Eisai Presents New LEQEMBI® (lecanemab-irmb) Investigational Subcutaneous Formulation Interim Study Results and Clinical Improvement Data in Earlier Stages of Early Alzheimer’s Disease From Additional Analyses of Clarity AD at The Clinical Trials On Alzheimer’s Disease (CTAD) Conference

Investigational Subcutaneous Formulation Clears 14% More Plaque Than IV, Pharmacokinetics (AUC) 11% Higher, And Similar ARIA Rates To IV

76% Of Patients Showed No Decline And 60% Showed Clinical Improvement At 18 Months in Low-Tau Subpopulation in Additional Analysis of Clarity AD

Dual-Acting LEQEMBI Supports Brain Neuron Function by Removing Highly Toxic Proteins (Protofibrils) That Can Continue to Cause Neuronal Injury and Death Even After Plaque Removal, Offering Early AD Patients the Opportunity for Continued Benefit

TOKYO and CAMBRIDGE, England, Oct. 25, 2023 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) introduced at present that Eisai offered new information for LEQEMBI^® (lecanemab-irmb) 100 mg/mL injection for intravenous (IV) use, within the Late Breaking Symposium 4 “Lecanemab for Early Alzheimer’s Disease: Long-Term Outcomes, Predictive Biomarkers and Novel Subcutaneous Administration” on the 16^th annual Clinical Trials on Alzheimer’s Disease (CTAD) convention held in Boston, Massachusetts, United States and just about October 24-27, 2023.

1. Subcutaneous Formulation Interim Data; Safety And Effects On Brain Amyloid

   1) Weekly subcutaneous (SC) administration confirmed 14% better amyloid plaque removing than biweekly IV administration as urged in a preliminary evaluation utilizing amyloid PET at 6 months of therapy. 

• The SC substudy, evaluating the SC formulation in an open-label extension (OLE) of the Clarity AD research*, included 72 sufferers who acquired LEQEMBI for the primary time because the SC formulation, and 322 sufferers who acquired intravenous (IV) LEQEMBI within the Clarity AD core research adopted by SC administration on this substudy. Reduction from baseline of amyloid within the mind by amyloid PET at 6 months within the newly handled SC sufferers by centiloid discount was -40.3 ± 2.27 in SC administration in comparison with -35.4 ± 1.14 in IV administration.¹

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   2) SC Pharmacokinetics (AUC) Higher Than IV By 11%

   3) Lower Systemic Injection Reaction Rates With SC As Compared To IV

• Systemic injection/infusion reactions are unusual and gentle with SC administration, and specifically haven’t been noticed in sufferers who acquired LEQEMBI for the primary time because the SC formulation. There was a low price of native injection web site reactions (8.1%) in SC handled sufferers general. Most had been gentle and average in severity consisting of redness, irritation, or swelling. No pores and skin rash or different hypersensitivity reactions had been reported.¹

   4) ARIA Rates Of IV Formulation In Clarity AD Core Study Consistent With Rates In First-Time LEQEMBI Patients Entering The SC Substudy In Clarity AD OLE

• The incidence of ARIA-E with SC was much like the IV. The incidences of ARIA-E, ARIA-H (cerebral microhemorrhage because of ARIA, cerebral hemorrhage, and mind floor hemosiderin deposition) and ARIA-H alone (ARIA-H with out ARIA-E) with IV within the Clarity AD core research (n=898) had been 12.6%, 17.3% and eight.9%, respectively. In newly handled sufferers within the SC substudy of the Clarity AD OLE (n=72), the incidences of ARIA-E, ARIA-H and ARIA-H alone had been 16.7%, 22.2% and eight.3%, respectively. However, because of the pattern measurement of newly handled sufferers within the SC substudy, no precise comparability will be made.¹

• Based on Phase II and III scientific research, Cmax (most publicity) was the strongest predictor of ARIA-E incidence following IV administration. In the SC substudy, the steady-state publicity (AUCss) seems to be a greater predictor of ARIA-E charges within the SC because of a comparatively secure publicity profile. ¹

Eisai goals to submit a LEQEMBI SC formulation Biologics License Application (BLA) with the U.S. Food and Drug Administration by March 31, 2024.

2. Latest Data From Tau Pet Longitudinal Substudy, Including A Post-Hoc Analysis Of The Low And Intermediate + High-Tau Subpopulations In The Clarity AD 18 Month Core Study

   1) 76% of sufferers confirmed no decline and 60% confirmed scientific enchancment at 18 months in low-tau / earlier stage early AD inhabitants.

• The Clarity AD research included an non-compulsory Tau PET substudy and used the tau PET probe MK6240** to establish sufferers with a low accumulation of tau within the mind, which represents the sooner stage of early AD.

• The low-tau subpopulation, which is within the earlier phases of early AD, is believed to indicate gradual illness development. In the low-tau subpopulation, 76% of the LEQEMBI group confirmed no deterioration and 60% confirmed scientific enchancment after 18 months of therapy within the major endpoint, Clinical Dementia Rating – Sum of Boxes (CDR-SB), in contrast with 55% and 28% of the placebo group, respectively.¹

• Importantly, on this low-tau subgroup, LEQEMBI therapy additionally confirmed constant scientific response throughout a number of endpoints.*** In this inhabitants, LEQEMBI therapy favored cognition and performance within the earlier stage of early AD.¹

• The efficacy outcomes of the Tau PET substudy within the Clarity AD research, which noticed tau pathology within the mind by tau PET, had been in keeping with general outcomes of the Clarity AD research.¹

   2) Tau PET Substudy Showed LEQEMBI Slows Development Of Tau Tangles In Early AD; Tau Spread In The Brain Is A Hallmark Of Disease Progression.

• In the Clarity AD Tau PET substudy, LEQEMBI therapy slowed the buildup of tau proteins within the temporal lobe (early Braak area), the place tau accumulation was noticed within the earlier stage of early AD. In the Tau PET substudy, LEQEMBI suppressed the buildup of tau within the medial temporal mind area in low-tau subpopulations, and in a broader vary of mind areas within the intermediate and better accumulation teams**. This means that LEQEMBI therapy could have totally different results on mind areas listed by tau relying on the stage of the illness.¹ The unfold of tau within the mind is a trademark of AD development.²

3. Efficacy Results From LEQEMBI Clarity AD Open-Label Extension Study

   1) LEQEMBI Patients Continued to Show Benefit at 24 Months of Treatment 

• In the 18-month core research of Clarity AD, there was a statistically vital distinction in world cognition and performance as measured by CDR-SB between the LEQEMBI and placebo teams. The separation in CDR-SB between the group that continued to obtain LEQEMBI (early begin group) and the group who switched from placebo to LEQEMBI (delayed begin group) was maintained in the course of the 6-month OLE following the core research. This signifies that related illness trajectory for each early and delayed begin teams occurred with LEQEMBI administration.¹

• The blood biomarker outcomes (plasma Aβ42/40 ratio, ptau181, GFAP and NfL) confirmed enchancment even after delayed initiation of therapy with LEQEMBI.¹ These outcomes counsel that LEQEMBI therapy could have an effect on scientific outcomes by means of enchancment of AD pathology.¹

4. The Mechanism-Based Rationale Of LEQEMBI Treatment In Early AD

 1) Dual-Acting LEQEMBI³ Continues To Support Brain Neuron Function^3,4,5 By Removing Highly Toxic Proteins (Protofibrils****)^2,4 That Can Cause Neuronal Injury And Death Even After Plaque Removal,^5-8 Offering Patients The Opportunity For Continued Benefit.

• LEQEMBI has a singular twin motion^1,3 that binds extra selectively to extremely poisonous protein (protofibrils****) along with quickly clearing plaque,⁷ and continues to assist neuronal perform^3,4 by eradicating protofibrils**** that may trigger neuronal damage and dying after plaque has been cleared.^5-8

Eisai is internet hosting a dwell webcast of the scientific session that includes the LEQEMBI displays, which will be seen on the investors section of the Eisai Co., Ltd. website. The content material will probably be available on demand afterward.

Eisai serves because the lead of LEQEMBI improvement and regulatory submissions globally with each Eisai and Biogen co-commercializing and co-promoting the product and Eisai having last decision-making authority.

This launch discusses investigational makes use of of brokers in improvement and isn’t supposed to convey conclusions about efficacy or security. There is not any guarantee that such investigational brokers will efficiently full scientific improvement or acquire well being authority approval.

*Phase III Clarity AD research is a placebo-controlled, double-blind, parallel-group, randomized research to judge the efficacy and security of LEQEMBI 10 mg/kg bi-weekly for 18 months in 1,795 folks residing with early AD (core research). An OLE is being carried out after the core research. SC dosing is at present being evaluated within the Clarity AD OLE.

**Using the MK6240 tau PET probe, tau accumulation within the mind was outlined as low tau accumulation group (MK6240 cutoff worth <1.06, 141 topics), intermediate accumulation group (MK6240 cutoff worth between 1.06 and a couple of.91, 191 topics), and excessive accumulation group (MK6240 cutoff worth >2.91, 10 topics).

***Multiple endpoints: CDR-SB, a numeric scale used to quantify the severity of signs of dementia; ADAS-Cog14, frequent cognitive evaluation instrument utilized in AD scientific trials all around the world; and ADCS MCI-ADL, a scale to evaluate the events’ actions of day by day residing.

****Protofibrils:

• One of the AD pathological options is the buildup of clusters (plaques) of amyloid beta (Aβ) within the mind. The formation of those plaques is the results of a steady course of by which individual Aβ proteins be a part of collectively, latching onto one another, one after the other, like including hyperlinks to a series.⁹ In the early a part of this course of these small chains of Aβ are soluble and are poisonous to the nerves inside the mind.^10,11

• The most poisonous of the soluble chains known as a protofibril. Protofibrils are believed to contribute to the mind damage that happens with AD and are thought-about to be essentially the most poisonous type of Aβ, having a major function within the cognitive decline related to this progressive, debilitating situation.^4,11

• Protofibrils trigger damage to neurons within the mind, which in flip, can negatively impression cognitive perform by way of a number of mechanisms, not solely rising the event of insoluble Aβ plaques but in addition rising direct injury to mind cell membranes and the connections that transmit alerts between nerve cells or nerve cells and different cells. It is believed the discount of protofibrils could stop the development of AD by lowering injury to neurons within the mind and cognitive dysfunction.¹²

INDICATION
LEQEMBI is indicated for the therapy of Alzheimer’s illness. Treatment with LEQEMBI needs to be initiated in sufferers with gentle cognitive impairment or gentle dementia stage of illness, the inhabitants through which therapy was initiated in scientific trials.

CONTRAINDICATION

LEQEMBI is contraindicated in sufferers with severe 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 may cause ARIA-E and ARIA-H. ARIA-E will be noticed on MRI as mind edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. ARIA can happen spontaneously in sufferers with Alzheimer’s illness. ARIA-H related to monoclonal antibodies directed in opposition to aggregated types of beta amyloid typically happens in affiliation with an prevalence of ARIA-E. ARIA-H and ARIA-E can happen collectively. ARIA often happens early in therapy and is often asymptomatic, though severe and life-threatening occasions, together with seizure and standing epilepticus, hardly ever can happen. Reported signs related to ARIA could embrace headache, confusion, visible modifications, dizziness, nausea, and gait problem. Focal neurologic deficits may additionally happen. Symptoms related to ARIA often resolve over time.

ARIA Monitoring and Dose Management Guidelines

• Obtain recent baseline mind magnetic resonance imaging (MRI) previous to initiating therapy with LEQEMBI. Obtain an MRI previous to the fifth, seventh and 14th infusions.

• Recommendations for dosing in sufferers with ARIA-E and ARIA-H rely upon scientific signs and radiographic severity. Depending on ARIA severity, use scientific judgment in contemplating whether or not to proceed dosing, quickly discontinue therapy, or completely discontinue LEQEMBI.

• Enhanced scientific vigilance for ARIA is beneficial in the course of the first 14 weeks of therapy with LEQEMBI. If a affected person experiences signs suggestive of ARIA, scientific analysis needs to be carried out, together with MRI if indicated. If ARIA is noticed on MRI, cautious scientific analysis needs to be carried out previous to persevering with therapy.

• There is not any expertise in sufferers who continued dosing by means of symptomatic ARIA-E or by means of asymptomatic, however radiographically extreme, ARIA-E. There is proscribed expertise in sufferers who continued dosing by means of asymptomatic however radiographically gentle to average ARIA-E. There are restricted information in dosing sufferers who skilled recurrent ARIA-E.

Incidence of ARIA

• In Study 2, symptomatic ARIA occurred in 3% (29/898) of LEQEMBI-treated sufferers. Serious signs related to ARIA had been reported in 0.7% (6/898) of sufferers handled with LEQEMBI. Clinical signs related to ARIA resolved in 79% (23/29) of sufferers in the course of the interval of remark.

• Including asymptomatic radiographic occasions, ARIA was noticed in LEQEMBI: 21% (191/898); placebo: 9% (84/897). ARIA-E was noticed in LEQEMBI: 13% (113/898); placebo: 2% (15/897). ARIA-H was noticed in LEQEMBI: 17% (152/898); placebo: 9% (80/897). There was no improve in remoted ARIA-H for LEQEMBI vs placebo.

ApoE ε4 Carrier Status and Risk of ARIA

• In Study 2, 16% (141/898) of sufferers within the LEQEMBI arm had been ApoE ε4 homozygotes, 53% (479/898) had been heterozygotes, and 31% (278/898) had been noncarriers.

• The incidence of ARIA was greater in ApoE ε4 homozygotes (LEQEMBI: 45%; placebo: 22%) than in heterozygotes (LEQEMBI: 19%; placebo: 9%) and noncarriers (LEQEMBI: 13%; placebo: 4%). Among sufferers handled with LEQEMBI, symptomatic ARIA-E occurred in 9% of ApoE ε4 homozygotes in contrast with 2% of heterozygotes and 1% noncarriers. Serious occasions of ARIA occurred in 3% of ApoE ε4 homozygotes, and roughly 1% of heterozygotes and noncarriers.

• The suggestions on administration of ARIA don’t differ between ApoE ε4 carriers and noncarriers.

Radiographic Findings

• The majority of ARIA-E radiographic occasions occurred early in therapy (inside the first 7 doses), though ARIA can happen at any time and sufferers can have greater than 1 episode. The most radiographic severity of ARIA-E in sufferers handled with LEQEMBI was gentle in 4% (37/898), average in 7% (66/898), and extreme in 1% (9/898). Resolution on MRI occurred in 52% of ARIA-E sufferers by 12 weeks, 81% by 17 weeks, and 100% general after detection. The most radiographic severity of ARIA-H microhemorrhage in LEQEMBI-treated sufferers was gentle in 9% (79/898), average in 2% (19/898), and extreme in 3% (28/898) of sufferers; superficial siderosis was gentle in 4% (38/898), average in 1% (8/898) , and extreme in 0.4% (4/898). Among LEQEMBI-treated sufferers, the speed of extreme radiographic ARIA-E was highest in ApoE ε4 homozygotes 5% (7/141), in comparison with heterozygotes 0.4% (2/479) or noncarriers 0% (0/278). Among LEQEMBI-treated sufferers, the speed of extreme radiographic ARIA-H was highest in ApoE ε4 homozygotes 13.5% (19/141), in comparison with heterozygotes 2.1% (10/479) or noncarriers 1.1% (3/278).

Intracerebral Hemorrhage

Concomitant Antithrombotic Medication:

• In Study 2, baseline use of antithrombotic medicine (aspirin, different antiplatelets, or anticoagulants) was allowed if the affected person was on a secure dose. The majority of exposures to antithrombotic drugs had been to aspirin. Antithrombotic drugs didn’t improve the chance of ARIA with LEQEMBI. The incidence of intracerebral hemorrhage was 0.9% (3/328 sufferers) in sufferers taking LEQEMBI with a concomitant antithrombotic medicine on the time of the occasion in comparison with 0.6% (3/545 sufferers) in those that didn’t obtain an antithrombotic. Patients taking LEQEMBI with an anticoagulant alone or mixed with an antiplatelet medicine or aspirin had an incidence of intracerebral hemorrhage of two.5% (2/79 sufferers) in comparison with none in sufferers who acquired placebo.

• Because intracerebral hemorrhages >1 cm in diameter have been noticed in sufferers taking LEQEMBI, extra warning needs to be exercised when contemplating the administration of anticoagulants or a thrombolytic agent (e.g., tissue plasminogen activator) to a affected person already being handled with LEQEMBI.

Other Risk Factors for Intracerebral Hemorrhage:

• Patients had been excluded from enrollment in Study 2 for findings on neuroimaging that indicated an elevated threat for intracerebral hemorrhage. These included findings suggestive of cerebral amyloid angiopathy (prior cerebral hemorrhage >1 cm in best diameter, >4 microhemorrhages, superficial siderosis, vasogenic edema) or different lesions (aneurysm, vascular malformation) that would doubtlessly improve the chance of intracerebral hemorrhage. The presence of an ApoE ε4 allele can also be related to cerebral amyloid angiopathy, which has an elevated threat for intracerebral hemorrhage. Caution needs to be exercised when contemplating using LEQEMBI in sufferers with elements that point out an elevated threat for intracerebral hemorrhage and specifically for sufferers who must be on anticoagulant remedy.

HYPERSENSITIVITY REACTIONS
Hypersensitivity reactions, together with angioedema, bronchospasm, and anaphylaxis, have occurred in LEQEMBI-treated sufferers. Promptly discontinue the infusion upon the primary remark of any indicators or signs in keeping with a hypersensitivity response, and provoke acceptable remedy.

INFUSION-RELATED REACTIONS

• In Study 2, infusion-related reactions had been noticed in LEQEMBI: 26% (237/898); placebo: 7% (66/897), and nearly all of circumstances in LEQEMBI-treated sufferers (75%, 178/237) occurred with the primary infusion. Infusion-related reactions had been largely gentle (69%) or average (28%) in severity. Infusion-related reactions resulted in discontinuations in 1% (12/898) of LEQEMBI-treated sufferers. Symptoms of infusion-related reactions included fever and flu-like signs (chills, generalized aches, feeling shaky, and joint ache), nausea, vomiting, hypotension, hypertension, and oxygen desaturation.

• In the occasion of an infusion-related response, the infusion price could also be decreased, or the infusion could also be discontinued, and acceptable remedy initiated as clinically indicated. Prophylactic therapy with antihistamines, acetaminophen, nonsteroidal anti-inflammatory medication, or corticosteroids previous to future infusions could also be thought-about.

ADVERSE REACTIONS

• In Study 2, the commonest adversarial reactions resulting in discontinuation of LEQEMBI was ARIA-H microhemorrhages that led to discontinuation in 2% (15/898) of sufferers handled with LEQEMBI in comparison with <1% (1/897) of sufferers on placebo.

• In Study 2, the commonest adversarial reactions reported in ≥5% of sufferers handled with LEQEMBI (N=898) and ≥2% greater than placebo (N=897) had been 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, together with Boxed WARNING.

[Notes to editors]
1. About Lecanemab (generic name, U.S. brand name: LEQEMBI^®),
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted traditional approval by the U.S. Food and Drug Administration (FDA) on July 6, 2023. LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) 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. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023 to manufacture and market of lecanemab as a treatment for slowing progression of MCI and mild dementia due to AD.

Please see full U.S. Prescribing Information for LEQEMBI, together with Boxed WARNING.

Eisai has additionally submitted purposes for approval of lecanemab in EU, China, Canada, Great Britain, Australia, Switzerland, South Korea and Israel. In China and Israel, the purposes have been designated for precedence overview, and in Great Britain, lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which goals to scale back the time to marketplace for progressive medicines.

Eisai has accomplished a lecanemab subcutaneous bioavailability research, and subcutaneous dosing remains to be being evaluated within the Clarity AD (Study 301) open-label extension (OLE). A upkeep dosing routine has been evaluated as a part of Study 201.

Since July 2020 the Phase 3 scientific research (AHEAD 3-45) for people with preclinical AD, which means they’re clinically regular and have intermediate or elevated ranges of amyloid of their brains, is ongoing. AHEAD 3-45 is carried out as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that gives the infrastructure for educational scientific trials in AD and associated dementias within the U.S, funded by the National Institute on Aging, a part of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen scientific research for Dominantly Inherited AD (DIAD), that’s carried out by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and consists of lecanemab because the spine anti-amyloid remedy.

2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint improvement and commercialization of AD remedies since 2014. Eisai serves because the lead of LEQEMBI improvement and regulatory submissions globally with each firms co-commercializing and co-promoting the product and Eisai having last decision-making authority.

3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration relating to the event and commercialization of AD remedies. Eisai obtained the worldwide rights to review, develop, manufacture and market LEQEMBI for the therapy of AD pursuant to an settlement with BioArctic in December 2007. The improvement and commercialization settlement on the antibody LEQEMBI back-up was signed in May 2015.

4. About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to offer first thought to sufferers and folks within the day by day residing area, and to extend the advantages that well being care offers.” Under this Concept (often known as human well being care (hhc) Concept), we goal to successfully obtain social good within the type of relieving nervousness over well being and lowering well being disparities. With a world community of R&D amenities, manufacturing websites and advertising and marketing subsidiaries, we try to create and ship progressive merchandise to focus on ailments with excessive unmet medical wants, with a specific focus in our strategic areas of Neurology and Oncology.

In addition, we reveal our dedication to the elimination of uncared for tropical ailments (NTDs), which is a goal (3.3) of the United Nations Sustainable Development Goals (SDGs), by engaged on varied actions along with world companions.

For extra details about Eisai, please go to www.eisai.com (for world headquarters: Eisai Co., Ltd.), and join with us on X, LinkedIn and Facebook.

5. About Biogen
Founded in 1978, Biogen is a number one world biotechnology firm that has pioneered a number of breakthrough improvements together with a broad portfolio of medicines to deal with a number of sclerosis, the primary accredited therapy for spinal muscular atrophy, and two co-developed remedies to handle a defining pathology of Alzheimer’s illness. Biogen is advancing a pipeline of potential novel therapies throughout neurology, neuropsychiatry, specialised immunology and uncommon ailments and stays acutely targeted on its goal of serving humanity by means of science whereas advancing a more healthy, extra sustainable and equitable world.

The firm routinely posts data that could be essential to traders on its web site at www.biogen.com. Follow Biogen on social media – X, LinkedIn, Facebook, YouTube.

Biogen Safe Harbor
This information launch incorporates forward-looking statements in regards to the potential scientific results of LEQEMBI; the potential advantages, security and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the therapy of Alzheimer’s illness; the anticipated advantages and potential of Biogen’s collaboration preparations with Eisai; the potential of Biogen’s industrial business and pipeline applications, together with LEQEMBI; and dangers and uncertainties related to drug improvement and commercialization. These statements could also be recognized by phrases akin to “goal,” “anticipate,” “imagine,” “may,” “estimate,” “count on,” “forecast,” “intend,” “could,” “plan,” “doable,” “potential,” “will,” “would” and different phrases and phrases of comparable which means. Drug improvement and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and improvement applications end in commercialization of a product. Results in early-stage scientific research is probably not indicative of full outcomes or outcomes from later stage or bigger scale scientific research and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements.

These statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation sudden considerations that will come up from extra information, evaluation or outcomes obtained throughout scientific research, together with the Clarity AD scientific trial, AHEAD 3-45 research and SC substudy; the prevalence of adversarial security occasions; dangers of sudden prices or delays; the chance of different sudden hurdles; regulatory submissions could take longer or be tougher to finish than anticipated; regulatory authorities could require extra data or additional research, or could fail or refuse to approve or could delay approval of Biogen’s drug candidates, together with LEQEMBI; precise timing and content material of submissions to and choices made by the regulatory authorities relating to LEQEMBI; uncertainty of success within the improvement and potential commercialization of LEQEMBI; failure to guard and implement Biogen’s information, mental property and different proprietary rights and uncertainties regarding mental property claims and challenges; product legal responsibility claims; third celebration collaboration dangers; and the direct and oblique impacts of the continuing COVID-19 pandemic on Biogen’s business, outcomes of operations and monetary situation. The foregoing units forth many, however not all, of the elements that would trigger precise outcomes to vary from Biogen’s expectations in any forward-looking assertion. Investors ought to take into account this cautionary assertion in addition to the chance elements recognized in Biogen’s most recent annual or quarterly report and in different studies Biogen has filed with the U.S. Securities and Exchange Commission. These statements communicate solely as of the date of this information launch. Biogen doesn’t undertake any obligation to publicly update any forward-looking statements.

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