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

Health22 healthhhnsd 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

<br /> 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<br />

PR Newswire



TOKYO

and

CAMBRIDGE, Mass.


,


Nov. 29, 2022


/PRNewswire/ — 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 results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical study of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) 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 published in the

New England Journal of Medicine

, one of the world’s most prestigious peer-reviewed medical journals. For the details of the paper, please refer to

here

.

The rapid publication of the Clarity AD study results demonstrates Eisai’s strong commitment to trust and transparency based on Eisai’s

human health care

mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.

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.

*

See Section

1 of “Notes to Editors”


Contacts


MEDIA CONTACT:


Eisai Co., Ltd.


Public Relations Department


TEL: +81-(0)3-3817-5120



Eisai Inc. (U.S.)


Libby Holman


+ 1-201-753-1945



[email protected]





Eisai Europe, Ltd.


(Europe, Australia, New Zealand and Russia)


EMEA Communications


Department



[email protected]





INVESTOR CONTACT:


Eisai Co., Ltd.


Investor Relations Department


TEL: +81-(0)70-8688-9685


MEDIA CONTACT:


Biogen Inc.


Natacha Gassenbach


+ 1-857-777-6573




[email protected]




INVESTOR CONTACT:


Biogen Inc.


Mike Hencke


+ 1-781-464-2442




[email protected]



[Notes to editors]



1.


Lecanemab Published Article in The New England Journal of Medicine



Christopher H. van Dyck


1)

,

Chad J. Swanson


2)

,

Paul Aisen


3)

,

Randall J. Bateman


4)

,

Christopher Chen


5)

,

Michelle Gee


6)

,

Michio Kanekiyo


2)

,

David Li


2)

,

Larisa Reyderman


2)

,

Sharon Cohen


7)

,

Lutz Froelich


8)

,

Sadao Katayama


9)

,

Marwan Sabbagh


11)

,

Bruno Vellas


12)

,

David Watson


13)

,

Shobha Dhadda


2)

,

Michael Irizarry


2)

,

Lynn D. Kramer


2)

, and

Takeshi Iwatsubo


10)

. Trial of Lecanemab in Early Alzheimer’s Disease.

N Engl J Med

2022.

The authors’ affiliations are as follows:

1)

The Alzheimer’s Disease Research Unit,

Yale School of Medicine

,

New Haven, CT

;

2)

Eisai,

Nutley, NJ

;

3)

The Alzheimer’s Therapeutic Research Institute,

University of Southern California

,

San Diego

;

4)


Washington University

School of Medicine in

St. Louis

,

St. Louis

;

5)

The Memory, Aging, and Cognition Center, Department of Pharmacology,

Yong Loo Lin School

of Medicine,

National University of Singapore

,

Singapore

;

6)

Eisai,

Hatfield

,

United Kingdom

;

7)

Toronto Memory Program,

Toronto

;

8)

Medical Faculty Mannheim, University of

Heidelberg

, Central Institute of Mental Health,

Mannheim

,

Germany

;

9)

Katayama Medical Clinic, Okayama,

Japan

;

10)

the Department of Neuropathology, Graduate School of Medicine,

University of Tokyo

, and the National Center of Neurology and Psychiatry,

Tokyo, Japan

;

11)

Barrow Neurological Institute,

Phoenix, AZ

;

12)

Toulouse Gerontopole University Hospital, Université

Paul Sabatier

, INSERM Unité 1295,

Toulouse, France

; and

13)

Alzheimer’s Research and Treatment Center,

Wellington

, FL.


2.


About Lecanemab


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.

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 Drug 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.  Eisai will discuss the results of Clarity AD study with regulatory authorities in the U.S.,

Japan

and

Europe

with the aim 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

.

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. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study.


3.


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 lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.


4.


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 lecanemab for the treatment of AD pursuant to an agreement with BioArctic in

December 2007

. The development and commercialization agreement on the antibody lecanemab back-up was signed in

May 2015

.


5.


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), with 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

@Eisai_SDGs

.


6.


About Biogen


As 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 developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

We routinely post information that may be important to investors on our website at

www.biogen.com

. Follow us 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.

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rt 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

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