news – page 24 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it has submitted to the u.s. food and drug administration (fda) a supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa^® (perampanel) seeking approval for an indication expansion to cover pediatric patients with epilepsy.
this snda aims to expand the indication for fycompa in the united states, which currently covers monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older, to also include children with epilepsy 2 years of age and older. based on data accumulated to date, the snda also seeks to potentially expand the pediatric indication to include children 2 years of age and older for the treatment of primary generalized tonic-clonic seizures.

fycompa has been approved in over 55 countries in the world as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa has also been approved as monotherapy use for the treatment of partial-onset seizures (with or without secondarily generalized seizures).

this application was based on the interim results of a phase iii clinical study (study 311) as well as the results from a phase ii clinical study (study 232). both studies suggested the safety and efficacy of adjunctive treatment with fycompa was similar between adult and pediatric patients.

study 311 evaluated the safety, tolerability and exposure-efficacy relationship of fycompa when administered as an adjunctive therapy in children (ages 4 to less than 12 years) with inadequately controlled partial onset seizures or primary generalized tonic clonic seizures. study 232 is evaluated the pharmacokinetics, efficacy and long-term safety of fycompa when given as an adjunctive therapy in pediatric subjects from 2 to less than 12 years of age with epilepsy.

furthermore, regarding the pediatric indication for fycompa, eisai has received from the fda a written request for pediatric studies, which means that priority review designation is possible.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic ampa receptors.

epilepsy affects approximately 2.9 million people in the united states, 1 million people in japan, 6 million people in europe, and approximately 60 million people worldwide. while epilepsy affects people of all ages, incidence is particularly high among children and the elderly. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds, this is a disease with significant unmet medical need.

eisai considers neurology a therapeutic area of focus, and together with the worldwide provision of fycompa, seeks to further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

● first new front-line treatment option for hcc approved in japan in nearly 10 years
● first approval under global strategic collaboration between eisai co., ltd. and merck & co., inc., kenilworth, n.j., u.s.a

tokyo march 23, 2018 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada), today announced that the multiple receptor tyrosine kinase inhibitor lenvima^® (generic name: lenvatinib mesylate) has been approved in japan for unresectable hepatocellular carcinoma (hcc). this is the first approval worldwide for lenvima for the indication of unresectable hcc and the first new systemic therapy to be approved in japan for the front-line treatment of hcc in approximately 10 years. additionally, this is the first regulatory approval for lenvima under the global strategic collaboration agreement executed in march 2018 between eisai and merck & co., inc., kenilworth n.j., u.s.a. for the co-development and co-commercialization of lenvima.

this approval was based on a phase iii clinical study (study 304 / reflect study) conducted by eisai investigating lenvima as a first-line treatment in patients with unresectable hcc. in this study, lenvima demonstrated statistically significant non-inferiority of overall survival (os) (13.6 months) compared to sorafenib (12.3 months) (hazard ratio [hr] 0.92, 95% confidence interval [ci]=0.79-1.06). additionally, lenvima showed highly statistically significant and clinically meaningful improvements as compared to sorafenib in the secondary endpoints of progression free survival (pfs) (hr 0.66, 95% ci=0.57-0.77, p<0.00001), time to progression (ttp) (hr 0.63, 95% ci=0.53-0.73, p<0.00001), and objective response rate (orr) (lenvima 24% versus sorafenib 9%, p<0.00001). furthermore, lenvima helped to delay deterioration in several quality of life (qol) and symptom domains (pre-specified secondary endpoint) including in areas such as pain and diarrhea, compared to sorafenib (nominal p-value<0.05).

in this study, the five most common adverse events observed in the lenvima arm were hypertension (42%), diarrhea (39%), decreased appetite (34%), weight loss (31%) and fatigue (30%), which is consistent with the known safety profile of lenvima.

liver cancer is the second leading cause of cancer related deaths with approximately 750,000 deaths per year estimated globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80 percent of which occur in asia, including japan and china. hcc accounts as the primary reason for 85 percent to 90 percent of liver cancer cases. it is estimated that there are approximately 42,000 hcc patients in japan, with approximately 26,000 deaths every year. to-date, treatment options for unresectable hcc have been limited and the prognosis is very poor, emphasizing that this is an area of high unmet medical need.

“with the approval of this additional indication of unresectable hcc for lenvima, we are proud to be able to deliver the first new front-line systemic therapy treatment option for hcc in japan in approximately 10 years, and expect this will contribute to hcc treatment” said dr. takashi owa, eisai oncology business group chief medicine creation officer. “eisai will continue with its efforts in oncology research and development in order to deliver hopes for a potential cure for cancer to patients and their families.”

“today‘s approval is an important first for lenvima and a significant first regulatory event under our collaboration with eisai,” said dr. roy baynes, senior vice president and head of global clinical development, chief medical officer, merck & co, inc. kenilworth, n.j., u.s.a. “we congratulate eisai on the approval of this new indication and look forward to working together to bring this important treatment option to patients.”

having received approval of this indication, eisai will receive a development milestone payment from merck & co., inc., kenilworth n.j. u.s.a. there are no changes to eisai’s consolidated financial results forecasts for the fiscal year ending march 31, 2018 based on the receipt of this milestone payment.

on march 12th, a group of executives from shinsei electronics co., ltd., inclusive of president yamashita noriyuki, division head isobe takashi, and etc., visited eisai (china) headquarter and had friendly and cordial talks with the management staff of eisai (china). the two parties reached a strategic cooperation agreement on “icg clearance meter,” and eisai (china) will become the exclusive distributor of the product in china which will be jointly promoted with indocyanine green for injection, a product of eisai (liaoning) pharmaceutical co., ltd. during the conversation, division head, isobe takashi introduced the development history, business overview and future cooperation prospects of shinsei electronics. both the chairman, kaneko norio, and the general manager, feng yanhui expressed that the cooperation with shinsei electronics is an attempt by eisai (china) to expand the business in new fields, and they look forward to a successful cooperation and mutual benefits. sincere thanks were given to shinsei electronics for choosing eisai (china) as a strategic partner to provide chinese doctors and patients with better treatment solutions. at the same time, misawa yukihiro, manager of business development department of eisai (china), and cai ningbo, senior product manager of merchants department, gave a detailed introduction of eisai (china) and the marketing model and strategy of “icg clearance meter”.

the project aims to break through the barriers in sales of liver reserve function testing through the equipment introduction, and to increase the market competitiveness of eisai (china) in this field. the introduction of the equipment will greatly stimulate the sale of indocyanine green, and also expand new business opportunities for the company to increase its business scope. thorough cooperation of all departments is the key to the success of eisai (china) in obtaining the distributorship of “icg clearance meter” in china.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its chinese subsidiary, eisai china inc. (eci) has completed construction of a new oral solid dose (osd) production facility and an administration building at the site of its new suzhou plant located within the suzhou industrial park.

aiming to further expand its contribution to patients in china, eisai has been working to establish a new suzhou plant on a new industrial site more than five times larger than the current suzhou plant (osd production facility) to further strengthen the stable supply chain as well as improve production efficiency. eci established a parenteral facility in november 2014, where it manufactures the injection formulation of methycobal®. the newly completed osd production facility stands three floors aboveground and contains floor space of approximately 20,240 m², and its production capacity (formulation of approximately 3 billion tablets / packaging for approximately 5 billion tablets per year) is approximately double that of the current suzhou plant. operations are expected to commence in the second half of fiscal 2018, and the new osd facility will handle the formulation and packaging of oral solid dose products such as methycobal, aricept® and pariet® for the domestic chinese market. the current plant will be closed after operations fully commence at the new suzhou plant‘s osd production facility.

eisai’s business operations in china are one of its core businesses which is third-largest in scale after japan and the united states. through the completion of the osd production facility at the new suzhou plant, eisai seeks to strengthen its in-house domestic production system in china and expand its stable supply chain of high quality pharmaceuticals, contributing to increasing the benefits to patients and their families in china.

1. outline of new suzhou plant
location: 168 xingpu road, suzhou industrial park, suzhou, jiangsu, china
site area: approximately 134,000 m²

(1)  oral solid dose production facility
(construction completed)
·  floor space: approximately 20,240 m² / three floors
·  main functions: formulation, packaging, storage, etc.
·  products to be manufactured: methycobal, aricept, pariet and other products

(2) parenteral production facility
(construction completed in november 2014)
· floor space: approximately 5,690 m² / two floors
· products manufactured: methycobal injection and other products

(3) administration building
(construction completed)
· floor space: approximately 2,230 m² / two floors
· main facilities: offices, meeting rooms, cafeteria, etc.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) for use in the treatment of hepatocellular carcinoma (hcc), which was submitted for approval in china in october 2017, has been designated for priority review and approval by the china food and drug administration (cfda) due to lenvatinib‘s significant clinical benefit compared to existing treatments.

the priority review and approval procedure was implemented by the cfda in february 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value. through designation for priority review and approval, the period of time until approval is expected to be shortened.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide.1 hcc accounts for 85% to 90% of primary liver cancer cases. unresectable hcc, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

eisai submitted applications for an additional indication for lenvatinib for the treatment of hcc in japan (june 2017), the united states and europe (july 2017), mainland china (october 2017) and chinese taiwan (december 2017).

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 lenvatinib 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that aricept® (donepezil hydrochloride, brand name in china: ) has been approved for the additional indication of severe alzheimer‘s disease in china. aricept is the first alzheimer’s disease treatment with a broad indication that covers mild to severe alzheimer‘s disease in china.

the approval of the additional indication was based on the results of a phase iii clinical study (study 339) in china. study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of aricept 10 mg per day in 313 chinese patients with severe alzheimer’s disease. in this study, aricept demonstrated a statistically significant improvement in total severe impairment battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. in the study, the four most commonly observed adverse events in the aricept arm were bradycardia, anorexia, qt interval prolongation, and dizziness.

in china, it has been estimated that approximately 6 million people suffer from alzheimer‘s disease. furthermore, with the progressive aging of the population, the number of patients with dementia is expected to greatly increase in the future. eisai launched aricept in china in september 1999, and in collaboration with various stakeholders including government, hospitals and non-government organizations, is actively promoting dementia disease awareness initiatives for civilians as well as support for establishing memory clinics and other initiatives.

with the approval of this indication covering severe alzheimer’s disease, eisai strives to further contribute to increasing the quality of life of patients with alzheimer‘s disease in china, and as the originator of aricept, continues to make comprehensive contributions in dementia such as improving treatment and care, increasing public awareness of the disease and discovering new treatment methods.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that the china food and drug administration (cfda) has accepted for review a new drug application (nda) submitted for eisai’s in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) for use in the treatment of hepatocellular carcinoma (hcc) in china.

the nda was based on the results of the reflect study (study 304), a multicenter, open-label, randomized, global phase iii trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for hcc, as a first-line treatment for the patients with unresectable hcc.

in the reflect study, lenvatinib demonstrated a treatment effect on the primary endpoint of overall survival (os) by the statistical confirmation of non-inferiority to sorafenib. additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements compared to sorafenib in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr). in this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited. therefore, hcc is extremely difficult to treat, and the development of new treatments is necessary.

eisai submitted applications for an additional indication for lenvatinib for the treatment of hcc in japan (june 2017), the united states and europe (july 2017).

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 lenvatinib 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.

results of subpopulation analysis of patients from greater chinese region (mainland china, hksa, and chinese taiwan)

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that the results of a subpopulation analysis of patients from the greater chinese region (mainland china, hksa, and chinese taiwan) in a phase iii trial (reflect / study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma (hcc) were orally presented for the first time during the 20th annual meeting of the chinese society of clinical oncology (csco), which took place in xiamen (amoy) in the fujian province of china. over half of the world‘s hcc patients come from the greater chinese region.

in the subpopulation analysis, lenvatinib demonstrated efficacy based on extension of overall survival (os) compared to sorafenib (nominal p = 0.026), with improvements also observed in progression free survival (pfs), time to progression (ttp) and objective response rate (orr) (see table below). approximately 80% of patients in the subpopulation were suffering from hcc resulting from chronic hepatitis b virus (hbv). for these patients, median os in the lenvatinib group (123 patients) was 14.9 months, compared to 9.9 months in the sorafenib group (119 patients) (hazard ratio [hr] 0.72, 95% confidence interval [ci] = 0.53-0.97). these findings are consistent with the overall results of the greater chinese region subpopulation.
hbv is considered to be a negative predictor of tumor response to existing drug therapies. however, this data supports the effect of lenvatinib in patients with hcc resulting from hbv. since there are many patients suffering from hcc resulting from hbv in the greater chinese region, lenvatinib is expected to be a new treatment option for hcc patients in this area.

additionally, lenvatinib’s safety profile for the greater chinese region subpopulation was consistent with previous studies.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited and the prognosis is very poor, making this an area of high unmet medical need.

following submissions in japan (june 2017), the united states and europe (july 2017), eisai will submit a regulatory application for lenvatinib in hcc in china within the latter half of fiscal 2017. eisai remains committed to generating scientific evidence aimed at maximizing the value of lenvatinib 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.

results of subpopulation analysis of patients with hepatitis b virus coinfection

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that the results of a subpopulation analysis of patients with hepatitis b virus (hbv) coinfection in a phase iii trial (reflect / study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) versus sorafenib as a first-line treatment for unresectable hcc were presented for the first time during the 11th annual conference of the international liver cancer association (ilca) held in seoul, south korea.

in the total population analysis of this study, the treatment effect of lenvatinib for all patients on the primary endpoint of overall survival (os) was demonstrated by statistical confirmation of non-inferiority to sorafenib. lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr).
the analysis results presented at ilca indicate that in comparison to the total population, lenvatinib demonstrated a lower hazard ratio for os, fps, and ttp, and a higher odds ratio for orr in the subpopulation of patients with hbv (see table below). hbv is considered to be a negative predictor of tumor response to existing drug therapies, so lenvatinib, which demonstrated a therapeutic effect in patients with hbv, is expected to be a new treatment option for patients with hcc.

additionally, safety results were similar in patients with hbv and the total population in the lenvatinib arm. the five most common treatment-emergent adverse events in patients with hbv in the lenvatinib arm were hypertension, diarrhea, decreased weight, fatigue and decreased appetite.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for 750,000 deaths per year globally. additionally, 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited and the prognosis is very poor, making this an area of high unmet medical need.
following submissions in japan (june 2017), the united states, and europe (july 2017), eisai will submit a regulatory application for lenvatinib in hcc in china within the latter half of fiscal 2017.

eisai remains committed to generating scientific evidence aimed at maximizing the value of lenvatinib 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.

on september 15, 2017, china population welfare foundation, alzheimer’s disease chinese (adc) and eisai china inc. (eci) jointly kicked off the “yellow bracelet” activity for caring the patients with alzheimer‘s disease. in line with the corporate philosophy of “human health care (hhc)” and according to the actual situation of chinese patients, eisai introduced into china the experiences for the treatment and care of the aging people of japan in hope of continuously enhancing the attention of the whole chinese society to the alzheimer’s disease and improving the grim situation of china‘s insufficient treatments and care concerning this disease through upgrading the entire solution that covering recognition, trainings and care. chairman hao linna of china population welfare foundation, professor wang luning from alzheimer’s disease chinese, professor xie hengge from the general hospital of people‘s liberation army of china, professor wang huali from peking university sixth hospital (institute of mental health), professor liu xueyuan from the tenth people’s hospital affricated to tongji university, professor he jincai from the first affiliated hospital of wenzhou medical college, mr. kaneko norio, the president of eci and ms. feng yanhui, the general manager of eci attended the conference and delivered speeches. the guests jointly kicked off the “alzheimer‘s care” activity and witnessed the important moment.

since the establishment of the company, eisai made “hhc” as its mission and the criterion of the company’s operation and charity activities. “in eisai, every employee gives first thought to patients and their families, and to increasing the benefits that health care provides them. every year the eisai employees spend 1% of their working time practicing the hhc mission together with the patients, experiencing their sufferings in a bid to provide better services for them. eisai carries out extensive health activities according to the needs of different countries. for example, eisai opened clinics and provided free clinical services, patient-care services and doctor educations in india, thailand, philippines, britain, canada, and etc. in india, eisai has provided over 1,000 free clinic services for patients with alzheimer‘s disease. the amount of patients with alzheimer’s disease got treatments there increased about 6 times in 5 years since eisai opened memory clinics there and trained relevant medical staff. eisai also brings this mission to china,” said mr. kaneko norio, the president of eci when talking about the original purpose of the “hhc” activities.

the “world alzheimer report 2016” indicated that the figure of patients with alzheimer‘s disease showed a rapid growth in china and the country saw a stark contrast of the huge patient amount to the insufficient treatment and care. only a few patients accepted standard diagnosis, and a considerable proportion of patients were mistaken for experiencing a natural part of the aging process and missed the best treatment time. what’s more, the coverage rate of professional medical care resources was obviously insufficient. based on the current situation, the “alzheimer‘s care” activity will establish a community-centered, comprehensive, hierarchical diagnosis and treatment system and a professional home-care platform, which help combat the disease with 5 practical measures as follow:

firstly, to strengthen the education to potential patients
distribute yellow bracelets to more elderly and help them better use it. enhance the technology of the yellow bracelet and enrich the relevant functions to reduce the risk of old people from getting lost;

secondly, to give full play to the power of yellow bracelet in wechat platform
rely on the wechat platform to promote the early diagnosis and treatment of the elders with alzheimer’s disease, give them early cognitive tests, recommend them the nearby memory clinic, show them care-introducing videos and provide them better caring methods;

thirdly, to explore and promote the community care model
make communities and pension institutions as the centers to establish home-care training platforms and livable environments. eisai plans to pilot this model in 6 chinese cities for the first batch;

fourthly, to carry out professional training in caring skills
to learn the global advanced caring experiences, design and develop standard courses to conduct professional trainings to improve the skills of medical staff.

fifthly, to strengthen the guidance on public awareness
carry out propaganda and education of disease-related knowledge and construct social environment that encourages respecting, loving and caring the elderly.

japan is a country with serious aging problem and experienced at elderly care. as a leading japanese pharmaceutical company, considering alzheimer‘s disease as a focus area for the long-term, eisai has introduced aricept® to china, made all efforts for its accessibility, and continuously increased the investments in the research and development of new drugs. what’s more, since 2012, eisai china began to support the yellow bracelet project, which helps prevent the elderly with alzheimer‘s disease from getting lost; eisai china has conducted a series of projects – “remember that i love you” patient-care activities, and has supported over 100 free clinical services, distributed 245,000 yellow bracelets and provided free drugs to 136 families. “the ’alzheimer‘s care’ activity is an upgrade of eisai‘s former hhc activities. based on the 20-year experiences in serving chinese families and communities, eisai china joins hands with institutions in different fields to help more patients get standard treatments at early stage, and to guide their families in taking care of the patients. eisai would like to introduce health management experiences accumulated for years through charitable organizations and academic institutions, and to protect the happiness of chinese families with the comprehensive alzheimer-treatment solutions,” said ms. feng yanhui, the general manager of eci.

news – page 24 – eisai china lnc.-pg电子app

results of subpopulation analysis of patients from greater chinese region (mainland china, hksa, and chinese taiwan)

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