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the content presented at the 13th clinical trials on alzheimer’s disease (ctad) conference

sysmex corporation (hq: kobe, japan; chairman and ceo: hisashi ietsugu; “sysmex”) and eisai co., ltd. (hq: tokyo, japan; ceo: haruto naito; “eisai”) announced that the most recent data from the project to develop a method of diagnosing alzheimer’s disease (ad) using blood plasma was presented at the 13th clinical trials on alzheimer’s disease (ctad) conference, held virtually from november 4 to 7, 2020. sysmex demonstrated on behalf of the two companies the performance of the amyloid beta (aβ) in plasma measured on sysmex’s hiscl^tm fully automated immunoassay analyzers in predicting amyloid pathology as defined by amyloid positron emission tomography (pet) imaging on the centiloid scale.¹

clinical trials: biomarkers including plasmalp10	plasma aβ ratio measured on a fully automated immunoassay predicts amyloid positivity defined by amyloid pet centiloid poster presentation: november 4 (wed.) to november 7 (sat.)
our group has hitherto used the visual read method², which is commonly used for clinical trials, to confirm amyloid pathology by amyloid pet scan. meanwhile, an increasing number of recent research projects quantify amyloid pet images with the index called suvr (standard uptake value ratio) and correct with a standardized technique called the centiloid method to assess amyloid pathology quantitatively.³ accordingly, to assess the performance of the plasma aβ_1-42/aβ_1-40(aβ ratio) as measured on a fully automated immunoassay system hiscl in predicting amyloid pathology, we used both the visual read method and centiloid method to determine amyloid pathology for 149 cases clinically diagnosed as having mci (mild cognitive impairment) and mild ad to ascertain the difference in their predictive performance. the results confirmed that the centiloid method exhibited a better performance in determining amyloid pathology with sensitivity and specificity measuring at 78% (auc = 0.82), whereas sensitivity and specificity was 72% and 71% (auc = 0.74), respectively, for the visual read method. also, a correlation (spearman’s rank correlation coefficient (r_s)⁴ = -0.57, p < 0.0001) was determined between the plasma aβ ratio and the centiloid values, indicating more strongly than ever the potential to predict amyloid pathology in the brain with the plasma aβ ratio. furthermore, it was observed that many instances where there was a mismatch between the decisions by the plasma aβ ratio and the centiloid method were false-positive cases (positive by the plasma aβ ratio, negative by amyloid pet centiloid). other research groups have also reported on such mismatches, suggesting that these false-positive subjects are more likely to test positive in amyloid pet imaging than the negative subjects.⁵ it follows from these findings that there is a possibility that the plasma aβ ratio measured on a fully automated immunoassay system hiscl reflects earlier amyloid pathology in the brain, which amyloid pet imaging cannot detect. to further assess clinical utility of our assay system, we will evaluate additional sample sets.

clinical trials: biomarkers including plasmalp10

plasma aβ ratio measured on a fully automated immunoassay predicts amyloid positivity defined by amyloid pet centiloid
poster presentation: november 4 (wed.) to november 7 (sat.)

our group has hitherto used the visual read method², which is commonly used for clinical trials, to confirm amyloid pathology by amyloid pet scan. meanwhile, an increasing number of recent research projects quantify amyloid pet images with the index called suvr (standard uptake value ratio) and correct with a standardized technique called the centiloid method to assess amyloid pathology quantitatively.³ accordingly, to assess the performance of the plasma aβ_1-42/aβ_1-40(aβ ratio) as measured on a fully automated immunoassay system hiscl in predicting amyloid pathology, we used both the visual read method and centiloid method to determine amyloid pathology for 149 cases clinically diagnosed as having mci (mild cognitive impairment) and mild ad to ascertain the difference in their predictive performance.
the results confirmed that the centiloid method exhibited a better performance in determining amyloid pathology with sensitivity and specificity measuring at 78% (auc = 0.82), whereas sensitivity and specificity was 72% and 71% (auc = 0.74), respectively, for the visual read method.
also, a correlation (spearman’s rank correlation coefficient (r_s)⁴ = -0.57, p < 0.0001) was determined between the plasma aβ ratio and the centiloid values, indicating more strongly than ever the potential to predict amyloid pathology in the brain with the plasma aβ ratio. furthermore, it was observed that many instances where there was a mismatch between the decisions by the plasma aβ ratio and the centiloid method were false-positive cases (positive by the plasma aβ ratio, negative by amyloid pet centiloid). other research groups have also reported on such mismatches, suggesting that these false-positive subjects are more likely to test positive in amyloid pet imaging than the negative subjects.⁵ it follows from these findings that there is a possibility that the plasma aβ ratio measured on a fully automated immunoassay system hiscl reflects earlier amyloid pathology in the brain, which amyloid pet imaging cannot detect.

to further assess clinical utility of our assay system, we will evaluate additional sample sets.

the total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 2 trillion usd in 2030.⁶ in japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 2025⁷, with the total societal cost of this disease being estimated to be equivalent to 4.1%⁸ of the gross domestic product (gdp) in 2025 (25.8 trillion yen⁹). of these sufferers, those living with ad are thought to account for more than 60% of those living with dementia.⁷

it is conceivable that ad is a disease that results in synaptic dysfunction and neuronal cell death due to tau deposition in neurons triggered by aβ aggregation on the outside of neurons. these brain changes cause cognitive impairment and psychological and behavioral symptoms, suggesting that the aβ aggregation and accumulation inside the brain is caused by ad before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting aβ. currently, amyloid pet and aβ ratio in cerebrospinal fluid (csf) are used for detecting amyloid aggregates in the brain, but this puts significant burden on patients in terms of access, costs, and their physical wellbeing.¹⁰

sysmex and eisai are working to create new diagnostic technologies for the prevention and treatment of dementia. accordingly, the overarching aim is to contribute to the advancement of healthcare and improve the quality of life for those living with the disease and their families.

terminology
1. a standardization scale for integration analysis of pet suvr values as measured by different amyloid pet imaging probes.
2. trained doctors qualitatively distinguish amyloid pet positive from amyloid negative subjects by visually reading images.
3. klunk we et al, alzheimer’s dementia (2014)
4. assesses how correlated two sets of data are based on two quantitative data distributions. for the purpose of this analysis, spearman’s rank correlation coefficient (rs), which is a correlation index as determined by the rankings of the two variables, was calculated.
5. schindler se et al, neurology (2019)
6. world alzheimer report 2018
7. promotion of comprehensive measures against dementia, ministry of health, labour and welfare
8. study on economic impact of dementia in japan, 2014 health labour sciences research grant annual report
9. estimated by sysmex based on japan’s medium-term economic outlook (february 2018), daiwa institute of research
10. aβ is a peptide made of amino-acid residues removed from amyloid precursor protein. many of them are aβ_1-40, which is comprised of 40-residues, and the aβ_1-40 level does not fluctuate significantly as ad progresses. comprised of 42-residues, aβ_1-42, on the other hand, is highly cohesive and decreases in cerebrospinal fluid (csf) from the early stages of ad. it is believed that aβ’s absolute values show individual and intrinsic variability but that the plasma aβ_1-42/aβ_1-40 ratio remains unchanged. it has also been reported that the plasma aβ_1-42/aβ_1-40 ratio in csf shows a high correlation with amyloid pet.

about the collaboration between sysmex and eisai

in february 2016, sysmex and eisai signed a comprehensive non-exclusive agreement aimed at the development of new diagnostic tests in the field of dementia. by leveraging each other’s technologies and knowledge, the objective has been to discover next-generation diagnostic reagents that will enable early diagnosis of dementia, selection of the most appropriate treatment options, and regular monitoring of the effects of such treatments. at the 12th ctad held in december 2019, the two companies reported on the performance of the plasma aβ ratio measured on a fully automated immunoassay system hiscl in predicting the amyloid pet scan results (sensitivity: 73%, specificity: 71% [auc = 0.74]), thus demonstrating the potential to predict amyloid pathology in the brain using the plasma aβ ratio.^* this finding was expected to lead to the development of a simple method of diagnosing alzheimer’s disease using blood.
^*

contacts for inquiries
sysmex corporation
ir & corporate communication
tel：078-265-0500

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

information contained in the press release is current as of the date of the announcement but may be subject to change without prior notice.

presenting the most recent data at the 12th clinical trials on alzheimer’s disease (ctad) conference

sysmex corporation (hq: kobe, japan; chairman and ceo: hisashi ietsugu; “sysmex”) and eisai co., ltd. (hq: tokyo, japan; ceo: haruo naito; “eisai”) are pursuing a joint project to develop a method of diagnosing alzheimer’s disease (ad) using blood, presented two posters showing the most recent data from the project. the presentations took place at the 12^th clinical trials on alzheimer’s disease (ctad) conference, from december 4 to 7, 2019, in san diego, california. at ctad, sysmex demonstrated on behalf of the two companies the possibility of understanding amyloid pathology in the brain from the brain-derived amyloid beta (aβ) in plasma measured using its protein measurement platform, the hiscl™ series of fully automated immunoassay analyzers.

the total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 220 trillion yen in 2030.¹ in japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 2025², with the total societal cost of this disease being estimated to be equivalent to 4.1%³ of the gross domestic product (gdp) in 2025 (25.8 trillion yen⁴). of these sufferers, those living with ad is thought to account for more than 60% of those living with dementia.²

it is conceivable that ad is a disease that results in synaptic dysfunction and neuronal cell death due to the tau deposition in neurons triggered by aβ aggregation on the outside of neurons. these brain changes cause the cognitive impairment and psychological and behavioral symptoms, suggesting that the aβ aggregation and accumulation inside the brain is caused by ad before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting aβ. currently, amyloid pet and the plasma aβ_1-42/ aβ_1-40 ratio in cerebrospinal fluid (csf) are used for detecting amyloid aggregates in the brain, but this puts significant burden on patients in terms of access, costs, and their physical wellbeing.⁵

at the alzheimer’s association international conference (aaic) held in july 2019, sysmex and eisai presented their joint research on the correlation (spearman’s rank correlation coefficient (r_s)⁶=0.502, p<0.001) between the aβ_1-42/ aβ_1-40 ratio in csf and the aβ_1-42/ aβ_1-40 ratio in plasma, and demonstrated that it may be possible to understand amyloid pathology in the brain by measuring the plasma aβ_1-42/ aβ_1-40ratio. subsequently, the two companies have examined the correlation between the plasma aβ_1-42/ aβ_1-40 ratio and amyloid pet.

sysmex and eisai are engaged in joint development aimed at creating a simple method of diagnosing ad from a blood sample. at ctad, sysmex demonstrated that it may be possible to understand pathological processes in the brain by measuring the plasma aβ_1-42/aβ_1-40 ratio based on the analysis result of the plasma aβ_1-42/aβ_1-40ratio measured with the hiscl™ series as a prediction factor for aβ pet positivity. also it was presented a technique for verifying that the hiscl™ measuring system correctly captures aβ in plasma on that occasion.

blood diagnosis p75	prediction of amyloid pathology by the plasma aβ(1-42)/aβ(1-40) ratio measured with a fully automated immunoassay system (hiscl™ series) poster presentation: december 4 (wed.) to december 5 (thu.)
in the presentation (p75), to create a simple blood diagnostic test for ad, the result of the receiver operating characteristic (roc) analysis of the plasma aβ_1-42/aβ_1-40 ratio, measured using the hiscl™ series, was used as a prediction factor for aβ-pet positivity. the hiscl™ system enables an automated immune assay to be completed in 17 minutes with sample volumes as small as 10-30µl, and it was demonstrated that the aβ assay in plasma had sufficient sensitivity and high reliability. in addition, it was confirmed that the aβ assay system using the hiscl™ series had a high correlation with ip-ms methods reported in poster 81. the samples from 192 persons living with the disease with mild cognitive impairment (mci) and ad associated with amyloid pet results were used for investigation with the hiscl™ series. using the plasma aβ_1-42/aβ_1-40ratio, amyloid pet positivity can be predicted with a sensitivity of 73% and a specificity of 71% (auc0.74), and it was confirmed that sensitivity and specificity were improved (auc0.82) by adding factors such as age and apoe4, a gene associated with a greatly increased risk of developing ad. this preliminary result indicates the plasma aβ_1-42/aβ_1-40ratio measured with the hiscl™ series could be used as a prescreening method for amyloid pet. to further assess its clinical utility, additional sample sets will be evaluated.

blood diagnosis p75

prediction of amyloid pathology by the plasma aβ(1-42)/aβ(1-40) ratio measured with a fully automated immunoassay system (hiscl™ series)
poster presentation: december 4 (wed.) to december 5 (thu.)

in the presentation (p75), to create a simple blood diagnostic test for ad, the result of the receiver operating characteristic (roc) analysis of the plasma aβ_1-42/aβ_1-40 ratio, measured using the hiscl™ series, was used as a prediction factor for aβ-pet positivity. the hiscl™ system enables an automated immune assay to be completed in 17 minutes with sample volumes as small as 10-30µl, and it was demonstrated that the aβ assay in plasma had sufficient sensitivity and high reliability. in addition, it was confirmed that the aβ assay system using the hiscl™ series had a high correlation with ip-ms methods reported in poster 81.

the samples from 192 persons living with the disease with mild cognitive impairment (mci) and ad associated with amyloid pet results were used for investigation with the hiscl™ series. using the plasma aβ_1-42/aβ_1-40ratio, amyloid pet positivity can be predicted with a sensitivity of 73% and a specificity of 71% (auc0.74), and it was confirmed that sensitivity and specificity were improved (auc0.82) by adding factors such as age and apoe4, a gene associated with a greatly increased risk of developing ad. this preliminary result indicates the plasma aβ_1-42/aβ_1-40ratio measured with the hiscl™ series could be used as a prescreening method for amyloid pet. to further assess its clinical utility, additional sample sets will be evaluated.

blood diagnosis p81	clinical utility of plasma amyloid beta measurements by immunoaffinity enrichment and lc-ms/ms poster presentation: december 4 (wed.) to december 5 (thu.)
in the presentation (p81), the development of high-sensitivity peptide (aβ_1-42 and aβ_1-40) measurement technology using mass spectrometry was described. with this technology, it is possible to measure the peptides in a liquid sample in two hours with a small sample volume of 250µl, and it was confirmed that the amounts of aβ_1-42and aβ_1-40 in csf and plasma could be measured. in addition to the presentation on the measurement performance (dynamic range, sensitivity, reproducibility, etc.) of this method under pure conditions, a good correlation between the csf aβ_1-42/aβ_1-40 ratio and plasma aβ_1-42/aβ_1-40 ratio in elderly persons with normal cognition and those living with mci and ad (44 people in total) was confirmed.

blood diagnosis p81

clinical utility of plasma amyloid beta measurements by immunoaffinity enrichment and lc-ms/ms
poster presentation: december 4 (wed.) to december 5 (thu.)

in the presentation (p81), the development of high-sensitivity peptide (aβ_1-42 and aβ_1-40) measurement technology using mass spectrometry was described. with this technology, it is possible to measure the peptides in a liquid sample in two hours with a small sample volume of 250µl, and it was confirmed that the amounts of aβ_1-42and aβ_1-40 in csf and plasma could be measured. in addition to the presentation on the measurement performance (dynamic range, sensitivity, reproducibility, etc.) of this method under pure conditions, a good correlation between the csf aβ_1-42/aβ_1-40 ratio and plasma aβ_1-42/aβ_1-40 ratio in elderly persons with normal cognition and those living with mci and ad (44 people in total) was confirmed.

¹ world alzheimer report 2018
² promotion of comprehensive measures against dementia, ministry of health, labour and welfare
³ study on economic impact of dementia in japan, 2014 health labour sciences research grant annual report
⁴ estimated by sysmex based on japan’s medium-term economic outlook (february 2018), daiwa institute of research
⁵ aβ, a peptide consisting of amino acid residues, is generated by excision from the amyloid precursor protein. aβ_1-40 consists of 40 residues, is the dominant substance, and does not fluctuate significantly as ad progresses. in contrast, aβ_1-42, which consists of 42 residues, has high aggregability and a reduction in aβ_1-42 is detected from the early stage of ad. there are individual differences in the absolute value of aβas well as intra-individual variabilities, therefore, it has been reported that there is a high correlation between the aβ_1-42/aβ_1-40 ratio in csf and amyloid pet.
⁶ the correlation coefficient indicates the strength of the relationship between the two sets pf data from the two quantitative data distributions. in this analysis, spearman’s rank correlation coefficient (r_s), which is an index of correlation obtained from rank data, is calculated.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the latest information on its in-house discovered and developed eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: halaven^®, “eribulin”) will be presented during the 42nd san antonio breast cancer symposium (sabcs2019). the symposium will be held from december 10 through 14, 2019, in san antonio, texas in the united states.

a total of five poster presentations will be given at this year’s sabcs including the study results evaluating absolute lymphocyte count at the baseline with eribulin as a predictor of overall survival from the post-hoc analysis of two phase iii clinical studies of eribulin in patients with advanced or metastatic breast cancer.

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.

major poster presentations at sabcs2019:

product, poster no.	title and scheduled presentation date (local time: central standard time)
eribulin poster no.: p2-15-13	a time-and-motion study of chemotherapy administration in metastatic breast cancer december 12 (thu), 7:00-9:00am
eribulin poster no.: p4-10-08	absolute lymphocyte count (alc) is a predictor of eribulin benefit in advanced or metastatic breast cancer (mbc) december 13 (fri), 7:00-9:00am
eribulin poster no.: p5-05-03	eribulin treatment activates type 1 ifns to promote a gene expression signature associated with antitumor immunity december 13 (fri), 5:00-7:00pm
eribulin poster no.: p6-07-02	evaluating the effects of eribulin and paclitaxel on exosome formation and release from triple negative breast cancer cells december 14 (sat), 7:00-9:00am
eribulin poster no.: ot2-09-01	a multicenter, randomized, phase ii trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally-recurrent or metastatic breast cancer patients after progression on endocrine therapy (revert study) december 12 (thu), 5:00-7:00pm

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 three oral presentations and eight poster presentations, highlighting the latest data on its alzheimer’s disease / dementia pipeline including anti-amyloid beta (aβ) protofibril antibody ban2401, orexin receptor antagonist lemborexant and a simple blood diagnostic for alzheimer’s disease (ad), will be given at the 12th clinical trials on alzheimer’s disease (ctad) conference taking place in san diego, california in the united states, from december 4 to 7, 2019. ban2401 is being jointly developed by eisai and biogen inc. (headquarters: cambridge, massachusetts, united states). in addition, the simple blood diagnostics for ad are being jointly developing by eisai and sysmex corporation (headquarters: hyogo, japan, “sysmex”).

for ban2401, the persistance of brain aβ levels in patients with early ad at the beginning of the open label extension phase of the phase ii study (study 201) will be presented in late-breaking oral communications session. study 201 is a first late-stage study which successfully demonstrated the potential disease-modifying effects on both clinical function and aβ accumulation in the brain. in addition, the study design and current status of ongoing clarity ad (study 301) will be presented.

meanwhile, for the investigational sleep-wake regulation agent lemborexant, the further data analysis results from phase ii clinical study (study 202) for ad patients with irregular sleep-wake rhythm disorder (iswrd) will be given.

in addition, regarding the creation of the simplified blood diagnostics for ad, jointly developed with sysmex, the latest data of the fully automated protein assay system using the sysmex’s automated protein measurement immunoassay platform hiscl^tmseries will be presented.

eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 35 years of experience of drug discovery activities in the area of alzheimers disease / dementia. eisai is striving to create innovative medicines as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.

oral presentations

product, session no.	title and scheduled presentation date (local time: pacific time)
ban2401 session no. lb10	persistence of ban2401-mediated amyloid reductions post-treatment: a preliminary comparison of amyloid status between the core phase of ban2401-g000-201 and baseline of the open-label extension phase in subjects with early alzheimer’s disease december 5 (thu), 11:15-11:30
elenbecestat session no. lb16	association between neuraceq levels and [18f]pi-2620 tau pet tracer accumulation in baseline scans of the elenbecestat mission ad program december 6 (fri), 8:30-8:45
ban2401 (presented by bioarctic) session no.oc29	binding profiles of ban2401 and aducanumab to different amyloid-beta species december 7 (sat), 11:30- 11:45

poster presentations

product/asset, poster no.	poster title and scheduled presentation date (local time: pacific time)
lemborexant p3	using network analysis and machine learning methods to evaluate the efficacy of lemborexant in patients with irregular sleep wake rhythm disorder and alzheimer’s disease dementia december 4 (wed) and december 5 (thu)
elenbecestat p24	the cognitive task force: a novel approach to improving the efficiency of cognitive screening for the elenbecestat mission ad global phase 3 studies in early alzheimer’s disease december 4 (wed) and december 5 (thu)
elenbecestat p46	amyloid positive subject characteristics in the elenbecestat mission ad phase 3 program december 4 (wed) and december 5 (thu)
blood diagnostics p75	prediction of amyloid pathology by the plasma aβ1-42/aβ1-40 ratio measured with fully automated immunoassay system (hiscl™ series) december 4 (wed) and december 5 (thu)
blood diagnostics p81	clinical utility of plasma amyloid beta measurements by immunoaffinity enrichment and lc-ms/ms december 4 (wed) and december 5 (thu)
clinical assessment p136	staging early alzheimer’s disease using the alzheimer’s disease composite score (adcoms) december 6 (fri) and december 7 (sat)
elenbecestat p149	asian and non-asian countries screen subjects with similar mmse scores for the elenbecestat mission ad global phase 3 studies in early alzheimer’s disease december 6 (fri) and december 7 (sat)
ban2401 p179	ban2401 in early alzheimer’s disease: a placebo-controlled, double-blind, parallel-group, 18-month study with an open-label extension phase to confirm safety and efficacy december 6 (fri) and december 7 (sat)

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

[notes to editors]
1. about ban2401
ban2401 is a humanized monoclonal antibody for alzheimer’s disease (ad) that is the result of a strategic research alliance between eisai and bioarctic. ban2401 selectively binds to neutralize and eliminate soluble, toxic aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in ad. as such, ban2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. eisai obtained the global rights to study, develop, manufacture and market ban2401 for the treatment of ad pursuant to an agreement concluded with bioarctic in december 2007. currently, a global clinical phase iii study (clarity ad) of ban2401 in early ad is underway.

2. about the joint development agreement between eisai and biogen for ad
eisai and biogen are widely collaborating on the joint development and commercialization of ad treatments. eisai serves as the lead in the co-development of ban2401, an anti-aβ protofibril antibody, while biogen serves as the lead for co-development of aducanumab, biogen’s investigational anti-aβ antibody for patients with ad, and the companies plan to pursue marketing authorizations for the two compounds worldwide. if approved, the companies will also co-promote the products in major markets, such as thep united states, the european union and japan.

3. about lemborexant
lemborexant, an orexin receptor antagonist, is eisai’s in-house discovered and developed small molecule that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-rem sleep, indicate its potential to be facilitate the onset and maintenance of sleep. as a result of clinical studies, the effect of lemborexant are suggested not only for primary insomnia but also for insomnia which the diseases, such as depression, associated with. eisai has submitted new drug applications seeking approval of lemborexant for use in the treatment of insomnia disorder in the united states (december 2018), japan (march 2019), and canada (august 2019), respectively. additionally, a phase ii clinical study of lemborexant in patients with iswrd associated with mild to moderate alzheimer’s dementia is underway.

4. about collaboration between eisai and sysmex
eisai and sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in february, 2016. leveraging each other’s technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.
hiscl™ is a trademark of sysmex corporation.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that lenvima (generic name: lenvatinib), the orally available kinase inhibitor discovered by eisai, has been accepted by the national medical products administration of china for an application for the additional indication of differentiated thyroid cancer. this application for additional indication marks the second in china following the indication for hepatocellular carcinoma, which was approved in september 2018.

this application was mainly based on the results of the select study (study 303)¹conducted globally for patients with radioactive iodine-refractory differentiated thyroid cancer. in the select study, lenvima demonstrated a statistically significant extension in progression-free survival (pfs), which is the primary endpoint, compared to placebo (median pfs in the lenvima group: 18.3 months, median pfs in the placebo group: 3.6 months; hazard ratio 0.21 [99% ci: 0.14-0.31]; p<0.001). eisai could submit this application earlier by utilizing the results of select study, while local phase iii clinical trial (study 308) evaluating lenvima in patients with radioactive iodine-refractory differentiated thyroid cancer is ongoing in china.

in china, approximately 190,000 new cases of thyroid cancer are diagnosed each year, and approximately 8,600 are likely to die annually.² although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai is committed to exploring the potential clinical benefits of lenvima, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, cancer patients, their families, and healthcare providers.

* 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.

eisai china inc. is certified as the “top employers china 2020” with its outstanding performance announced by the top employers institute on december 2, 2019.

eisai china’s trophy of “top employers china 2020”

initiated by the top employers institute, it aims to identify top employers in china through a globally unified certification research standard and process, which fields are covered by the survey: talent strategy, workforce planning, talent acquisition, onboarding, learning and development, performance management, leadership development, career and succession management, compensation and benefits, and culture. the whole certification process complies with international standards, which is rigorous and normative. a total of more than 600 companies applied for certification in 2020, and only fewer than 100 companies passed it. eisai china inc. has been certified as the “top employers china 2020” certification when participating in the activity for the first time.

ms. feng yanhui was interviewed.

ms. feng yanhui, vice president of eisai co., ltd. and president of eisai china holdings ltd. and eisai china inc., said: “eisai china has always regarded the improvement of staff capabilities as one of its long-term strategies for corporate development. an excellent human resources management strategy is also one of the key elements in achieving eisai’s strategic goals of eway2025. in the past 28 years, eisai has always been rooted in china and has maintained healthy, healthy, and rapid growth. it is inseparable from the continuous exploration and pursuit of excellence in talent training and development models, tapping the expertise and potential of each employee, and deeply creating an employer brand with eisai chinese characteristics.”

group photo #1

the fast development of eisai in china, owes to highly democratic and transparent management style and timely grasp of the market change. we fully respect every employee, and encourage the knowledge innovation and adherence to strict moral standard. and highly advocate the working atmosphere of cooperation. just as the corporate philosophy “human health care (hhc)” described, eisai pays attention to the physical and mental health of every employee and family members, and purchases comprehensive commercial insurance for every employee who joins the big family of eisai in china. employees can not only enjoy corporate benefits such as paid annual leave, company trip, overseas annual conferences, etc., but also take family members to participate in recreational activities such as family day, eisai’s family feast, marathons and so on, experience hhc’s corporate culture and enjoy family parent-child time with their family members.

group photo #2

in recent years, eisai has created an individual development plan (idp) to accelerate the rapid development and promotion of employees by combining the market’s new technology and the trend of self-media, and utilizing online and offline combination and personalized customization. at the same time, a mentor-led learning ecosystem has been established, and projects such as the eisai management institute, the eagle program, cross-departmental and overseas work shift have been continuously improved to provide employees with complete technical and ability support and enable employees to have growth mindset. obtaining the top employer certification is also an important recognition of achievements in talent training.

taking “innovation, inspire high, ownership, integrity, teamwork” as the core value, eisai china inc. continuously carries out talent development and structural optimization and values the personal value of every employee based on compliance, provides training and opportunities for career development, competitive compensation and benefits, and comprehensive care and protection for employees. we instill in our employees a strong commitment to our hhc philosophy and continually encourage them to contribute to the betterment of the healthcare community, particularly the patients and their families. we hope that eisai china can work with all employees to create a respected, healthy and happy company.

eisai china inc. (hereinafter referred to as “eisai china”) successfully held the launch meeting of fycompa® (perampanel) in china on december 1, 2019, which marks the official launch of the new third-generation antiepileptic drug of fycompa^® in china. this means that the first non-competitive ampa receptor antagonist is officially ushered in the field of epilepsy treatment in china, which will bring new treatment methods and means for the majority of patients with epilepsy and their families.

at the fycompa® launch meeting in china, mr. okada yasushi, the executive officer of eisai co., ltd., the chairman of eisai china holdings ltd. and eisai china inc., said, “first of all, i would like to welcome the experts and scholars who are here and teachers from nearly 200 epilepsy centers who are watching this meeting online to participate in the launching meeting of fycompa in china and the following academic discussion. eisai regards neuroscience, including epilepsy, as a key therapeutic area. with the approval and official launch of fycompa^® in china, eisai china will also officially enter the antiepileptic market from now on, benefiting epilepsy patients in china. in keeping with the mission of freeing numerous epilepsy patients from epilepsy, eisai is committed to meeting the diverse needs of epilepsy patients and their families, and improving their well-being.”

mr. okada yasushi delivered a welcome speech

it is learned that fycompa^® has been granted priority status by the national medical products administration since the application for new drug listing was submitted in september 2018 on the basis that it has significant clinical benefits compared with existing treatment methods. about 12 months later, namely on september 29, 2019, the national medical products administration approved the import license of the new drug of eisai, fycompa®, which is applicable to additional treatment of partial onset seizures (with or without secondary generalized seizures) in epilepsy adults and children aged 12 and above.

fycompa^® launching ceremony

epilepsy is a chronic non-communicable disease of the brain that affects approximately 50 million people worldwide, making it one of the most common neurological diseases around the world. the disease is characterized by recurrent attacks. during an epileptic seizure, patients present a temporary involuntary convulsion of a part or whole of the body (i.e., partial or general seizure), and sometimes accompanied by loss of consciousness and incontinence. about 9 million people in china suffer from epilepsy, 60% of whom are affected by partial seizures, and 40% of those require additional treatment. in addition, the disease of about 30% of epilepsy patients can’t be controlled with existing antiepileptic drugs. epilepsy is a disease with great medical needs which have not yet been met.

fycompa^®is an innovative antiepileptic drug developed by the eisai tsukuba research institute, with dosage and administration of oral administration, once daily. this drug is a highly selective, non-competitive ampa-type receptor antagonist that can reduce the over-excitation of neurons associated with epilepsy attack via targeted inhibition of glutamate activity of the post-synaptic membrane ampa receptor. fycompa® has currently received class a recommendation for the combination therapy of refractory epilepsy with partial seizures (trafe) for adults in the 2018 aan / aes guidelines.

venue of fycompa^® launch meeting in china

fycompa^® has been approved in more than 60 countries worldwide for the additional treatment of partial onset seizures (with or without secondary generalized seizures) in epilepsy patients aged 12 and above. in addition, fycompa® has been approved in 55 countries worldwide for the additional treatment of primary generalized tonic-clonic seizures in epilepsy patients aged 12 years and above. in the united states, fycompa® has been approved for monotherapy and additional treatment of partial onset seizures (with or without secondary generalized seizures) in children aged 4 and above.

with the launch of fycompa® in china, eisai china will further strengthen the leadership position in the field of neuroscience based on more than 35 years of drug development experience in neuroscience and the philosophy of “human health care (hhc)” aiming at “giving first thought to patients and their families, and increasing the benefits health care provides”, which has been rooted in china for more than 25 years.

while continuously introducing new drugs and providing disease solutions, we also provide long-term communication and learning platforms to medical professionals, build bridges for the latest medical information exchange at home and abroad, and present rich disease management experience and cutting-edge academic progress. eisai china is willing to join hands with all walks of life to promote the attention and development of the entire chinese society in the field of neuroscience.

mr. yamada koki, deputy general manager of eisai (china) pharmaceutical co., ltd. (hereinafter referred to as “eisai china”), attended the 2018-2019 annual awards ceremony for advanced collectives and outstanding individuals in peking university health science center, on behalf of eisai china, on november 26, 2019. a total of 40 students won the eisai china scholarships for their outstanding performance, and 10 students got the eisai china grants during this academic year. eisai china has awarded scholarships and grants to outstanding students at peking university health science center for 8 consecutive years.

mr. yamada koki, vice general manager of eisai china, is taking a group photo with the winners

in retrospect, eisai and peking university health science center has a long history of communication. in 1972, when china had not established diplomatic relations with japan, miller, vice president of beijing medical college (now the peking university health science center) and his wife visited the eisai factory in kawajima. under the flying five-starred red flag, kimura hiroshi and the factory leaders welcomed miller and his companions. it was the first time that a five-starred red flag was raised in japan, which laid a solid and long-lasting foundation of friendship for eisai and peking university health science center.

mr. yamada koki, vice general manager of eisai china, is awarding scholarships and grants to the winners

eisai china launched the scholarships and grants program in 2000. by now the company has donated scholarships and grants of more than 8 million yuan to chinese medical institutions, which benefited more than 2000 outstanding students or students with financial difficulties. congratulations to all those who have harvested both excellent results and rewards through hard work in 2019. we hope that you will work even harder and complete your studies with persistent diligence and excellent performance to contribute to the medical and pharmaceutical industry in china.

trophy presented by peking university

in recent years, the eisai china scholarships and grants program has been highly valued and strongly supported by ms. yanhui feng , the china region general manager of eisai, and the eisai top management team. relevant leaders have participated in a lot of such scholarships and grants awarding ceremonies, and adjusted and improved the awards setting for times. the original purpose of the eisai china scholarships and grants program is to promote the development of china’s higher medical education, reward the outstanding students, help students with financial difficulties successfully complete their studies, train more medical professionals for the society, and practice the firm’s hhc corporate philosophy (human health care) with practical actions.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the latest data on its antiepileptic drug (aed) perampanel (product name: fycompa^®) will be presented at the 73rd american epilepsy society annual meeting (aes 2019) to be held from december 6 to december 10, 2019 in baltimore, maryland in the united states.

thirty-eight poster presentations will be given by eisai at aes 2019, including results of a phase iii clinical study (freedom / study 342) to assess efficacy and safety of perampanel monotherapy for untreated patients from 12 to 74 years of age with partial onset seizures and results of a retrospective phase iv study (study 506) of perampanel in real-world clinical care of patients with epilepsy. including investigator initiated studies, more than 40 scientific posters on perampanel will be presented at aes 2019.

perampanel is a first-in-class aed and a once-daily tablet discovered at eisai’s tsukuba research laboratories. in the united states and europe, a new oral suspension formulation has been approved and is being marketed. the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation by targeting glutamate activity at ampa receptors on postsynaptic membranes. perampanel is currently approved in countries around the world as an adjunctive therapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures) and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. furthermore, perampanel is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older in the united states.

eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver perampanel throughout the world in pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

major poster presentations for perampanel:

abstract number date and time of presentation	abstract title
study 342 (freedom study)
abstract number: #2.215 sunday december 8 poster presentation: 10:00-16:00 poster discussion: 12:00-14:00	efficacy and safety of perampanel monotherapy in patients with newly diagnosed or currently untreated recurrent partial-onset seizures: final analysis of study 342 (freedom) 4 and 8 mg/day core data
abstract number: #3.318 monday december 9 poster presentation: 8:00-14:00 poster discussion: 12:00-14:00	perampanel monotherapy in patients (pts) with newly diagnosed or currently untreated recurrent partial-onset seizures (pos): efficacy and safety in the extension phase of study 342 (freedom)
study 506 (prove study)
abstract number: #1.304 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	prove study 506: perampanel as adjunctive therapy or monotherapy in real-world clinical care of patients with epilepsy
abstract number: #1.306 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	perampanel in real-world clinical care of patients with epilepsy at duke university medical center, durham, north carolina: a regional comparison of results from prove study 506
abstract number: #1.311 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	prove study 506: retrospective, phase iv study of perampanel in real-world clinical care of patients aged ≥18 years with epilepsy
abstract number: #1.312 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	perampanel in real-world clinical care of patients with epilepsy: results from the retrospective, phase iv prove study 506
abstract number: #1.313 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	prove study 506: retrospective, phase iv study of perampanel in real-world clinical care of patients aged <4 years with epilepsy
abstract number: #2.209 sunday december 8 poster presentation: 10:00-16:00 poster discussion: 12:00-14:00	prove study 506: retrospective, phase iv study of perampanel in real-world clinical care of patients aged 12 to <18 years with epilepsy
abstract number: #3.301 monday december 9 poster presentation: 8:00-14:00 poster discussion: 12:00-14:00	perampanel in real-world clinical care of patients with epilepsy: effect of enzyme-inducing anti-seizure drugs on retention rate in the retrospective phase iv prove study 506
abstract number: #3.303 monday december 9 poster presentation: 8:00-14:00 poster discussion: 12:00-14:00	prove study 506: retrospective, phase iv study of perampanel in real-world clinical care of patients aged 4 to <12 years with epilepsy
abstract number: #3.316 monday december 9 poster presentation: 8:00-14:00 poster discussion: 12:00-14:00	perampanel in real-world clinical care of patients with epilepsy at northeast regional epilepsy group, hackensack, new jersey: a regional comparison of results from prove study 506
other major presentations
abstract number: #1.303 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	elevate study 410 enrollment update: phase iv study of perampanel as monotherapy or first adjunctive therapy in patients aged ≥12 years with partial-onset or primary generalized tonic-clonic seizures
abstract number: #1.305 saturday december 7 poster presentation: 12:00-18:00 poster discussion: 12:00-14:00	efficacy and safety of perampanel as first adjunctive therapy in patients with partial-onset seizures: post hoc analysis of the fame study by first-line antiepileptic drug use (study 412)
abstract number: #2.207 sunday december 8 poster presentation: 10:00-16:00 poster discussion: 12:00-14:00	perampanel exposure–response relationships for cognition and safety in pediatric patients (aged 4 to <12 years) with epilepsy (study 311, 232)
abstract number: #2.216 sunday december 8 poster presentation: 10:00-16:00 poster discussion: 12:00-14:00	adverse event profile with perampanel as first adjunctive therapy in patients with partial-onset seizures: analysis of the fame study (study 412)

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

[notes to editors]
1. about fycompa (perampanel)
fycompa is a first-in-class aed discovered and developed by eisai. with epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. fycompa is available in tablet form to be taken once daily orally at bedtime. in addition, an oral suspension formulation has been approved and marketed in the united states and in europe. to date, fycompa has been used to treat more than 270,000 patients worldwide across all indications.

fycompa is currently approved in more than 65 countries and territories, including the united states, japan, china, in europe and in asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. in addition, fycompa has been approved in more than 60 countries, including the united states, japan, in europe and in asia for treatment as an adjunctive therapy for primary generalized tonic clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older.

in japan, a supplementary new drug application has been filed seeking approval of fycompa for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a fine granule formulation. in europe, an application has been submitted seeking the additional approval of fycompa for adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures in pediatric patients with epilepsy.

furthermore, eisai is conducting a global phase iii clinical study (study 338) for the agent in patients with seizures associated with lennox-gastaut syndrome.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an agreement to transfer the rights to receive royalties on the sales outside of japan for an investigational anti-cancer agent tazemetostat (generic name) to royalty pharma (headquarters: new york, united states).

tazemetostat is a first-in-class, oral ezh2 inhibitor discovered by epizyme, inc. (headquarters: massachusetts, united states, “epizyme”). under the terms of the march 2015 amended and restated agreement with epizyme, eisai is responsible for development and commercialization of tazemetostat within japan, as well as paying to epizyme royalties on net sales of tazemetostat in japan. epizyme is responsible for development and commercialization outside of japan, and paying to eisai certain development and regulatory milestones, as well as royalties on net sales of tazemetostat in all regions outside of japan.

in this agreement with royalty pharma, eisai transfers to royalty pharma its rights to receive royalties from epizyme on sales outside of japan. eisai will receive an upfront payment of 110 million u.s. dollars for the transfer and obtain the right to receive up to an additional 220 million u.s. dollars upon marketing approvals for tazemetostat in the united states for certain indications.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. by the effective use of management resources including the funds obtained through this agreement, eisai will accelerate to discover the new medicines based on the cuttingedge 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

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