indicators in accordance with the administrative issues to be solved by the projects that local public entities, etc. contract out to private sectors for its implementation, and the amount paid by the local public entity, etc. to the private sector for outsourcing a project is linked to improvement of the relevant outcome indicators as evaluated by a third party. PFS is a policy promoted by the Cabinet Office of Japan, which is expected to improve the quality of public services and reduce expenditures.