news – page 13 – eisai china lnc.-pg电子app

the 7th “award ceremony for 2020 greater suzhou best employer and employer brand forum” was grandly held in the studio of suzhou radio and television general station recently. eisai china inc. stood out among thousands of participating enterprises with its good employer brand image, excellent performance of employer social responsibilities and excellent employee engagement, and has been awarded the “greater suzhou best employer” award for four consecutive years.

eisai china inc. wins “greater suzhou best employer” award for four consecutive years

the “greater suzhou best employer” project has been held for 7 consecutive years since 2013. the selection of the best employers in 2020 underwent four processes: expert review, employee survey, public voting and brand diagnosis, which lasted for three months. more than 200 entrepreneurs and human resources professionals in suzhou witnessed the birth of the “2020 greater suzhou best employer”. the “greater suzhou best employer” project is the most influential and appealing employer brand and selection activity in suzhou at present, and has become the annual employer brand display ceremony in suzhou. it has won this heavyweight trophy for four consecutive years, which represents the great recognition and affirmation of its years of devotion to its employer brand by the expert jury, society and employees.

photo of eisai china inc. at scene of award ceremony

since its entry into suzhou industrial park in 1996, eisai china inc. promotes tens of pharmaceutical brands in china, specializing in neurology, oncology and gastrointestinal areas, and has been rooted in suzhou industrial park for 24 years. it has always adhered to its business philosophy of hhc (human health care), provided chinese doctors with medical treatment support, and provided patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. it requires every employee to devote 1% of their working time to hhc activities every year, walk into communities together, approach patients, listen to the voices of patients and their families, and understand their sufferings, so as to better meet their needs.

it always regards the improvement of employees’ ability as one of its long-term strategies. in order to enhance the sense of belonging of employees and strengthen the corporate cohesiveness, the “honorary staff award” has been set up for employees who have served the company for 5, 10, 15 and 20 years respectively. the enhancement of employees’ ability and loyalty is the greatest reward and affirmation for an enterprise. it attaches importance to the personal value of each employee, and through the skill development system, it gives employees systematic training paths and clear development channels, and encourages everyone to solve problems with innovative thinking. meanwhile, it offers competitive remuneration and welfare, and provides employees with comprehensive care and protection. it is committed to providing a healthy and happy working environment for its employees and hopes to work with them to build itself into a respectable hhc company.

on september 1, 2020, the second hhc summit of eisai china holdings ltd. (hereinafter referred to as “eisai china”) was successfully held in shanghai. feng yanhui, senior vice president of eisai global, president of eisai china, and chairman of eisai china hhc committee, led the senior management team of eisai china and leaders of various departments to attend the summit.

feng yanhui delivered a speech

feng yanhui said at the summit that hhc is based on well-being improvement for patients and their families to achieve business innovation; hhc is the mission, core philosophy and original intention of eisai china. all employees of eisai china should not forget the original intention, carry forward the hhc spirit, meet the unmet needs of patients and their families, and keep increasing their business innovation ability in their daily work.

the highlight of this summit was the combination of theory and practice. at the same time, 8 groups of patients were invited, and all participants were divided into 8 groups. a socialization process was undergone, that is, the staff members communicated with the patients, their families and people living together with them, discovered their needs, and shared and discussed hhc needs and put forward innovative ideas.

communication with patients (socialization)

at the summit, awards were presented to those award-winning hhc projects and outstanding hhc fulfillers of eisai china in the 2019 fiscal year.

hhc committee members had a group photo taken with hhc award-winning representatives

hhc stands for the initials of “human health care”, is the foundation of the global concept of eisai, and is consistent with the nursing concept of florence nightingale, the founder of modern nursing. the hhc logo is directly derived from the handwriting of florence nightingale.

the hhc philosophy is realized through the knowledge creation model -seci model, which is socialization, externalization, combination, and internalization respectively. the unmet needs of patients and their families are discovered through practice with the above model, and are met through actual work to realize business innovation.

on august 30, 2020, “the 37^th china pharmaceutical industry information annual conference2020″ hosted by china pharmaceutical industry information center was held in zhuhai, guangdong province, and the conference released the list of the top 100 pharmaceutical enterprises in china in 2019, which attracted much attention from the industry. eisai china holdings ltd. (hereinafter referred to as “eisai china”) ranked the 71st, being on this list for five consecutive years. the ranking has risen from the 97th in 2015 to the 71st in 2019, manifesting the strong development of eisai china in recent years.

eisai china ranks 71st in list of top 100 pharmaceutical enterprises in china

with the theme of “innovation power”, this conference focused on the thoughts and explorations of new paths of innovation and development of chinese medicine in the post-covid19 period. the list of top 100 pharmaceutical enterprises in china reflects the economic operation of china’s pharmaceutical industry, in which enterprises are ranked according to the annual chinese pharmaceutical statistics report published by the ministry of industry and information technology. the entry threshold of the top 100 in 2019 was increased from 2.61 billion yuan in 2018 to 2.86 billion yuan. according to the statistics and analysis of china pharmaceutical industry information center, the top 100 enterprises in 2019 continued their consistent strong growth momentum, with their main business income reaching 929.64 billion yuan, up by 10.7%. driven by the leading role of the top 100 enterprises, the pharmaceutical industry enterprises have maintained strong revenue capacity and sufficient development momentum. the list of top 100 pharmaceutical enterprises in china can stimulate the innovative impetus of more enterprises, drive more enterprises to transform and upgrade, and promote the high-quality development of china’s pharmaceutical industry.

ms. rao ying from access management division of eisai china received the award on behalf of the company

eisai china has been developing smoothly since it entered the chinese market in the early 1990s. it has set up shenyang eisai pharmaceutical co., ltd and eisai (suzhou) pharmaceutical co., ltd. since 1991, and was officially renamed eisai china inc. in 2002. with the business development in china, eisai (suzhou) trade co., ltd. was established in 2010, eisai holdings ltd. was established in 2014, and eisai (liaoning) pharmaceutical co., ltd. was officially established in 2015 through full acquisition of local generic pharmaceutical enterprises. so far, a development mode has been formed, consisting of eisai china holdings ltd. for capital control and management, while eisai china inc., eisai (liaoning) pharmaceutical co., ltd. and eisai (suzhou) trading co., ltd. for business support. in november 2018, the new factory in suzhou of eisai china was opened for business. it is one of the main factories of the group, and the products it produces will not only meet the demand of the chinese market, but also be supplied to 23 countries and regions such as east asia, southeast asia, middle east, central and south america and europe. eisai china’s sales have been among the highest among the japanese-funded pharmaceutical companies in china for more than 10 consecutive years.

eisai china will always uphold its business philosophy of hhc (human health care) and provide patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. hopefully eisai china can work with all its employees to build itself into a respectable hhc company.

sahne medical spray is the first otc drug spray-type lotion containing heparinoid

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched sahne^® medical spray and sahne^® medical cream (both are category-2 otc drugs, “sahne medical”) on august 25, 2020 at pharmacies and drugstores throughout japan, as a new product of the sahne brand lineup which has been a favored hand care for generations.

eisai conducted a survey of 1,000 women in their 40s to 50s in april 2020. as a result, it was found that approximately 70% of the subjects felt that the dryness of their skin and/or the dry skin expanse had increased compared to its condition five years ago. additionally, a number of comments regarding the discomfort of dryness from people with dry skin were received as follows: “the dryness has spread to my thighs, shins, sides, and back.”, “i’m distracted just by my underwear rubbing against my skin.”, and “my dry skin flakes stick inside my clothes whenever i get undressed, which makes me uncomfortable.” it is considered that the skin condition of women after their late 30s requires more reliable moisturizing effects of pharmaceuticals, since the amounts of sebum, natural moisturizing factors, and intercellular lipids in the stratum corneum necessary for water retention of the skin decrease.

“sahne medical” is a category-2 otc drug containing the active ingredient “heparinoid”, which exerts a high moisturizing effect against dry skin (xeroderma) that worsens with age. heparinoid penetrates into the stratum corneum, increases natural moisturizing factors, and restores the structure of intercellular lipids in the stratum corneum to moisturize dry skin.

there are two types of product lines, spray and cream, which can be selected depending on the part of the body where the product is applied and/or the principles of tpo (time, place and occasion). “sahne medical spray” is the first otc drug spray-type lotion containing heparinoid. this product is handy for the consumer to use on the back, side and back of thigh, where it is difficult to apply the medicine by themselves, as it features a container that can be sprayed upside down and a fine mist-like lotion. in addition, the tube-type “sahne medical cream” is recommended for relieving unbearable discomfort of dryness upon going out, as it is convenient to carry.

the sahne brand has continued to be a gentle companion to the daily lives of many people for 66 years since its launch. with the new launch of sahne medical, a pharmaceutical product, eisai is now able to provide a remedy for skin problems that it had not been able to contribute to before. eisai will further respond to the wishes of consumers who want to be relieved of the discomfort of dry skin, with the moisturizing effect of pharmaceutical care products and the gentle nature of sahne products.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that a total of 10 presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: dayvigotm civ) will be given at the 34th annual meeting of the associated professional sleep societies (sleep 2020), to be held virtually from august 27 to 30, 2020.

the main presentations from eisai at this conference include presentations relating to the sunrise 2 phase iii clinical trial conducted globally, including sites in japan: long-term efficacy and safety results of lemborexant in elderly adults with insomnia (oral presentation, presentation number o-01, 474), responder profiles on treatment with lemborexant (poster number 479), efficacy and safety results of lemborexant in perimenopausal female subjects with insomnia (poster number 480), and others.

lemborexant is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (ox1r and ox2r). lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythms. lemborexant was approved in the u.s. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, and was approved in japan for the treatment of insomnia. the clinical development of lemborexant in patients with irregular sleep wake rhythm disorder (iswrd) associated with mild-to-moderate alzheimer’s dementia is ongoing.

insomnia is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep, that can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.^1,2 insomnia is one of the most common sleep-wake disorders. approximately 30% of adults worldwide have symptoms of insomnia.^3,4 in particular, older adults tend to have a higher prevalence rate with many experiencing insomnia symptoms for months to years. as a result, insomnia causes various social losses, such as long absences and reduced productivity.

eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of new drugs based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of patients and their families in diseases with high unmet needs, such as insomnia.

■ virtual oral presentation:

presentation number	title・planned date and time (central daylight time)
oral o-01 474	long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder: results from sunrise-2 august 28 (fri) 11:52 am – 12:03 pm

■ virtual poster presentation:

presentation number	title
poster 473	effectiveness and safety of lemborexant in subjects previously treated with placebo for 6 months in sunrise-2
poster 477	characteristics of insomnia subjects screened for transitioning from zolpidem tartrate to lemborexant in a multicenter pilot study
poster 478	a multicenter pilot study to evaluate next-dose transition from zolpidem to lemborexant for the treatment of insomnia
poster 479	sleep onset and sleep maintenance responder profiles over 12 months of treatment with lemborexant: results from sunrise-2
poster 480	efficacy and safety of lemborexant in female subjects of perimenopausal age with insomnia disorder
poster 481	impact of lemborexant on fatigue severity in subjects with clinically significant levels of fatigue at baseline
poster 484	how much improvement in subject-reported sleep onset latency is needed for patients to report a positive impact of their insomnia medication?
poster 485	experience and attitudes about prescription insomnia medications: results from an online survey of individuals with sleeping difficulties and insomnia
poster 486	impact of intrinsic factors on efficacy of lemborexant: subgroup analyses of sunrise-2

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

[notes to editors]

1. about lemborexant

lemborexant is eisai’s in-house discovered and developed small molecule that binds to orexin receptors, ox1r and ox2r, and acts as a competitive antagonist (ic50 values of 6.1 nm and 2.6 nm, respectively). the mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. the orexin neuropeptide signaling system plays a role in wakefulness. blocking the binding of wake-promoting neuropeptides orexin to receptors ox1r and ox2r is thought to suppress wake drive (ki values of 8.1 nm and 0.48 nm, respectively). higher affinity and faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-rem sleep, indicates its potential to facilitate non-sedative onset and maintenance of sleep. in june 2020, dayvigo was launched in the u.s. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in july 2020, dayvigo was launched in japan for the treatment of insomnia. in addition, eisai has submitted new drug applications seeking approval of dayvigo in canada, australia and hksa. in addition, a phase ii clinical study of lemborexant in patients with irregular sleep wake rhythm disorder (iswrd) associated with mild-to-moderate alzheimer’s dementia is underway.

2. about sunrise 2（study 303）

sunrise 2 is a 12-month multicenter, global (japan, north america, south america, europe, asia, and oceania), randomized, placebo-controlled, double-blind, parallel group phase iii study of 949 male or female adult participants (18 to 88 years of age) with insomnia disorder. sunrise 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment, and a two-week period without treatment prior to the end-of-study-visit. lemborexant 5 mg, 10 mg or matching placebo was taken orally in tablet form at home each night immediately before the patient intended to try to sleep for the first six months of study. patients who received placebo during the first six-month period were administered lemborexant 5 mg or 10 mg for the second six-month period. patients who received active treatment during the first period continued on the treatment to which they were originally randomized.

the primary outcome measure was mean change from baseline in subjective sleep onset latency after six months of placebo-controlled treatment. key secondary outcome measures were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset after six months of placebo-controlled treatment.

from the results, the primary endpoint and all secondary endpoints for efficacy were achieved for lemborexant arms, and statistically significant improvements in sleep onset and sleep maintenance were confirmed for lemborexant arms compared to placebo during the six-month treatment period. the common adverse events in the lemborexant arms were somnolence, nasopharyngitis, headache and influenza.

¹ institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
² ohayon mm, et al. epidemiology of insomnia: what we know and what we still need to learn. sleep med rev. 2002;6(2):97-111.
³ ferrie je, et al. sleep epidemiology – a rapidly growing field. int j epidemiol. 2011;40(6):1431–1437.
⁴ roth t. insomnia: definition, prevalence, etiology and consequences. j clin sleep med. 2007;3(5 suppl):s7–s10.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and msd k.k. (headquarters: tokyo, president: jannie oothuizen, “msd”), a subsidiary of merck & co., inc., kenilworth, n.j., u.s.a., announced today that eisai has submitted an application in japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor lenvima ^® (generic name: lenvatinib mesylate). in june 2020, lenvima received orphan drug designation in japan for unresectable thymic carcinoma.

this application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase ii study (ncch1508) conducted in japan, evaluating lenvima as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.

the primary endpoint of this study, objective response rate (orr, assessed by independent imaging review) was 38.1% (90% confident interval (ci): 25.6-52.0). this study met its endpoint as the lower value of the ci exceeded the pre-specified statistical criteria, a threshold orr of 10%. the most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.

thymic carcinoma is an extremely rare disease with low prevelance. it is estimated that there are only 140 to 200 patients in japan. for unresectable thymic carcinoma, platinum-based first-line therapy is recommended. however, since the standard treatment has not yet been established for second-line or later therapy, it remains a disease with a poor prognosis, thus the development of new therapeutic agents is desired.

eisai and msd have been collaborating through the provision of information on lenvima in japan since october 2018, and will work together to expedite the maximization of lenvima’s contribution to patients with cancer.

media inquiries
eisai co., ltd.
public relations department
tel： 81-(0)3-3817-5120

msd k.k.
communication department
tel： 81-(0)3-6272-1001

1. about lenvima^® (generic name: lenvatinib mesylate)
lenvima, discovered and developed by eisai, is a 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. currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 65 countries including japan, the united states, in europe and in asia, and for unresectable hepatocellular carcinoma in over 65 countries including japan, the united states, in europe, china and in asia. additionally, it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 55 countries, including the united states, in europe (where it was launched under the brand name kisplyx^® for renal cell carcinoma) and in asia. in addition, it is approved in combination with keytruda^® (generic name: pembrolizumab) as a treatment for advanced endometrial cancer that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in countries including the united states, australia, and canada. continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

2. about ncch1508 (remora study)*
this study is an open-label, single-group, multicenter, investigator initiated clinical phase ii study (8 centers nationwide including the national cancer center hospital). forty-two patients with thymic carcinoma were enrolled who had progressed after at least one prior platinum-based therapy. the primary endpoint is objective response rate (orr) by independent image review using recist1.1, and secondary efficacy endpoints include progression free survival (pfs), disease control rate (dcr), and overall survival (os). lenvatinib was administered at a starting dose of 24 mg once daily, and the dose was appropriately reduced according to the patient’s condition until the disease progressed or unacceptable toxicity was observed.

for efficacy analysis, orr was 38.1% (90% confidence interval (ci): 25.6-52.0) and the best overall response was 38.1% for partial response, 57.1% for stable disease, and 4.8% for disease progression. pfs (median) was 9.3 months (95% ci: 7.7-13.9), dcr was 95.2% (95% ci: 83.8-99.4), and the median os was not reached (95% ci: 16.1-nr (not reached)). the major treatment-related adverse events** (more than 30%) were hypertension (88.1%), proteinuria (71.4%), palmar-plantar erythrodysesthesia syndrome (69.0%), hypothyroidism (64.3%), diarrhea (57.1%), thrombocytopenia (54.8%), decreased appetite (42.9%), weight loss (40.5%), dysphonia (40.5%), increased aspartate aminotransferase (33.3%), malaise (33.3%), and stomatitis (33.3%).

* jun sato, miyako satouchi, shoichi itoh, yusuke okuma, seiji niho, hidenori mizugaki, haruyasu murakami, yasuhito fujisaka, toshiyuki kozuki, kenichi nakamura, yukari nagasaka, mamiko kawasaki, tomoaki yamada, ryunosuke machida, aya kuchiba, yuichiro ohe, noboru yamamoto; lenvatinib in patients with advanced or metastatic thymic carcinoma (remora): a multicentre, phase 2 trial. the lancet oncology, 2020, vol.21, no. 6, p843-850
** the adverse event data used for the application has beed updated from the data in the paper.

3. about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. 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 a monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda^® (generic name: pembrolizumab).

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 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

4. about eisai co., ltd.
eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. eisai defines 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, eisai takes 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), (for u.s.) or (for europe, middle east, africa), and connect with us on twitter ( and ) and (for u.s.).

5. about msd
for more than 125 years, msd 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. msd is a trade name of merck & co., inc., with headquarters in kenilworth, n.j., u.s.a. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, msd 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 .

eisai dementia platform easiit commences

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and dena co., ltd.’s subsidiary desc healthcare co., ltd. (headquarters: tokyo, ceo: sho segawa, cmo: kuniaki miyake, “dena”) announced that they have begun provision of the brain performance application “easiit” (non-medical device, referred to below as “easiit app”), for preparation against dementia, on july 28, 2020. this provision is based on a business alliance agreement aiming for support and creation of new solutions in the dementia area as well as co-development of the easiit app as a base element of the digital platform for dementia that eisai is currently constructing. with the beginning of provision of the easiit app, the eisai dementia platform easiit has commenced.

eisai possesses over 35 years of experience in medicine creation and business activity in the dementia field, and dena has demonstrated performance in providing healthcare services and altering consumer behavior while applying know-how from its gaming and sports industry experiences with the theme of “staying healthy with fun”. both companies aim to contribute towards better health practices by all people through such approaches as visualizing brain and body health data, supporting brain performance maintenance, and providing useful lifestyle information. both companies will continue their efforts in partnership for creating the digital platform, including the expansion of functions of the easiit app.

background on the co-development and provision of the easiit app

in its medium-term business plan, eway2025, eisai is aiming to become a “medico societal innovator”, a company that changes society through creating medicines and providing various innovative solutions that change society. particularly in the dementia field, eisai is collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, fitness clubs, automobile makers, retailers, and care facilities to realize construction of a “dementia ecosystem” for delivering new benefits. the base of this ecosystem will be the dementia platform easiit. through this platform, eisai aims to collect information from participants, combine this information with eisai’s independent data set comprising elements such as know-how, experience, and clinical data, and perform analysis in compliance with relevant regulations in order to deliver new benefits to participants in the form of various healthcare predictions and advice.

dena’s healthcare business aims for the extension of “healthy life expectancy” by realizing the conversion of “sick care” through treatment after becoming sick to “healthcare” through preventing sickness from occurring. dena provides various internet based healthcare services that apply its unique know-how for making enjoyable user experiences and extending use as cultivated through its activities in the gaming and sports fields.

in recent years, various research has demonstrated the possibility that decline in brain health may be mitigated through readjustments to lifestyle such as regular exercise, a well-balanced diet, and social interaction. on the other hand, according to a survey conducted by eisai, the number of people who understand the correct preventive measures or perform cognitive function checks regularly are few, which indicates disparities (“chasms”).

the easitt app, which aims to contribute to the promotion of healthy habits by making brain and body health visible, is core to eisai’s digital platform business directed at eliminating these chasms. both companies combined their respective strengths to co-develop this app, and have now begun provision of the first version.

the brain performance app “easiit app”

in the easiit app, a menu of individualized recommendations based on users’ footsteps, diet, sleep, and weight records (lifelog) is updated on a weekly basis and displayed. individualized scoring is conducted based on actions and habits which are good for brain performance. the easiit app confirms score changes and breakdown, and encourages formation of good habits for brain performance moving forward. for diet record in particular, easy diet management is made possible as the easiit app evaluates users’ meals via photo upload for calorie intake and eleven essential nutrients, and displays this information in relation to an age-based standard for calorie and nutrient intake. additionally, with every use of the app one can collect easiit miles, which can be exchanged for prizes such as gift cards. through connection to wearables and subsequent functions such as sleep time tracking, the easiit app can encourage the creation of good habits for brain performance.

all of the functions within the easiit app are designed, developed, and operated on a framework for protection of individual information.

planned functions moving forward

in the end of september of this year, eisai plans to equip the easiit app with a linkage to the brain performance self-check tool “nouknow” (non-medical device), which eisai is currently selling to legal entities. in the future, the addition of a new function is planned for use in families in which members are living separately from each other.

additionally, eisai is investigating future equipment of the easiit app with a function allowing for connection to medical data (as a non-medical device) on top of daily lifestyle data.

commentary from persons in charge of operations in both companies

eisai vice president, president of dementia total inclusive ecosystem business unit and chief digital officer keisuke naito said, “i believe that recording the health state of one’s brain and body alike and making those records visible is critical to the realization of one’s well-being in one’s own way. this app, which we have co-developed with dena, enables one to easily record one’s footsteps, sleep time, diet, nutrient deficiencies, and other elements. through the expansion and wide adoption of the easiit app, we will work steadfastly in this first step towards the realization of a society in which anyone may measure their own brain performance easily, make lifestyle improvements for the future, and receive early stage medical examination.”

dena vice president, head of healthcare business division and president of desc healthcare co., ltd. sho segawa said, “i encountered eisai at a time when i was watching my parents care for my grandfather, who had developed dementia, and thinking to myself, ‘is there not something i can do as a player of the healthcare industry?’. with the combination of eisai’s experience in the dementia field and dena’s services, we will concentrate our expertise for encouraging and sustaining enjoyable healthy lifestyles in the easiit app, making an effort to accelerate the creation of solutions for dementia.”

[notes to editors]

1. about brain performance (brain health) and issues surrounding it

in recent years, various research has demonstrated the possibility that decline in brain performance (brain health) may be mitigated through major readjustments to lifestyle such as regular exercise, a well-balanced diet, and social interaction. on the other hand, according to survey* conducted by eisai on men and women in japan between forty and seventy-nine years of age, it was revealed that 55.7% of participants understood the meaning and contents behind early assessment and prevention, 19.7% of participants were taking correct preventive actions in diet, exercise, sleep, etc. on a regular basis, and no more than 2.1% of participants were habitually performing self-assessments of cognitive function. these statistics represent disparities (“chasms”) which must be overcome in order to promote disease understanding and the incorporation of cognitive function checks into daily lifestyle.

*independent online survey conducted in december 2019 by eisai in japan on participants in their 40’s, 50’s, 60’s, and above 70, with 200 male and 200 female participants per age bracket (total: 1,600).

2. summary of easiit app details

availability: ios version available july 28, 2020 (tuesday), android version planned availability for end of august 2020.

cost: free of charge; the high function edition with various additional contents and continuous individual data visualization is to be launched for a charge in the winter of 2020.

supervising editor: dr. atsushi iwata, director, department of neurology, tokyo metropolitan geriatric hospital and institute of gerontology

easiit website:

presents weekly menu customized for the user, including suggestions for exercise, diet, sleep, etc.
presents footstep count, diet record, sleep time, and body weight in graph form for user confirmation
evaluates users’ meal photos for amount of calories and eleven essential nutrients and displays this information in relation to an age-based standard for intake
awards easiit miles with every use, which can be collected and exchanged for gift cards, etc.
connects with the fitbit wearable device to automate footstep count, sleep time, and body weight measurement
conducts individual scoring [easiit score] based on records of actions and habits which are good for brain performance in correspondence with the menu. the easiit score provides a positive motivation for the user to practice a lifestyle that is good for brain performance.

3. about the dementia ecosystem business

leveraging experience gained from the development and marketing of aricept^®, a treatment for alzheimer’s disease and dementia with lewy bodies, eisai aims to establish the “dementia platform easiit” for analyzing participants’ health and lifestyle information and subsequently providing advice on brain health. in the future, eisai is planning to evolve this platform to a digital platform that spans areas of daily life and medicine.

with the digital platform as a base, eisai aims to construct a “dementia ecosystem” for delivering new benefits by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance, fitness clubs, automobile makers, retailers, and care facilities.

4. about eisai co., ltd.

eisai co., ltd. is a leading global pharmaceutical company headquartered in japan. eisai’s corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. with a global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of neurology and oncology. for more information about eisai co., ltd., please visit .

5. about dena’s healthcare initiatives

with its healthcare business mission of “staying healthy with fun”, dena provides healthcare services such as its gene screening service “mycode” and its healthcare engagement app “kencom” aimed at healthcare insurance agencies and municipalities, applying engagement science as cultivated through its gaming and sports businesses. dena was selected in 2019 and 2020 consecutively for the “health and productivity branding”, a designation that is granted by japan’s ministry of economy, trade, and industry in collaboration with the tokyo stock exchange for companies that are evaluated to think and act strategically with an operational perspective for the health of their employees.

6. about dena co., ltd.

dena co., ltd.’s corporate mission is to “delight and impact the world”. applying its strengths in internet and ai, dena aims to create various solutions for various social issues in fields ranging from entertainment, including gaming and social concerts, to an expanding sports presence, including sponsorship of the yokohama bay stars baseball team, as well as in the healthcare and automotive industries. for more information about dena co., ltd., please visit .

media inquiries
eisai co., ltd.
public relations department
tel : 81-(0)3-3817-5120

dena co., ltd.
pr group
e-mail: pr@dena.jp

preventing medical infrastructure collapse by a monitoring system linked to line

allm inc. (shibuya-ku, tokyo, president: teppei sakano, hereafter allm), tokyo medical and dental university (bunkyo-ku, tokyo, president: yujiro tanaka) and eisai co., ltd. (headquarters: bunkyo-ku, tokyo, ceo: haruo naito, hereafter eisai) announced that their jointly submitted study and development project has been selected by the japan agency for medical research and development (amed) for its publicly advertised 2020 “field of support for experimental study on medical devices and systems that contribute to measures against viruses and other infectious diseases” as part of its “technology development project for measures against viruses and other infectious diseases “, and that allm has entered into an industry-academia-government joint research agreement with tokyo medical and dental university and eisai respectively.

the selected study and development project is as follows:

study of the monitoring system for covid-19 patient on the home/hotel recuperation.

representative organization: allm inc.

duration of study and development: from grant delivery decision date during 2020 until march 31, 2021 (1 year).

(reference) amed website （japanese only）

■summary of the experimental study

since april 2020, allm has been operating a medical treatment administration system linking the communication application “line” and the medical information collaboration system “team”, developed and operated by allm, for use in treatment of patients with mild cases of the novel coronavirus infection at home or in accommodations in kanagawa prefecture. on the other hand, while vital signs such as body temperature in addition to blood pressure, respiratory rate, and spo₂ are indispensable for the physical management of medical care recipients, measurement equipment supplies were not sufficient. accommodation care facilities were insufficient such that among patients testing positive, those with mild symptoms or without symptoms had to share accommodations. provision for patients receiving treatment at home was even more difficult. with predicted increases in patients yet to come, establishment of a system to allow for arrangement of secure medical treatment at home became an urgent task. therefore this study will apply widely used smartphone and sns technologies and add a function that allows for remote acquisition of various data that contribute to medical decision making to an existing communication system, without requiring special knowledge or equipment from users. demonstrations are planned in kanagawa prefecture and tokyo metropolis.

this study will first implement a non-contact body monitoring function in the lifesaving and health support application “mysos” developed by allm. this function is equipped with ai to measure vital signs including spo₂, respiratory rate, and blood pressure using a smartphone camera.

the vital information obtained by this function is applied to optimize the content of a medical inquiry, sent to the patient through line chat, according to the patient’s condition. in addition, the following three points will be verified by combining an olfactory test (classified as miscellaneous goods) provided by eisai with other commercially available antibody tests and antigen tests, under the supervision of tokyo medical and dental university:

1. designation of remote assessment criteria for patient consultation to eliminate patient anxiety and prevent inundation of medical institutions
2. construction of an alert system that predicts serious deterioration, in order to prevent sudden changes and serious deterioration of patients receiving medical treatment at home.
3. designation of criteria for determining when medical treatment may be ended and the patient may return to society

this study aims to make a great contribution to solving problems in the medical field by enhancing communication with medical institutions through ai and ict in situations where the work of medical institutions and public health centers is saturated and patients’ anxiety is amplified due to the rapid spread of infection.
■ about amed’s “technology development project for measures against viruses and other infectious diseases”

in response to the global spread of the novel coronavirus infection (covid-19), expectations are high for the development of simple, rapid and decentralized virus tests, systems for preventing the spread of infection, and development of therapeutic devices for critically ill patients. in light of these expectations, we will support research and development that will lead to the resolution of problems caused by infectious diseases, as well as the development and verification of equipment and systems that meet the needs of the field for measures against the novel coronavirus infection.

■ about mysos

mysos is an application developed and provided by allm inc. that records the health and medical records of patients and their families, and supports a smooth response in the event of an emergency. since mysos allows for medical examination results and medical images such as mri and ct to be checked via smartphone, this app can also be used as a phr (personal health record) and may thus play a role in daily health management.

■ about team

team is a solution developed and provided by allm inc. that seamlessly connects medical and nursing care services and supports the promotion of a regional comprehensive care system. it enables information sharing and collaboration among professions based on operation records stored in the applications “kaigo” and “kango” for the nursing care business and the nursing business, respectively.

■ about allm

allm inc. has cited “shaping healthcare” as its corporate message, as a company that “supports all medical care (all medical)” through providing mobile ict solutions in the medical and welfare fields. in addition, in the medical ict business, including the application “join” for communication among medical personnel, we are actively engaged in global expansion and providing solutions to 19 countries as a medical ict company originating in japan.

company name: allm inc
head office: yushin bldg. shinkan 2f, 3-27-11 shibuya, shibuya-ku, tokyo, zip code: 150-0002 japan
representative director/ceo: teppei sakano
founded: april 18, 2001
capital: 1,541,650,000 yen
website:

※mysos and team are trademarks or registered trademarks of allm, inc.

■ about tokyo medical and dental university

tokyo medical and dental university was founded in october 12, 1928 as the administration, in the yushima/shohei hill area of tokyo famed as a place for education and learning. through the blending of medicine and dental medicine, tokyo medical and dental university was created as the only comprehensive medical institution in japan under the slogan “carpenter of knowledge and healing”, practicing innovative medical care in japan and contributing to the health of individuals and the welfare of society. for more information, please visit the university website:

■ about eisai

eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. 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. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of neurology and oncology. as a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

for more information about eisai co., ltd., please visit .

contact information:
allm inc. team
platform department pr
tel: 03-6418-3012
email: press@allm.jp

national university corporation tokyo medical and dental university
tel: 03-5803-5833 fax: 03-5803-0272
email: kouhou.adm@tmd.ac.jp

eisai co., ltd.
pr department
tel：03-3817-5120

the alzheimer’s clinical trials consortium (actc), eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”), and biogen inc. (nasdaq: biib, headquarters: cambridge, massachusetts, united states, ceo: michel vounatsos, “biogen”) announced today that a new phase iii clinical study (ahead 3-45) of ban2401, an anti-amyloid beta (aβ) protofibril antibody, has been initiated in the united states of america for individuals with preclinical alzheimer’s disease (ad), meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. currently, ban2401 is being studied in a pivotal phase iii clinical study in symptomatic early ad (clarity ad), following the outcome of the phase ii clinical study (study 201). the ahead 3-45 will be conducted in the us, japan, canada, australia, singapore, and europe.

ahead 3-45 is a phase iii clinical study, conducted as a public-private partnership between the actc, funded by the national institute on aging, part of the national institutes of health, and eisai. after a common screening period in ahead 3-45, participants will be enrolled into one of two randomized, double-blind, placebo controlled trials based on the level of amyloid in the brain: the a45 trial and the a3 trial. a total of 1400 participants will be enrolled in the study and treated with ban2401 for 216 weeks. the a45 trial will enroll cognitively unimpaired participants who have elevated levels of amyloid in the brain, and aims to prevent cognitive decline and suppress the progression of brain ad pathology with ban2401 administration. the primary endpoint for a45 is the change from baseline in the preclinical alzheimer cognitive composite 5 (pacc5) at 216 weeks of treatment. secondary endpoints are changes from baseline in brain amyloid levels as measured by amyloid positron emission tomography (pet) and in brain tau levels as measured by tau pet and cognitive function index, a participant and study partner reported outcome. the a3 trial will enroll cognitively unimpaired participants who have an intermediate amount of amyloid in the brain, and who are at high risk for further aβ accumulation. the primary endpoint for a3 is change from baseline in brain amyloid levels as measured by amyloid pet. the secondary endpoint is change from baseline in brain tau levels as measured by tau pet. both trials include additional clinical assessment scales, imaging, blood biomarkers and cerebrospinal fluid (csf) in a subset, as exploratory endpoints. an atn (amyloid, tau, neurodegeneration) biomarker panel of imaging and biofluid, especially csf, markers including aβ 1-42, aβ 1-40, t-tau, p-tau, neurogranin, neurofilament light chain, will be used to evaluate therapeutic effects on the progression of ad pathophysiologic changes.

“it is hoped that initiating treatment much earlier in the disease process may be advantageous in preventing future cognitive decline. the ahead 3-45 should provide critically important answers about the optimal time to intervene with anti-amyloid therapy” said dr. reisa sperling, director, center for alzheimer research and treatment at brigham and women’s hospital and co-principal investigator, actc.

dr. aisen, director of the university of southern california alzheimer’s therapeutic research institute, which serves as the coordinating center for the actc, noted, “the mission of the actc includes the development of public-private partnerships to conduct trials of promising candidate therapies. ahead 3-45 is the type of collaboration we need in the fight against alzheimer’s disease.”

“the initiation of ahead 3-45 with ban2401, focused on therapies for the earliest stages of the ad continuum through our collaboration with the actc group, marks an exciting time for us,” says lynn kramer, m.d., chief clinical officer, neurology business group, eisai. “this represents a next step in developing precision therapies for ad using biomarker panels as part of our human health care mission; we are committed to making a difference for patients, their families, and health care professionals across the globe.”

for additional information please visit:

ban2401 is a humanized, monoclonal, anti- aβ soluble aggregate (protofibril) antibody obtained through collaboration research between eisai and bioarctic ab (sweden). ban2401 selectively binds to neutralize and eliminate toxic aβ protofibrils that are thought to be a causative factor for ad. this suggests that ban2401 may have the potential to have an effect on disease pathology and to slow the progression of ad. study 201 demonstrated a statistically significant slowing of disease progression and decreasing of brain aβ accumulation as the first late-stage large scale clinical study for early ad, and successfully showed potential disease-modifying effects. it is being conducted along with the 201 open-label extension (ole) study (open-label continuous administration study) and one pivotal clinical study (clarity ad). eisai and biogen inc. have entered into a collaboration to develop and commercialize ban2401.

[notes to editors]

1. about the alzheimer’s clinical trials consortium (actc)

the actc, funded by the national institute on aging at the national institutes of health (grant number u24ag057437), provides the infrastructure for academic clinical trials in alzheimer’s disease and related dementias. the consortium, based at the university of southern california, harvard university and the mayo clinic, includes expert units to support clinical trials design, biostatistics, informatics, medical safety, regulatory oversight, recruitment, clinical operations, data management, site monitoring, a biomarker laboratory and repository, and neuroimaging. the actc includes 35 primary clinical sites across the united states.
2. about eisai co., ltd.

leveraging the experience gained from the development and marketing of aricept^®, a treatment for alzheimer’s disease and dementia with lewy bodies, eisai aims to establish the “eisai dementia platform.” through this platform, eisai plans to deliver novel benefits to those living with dementia and their families through constructing a “dementia ecosystem,” by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance, fitness clubs, automobile makers, retailers, and care facilities. for more information about eisai co., ltd., please visit .
3. about biogen

at biogen, our mission is clear: we are pioneers in neuroscience. biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. one of the world’s first global biotechnology companies, biogen was founded in 1978 by charles weissmann, heinz schaller, kenneth murray and nobel prize winners walter gilbert and phillip sharp. today biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.

we routinely post information that may be important to investors on our website at . follow us on social media – , , , .
4. about the national institutes of health (nih), national institute of aging (nia)

nia, one of the 27 institutes and centers of nih, leads a broad scientific effort to understand the nature of aging and to extend the healthy, active years of life. nia is the primary federal agency supporting and conducting alzheimer’s disease research. the national institutes of health, national institute of aging are providing funding for the a45 study (grant number r01ag061848) and a3 study (grant number r01ag054029)
5. about the preclinical ad cognitive composite 5 (pacc5)

the pacc5 is a composite score for evaluating the severity of cognitive decline to enable highly-sensitive detection of changes in clinical functions in the preclinical ad stage.
6. about the cognitive function index (cfi)

the cognitive function index is an evaluation index that assesses the ability to perform advanced functional tasks in daily life and general cognitive function.

biogen safe harbor

this news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the private securities litigation reform act of 1995, about the potential clinical effects of ban2401; the potential benefits, safety, and efficacy of ban2401; the clinical development program for ban2401, including the ahead 3-45 study and the clarity ad study; the results of the phase ii study of ban2401; the identification and treatment of ad; the anticipated benefits and potential of biogen’s collaboration arrangements with eisai; the potential of biogen’s commercial business and pipeline programs, including ban2401; and risks and uncertainties associated with drug development and commercialization. these statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. you should not place undue reliance on these statements or the scientific data presented.

these statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; the occurrence of adverse safety events; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce biogen’s data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing covid-19 pandemic on biogen’s business, results of operations, and financial condition. the foregoing sets forth many, but not all, of the factors that could cause actual results to differ from biogen’s expectations in any forward-looking statement. investors should consider this cautionary statement, as well as the risk factors identified in biogen’s most recent annual or quarterly report and in other reports biogen has filed with the u.s. securities and exchange commission. these statements are based on biogen’s current beliefs and expectations and speak only as of the date of this news release. biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

research activities commence

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an industry-academia-government joint research agreement with four universities in japan concerning the “industrialization of japan-originated toll-like receptor research by academia-industry collaborating all-japan system: creation of new drug for sle treatment”, which is a research project with eisai as the representative research organization. this joint research project was selected by the japan agency for medical research and development (amed) for its cyclic innovation for clinical empowerment (cicle) grant program. in this project, eisai aims at creating a japan-originated therapeutic drug for systemic lupus erythematosus (sle) through industry-academia-government collaboration, using its in-house discovered new oral toll-like receptor (tlr) 7/8 inhibitor e6742.

sle is a designated intractable autoimmune disease that causes various organ disorders involving the disorders of the skin and the musculoskeletal system. the estimated number of patients with sle in japan is 60,000 to 100,000. in particular, the onset of sle appears more commonly in females in their 20s to 40s. as such, sle is a disease with extremely high unmet medical needs. the current treatment mainstays are corticosteroids, hydroxychloroquine, and an immunosuppressant, but the development of new effective therapeutic agents with fewer side effects is desired.

according to the latest research findings, it has been reported that tlr7/8, a member of the tlrs-family of receptors, is associated with the pathogenesis of sle, suggesting the possibility of controlling sle by a tlr7/8-specific inhibitor. e6742 has selective and potent inhibitory activity against tlr7/8, and is expected to potentially become a new therapeutic agent for sle.

in this project, eisai will conduct the clinical development of e6742. in addition, the top-class research institutes for tlr and sle research in japan (university of occupational and environmental health, japan; osaka university; hokkaido university; tohoku university) and eisai’s research subsidiary kan research institute will carry out an academic-driven clinical observational research in order to clarify the pathogenesis of sle.

by creating new innovation based on industry-academia-government collaboration and fulfilling unmet medical needs, eisai will contribute to increasing the benefits of patients and their families.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

[notes to editors]1. about cicle
amed’s cicle is a grant program to promote the establishment of infrastructure (including human resources) to respond to medical needs and the creation of an environment for open innovation and venture development based on industry-academia-government collaboration.
2. about tlr and e6742
tlrs are receptors of the innate immune system, and recognize the specific molecular structure of pathogens. it is considered that tlr initiated activation of the innate immune system plays a critical role in eliminating pathogens, causing an inflammatory reaction or an antiviral response. tlrs constitute a family of various receptors. according to the latest research findings, it has been reported that tlr7/8, a member of the tlrs-family of receptors, is associated with the pathogenesis of sle, suggesting the possibility of controlling sle disease by a tlr7/8-specific inhibitor. e6742 is a highly active and selective tlr7/8 inhibitor created by eisai’s former andover research laboratories in the united states. in non-clinical studies, e6742 has been shown to suppress tlr7/8 stimulation induced cytokine production specifically and potently, and in addition, in a mouse model with sle-like pathological conditions, it has been confirmed that e6742 is effective in improving the pathology. furthermore, a phase i single dose clinical trial of e6742 has been completed in the united states.
3. systemic lupus erythematosus (sle)
systemic lupus erythematosus (sle) is a systemic autoimmune disease induced by antibodies that causes various organ disorders involving disorders of the skin and the musculoskeletal system. about 90% of patients with sle are female, especially among 20-40 years old, and the estimated number of patients is 60,000 to 100,000 in japan. the cause of sle is unknown, and it is designated as an intractable autoimmune disease in japan (designation 49)¹. in japan, the global standard drug for sle, hydroxychloroquine, was approved in 2015 and the biologic berimumab was approved as a treatment for sle in 2017, respectively. however, sle is a disease with huge unmet medical needs, with great expectations for the establishment of new treatment options.
4. activity of amed’s cicle in eisai
as a key initiative for industry-academia-government collaboration in which eisai is participating, a project aiming to identify and verify novel drug discovery target candidates linked to the development of next-generation treatments and preventative medicines for dementia at the eisai-keio innovation lab for dementia (ekid) (location: keio university shinanomachi campus) has also been selected by amed for the cicle program. in addition, a research project represented by kan on nucleic acid drug discovery research using novel nucleic acid synthesis and delivery technologies, and an initiative originated in japan to develop biologics and new biomarkers for crohn’s disease represented by eisai’s gastrointestinal disease business subsidiary ea pharma co., ltd. have been respectively selected by amed for cicle.

1. japan intractable diseases information center – systemic lupus erythematosus (sle) (designation 49): (available in japanese only)

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