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 ENGLAN - Yahoo Finance

, /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 contiguous that the results from Eisai's ample planetary Phase 3 confirmatory Clarity AD objective survey of lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the attraction of mild cognitive impairment (MCI) owed to Alzheimer's illness (AD) and mild AD (collectively known arsenic aboriginal AD) with confirmed beingness of amyloid pathology successful the brain, were published successful the New England Journal of Medicine, 1 of the world's astir prestigious peer-reviewed aesculapian journals. For the details of the paper, delight notation to here.

The accelerated work of the Clarity AD survey results demonstrates Eisai's beardown committedness to spot and transparency based connected Eisai's human wellness care mission. Eisai and Biogen stay committed to disclosing information and accusation connected lecanemab. If approved, we volition enactment to bring the cause expeditiously to radical surviving with aboriginal AD and their families.

Eisai serves arsenic the pb of lecanemab improvement and regulatory submissions globally with some Eisai and Biogen co-commercializing and co-promoting the merchandise and Eisai having last decision-making authority.

This merchandise discusses investigational uses of an cause successful improvement and is not intended to convey conclusions astir efficacy oregon safety. There is nary warrant that specified an investigational cause volition successfully summation wellness authorization approval.

*See Section 1 of "Notes to Editors"

[Notes to editors]
1.   Lecanemab Published Article successful The New England Journal of Medicine
Christopher H. van Dyck¹⁾, Chad J. Swanson²⁾, Paul Aisen³⁾, Randall J. Bateman⁴⁾, Christopher Chen⁵⁾, Michelle Gee⁶⁾, Michio Kanekiyo²⁾, David Li²⁾, Larisa Reyderman²⁾, Sharon Cohen⁷⁾, Lutz Froelich⁸⁾, Sadao Katayama⁹⁾, Marwan Sabbagh¹¹⁾, Bruno Vellas¹²⁾, David Watson¹³⁾, Shobha Dhadda²⁾, Michael Irizarry²⁾, Lynn D. Kramer²⁾, and Takeshi Iwatsubo¹⁰⁾. Trial of Lecanemab successful Early Alzheimer's Disease. N Engl J Med 2022.

The authors' affiliations are arsenic 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 successful 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 illness (AD) that is the effect of a strategical probe confederation betwixt Eisai and BioArctic. Lecanemab selectively binds to neutralize and destruct soluble, toxic amyloid-beta (Aβ) aggregates (protofibrils) that are thought to lend to the neurodegenerative process successful AD. As such, lecanemab whitethorn person the imaginable to person an effect connected illness pathology and to dilatory down the progression of the disease. Currently, lecanemab is being developed arsenic the lone anti- Aβ antibody that tin beryllium utilized for the attraction of aboriginal AD without the request for titration.

In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai's Biologics License Application (BLA) for lecanemab nether the accelerated support pathway and granted Priority Review. The Prescription Drug User Fee Act enactment day (PDUFA) is acceptable for January 6, 2023. The FDA has agreed that the results of Clarity AD tin service arsenic the confirmatory survey to verify the objective payment of lecanemab. In an effort to unafraid accepted FDA support for lecanemab arsenic soon arsenic possible, Eisai submitted the BLA done the FDA's Accelerated Approval Pathway truthful that the bureau could implicit its reappraisal of each lecanemab information with the objection of the information from the confirmatory Clarity AD study. In March 2022, Eisai began submitting exertion data, with the objection of Clarity AD data, to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) nether the anterior appraisal consultation system.  Eisai volition sermon the results of Clarity AD survey with regulatory authorities successful the U.S., Japan and Europe with the purpose to record for accepted support successful the U.S. and for selling authorization applications successful Japan and Europe by the extremity of Eisai's FY2022, which ends March 31, 2023.

Since July 2020 the Phase 3 objective survey (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically mean and person intermediate oregon elevated levels of amyloid successful their brains, is ongoing. AHEAD 3-45 is conducted arsenic a public-private concern betwixt the Alzheimer's Clinical Trial Consortium that provides the infrastructure for world objective trials successful AD and related dementias successful the U.S, funded by the National Institute connected Aging, portion of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen objective survey for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine successful St. Louis, is ongoing. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study.

3.   About the Collaboration betwixt Eisai and Biogen for AD
Eisai and Biogen person been collaborating connected the associated improvement and commercialization of AD treatments since 2014. Eisai serves arsenic the pb of lecanemab improvement and regulatory submissions globally with some companies co-commercializing and co-promoting the merchandise and Eisai having last decision-making authority.

4.   About the Collaboration betwixt Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic person had a semipermanent collaboration regarding the improvement and commercialization of AD treatments. Eisai obtained the planetary rights to study, develop, manufacture and marketplace lecanemab for the attraction of AD pursuant to an statement with BioArctic successful December 2007. The improvement and commercialization statement connected the antibody lecanemab back-up was signed successful May 2015.

5.   About Eisai Co., Ltd.
Eisai's Corporate Concept is "to springiness archetypal thought to patients and radical successful the regular surviving domain, and to summation the benefits that wellness attraction provides." Under this Concept (also known arsenic human wellness attraction (hhc) Concept), we purpose to efficaciously execute societal bully successful the signifier of relieving anxiousness implicit wellness and reducing wellness disparities. With a planetary web of R&D facilities, manufacturing sites and selling subsidiaries, we strive to make and present innovative products to people diseases with precocious unmet aesculapian needs, with a peculiar absorption successful our strategical areas of Neurology and Oncology.

In addition, we show our committedness to the elimination of neglected tropical diseases (NTDs), which is simply a people (3.3) of the United Nations Sustainable Development Goals (SDGs), with moving connected assorted activities unneurotic with planetary partners.

For much accusation astir Eisai, delight sojourn www.eisai.com (for planetary headquarters: Eisai Co., Ltd.), and link with america connected Twitter @Eisai_SDGs.

6.   About Biogen
As pioneers successful neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for radical surviving with superior neurological diseases arsenic good arsenic related therapeutic adjacencies. One of the world's archetypal planetary biotechnology companies, Biogen was founded successful 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a starring portfolio of medicines to dainty aggregate sclerosis, has introduced the archetypal approved attraction for spinal muscular atrophy, and developed the archetypal and lone approved attraction to code a defining pathology of Alzheimer's disease. Biogen is besides commercializing biosimilars and focusing connected advancing 1 of the industry's astir diversified pipelines successful neuroscience that volition alteration the modular of attraction for patients successful respective areas of precocious unmet need.

We routinely station accusation that whitethorn beryllium important to investors connected our website astatine www.biogen.com. Follow america connected societal media - Twitter, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor
This quality merchandise contains forward-looking statements, including statements made pursuant to the harmless harbor provisions of the Private Securities Litigation Reform Act of 1995, astir the imaginable objective effects of lecanemab; the imaginable benefits, information and efficacy of lecanemab; imaginable regulatory discussions, submissions and approvals and the timing thereof; the attraction of Alzheimer's disease; the anticipated benefits and imaginable of Biogen's collaboration arrangements with Eisai; the imaginable of Biogen's commercialized concern and pipeline programs, including lecanemab; and risks and uncertainties associated with cause improvement and commercialization. These statements whitethorn beryllium identified by words specified arsenic "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and different words and presumption of akin meaning. Drug improvement and commercialization impact a precocious grade of risk, and lone a tiny fig of probe and improvement programs effect successful commercialization of a product. Results successful early-stage objective studies whitethorn not beryllium indicative of afloat results oregon results from aboriginal signifier oregon larger standard objective studies and bash not guarantee regulatory approval. You should not spot undue reliance connected these statements oregon the technological information presented.

These statements impact risks and uncertainties that could origin existent results to disagree materially from those reflected successful specified statements, including without regulation unexpected concerns that whitethorn originate from further data, investigation oregon results obtained during objective studies, including the Clarity AD objective proceedings and AHEAD 3-45 study; the occurrence of adverse information events; risks of unexpected costs oregon delays; the hazard of different unexpected hurdles; regulatory submissions whitethorn instrumentality longer oregon beryllium much hard to implicit than expected; regulatory authorities whitethorn necessitate further accusation oregon further studies, oregon whitethorn neglect oregon garbage to o.k. oregon whitethorn hold support of Biogen's cause candidates, including lecanemab; existent timing and contented of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of occurrence successful the improvement and imaginable commercialization of lecanemab; nonaccomplishment to support and enforce Biogen's data, intelligence spot and different proprietary rights and uncertainties relating to intelligence spot claims and challenges; merchandise liability claims; 3rd enactment collaboration risks; and the nonstop and indirect impacts of the ongoing COVID-19 pandemic connected Biogen's business, results of operations and fiscal condition. The foregoing sets distant many, but not all, of the factors that could origin existent results to disagree from Biogen's expectations successful immoderate forward-looking statement. Investors should see this cautionary connection arsenic good arsenic the hazard factors identified successful Biogen's astir caller yearly oregon quarterly study and successful different reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based connected Biogen's existent beliefs and expectations and talk lone arsenic of the day of this quality release. Biogen does not undertake immoderate work to publically update immoderate forward-looking statements, whether arsenic a effect of caller information, aboriginal developments oregon otherwise.

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