news – page 22 – eisai china lnc.-nba直播小9直播

news – page 22 – eisai china lnc.-nba直播小9直播

thirteen presentations to be given including on phase ii study results of ban2401 and elenbecestat

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announces today that a total of 13 presentations highlighting results from a phase ii clinical study (study 201) of the anti-amyloid beta (aβ) protofibril antibody ban2401 and a phase ii clinical study (study 202) of the oral bace (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: e2609) in addition to the latest data on its alzheimer‘s disease / dementia pipeline including anti-aβ antibody aducanumab, will be given at the alzheimer’s association international conference (aaic) 2018, in chicago from july 22 to 26, 2018. ban2401, elenbecestat and aducanumab are being jointly developed by eisai and biogen inc. (headquarters: cambridge, massachusetts, united states, “biogen”).

as previously announced on july 10, an oral presentation will be given on the results of study 201 (clinicaltrials.gov identifier: nct01767311) on ban2401 in early alzheimer‘s disease (mild cognitive impairment due to alzheimer’s disease or mild alzheimer‘s disease dementia) as a late-breaking abstract. eisai and biogen announced on july 6 that study 201 achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in alzheimer’s disease composite score (adcoms) and on reduction of amyloid accumulated in the brain as measured using amyloid-pet (positron emission tomography). this study was first late-stage study data successfully demonstrating potential disease-modifying effects on both clinical function and amyloid beta accumulation in the brain. the most commonly reported adverse events were infusion reactions and amyloid related imaging abnormalities (aria).

the ban2401 study 201 data presentation will be webcast live. to access the live webcasts, please visit the investors section of eisai‘s website on the day at .

for elenbecestat, a poster presentation will similarly be given as a late-breaking abstract on the results of study 202 (clinicaltrials.gov identifier nct02322021) on elenbecestat in patients with mild cognitive impairment and mild-to-moderate dementia due to alzheimer’s disease. on june 6, 2018, it was announced that from the positive topline results of study 202 at 18 months, elenbecestat demonstrated acceptable safety and tolerability (primary endpoint), as well as a statistically significant effect on aβ levels in the brain as measured by amyloid-pet (exploratory endpoint). a numerical slowing of decline in functional clinical scales of a potentially clinically important difference was also observed, although this effect was not statistically significant. the six most common adverse events observed were contact dermatitis, upper respiratory infection, headache, diarrhea, fall, and dermatitis. elenbecestat is currently being investigated in two ongoing phase iii clinical studies (mission ad1/2) in patients with early alzheimer‘s disease.

in addition, regarding aducanumab, an oral presentation and a poster presentation will be made on the long-term administration of aducanumab from a phase ib clinical study being conducted by biogen. currently, eisai and biogen are advancing two phase iii clinical studies (engage/emerge) on aducanumab.

furthermore, presentations will also be made on the novel phosphodiesterase-9 inhibitor e2027, including an oral presentation on the results of a phase i clinical study as well as poster presentations on non-clinical studies. discovered and developed solely by eisai, e2027 is currently being investigated in a phase ii/iii clinical study as a potential treatment for dementia with lewy bodies.

regarding the investigational sleep-wake agent lemborexant, baseline data from a phase ii clinical study (study 202) in patients with irregular sleep-wake rhythm disorder (iswrd) and alzheimer’s disease will also be presented at aaic 2018. discovered by eisai, lemborexant has been jointly developed with purdue pharma l.p. (headquarters: connecticut, united states, “purdue pharma”) since august 2015.

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 30 years of experience of drug discovery activities in the area of alzheimer‘s 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.

presentations at aaic2018:

please note aaic embargo policy: all materials submitted to aaic are embargoed for publication and broadcast until the officially scheduled date and time of presentation.

 

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 that is the result of a strategic research alliance between eisai and bioarctic. ban2401 selectively binds to neutralize and eliminate soluble, toxic aβ aggregates that are thought to contribute to the neurodegenerative process in alzheimer‘s disease. 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 alzheimer’s disease pursuant to an agreement concluded with bioarctic in december 2007.

2. about elenbecestat (generic name, development code: e2609)

elenbecestat is an oral bace (beta amyloid cleaving enzyme) inhibitor currently being investigated in phase ⅲ clinical studies for alzheimer‘s disease discovered by eisai. by inhibiting bace, a key enzyme in the production of aβ peptides, elenbecestat reduces aβ production, which is thought to lead to a reduction in amyloid plaque formations caused by the aggregation of toxic oligomers and protofibrils in the brain. currently, two global phase iii clinical studies (mission ad1/2) of elenbecestat in early alzheimer’s disease including mild cognitive impairment (mci) due to ad/prodromal ad and the early stages of mild ad are underway. in addition, the u.s. food and drug administration (fda) has granted fast track designation for the development of elenbecestat, a process to facilitate development and expedite review by fda for drugs deemed as having potential to treat serious conditions and addressing unmet medical needs.

3. about aducanumab (biib037)

aducanumab is an investigational compound being developed for the treatment of alzheimer‘s disease. aducanumab is a human recombinant monoclonal antibody (mab) derived from a de-identified library of b cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using neurimmune’s technology platform called reverse translational medicine (rtm). biogen licensed aducanumab from neurimmune under a collaborative development and license agreement.
aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of alzheimer‘s disease patients. based on pre-clinical and phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.
in august 2016 aducanumab was accepted into the european medicines agency’s prime program. in september 2016 the u.s. food and drug administration accepted aducanumab into its fast track program and in april 2017 aducanumab was accepted into the japanese ministry of health, labour and welfare‘s (mhlw) sakigake designation system.
as of october 2017, biogen and eisai entered into a global collaboration agreement to jointly develop and commercialize aducanumab.

4. about the joint development agreement between eisai and biogen for alzheimer’s disease
eisai and biogen are widely collaborating on the joint development and commercialization of alzheimer’s disease treatments. eisai serves as the lead in the co-development of elenbecestat, a bace inhibitor, and 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 alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. if approved, the companies will also co-promote the products in major markets, such as the united states, the european union and japan.

5. about e2027
discovered by eisai, e2027 is a selective phosphodiesterase (pde) 9 inhibitor. inhibiting pde9 reduces the degradation of cyclic gmp which is critical to signal transmission among cells. by helping maintain the concentration of cyclic gmp in the brain, e2027 has the potential to be a new treatment for dementia with lewy bodies.

6. about lemborexant (generic name, development code: e2006)
lemborexant, a dual orexin receptor antagonist, is eisai‘s in-house discovered and developed small molecule compound that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). in individuals with sleep disorders, it is possible that the orexin system that regulates sleep and wakefulness is not functioning normally. during normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission. therefore, eisai and purdue have been developing lemborexant as a treatment for multiple sleep disorders.
in addition, a phase ii clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (iswrd) and mild to moderate alzheimer’s dementia is underway.

tokyo, june 21, 2018 – abbvie gk (headquarters: tokyo, president: james feliciano, “abbvie”) and eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that humira® for subcutaneous injection 20 mg syringe 0.2 ml, a new pediatric formulation of humira ® (generic name: adalimumab [recombinant], “humira”), a fully human anti-tnf-α monoclonal antibody formulation, has been launched today after being listed in the national health insurance reimbursement price list on june 15.

humira has an indication of “treatment of polyarticular juvenile idiopathic arthritis (jia)” that develops in pediatric patients.
humira® for subcutaneous injection 20 mg syringe 0.2 ml is a higher-concentration formulation, which is produced by removing some excipients, and has the same active ingredient as that of, humira® for subcutaneous injection 20 mg syringe 0.4 ml that has been commercially available since september 2011. it has also the same formulation and concentration as those of humira® for subcutaneous injection 40 mg syringe 0.4 ml and humira® for subcutaneous injection 80 mg syringe 0.8 ml that were launched in november 2016. outside of japan, two phase 2, randomized, single- blind, two-period crossover studies were conducted with humira® for subcutaneous injection 40 mg syringe 0.4 ml, to compare injected site-related pain between this higher-concentration formulation and the former formulation, using a visual analog scale (vas). patients with rheumatoid arthritis showed a significantly lower vas pain score after injection of the higher-concentration formulation, as compared with the former formulation.

jia is an autoimmune disease that generally affects children under 16 years of age and is an umbrella term used to define a group of conditions occurring among children that include some form of chronic arthritis. in japan, jia affects 10-15 persons per 100,000 children, and is designated as an incurable disease by the ministry of health, labour and welfare. polyarticular jia is a type of jia which involves five or more joints. symptoms include painful and swollen joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg.

abbvie and eisai will continue to promote and provide information on the proper use of humira® while making further contributions to improve the quality of life of patients including children.


grand launching campaign

june 20, 2018, eisai china region held a grand launching campaign for its rk-1000 model a, a new generation of icg clearance meter, in jw marriott hotel shanghai. the staff from merchants department and partners in china region got together witnessing the company’s first clinical diagnosis device hitting the market. the device will be promoted together with indocyanine green for injection, a product of eisai (liaoning) pharmaceutical co. ltd. this is an attempt of eisai china to expend its business to a new field, which will enrich its product line in the treatment of hepatic diseases such as hepatic carcinoma, hepatic injury, hepatic encephalopathy, and etc., greatly improve its market competitiveness and provide better solution of diagnosis and treatment for both doctors and patients in china.


mr. dali wang and mr. ningbo cai introduced the company and the product

eisai china always gives first thought to patients and their families, and contributes to increasing the benefits provided to them. 
mr. dali wang, director of merchants department, indicated in his speech, “as a multi-national company focusing on the r&d of pharmaceutical products, eisai always gives first thought to patients and their families, and contributes to increasing the benefits provided to them; and as a japanese pharmaceutical company in china, we always adhere to our company philosophy, “human health care (hhc)”. in december 2015, through the full acquisition of a local pharmaceutical enterprise, eisai china established eisai (liaoning) to enter the generic pharmaceutical business to expand its existing business focused on new medicines, in a bid to adapt to chinese market. by providing a stable supply of high quality generic pharmaceuticals with reasonable price, eisai china is able to fulfill an even wider range of medical needs in china. this is the mission of eisai, in accordance with the company’s hhc philosophy. the new business in medical devices bears the same philosophy and spirit. we look forward to working together with our partners to better serve medical practitioners and benefit more chinese patients.


grand launching campaign

liver reserve function testing is the technical basis of precise liver resection of the hepatobiliary surgery.
yangqing huang, head of shanghai public health clinical center, introduced the importance of the liver reserve function testing to hepatobiliary surgeons. huang indicated that the liver reserve function testing is the technical basis for the precise liver resection in the hepatobiliary surgery, and icg clearance test, currently a widely used quantitative assay method of the liver reserve function, is regarded as the standard evaluation index in a large number of guiding documents in both china and overseas. preoperative icg clearance test helps assess the safe range of liver resection and reduce the incidence rate of postoperative liver failure and death, while the postoperative icg clearance test can predict the incidence rate of liver dysfunction and severe complications.

in the campaign, the sponsor introduced in detail the clinically applicable departments of liver reserve function testing and the clinical benefits it brings, explained the guide documents, marketing strategies and gave product demonstrations.

liver reserve function testing is applicable to multiple departments including hepatobiliary surgery, liver transplantation, hepatology, intervention, and etc. in the hepatobiliary surgery department it can be used to assess the safe range of liver resection, to reduce the risks of postoperative liver failure and death, and to predict the incidence rate of postoperative liver dysfunction. in the liver transplant department it can be used to evaluate the quality of the donor liver and the success rate of the operation. in the hepatology department it is manly used in the early diagnosis of liver injury and prognosis evaluation of cirrhosis. in the interventional department it can be used to guide the interventional operation plan and to evaluate the prognosis of operation.


rk-1000 model a, a new generation of icg clearance meter

the new generation icg clearance tester rk-1000 model a is a professional liver reserve function testing device with exclusive dynamic calibration technology and continuous spectrophotometric method bringing a lot of advantages such as dynamic, real-time, accurate, convenient test and so on. this device will be sure to bring more benefits to the broad masses of patients and clinical practitioners.

● first presentation of lenvima/keytruda data in patients with unresectable hepatocellular carcinoma (hcc), which aims to be the first systemic combination of a tki and immunotherapy for these patients, as well as squamous cell carcinoma of the head and neck (scchn)
● updated results show antitumor activity with a consistent safety profile in advanced renal cell carcinoma (rcc) and advanced endometrial carcinoma (ec)
● the lenvima/keytruda combination was recently granted u.s. food and drug administration (fda) breakthrough therapy designation for advanced rcc
● phase iii trials underway in advanced rcc (nct02811861) and advanced ec (nct03517449)

tokyo jun 4, 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), announced today that results from presentations of new data and analyses of lenvima® (lenvatinib), an orally available kinase inhibitor discovered by eisai, in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy, keytruda® (pembrolizumab), in four different tumor types: unresectable hepatocellular carcinoma (hcc) (abstract #4076), squamous cell carcinoma of the head and neck (scchn) (abstract #6016), advanced renal cell carcinoma (rcc) (abstract #4560), and advanced endometrial carcinoma (ec) (abstract #5596 and abstract #5597). the data are included in presentations at the 54th annual meeting of the american society of clinical oncology (asco) in chicago from june 1-5. lenvima and keytruda are not approved for use in combination in any cancer types today.

“the data we have observed in the combination studies of lenvima plus keytruda have fueled our commitment to help meet the diverse health care needs of patients living with cancer through clinical studies and research in specific tumor types that are notoriously difficult to treat and continue to have a significant need for new therapeutic options,” said alton kremer, md, phd, chief clinical officer and chief medical officer, oncology business group at eisai. “we are pleased to share the activity observed in clinical studies of the lenvima plus keytruda combination, as well as rationale for the combination in advanced endometrial carcinoma through translational research.”

“with these data at asco, we are continuing to see encouraging overall response rates, as well as a safety profile that supports the scientific rationale of adding lenvima to keytruda,” 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. “these findings add to the growing body of evidence showing the potential of this combination regimen across a number of tumor types and underscore the strategy behind our collaboration with eisai.”

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced the u.s. food and drug administration (fda) has accepted for review the supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa®(perampanel). this application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (pgtc) seizures. furthermore, eisai has included a study in this snda requested by the fda in a pediatric written request, and therefore fda has designated this application for priority review, which means the review period will be six months. the fda has assigned a prescription drug user fee act (pdufa) action date of september 28, 2018.

this snda 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 pediatric patients and patients 12 years of age and older. the application 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 the age range down to 2 years of age. based on data accumulated to date, the snda also seeks to expand the pediatric indication to include children 2 years of age and older for the adjunctive treatment of pgtc seizures.

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. fycompa has been approved in countries around the world including the united states as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as pgtc seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa has also been approved as monotherapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures). a new oral suspension formulation has also been approved and is available in the united states.

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,1 this is a disease with significant unmet medical need.

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


media inquiries:

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

[notes to editors]

about study 311
study 311 is a global (united states, europe, japan, asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of fycompa orally once-daily, long term safety was assessed during an extension phase. in japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of fycompa orally once-daily. the adverse events (≥10% in the perampanel arms) observed in study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.

about study 232
study 232 was a global (united states, europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). the study evaluated the pharmacokinetics, safety, tolerability and efficacy of fycompa oral suspension taken at the same time as other aeds. administration of once-daily fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). the most common adverse events (≥10% in the perampanel arms) observed in study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.

1. “the epilepsies and seizures: hope through research. what are the epilepsies?” national institute of neurological disorders and stroke, accessed may 24, 2016, 

on may 29, the china human capital forum 2018 was held in china world hotel beijing, announcing that the human resource team of eisai china won the “best hr teams in greater china” of hroot awards 2018 for their outstanding achievements and contributions in pushing the development and innovation of the corporate, building excellent workplaces and promoting business development. mr. yamada koki, head of pharmaceutical affairs division of eisai china, mr. yu ruilong, director of drug affairs & relationship department of eisai china, and ms. wang li, manager of human resource department of eisai china attended the award ceremony. 


mr. yamada koki accepted the award


china human capital forum, sponsored annually by china’s leading hr media – hroot, is a foremost hr summit in the hr field in china region. it seeks to provide senior executives and hr managers with a communicating platform for sharing high-end, forward-looking management concepts and discussing the up-to-date practices. the forum was inaugurated in 2008 and has been successfully operated for 10 years. it attracted nearly 2,000 participators this time, including senior hr executives from 64 state-owned enterprises, 271 fortune global 500 enterprises, and 359 china top 500 enterprises.


eisai china won the best hr teams in greater china” of hroot award 2018


eisai china‘s hr team always dedicates to promoting the “human health care (hhc)” corporate philosophy and rooting it in the hearts of eisai’s employees. hhc is the soul of the eisai employees and is where the significance of their endeavors lie. a half-day hhc activity is specially included in the new employee training in eisai china to better implement and practice this corporate philosophy instead of just introducing it as a terminology. eisai china recommends that all of its employees spend 1% of their business time each year practicing hhc. what‘s more, the corporate carries out over 300 hhc activities each year such as eisai china cognition school, the serving chopsticks action, the yellow wristband action, eisai china scholarships for medical school students, and etc. 


mr. yamada koki, mr. yu ruilong and ms. wang li

in the internet era, working people study in fragmented time and through mobile applications more than ever. eisai china’s employees, of whom 70% are sales & marketing personnel, work in over 40 cities. for better using the existing resources to provide better learning channels for its employees, eisai china‘s hr department established “eisai library (shu-yuan)” platform in 2016, providing both online and offline learning services. this platform includes a real library, “joyful reading room(yue-xiang-ge)”, for offline reading, and gives online book recommendations, book introductions, sofa talks, live broadcasts and masters’ sharing, and etc., which attracted a maximum of 1,274 person-time interactions. in 2018, the eisai library (shu-yuan) was updated to include a comprehensive learning platform – “cloud library (yun-xue-yuan)”, an online sharing community for independent learning – “eisai courses (wei-ke-tang)”, an independent learning community – “talents fusion (da-ren-hui)”, an offline learning salon – “travel-know class (xing-zhi-tang)”, and the offline library “joyful reading room (yue-xiang-ge)” was expanded to eisai china‘s beijing branch.

in 2015, eisai china’s hr department launched eisai management academy, a talent project accelerating the development of the high-potential supervisors and managers and preparing managerial staff for the business expansion of the corporate. to date, 45% trainees of the current 2 sessions have got promotion. what‘s more, the corporate continuously develops cross-function rotations, overseas rotations and the tutorial system to enrich the vocational developments of its employees. currently, 60% management positions were selected from its internal personnel. the project “eisai management academy” won the “top 10 influential events award” of eisai china in fiscal year 2017, and the “top 20 most popular projects award” of ceibs business online in march, 2018.

eisai china always regards the improvements in employees‘capability as one of its long-term strategies. in a bid to strengthen its staff‘s sense of belonging and enhance the cohesive force in the corporate, eisai china has established “honorary staff awards” for the employees who have served the company for 5, 10, 15 and 20 years separately. by the end of march, 2018, eisai has 23 20-year employees, 71 15-year employees, 182 10-year employees and 542 5-year employees. the corporate regards employees’ability improvements and loyalty as the biggest return and a positive response. in eisai china, you have huge vocational development space, and grow together with the corporate. 

it has been 18 years since eisai china launched the eisai china scholarships program (hereafter referred to as “the program”) in 2000. a total of approximately 7.29 million rmb has been contributed to seven universities in china to support more than 1,500 outstanding students and those in straitened circumstances. the 7 universities include sun yat-sen university, medical college of soochow university, school of basic medical sciences of fudan university, peking university health science center, china medical university, west china medical center of sichuan university as well as school of pharmacy of shenyang pharmaceutical university.

the program was initially established to promote the development of higher medical education in china, to award outstanding students, to support those in straitened circumstances, and to train more medical professionals for the society. the program embodies the corporate responsibility of eisai china in repaying the society, and the corporate philosophy of “human health care (hhc)”.

in 2017, eisai china offered scholarships value of 708,000rmb to 296 students from the seven medical universities. among them, 144 students were academically excellent and morally upright, accounting for 49%; 47 students were those attaining all-round development in the domains of ethics, intellect, physique and having excellent performances in communities, accounting for 16%; 105 students were hardworking students with financial difficulties, accounting for 35%. in addition, 14 students gained opportunities for international exchanges, thanks to the program, which could enrich their experiences.

all along, the program has been highly valued and greatly supported by ms. feng yanhui, general manager of eisai china. in 2017, ms. feng, mr. yamada koki, head of pharmaceutical affairs division, mr. zhang jianzhong, head of pharmaceutical business division (pbd), mr. zhang dayong, south regional sales director of nta business unit, pbd, as well as mr. zhang wei, hr director of edcs, were invited to attend the scholarship recognition ceremonies in sichuan university, peking university, china medical university, sun yat-sen university and suzhou university, respectively. in the ceremonies, on behalf of eisai china, they gave their best wishes to the students. meanwhile, eisai china was highly appreciated by the seven universities and their students for its active participation in social welfare undertakings.

eisai china is firmly convinced that public welfare undertakings are corporate responsibilities as well as obligations. in 2018, eisai china will continue in inheriting and carrying forward the spirit of hhc and radiate positive energy of charitable causes.

pictures of the program in 2017


on january 5, 2018, ms. feng yanhui, general manager of eisai china, attended the scholarship recognition ceremony in sichuan university


on december 18, 2017, mr. zhang jianzhong, head of pharmaceutical business division of eisai china, attended the scholarship recognition ceremony in shenyang pharmaceutical university


on december 14, 2017, mr. yamada koki, head of pharmaceutical affairs division of eisai china, participated in the scholarship recognition ceremony in peking university health science center



on march 12, 2018, mr. zhang wei, hr director of edcs of eisai china, participated in the scholarship recognition ceremony in west china medical center of sichuan university

eisai co., ltd. (ceo: haruo naito; headquarters: tokyo, japan) (hereinafter “eisai”), eisai‘s subsidiary for gastrointestinal diseases ea pharma co., ltd. (president & ceo: yuji matsue; headquarters: tokyo, japan) (hereinafter “ea pharma”) and mochida pharmaceutical co., ltd. (president: naoyuki mochida; headquarters: tokyo, japan) (hereinafter “mochida”) today announced that the bile acid transporter inhibitor “goofice® 5mg tablet” (nonproprietary name: elobixibat hydrate; development code: ajg533) (hereinafter “goofice® tablet”) was listed in japan’s national health insurance drug price list as of april 18, 2018, and ea pharma and mochida launched the product onto japan‘s market today.

goofice® tablet, which ea pharma in-licensed from albireo ab (sweden), is a once-daily, orally available constipation treatment with a novel action mechanism. goofice® tablet inhibits the bile acid transporter that regulates reabsorption of bile acids thereby increasing the flow of bile acids to the colon. the dual action of moisture secretion and bowel movement promotion is expected to enhance natural defecation. goofice® tablet is the first ileal bile acid transporter inhibitor approved anywhere in the world.

constipation is a very common disease. the prevalence is high in young women and both elderly men and women. in japan, the number of patients with subjective symptoms of constipation is estimated to be about 4.5 million. in constipation, symptoms such as sensation of incomplete evacuation and hard stools appear in addition to reduction of bowel movement frequency. when such symptoms become chronic, many patients suffer a decline in qol (quality of life). in a placebo-controlled, double-blind phase 3 clinical study conducted in japan, which was the basis for marketing approval, there were statistically significant improvements observed in changes in spontaneous bowel movement (primary endpoint), complete spontaneous bowel movement (secondary endpoint), time to first spontaneous bowel movement, stool consistency and other parameters for the goofice® tablet-treated group compared to the placebo group. no serious adverse events were observed.

goofice® tablet was jointly developed by ea pharma and mochida. ea pharma and mochida will distribute the product under the same brand name, respectively. ea pharma and eisai have signed a co-promotion agreement and will jointly provide information for proper use of the product.
by providing goofice® tablet with its novel mechanism of action, ea pharma, eisai and mochida strive to broaden treatment options for patients with chronic constipation to make a further contribution to improve patients’ qol.

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.

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