news – page 7 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been included in the ftse4good index series for the 21^st consecutive year since its initial inclusion in 2002. the ftse4good index series is a global index series for socially responsible investment.

the ftse4good index series was developed by ftse russell to promote investment in companies that meet global environmental, social and governance (esg) standards. eisai received particularly high scores in “corporate governance”, “customer responsibility”, “labor standards” and “tax transparency”, among others. as of the end of june 2022, 1,092 companies worldwide and 224 japanese companies were included in the ftse4good developed index series.

currently, in addition to the msci esg leaders indexes, another global esg investment index, eisai is also listed in the ftse blossom japan index, the ftse blossom japan sector relative index, the msci japan esg select leaders index, the msci japan empowering women index (win) and the s&p/jpx carbon efficient index, which are esg investment indices for japanese stocks adopted by the government pension investment fund (gpif).

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 to them, as well as address diverse healthcare needs worldwide. by strengthening its esg initiatives and increasing non-financial value, eisai is striving to sustainably enhance corporate value based on this concept.

for more information on our esg initiatives, please visit .

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eisai co. ltd (headquarters: toyoko, ceo: haruo naito, “eisai”) announced today that the company will present research from its alzheimer’s disease (ad) pipeline, including new data for lecanemab (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, at the (aaic) to be held in san diego, ca and virtually from july 31 to august 4, 2022. eisai will present data and research in three oral and 18 poster presentations at the meeting.

on july 5, 2022 (u.s), eisai announced that the u.s. food and drug administration (fda) accepted the biologics license application (bla) for lecanemab under the accelerated approval pathway and was granted priority review, with a prescription drug user fee act (pdufa) action date of january 6, 2023. the readout of the primary endpoint data of clarity ad will occur in the fall of 2022. the fda has agreed that the results of clarity ad when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.

key eisai aaic presentations

· effect of genotype on aria-e incidence by lecanemab: results from a modeling simulation to evaluate the effect of apoe4 genotype on aria-e incidence from study 201 core and comparison to the observed incidence in the open-label extension among those newly treated with lecanemab. (virtual developing topics #69402)

· lecanemab subcutaneous dosing:

* results from a study in healthy subjects to evaluate the absolute bioavailability, pharmacokinetics, safety, and immunogenicity of lecanemab following a single fixed 700 mg subcutaneous dose. (poster/abstract #69438)

* modeling and simulation analysis aimed at showing the equivalence of fixed weekly subcutaneous dose of lecanemab to body weight-based 10mg/kg biweekly intravenous dose. (poster/abstract #69429)

· ethnic and racial diversity in eisai clinical trials: an evaluation of us enrollment across lecanemab (study 201 and clarity ad) and elenbecestat missionad studies in early ad to assess racial and ethnic groups and the impact of eligibility criteria in the united states. (poster/abstract # 69198)

· β-amyloid assays predict brain β-amyloid pathology: data from the eisai and sysmex collaboration reporting on the fully automated plasma aβ40 and aβ42 immunoassays and their performance for predicting brain aβ pathology defined by amyloid pet. (poster/abstract # 68727)

· comprehensive csf tau profiling from dominantly inherited alzheimer network (dian): an oral presentation that shares results from a study in patients enrolled in washington university school of medicine’s dian-observational cohort that used eisai’s anti-microtubule binding region (mtbr) antibody, e2814, to profile mtbr-tau and then assessed timing to mtbr-tau changes in csf and correlation to clinical, cognitive, and biomarker changes. (oral presentation # 65313)

“the lecanemab data eisai will present at aaic 2022 continues to build the body of knowledge about our investigational anti-amyloid beta protofibril antibody as we work toward the phase 3 confirmatory clarity ad readout this fall,” said michael irizarry, m.d., senior vice president, deputy chief clinical officer, alzheimer’s disease and brain health, eisai inc. “additional research presented will highlight eisai’s efforts to improve ethnic and racial diversity in our early alzheimer’s disease clinical trials in the united states so that study populations mirror the u.s. medicare population, as well as research from our collaboration with sysmex on potential biomarkers that may contribute to early diagnosis of alzheimer’s disease.”

aaic 2022 presentations relating to eisai’s key compounds and research

■ eisai oral presentations

this release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.

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eisai inc. (u.s.)

libby holman

1-201-753-1945

second publication on the potential value of lecanemab in patients with early alzheimer’s disease using simulation modeling

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (aβ) protofibril antibody lecanemab in people living with early alzheimer’s disease (ad) using a validated disease simulation model, ad archimedes condition event (ad ace) model^1,2,3 from the healthcare payer and societal perspectives in the united states, in the peer-reviewed journal neurology and therapy. this is the second publication of lecanemab’s potential value. it follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in neurology and therapy in april 2022.⁴ while the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). as reported in the previous publication, it was suggested that compared to standard of care* (soc), individuals treated with lecanemab in addition to soc (lecanemab soc) may potentially experience slower disease progression to mild, moderate and severe ad from baseline by 2.51, 3.13 and 2.34 years on average, respectively. the preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (qaly**) and reduction in the formal and informal care costs***. additionally, the ad ace model framework used in this study allowed assessment of the potential value of lecanemab in different scenarios and sensitivity analyses, including the impact of patient subsets, alternative treatment stopping rules**** and potential dosing regimens as well as major sources of uncertainty.

eisai is committed to conducting and sharing these types of clinical and socioeconomic analyses to establish trust as we work to potentially bring lecanemab to people living with early ad who have confirmed presence of amyloid pathology in the brain. to that end, eisai would like to provide a common foundation for stakeholders’ discourse regarding the potential clinical and socioeconomic value of lecanemab from the societal perspective, not to assign a price for lecanemab at this time.

this model-based simulation was conducted using the results of a phase 2b clinical trial (study 201) evaluating the efficacy and safety of lecanemab for early ad with confirmed amyloid pathology as well as published literature. it also estimated the potential economic value of lecanemab soc over a broad range of willingness-to-pay thresholds from $50,000 to $200,000 per qaly gained as recommended by the institute for clinical and economic review (icer)*****. lecanemab soc was predicted to result in a gain of 0.61 qalys and a decrease in total non-treatment costs of $8,707 per person from the healthcare payer perspective (societal perspective: 0.64 qalys gain and $11,214 decrease) compared to the soc for patients with early ad who have confirmed presence of amyloid pathology. the potential annual value-based price (vbp) of lecanemab was estimated at $9,249 to $35,605 (societal perspective: $10,400 to $38,053) based on this early economic assessment.

icer’s value framework⁵ indicates that value cannot be wholly derived from measures of clinical and cost-effectiveness, so contextual considerations and an examination of other benefits and disadvantages are also added into the framework when assessing long-term value. this may lead to using the societal perspective and higher end of the broad range of willingness-to-pay threshold in estimating the justifiable price of lecanemab, given the large societal burden of ad relative to direct healthcare costs.

many people living with ad received informal care from their family and friends totaling more than 16 billion hours of unpaid care valued at $271.6 billion in the u.s. in 2021.⁶these predicted and simulated findings suggest that early treatment with lecanemab may reduce these costs and economic burdens, and provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. the phase 3 lecanemab clarity ad data will soon be available to inform the model inputs and refine the findings. in the event that lecanemab receives the u.s. food and drug administration’s (fda) approval, eisai may determine a vbp using this framework along with other considerations, such as affordability, health system sustainability, etc.

“eisai’s goal is to create therapies, such as our investigational anti-amyloid beta protofibril antibody lecanemab, that may help impact the anxieties of people living with alzheimer’s disease and their families. for alzheimer’s disease, it is important to evaluate the holistic value of therapies taking into account not only medical costs but also the immense societal costs,” said ivan cheung, senior vice president, president neurology business group and global alzheimer’s disease officer, eisai co., ltd., chairman and ceo, eisai inc. “as part of eisai’s commitment to our human health care mission, trust and transparency, we will continue to publish data and information about lecanemab and look forward to sharing the results of the lecanemab confirmatory phase 3 clarity ad clinical trial this fall.”

eisai completed lecanemab’s rolling submission of a biologics license application (bla) for the treatment of early ad to the fda under the accelerated approval pathway in may 2022. the clarity ad phase 3 clinical study for lecanemab in early ad is ongoing and completed enrollment in march 2021 with 1,795 patients. the readout of the primary endpoint data of clarity ad will occur in the fall of 2022. the fda has agreed that the results of clarity ad, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. dependent upon the results of the clarity ad clinical trial, eisai may submit for full approval of lecanemab to the fda during eisai’s fiscal year 2022, which ends in march2023. in japan, in march 2022, eisai initiated submission of application data to the pharmaceuticals and medical devices agency (pmda) under the prior assessment consultation system with the goal of obtaining early approval for lecanemab, and aims to file for the manufacturing and marketing approval based on the results of clarity ad during eisai’s fiscal year 2022. also, in europe, based on the results of the clarity ad study, eisai plans to submit a new drug application in fiscal year 2022.

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.

* standard of care (soc) for ad currently consists of lifestyle modifications and pharmacologic treatment of symptoms.

** the quality-adjusted life year (qaly) is a measure of the value of health outcomes. since health is a function of length of life (i.e., quantity) and quality of life (qol), the qaly was developed as an attempt to combine the value of these attributes into a single index number. one qaly equates to one year in perfect health. qaly scores range from 1 (full health) to 0 (dead). for example, a new intervention may increase length of life by 3 years and improve quality of life by 70% (qaly score of 2.1) compared to an existing intervention that may increase length of life by 3 years and only improve qol by 50% (qaly score of 1.5), the incremental qaly for this new intervention will be 0.6 qalys.

*** formal and informal care costs do not include lecanemab drug cost.

**** alternative treatment stopping rules were explored in scenario analyses where treatment with lecanemab was stopped after a fixed duration of 1.5, 3 and 5 years.

***** icer is a non-profit research organization in the u.s. that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations.

¹kansal ar, tafazzoli a, ishak kj, krotneva s. alzheimer’s disease archimedes condition-event simulator: development and validation. alzheimers dement (ny). 2018;4:76-88. published 2018 feb 16. doi:10.1016/j.trci.2018.01.001.

² tafazzoli and kansal. disease simulation in drug development, external validation confirms benefit in decision making. the evidence forum. 2018.

³tafazzoli a, weng j, sutton k, et al. validating simulated cognition trajectories based on adni against 436 trajectories from the national alzheimer’s coordinating center (nacc) dataset. 11th edition of clinical trials on 437 alzheimer’s disease (ctad); barcelona, spain: 2018.

⁴tahami monfared aa, tafazzoli a, ye w, chavan a, zhang q. long-term health outcomes of lecanemab in patients with early alzheimer’s disease using simulation modeling. neurol ther 11, 863–880 (2022). https://link.springer.com/article/10.1007/s40120-022-00350-y.

⁵icer value framework 2020-2023. 2022.

⁶ alzheimer’s association. 2022 alzheimer’s disease facts and figures 2022 available from:

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eisai inc. us

libby holman

201-753-1945

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that eisai has acquired a majority of the shares issued by arteryex inc. (headquarters: tokyo, ceo: li dongying, “arteryex”), a company that plans and develops software related to digital solutions such as provision of medical information platforms, through purchase of shares and subscription of a third-party allocation of common shares, and made it a subsidiary, as of march 31, 2022. the two companies will work together to develop and provide phr (personal health record)-related services for patients, healthcare professionals and society at large.

eisai launched its medium-term business plan “eway future & beyond” in april 2021, where the perspective to be shifted from that of patients to the people or each consumer. with “empowering the people to realize their fullest life” as the vision, eisai delivers not only pharmaceutical products but also solutions to the people, by utilizing the latest digital technology such as ai, and aims to remove the anxiety of the people.

arteryex has excellent software development capabilities and has developed its own phr-related product services, including apps for storing and converting health-related information of patients undergoing treatment and a wide range of users into data, as well as apps for companies for employee health management.

eisai aims to strengthen and rapidly expand its digital solution business base by acquiring arteryex’s development capabilities and quality phr products through the subsidiary acquisition. in addition to reaching a new customer segment of existing products, eisai will promote developing products including new applications by utilizing arteryex’s input technology and systems used in image data. furthermore, eisai will advance the utilization of data acquired through phr-related products, as the entire eisai group, leveraging the data management know-how that eisai has practiced in its medicine creation activities and disease awareness activities.

for building the eisai universal platform (eup), through those initiatives, eisai will enhance creating a packaged solution, as well as strengthen its delivery infrastructure, for maintenance and improvement of health, prevention and disease awareness, and will expand its contribution to the people.

the current management team of arteryex will remain after the conversion to a subsidiary. the acquisition by eisai of arteryex as a subsidiary will not have a material impact on the consolidated financial results of arteryex.

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[notes to editors]

1. about arteryex inc.

arteryex is a software planning and development company specializing in systems and application software in the medical and healthcare fields. in the era of 100 years of life, it is becoming increasingly important for people to stay healthy. on the other hand, the data needed to advance medical care is fragmented and dispersed in various fields. the company’s goal is to better understand the needs of each individual and to achieve optimal health care and medical treatment for each person with combining the latest technologies, such as blockchain and ai, to maximize the use of data that is currently underutilized.

outline of arteryex

company name:	arteryex inc.
location:	1-4-4, iwamoto-cyo, chiyoda-ku, tokyo, japan
representative:	li dongying
principal businesses:	software planning and development
capital:	32 million yen
foundation:	march, 2018
number of employees:	19

for more information about arteryex, please visit

2. about phr products owned by arteryex

■ click-karte

“click-karte” is a smartphone application for general consumers that automatically converts information, such as the items listed in the medication handbook and the results of blood tests and/or medical examinations, into data by photographing them with a smartphone and uploading to the system. after launching in november 2020, the app has had more than 20,000 downloads at this point. this may contribute to simplification of data input in apps to be developed by eisai in the future.

■ with leaf

“with leaf” is a smartphone application developed for companies to manage employee health internally with the goal of promoting employee health and improving company productivity. the app is designed not only to contribute to promoting employees’ habitual exercise with application-based activities that encourage employees to practice exercise by setting the number of steps and walking distance, but also to raise awareness of employees for their health and exercise status by recording the number of steps taken, distance walked, and calories burned on a daily basis. it also has a chat function for individuals and groups, which can be used to stimulate communication among employees.

■ sasaeru note

“sasaeru note” is a system that links a smartphone application for patients with a viewing system exclusively for healthcare professionals, enabling medical personnel to capture the health status reported by patients while in the home environment. it allows patients and their families to review records of the occurrence of adverse reactions to medications, as well as enables to prevent patients and their families from unintentionally forget to report about a patient’s daily records and health status when they share the information with healthcare professionals.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it was selected as the winner of the tokyo governor prize for corporate governance of the year^® 2021, which is an award program organized by the japan association of corporate directors (jacd; chairman: yoshihiko miyauchi). the award ceremony was held on january 31, 2022.

the awards have been established to recognize the companies which have achieved and maintained the medium to long term profitability by implementing good corporate governance, since 2015. among the eligible companies for selection of the corporate governance of the year 2021, the tokyo governor prize goes to a company which has excellent corporate governance and also practices esg activities such as environmental activities, women empowerment, initiatives for diversity and work style reforms.

commenting on the reason for selecting eisai, mr. eiichiro kodama, director general for global financial city strategy, office of the governor for policy planning, tokyo metropolitan government stated, “eisai is a pioneer in incorporating its corporate philosophy into the articles of incorporation and practicing “purpose management.” with regard to corporate governance, eisai makes the most of its status as a company with a nomination committee, etc., system to clearly separate management oversight and business execution, and places great importance to dialogue with its stakeholders including patients. in terms of esg, eisai is a signatory to the united nations global compact and actively participates in climate change-related initiatives such as “re100” and the japan climate initiative. in addition, eisai is taking on the challenge of quantifying values that do not appear on the balance sheet, such as investments in human capital, with attempting to select kpis related esg including the ratio of women in management positions, analyze its relationship with pbr (price book-value ratio), and utilize the verification results for engagement with investors. eisai is actively working to tell the story of the cause-and-effect relationship between the esg initiatives and the enhancement of corporate value, thus taking on the extremely important challenge to visualize invisible value, embody the value of esg, and disseminate them.”

eisai defines its corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides” in the articles of incorporation, and shares it with its stakeholders. eisai calls this philosophy the human health care (hhc) philosophy, in one word, and believes that practicing philosophical management based on the hhc philosophy will contribute to achieving sustainable development goals (sdgs) and further enhance its corporate value.

eisai is committed to further strengthening its corporate governance in order to realize the hhc philosophy.

10 year anniversary event of the public-private partnership “london declaration”

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its ceo haruo naito participated in the online event entitled “100% committed to end ntds” celebrating the 10th anniversary of the london declaration, an international public-private partnership to eliminate neglected tropical diseases (ntds), on january 27, 2022. ceo naito represented pharmaceutical companies and highlighted the achievements of ntds elimination activities by the industry and successes achieved by multi-sectoral partnerships. he also expressed eisai’s continued support for the elimination of ntds towards the achievement of ntd road map 2021-2030 launched by the world health organization (who) last year. the 10th anniversary event aimed to recognize a decade of progress since the london declaration, to confirm the strong commitment of stakeholders to continue the efforts for ntds, and to strengthen endorsements from stakeholders to the kigali declaration on ntds, the successor of the london declaration which will be unveiled at the commonwealth heads of government meeting (chogm) scheduled for june 2022 in kigali, the capital of the republic of rwanda.

tremendous achievements have been made through public-private partnership since the launch of the london declaration to 2020. the pharma industry has contributed to the elimination of ntds via supply of medicines which resulted in donation of 13 billion high-quality treatments. forty-three countries have eliminated at least one ntd and 600 million people no longer require interventions against ntds. despite such progress, more than 1.7 billion people remain threatened by ntds.

in the event, ceo haruo naito said “our initiatives toward ntds elimination are rooted in the pharmaceutical company’s fundamental mission to deliver medicines to those who need them to treat illness and save lives. while r&d for ntds treatments have become more active after the london declaration, establishment of agile and flexible regulatory approval system as well as expansion of funding which leverages public-private partnership will be required to accelerate further innovations. utilization of digital technologies such as remote medicine will help ensure delivery of and access to healthcare service under the vulnerable social infrastructure.”

under the london declaration, eisai has been manufacturing and supplying diethylcarbamazine (dec) tablets, one of the lymphatic ﬁlariasis (lf) treatments, free of charge to the who for the elimination of lf. to date, 2.05 billion dec tablets manufactured at eisai’s vizag plant in india have been supplied to 29 countries (as of january 2022). although lf has been eliminated in 17 countries and the number of infected people has declined by 74% since 2000, 860 million people worldwide are still exposed to the risk of infection. eisai is committed to providing dec tablets for free to endemic countries that need dec until lf is eliminated in these countries. in addition to the supply of dec tablets, eisai is working on various initiatives such as support for the mass drug administrations (mda), disease awareness and improvements in sanitation.

furthermore, eisai is proactively engaged in development of new treatments for ntds through partnerships with global research organizations. utilizing the funding from the global health innovative technology fund (ghit fund) and others, eisai is conducting joint development of new treatments such as a new treatment for lf in collaboration with the liverpool school of tropical medicine and the university of liverpool as well as treatments for mycetoma and leishmaniasis in collaboration with the drugs for neglected diseases initiative (dndi).

eisai commits to the kigali declaration and strengthens collaborations with global partners to tackle ntds towards the achievement of ntd road map 2021-2030.

based on human health care (hhc) philosophy, eisai seeks to contribute to the health and welfare of people in developing and emerging countries. once they recover their health, they can resume productive activities, which will in turn contribute to economic development and expansion of the middle-income class. eisai considers this to be a long-term investment in creating the markets for the future. eisai is actively engaged in leveraging partnerships with governments, international organizations, academia, and non-profit private sector organizations to accelerate the development of new treatments for infectious diseases including ntds and facilitate initiatives to improve access to medicine such as support for mdas and disease awareness activities. through these initiatives, eisai seeks to further contribute to patients and their families worldwide and increase the benefits that health care provides.

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[notes to editors]

1. about neglected tropic diseases (ntds)

neglected tropic diseases (ntds) include 20 diseases that the who identifies as tropical diseases which human race must overcome. more than 1.7 billion people living in the poorest and most marginalized communities worldwide are exposed to the risk of ntds infection. the spread of ntds is mainly caused by poor hygienic conditions associated with poverty. infections from these diseases may result in serious physical impairment and this often results in normal economic and social activities becoming highly challenging to the individual. in the worst cases, ntds may also result in death. the prevalence of ntds is a stumbling block to economic growth for developing and emerging countries and represents a serious issue for these regions.

the following 20 ntds have been designated by who for control or elimination: dengue and chikungunya, rabies, trachoma, buruli ulcer, yaws (endemic treponematoses], leprosy (hansen’s disease], chagas disease, human african trypanosomiasis (sleeping sickness], leishmaniasis, taeniasis / cysticercosis, dracunculiasis (guinea-worm disease), echinococcosis, food-borne trematodiases, lymphatic filariasis, onchocerciasis (river blindness], schistosomiasis, soil-transmitted helminthiases, mycetoma, scabies and other ectoparasites, and snakebite envenoming.

2. about london declaration on neglected tropical diseases

on january 30, 2012, the ceos of 13 pharmaceutical companies*, the bill & melinda gates foundation, who, the u.s. agency for international development (usaid), the u.k. department for international development (dfid), the world bank, and officials from ntd-endemic countries gathered in london to pledge their support for a coordinated effort to combat 10 ntds**^. the london declaration represents the largest international public-private partnership in the field of global health to date, and unlike past approaches undertaken by an individual organization or for a single disease, the group has committed itself to working collaboratively in an effort to comprehensively tackle issues pertaining to drug supply, distribution, development, and implementation programs as it seeks to more effectively combat ntds.

commemorating the london declaration, january 30 has been designated as the world ntd day since 2020 and campaigns are held worldwide to light up the iconic landmarks and monuments in orange and purple, the symbol colors of ntds. eisai is sponsoring the light up of tokyo tower to raise disease awareness and disseminate the importance of eliminating ntds. (please click for the details of the world ntd day.)

* abbvie, astrazeneca, bayer, bristol-myers squibb, eisai, glaxonsmithkline, gilead, johnson & johnson, merck (merck kgaa: germany), merck sharp & dhome, novartis, pfizer, sanofi

** guinea worm disease, lymphatic filariasis, blinding trachoma, sleeping sickness (human african trypanosomiasis], leprosy, soil-transmitted helminthes, schistosomiasis, river blindness, chagas disease, and visceral leishmaniasis

3. about kigali declaration on neglected tropical diseases

as the successor of the london declaration on ntds launched in 2012, the kigali declaration represents a collective commitment from stakeholders to fight against ntds. with the endorsements from stakeholders being initiated at the online event entitled “100% committed to end ntds”, a campaign to commemorate the 10th year anniversary of the london declaration held on january 27, 2022, the kigali declaration will be unveiled at the commonwealth heads of government meeting (chogm) scheduled for june 2022 in kigali, the capital of the republic of rwanda. to achieve the who’s ntd roadmap 2021-2030, the kigali declaration aims to tackle ntds comprehensively and sustainably by sustaining a multisectoral and multidisciplinary approach through public-private partnership, strengthening country ownership including establishment of local health system and domestic financing, accelerating research and development of treatments and diagnostics for ntds and ensuring equitable access to these ntds related products and services.

4. about lymphatic filariasis

lymphatic filariasis (lf) is an ntd transmitted to humans via carrier mosquitoes. lf causes lymphatic dysfunction and can lead to the swelling of body parts such as legs, and cause severe pain, permanent disability and social stigma associated with disfiguring visible manifestations. as a result, patients suffer mental, social and financial losses. it is estimated that 860 million people worldwide, mainly those in developing countries, are exposed to the risk of lf. elimination of lf is possible by stopping the spread of the infection through mdas of three types of lf treatments including dec tablets.

5. about eisai’s commitment to improving global access to medicines including lf elimination program

in line with its hhc philosophy, eisai is committed to improving global access to medicines over the medium-to-long term through partnership strategies that involve working with governments, international organizations, private entities and non-profit organizations.

in november 2010, eisai agreed to supply a total of 2.2 billion dec tablets to the who free of charge by 2020, as there was a global shortage of high-quality dec tablets for use in mdas. in 2012, eisai became the only japanese company to participate in the london declaration, a coordinated effort to eliminate 10 ntds and the largest public-private partnership of its kind in the field of global health. at the london declaration’s fifth anniversary event held in april 2017, eisai announced its plan to supply dec tablets continuously beyond 2020, until lf is eliminated in all endemic countries where dec tablets are needed.

eisai has supplied 2.05 billion tablets to 29 countries through the who’s elimination program (as of january 2022). furthermore, in order to support the smooth implementation of the who’s mda programs, eisai is engaging in initiatives to raise public awareness of lf in endemic countries. staff members of eisai group cooperate with the relevant representatives in endemic countries to eliminate lf as early as possible.

in addition to the above-mentioned initiatives, eisai is moving ahead with new drug development projects targeting malaria and ntds such as mycetoma and lf, based on partnerships with international non-profit organizations such as the drugs for neglected diseases initiative (dndi) and medicines for malaria venture (mmv), as well as research organizations such as liverpool school of tropical medicine, university of kentucky, and the broad institute (please refer to the table below).

furthermore, eisai co-established the global health innovative technology fund (ghit fund), japan’s first public–private partnership to advance development of new health technologies for the developing world, is a member of the world intellectual property organization (wipo) re:search consortium, an international joint enterprise for the development of treatments for ntds, malaria and tuberculosis led by wipo, is a signatory to the tuberculosis drug accelerator (tbda) partnership, and is participating in the access accelerated initiative to promote prevention and treatment of non-communicable diseases.

*¹mrc: medical research council (uk); *²dod: department of defense (us); *³mmv: medicines for malaria venture (swiss); *⁴dhodh: dihydroorotate dehydrogenase; *⁵aso: anti-sense oligo-nucleotide

for further information on eisai’s access to medicines initiatives, please visit the access to medicines page on the eisai global website:

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: lenvima^®, the orally available kinase inhibitor, “lenvatinib”) will be given at the 2022 american society of clinical oncology (asco) gastrointestinal cancers symposium (#gi22), taking place in-person in san francisco, california, and virtually, from january 20 to 22, 2022.

at this symposium, the results of a primary analysis of a prospective clinical study evaluating transcatheter arterial chemoembolization (tace) therapy in combination strategy with lenvatinib (tactics-l) in patients with unresectable hepatocellular carcinoma (uhcc) in japan (abstract no: 417), as well as research updates on the phase iv study (stellar) to evaluate safety and tolerability of lenvatinib in patients with advanced/unresectable hepatocellular carcinoma (abstract no: tps485) and results from a clinical study to evaluate the efficacy of lenvatinib for conversion surgery in patients with uhcc (investigator-initiated study in japan, abstract no: 458), will be presented.

in addition, trial-in-progress (tip) posters from the clinical program evaluating the combination therapy of lenvatinib plus pembrolizumab (product name: keytruda^®), the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada), include the phase iii leap-014 study of the combination plus chemotherapy in patients with esophageal carcinoma squamous cell carcinoma (abstract no: tps367), phase iii leap-015 study of the combination plus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma (abstract no: tps369), phase iii study leap-012 of the combination plus tace in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment (abstract no: tps494), and phase ii study of the combination plus belzutifan in patients with advanced solid tumors (abstract no: tps669).

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

the full list of eisai poster presentations is below.

compound abstract no.	title / scheduled date
lenvatinib 417	transcatheter arterial chemoembolization therapy in combination strategy with lenvatinib in patients with unresectable hepatocellular carcinoma (tactics-l) in japan: primary analysis january 21 (fri)
lenvatinib tps485*	a multicenter, observational, phase 4 study (stellar) to evaluate the safety and tolerability of lenvatinib (len) in patients with advanced or unresectable hepatocellular carcinoma (uhcc) january 21 (fri)
lenvatinib 458	multicenter prospective study to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: lens-hcc trial (investigator-initiated study in japan) january 22 (sat)
lenvatinib pembrolizumab tps367*	leap-014: an open-label, randomized, phase 3 study of first-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal carcinoma squamous cell carcinoma january 20 (thu)
lenvatinib pembrolizumab tps369*	leap-015: a randomized phase 3 study evaluating the efficacy and safety of first-line pembrolizumab plus lenvatinib plus chemotherapy versus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma january 20 (thu)
lenvatinib pembrolizumab tps494*	leap-012 trial in progress: transarterial chemoembolization with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma not amenable to curative treatment january 20 (thu)
lenvatinib pembrolizumab tps669*	mk-6482-016： phase 2, open-label study of pembrolizumab plus lenvatinib and belzutifan in patients with advanced solid tumors january 20 (thu)

compound
abstract no.

title / scheduled date

lenvatinib

417

transcatheter arterial chemoembolization therapy in combination strategy with lenvatinib in patients with unresectable hepatocellular carcinoma (tactics-l) in japan: primary analysis

january 21 (fri)

lenvatinib

tps485*

a multicenter, observational, phase 4 study (stellar) to evaluate the safety and tolerability of lenvatinib (len) in patients with advanced or unresectable hepatocellular carcinoma (uhcc)

january 21 (fri)

lenvatinib

458

multicenter prospective study to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: lens-hcc trial (investigator-initiated study in japan)

january 22 (sat)

lenvatinib pembrolizumab

tps367*

leap-014: an open-label, randomized, phase 3 study of first-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal carcinoma squamous cell carcinoma

january 20 (thu)

lenvatinib pembrolizumab

tps369*

leap-015: a randomized phase 3 study evaluating the efficacy and safety of first-line pembrolizumab plus lenvatinib plus chemotherapy versus chemotherapy in patients with advanced/metastatic gastroesophageal adenocarcinoma

january 20 (thu)

lenvatinib pembrolizumab

tps494*

leap-012 trial in progress: transarterial chemoembolization with or without lenvatinib plus pembrolizumab for intermediate-stage hepatocellular carcinoma not amenable to curative treatment

january 20 (thu)

lenvatinib pembrolizumab

tps669*

mk-6482-016： phase 2, open-label study of pembrolizumab plus lenvatinib and belzutifan in patients with advanced solid tumors

january 20 (thu)

* the presentation with tps (trial in progress submission) attached to the abstract number indicates that the study is in the intermediate stage, and the presentation does not report the final study results.

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[notes to editors]

1．about the merck & co., inc., kenilworth, n.j., u.s.a. and eisai strategic collaboration

in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as monotherapy and in combination with keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a.

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in more than 10 different tumor types across more than 20 clinical trials.

2. eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment (with experience and knowledge from existing in-house discovered compounds) and the driver gene mutation and aberrant splicing (leveraging rna splicing platform) as areas (ricchi) where real patient needs are still unmet, and where eisai can aim to become a frontrunner in oncology. eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these ricchi, with the aim of contributing to the cure of cancers.

keytruda^® is a registered trademark of merck sharp & dohme corp., a subsidiary of merck & co., inc., kenilworth, n.j., u.s.a.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into a license agreement granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent h3b-8800 to a subsidiary of roivant sciences ltd. (nasdaq: roiv, headquarters: london, u.k., “roivant”). h3b-8800 (roivant’s development code: rvt-2001) is a splicing modulator compound, discovered by eisai’s u.s. research subsidiary h3 biomedicine inc., which is undergoing development as an investigational anticancer agent.

h3b-8800 is an orally available small molecule modulator of splicing factor 3b subunit 1 (sf3b1), discovered by h3 biomedicine inc. splicing occurs to remove introns that are base sequence of pre-messenger rna (mrna), unneeded for protein synthesis, in the process of synthesizing proteins based on the genetic code. mutations in splicing factor-encoding genes are observed in multiple hematological malignancies and solid tumors. sf3b1 is a particularly frequent gene mutation in splicing factors.^1,2 h3b-8800 binds to sf3b1, and demonstrated significant antitumor activity in preclinical models by modulating the disruption of mrna splicing in cancer.³ eisai and h3 biomedicine inc. are currently conducting a phase i clinical trial of h3b-8800 in the u.s. and europe in patients with myelodysplastic syndrome carrying sf3b1 mutations.

under the terms of the agreement, eisai will receive a contractual up-front payment, development, and regulatory milestone payments for h3b-8800, and will also receive a certain amount of royalties on sales revenue of h3b-8800 after the launch.

roivant is a biopharmaceutical company with a unique business model. roivant builds and launches subsidiaries, called “vants” which conduct efficient clinical development in diverse therapeutic areas. eisai believes that this license agreement with roivant will lead to the maximization of the value of h3b-8800. eisai will continue to accelerate its discovery of new medicines based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

[notes to editors]

1. about h3 biomedicine, inc.

h3 biomedicine, inc., a cambridge, massachusetts-based biopharmaceutical company specializing in the discovery and development of precision oncology treatments using its integrated data science, human biology and precision chemistry discovery engine with the goal of improving the lives of patients. the company was established on december 2010 as a subsidiary of eisai’s u.s. pharmaceutical operation, eisai inc. h3 biomedicine focuses on sustained long-term delivery of its pipeline, collaborating with eisai co., ltd., who provides essential research funding and access to the capabilities and resources of a global pharmaceutical company.

for more information, please visit .

2. about roivant

roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the roivant platform to launch vants – nimble and focused biopharmaceutical and health technology companies.

for more information, please visit .

¹ yoshida, et al. (2011). frequent pathway mutations of splicing machinery in myelodysplasia. nature 478(7367): 64-69. doi: 10.1038/nature10496.

²seiler, et al. (2018). somatic mutational landscape of splicing factor genes and their functional consequences across 33 cancer types. cell reports 23(1): 282-296.e4. doi: 10.1016/j.celrep.2018.01.088.

³seiler, et al. (2018). h3b-8800, an orally available small-molecule splicing modulator, induces lethality in spliceosome-mutant cancers. nature medicine 24(4): 497-504. doi: 10.1038/nm.4493.

first approval in japan for the lenvima plus keytruda combination

tokyo and kenilworth, n.j., december 24, 2021 – eisai (headquarters: tokyo, ceo: haruo naito) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada) today announced that the japanese ministry of health, labour and welfare (mhlw) has approved the combination of lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda, the anti-pd-1 therapy from merck & co., inc., kenilworth, n.j., u.s.a., for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. this approval marks the first time the combination of lenvima plus keytruda has been approved in japan. lenvima plus keytruda is now approved in japan, the u.s. and europe for certain types of advanced endometrial carcinoma.

“rates of endometrial carcinoma have been steadily increasing in japan each year¹, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned,” said dr. gregory lubiniecki, vice president, clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “with today’s approval, patients in japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”

“this is the first approval of the lenvima plus keytruda combination in japan,” said terushige iike, president of eisai japan, senior vice president, eisai. “we thank the patients, families and healthcare providers who made this approval possible. by delivering this combination therapy, we are proud to provide patients with advanced or recurrent endometrial carcinoma an additional treatment option.”

the approval is based on results from the pivotal phase 3 study 309/keynote-775 trial, in which lenvima plus keytruda demonstrated statistically significant improvements in overall survival (os), reducing the risk of death by 38% (hr=0.62 [95% ci, 0.51-0.75]; p<0.0001), and progression-free survival (pfs), reducing the risk of disease progression or death by 44% (hr=0.56 [95% ci, 0.47-0.66]; p<0.0001), versus chemotherapy (investigator’s choice of doxorubicin or paclitaxel). the median os was 18.3 months (95% ci, 15.2-20.5) for lenvima plus keytruda versus 11.4 months (95% ci, 10.5-12.9) for chemotherapy. the median pfs was 7.2 months (95% ci, 5.7-7.6) for lenvima plus keytruda versus 3.8 months (95% ci, 3.6-4.2) for chemotherapy.

the japanese package inserts for keytruda and lenvima note that in the study 309/keynote-775 trial, adverse reactions were observed in 395 patients (97.3%) out of the safety analysis set of 406 patients (including 51 out of 52 japanese patients) receiving lenvima　 plus keytruda. the most common adverse reactions were hypertension in 249 patients (61.3%), hypothyroidism in 222 patients (54.7%), diarrhea in 171 patients (42.1%), nausea in 158 patients (38.9%), decreased appetite in 151 patients (37.2%), fatigue in 113 patients (27.8%), proteinuria in 105 patients (25.9%), vomiting in 98 patients (24.1%), weight decreased in 91 patients (22.4%), arthralgia in 87 patients (21.4%) and palmar-plantar erythrodysesthesia syndrome in 84 patients (20.7%).

endometrial carcinoma begins in the inner lining of the uterus, which is known as the endometrium, and accounts for more than 90% of uterine cancers². in japan, it is estimated there were more than 17,000 new cases of uterine cancer and more than 3,000 deaths in 2020 alone³. lenvima and keytruda have each received orphan drug designation in japan for endometrial carcinoma.

in addition to advanced endometrial carcinoma, eisai and merck & co., inc., kenilworth, n.j., u.s.a. continue to study the lenvima plus keytruda combination across several types of cancer with more than 20 clinical trials.

eisai co., ltd.

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about study 309/keynote-775 trial

the approval was based on data from study 309/keynote-775 (), a phase 3 multicenter, open-label, randomized, active-controlled study conducted in 827 patients (including 104 japanese patients) with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting, including in the neoadjuvant and adjuvant settings. the primary efficacy outcome measures were os, and pfs as assessed by blinded independent central review (bicr) according to recist v1.1.

patients were randomized 1:1 to receive lenvima (20 mg orally once daily) plus keytruda (200 mg intravenously every three weeks) or investigator’s choice, consisting of either doxorubicin (60 mg/m² every three weeks) or paclitaxel (80 mg/m² given weekly, three weeks on/one week off). treatment with lenvima plus keytruda continued until recist v1.1-defined progression of disease as verified by bicr, unacceptable toxicity, or for keytruda, a maximum of 24 months. administration of lenvima plus keytruda was permitted beyond recist-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated.

about lenvima^® (lenvatinib) capsules

lenvima, discovered and developed by eisai, is an orally available kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells, and demonstrated greater antitumor activity in combination with an anti-pd-1 monoclonal antibody compared to either treatment alone.

currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 75 countries including japan, in europe, china and in asia, and in the united states for locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer. in addition, lenvima has been approved for monotherapy as a treatment for unresectable hepatocellular carcinoma in over 70 countries including japan, in europe, china and in asia, and in the united states for first-line unresectable hepatocellular carcinoma. lenvima has been approved for monotherapy as a treatment for unresectable thymic carcinoma in japan. it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 60 countries, including in europe and asia, and in the united states the treatment of adult patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy. in europe, the agent was launched under the brand name kisplyx^® for renal cell carcinoma. lenvima has been approved in combination with keytruda (generic name: pembrolizumab), for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc) in united states and in europe. lenvima has been approved in combination with keytruda as a treatment for advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation in the united states, and has been approved for the similar indication (including conditional approval) in over 10 countries such as canada and australia. in some regions, continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials. in europe, it has been approved in combination with keytruda (generic name: pembrolizumab) as the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. in japan, it is approved in combination with keytruda (generic name: pembrolizumab) as the treatment of patients with unresectable advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy.

about keytruda^® (pembrolizumab) injection, 100mg

keytruda is an anti-programmed death receptor-1 (pd-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. keytruda is a humanized monoclonal antibody that blocks the interaction between pd-1 and its ligands, pd-l1 and pd-l2, thereby activating t lymphocytes which may affect both tumor cells and healthy cells.

merck & co., inc., kenilworth, n.j., u.s.a. has the industry’s largest immuno-oncology clinical research program. there are currently more than 1,600 trials studying keytruda across a wide variety of cancers and treatment settings. the keytruda clinical program seeks to understand the role of keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with keytruda, including exploring several different biomarkers.

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration

eisai’s focus on cancer

about eisai

eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit (for global headquarters: eisai. co., ltd.), (for u.s. headquarters: eisai, inc.) or (for europe, middle east, africa, russia, australia and new zealand headquarters: eisai europe ltd.), and connect with us on twitter (. and ) and linkedin (for and ).

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer

our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, visit .

about merck & co., inc., kenilworth, n.j., u.s.a. 　

for over 130 years, merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, merck & co., inc., kenilworth, n.j., u.s.a. continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive　biopharmaceutical company in the world. for more information, visit and connect with us on , , , and .

forward-looking statement of merck & co., inc., kenilworth, n.j., usa

this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (covid-19); the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

¹ yamagami w et al. clinical statistics of gynecologic cancers in japan. j gynecol oncol. 2017 mar;28(2):e32.

² american cancer society, “about endometrial cancer.”

³ international agency for research on cancer, world health organization. “japan fact sheet.” cancer today, 2020.

tokyo and cambridge, mass, dec. 24, 2021 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: michel vounatsos, “biogen”) announced today that lecanemab, an investigational anti-amyloid beta (aβ) protofibril antibody for the treatment of early alzheimer’s disease (ad), was granted fast track designation by the u.s. food and drug administration (fda). fda granted breakthrough therapy designation for lecanemab in june of 2021. breakthrough therapy designation and fast track designation are two fda programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as ad and provide opportunities for frequent interactions with the fda.

in september 2021, eisai initiated a rolling submission to the fda of a biologics license application (bla) for lecanemab under the accelerated approval pathway. the bla is primarily based on clinical, biomarker and safety data from the phase 2b clinical study (study 201) in people with early ad and confirmed amyloid pathology, and non-clinical and clinical parts of the application which consists of three parts (non-clinical, clinical and cmc) have already been submitted. the lecanemab phase 2b study results demonstrated a high degree of aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints. the correlation between the extent of aβ plaque reduction and effect on clinical endpoints in study 201 further supports aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit.

the lecanemab clarity ad phase 3 clinical study in early ad is ongoing and completed enrollment in march 2021 with 1,795 patients. the fda has agreed that the results of clarity ad, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. blinded safety data from clarity ad is included to support the ongoing rolling submission. another phase 3 clinical study, ahead 3-45, is evaluating the efficacy of treatment with lecanemab in participants with preclinical ad and elevated amyloid and in participants with early preclinical ad and intermediate amyloid. additionally, eisai has initiated a lecanemab subcutaneous dosing phase 1 study.

alzheimer’s disease is a serious, progressive and devastating disease with few treatment options. eisai and biogen are committed to bring new treatment options to people living with early ad, their families and healthcare professionals who are waiting for them as early as possible.

second publication on the potential value of lecanemab in patients with early alzheimer’s disease using simulation modeling

10 year anniversary event of the public-private partnership “london declaration”

first approval in japan for the lenvima plus keytruda combination

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