news – page 16 – eisai china lnc.-pg电子app

news – page 16 – eisai china lnc.-pg电子app

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

  • new analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early alzheimer’s disease as measured by the pre-specified primary and secondary endpoints
  • based on discussions with the fda, the company plans to submit a biologics license application in early 2020
  • biogen aims to offer aducanumab to eligible patients previously enrolled in clinical studies 
  • the positive results of this new analysis were driven primarily by greater exposure to high dose aducanumab in the larger dataset as compared to data available at the time of the futility analysis 


cambridge, mass. and tokyo, japan – october 22, 2019 – biogen (nasdaq: biib) and eisai, co., ltd. (tokyo, japan) today announced that, after consulting with the u.s. food and drug administration (fda), biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early alzheimer’s disease (ad). the phase 3 emerge study met its primary endpoint showing a significant reduction in clinical decline, and biogen believes that results from a subset of patients in the phase 3 engage study who received sufficient exposure to high dose aducanumab support the findings from emerge. patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home. if approved, aducanumab would become the first therapy to reduce the clinical decline of alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

the decision to file is based on a new analysis, conducted by biogen in consultation with the fda, of a larger dataset from the phase 3 clinical studies that were discontinued in march 2019 following a futility analysis. this new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid and in reducing clinical decline as assessed by the pre-specified primary endpoint clinical dementia rating-sum of boxes (cdr-sb). in both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab.

“with such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against alzheimer’s. this is the result of groundbreaking research and is a testament to biogen’s steadfast determination to follow the science and do the right thing for patients,” said michel vounatsos, chief executive officer at biogen. “we are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

based on discussions with the fda, the company plans to file a biologics license application (bla) in early 2020 and will continue dialogue with regulatory authorities in international markets including europe and japan. the bla submission will include data from the phase 1/1b studies as well as the complete set of data from the phase 3 studies.

the company aims to offer access to aducanumab to eligible patients previously enrolled in the phase 3 studies, the long-term extension study for the phase 1b prime study, and the evolve safety study. biogen will work towards this goal with regulatory authorities and principal investigators with a sense of urgency.


study results

emerge (1,638 patients) and engage (1,647 patients) were phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of two dosing regimens of aducanumab. these studies were discontinued on march 21, 2019, following the results of a pre-specified futility analysis which relied on an earlier and smaller dataset. the futility analysis was based on data available as of december 26, 2018, from 1,748 patients who had the opportunity to complete the 18-month study period and predicted that both studies were unlikely to meet their primary endpoint upon completion. futility analyses are common in large clinical studies and use statistical modeling to attempt to predict the outcome of the studies based on a number of pre-specified assumptions and criteria.

following the discontinuation of emerge and engage, additional data from these studies became available resulting in a larger dataset, which included a total of 3,285 patients, 2,066 of whom had the opportunity to complete the full 18 months of treatment. a new extensive analysis of this larger dataset showed a different outcome than the outcome predicted by the futility analysis. specifically, the new analysis of this larger dataset showed emerge to be statistically significant on the pre-specified primary endpoint (p=0.01). biogen believes that data from a subset of engage support the findings from emerge, though engage did not meet its primary endpoint. biogen consulted with external advisors and the fda on these different results and their implications.

“this large dataset represents the first time a phase 3 study has demonstrated that clearance of aggregated amyloid beta can reduce the clinical decline of alzheimer’s disease, providing new hope for the medical community, the patients, and their families,” said dr. anton porsteinsson, william b. and sheila konar professor of psychiatry, neurology and neuroscience, director of the university of rochester alzheimer’s disease care, research and education program (ad-care), and principal investigator. “there is tremendous unmet medical need, and the alzheimer’s disease community has been waiting for this moment. i commend biogen, the fda, the medical community, and the patients and their study partners for their persistence in working to make today’s announcement a reality.”

in emerge, which met its pre-specified primary endpoint in the new analysis, patients treated with high dose aducanumab showed a significant reduction of clinical decline from baseline in cdr-sb scores at 78 weeks (23% versus placebo, p=0.01). in emerge, patients treated with high dose aducanumab also showed a consistent reduction of clinical decline as measured by the pre-specified secondary endpoints: the mini-mental state examination (mmse; 15% versus placebo, p=0.06), the ad assessment scale-cognitive subscale 13 items (adas-cog 13; 27% versus placebo, p=0.01), and the ad cooperative study-activities of daily living inventory mild cognitive impairment version (adcs-adl-mci; 40% versus placebo, p=0.001). imaging of amyloid plaque deposition in emerge demonstrated that amyloid plaque burden was reduced with low and high dose aducanumab compared to placebo at 26 and 78 weeks (p<0.001). additional biomarker data of tau levels in the cerebrospinal fluid supported these clinical findings. biogen believes that data from patients in engage who achieved sufficient exposure to high dose aducanumab supported the findings of emerge.

in both studies, the most commonly reported adverse events were amyloid-related imaging abnormalities-edema (aria-e) and headache. the majority of patients with aria-e did not experience symptoms during the aria-e episode, and aria-e episodes generally resolved within 4 to 16 weeks, typically without long-term clinical sequelae. biogen plans to present further detail on the new analysis of the larger dataset from emerge and engage at the clinical trials on alzheimer’s disease (ctad) meeting in december 2019.

after reviewing the data in consultation with the fda, biogen believes that the difference between the results of the new analysis of the larger dataset and the outcome predicted by the futility analysis was largely due to patients’ greater exposure to high dose aducanumab. multiple factors contributed to the greater exposure to aducanumab in the new analysis of the larger dataset, including data on a greater number of patients, a longer average duration of exposure to high dose, the timing of protocol amendments that allowed a greater proportion of patients to receive high dose, and the timing and pre-specified criteria of the futility analysis.

 

biogen conference call and webcast

on october 22, 2019, at 8:00 a.m. et, biogen will host its third quarter 2019 earnings conference call, which will include a discussion of the new analysis of the larger dataset from the phase 3 studies of aducanumab. this conference call will be broadcast via the internet and will be accessible through the investors section of biogen’s website, www.biogen.com. following the live webcast, an archived version of the call will be available on the website. supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least one month.

 

about aducanumab

aducanumab (biib037) is an investigational human monoclonal antibody studied for the treatment of early alzheimer’s disease. biogen licensed aducanumab from neurimmune under a collaborative development and license agreement. since october 2017 biogen and eisai have collaborated on the development and commercialization of aducanumab globally.

emerge and engage were phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. the primary objective of the studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing cognitive and functional impairment as measured by changes in the cdr-sb score. secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical decline as measured by mmse, adas-cog 13, and adcs-adl-mci.

 

about biogen

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

we routinely post information that may be important to investors on our website at . to learn more, please visit  and follow us on social media – , , , .

about eisai co., ltd.

eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. eisai’s corporate philosophy is to give first thought to patients and their families, and to increase the benefits that health care provides to them. under this philosophy, the company endeavors to become a human health care (hhc) company. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of neurology and oncology.

leveraging the experience gained from the development and marketing of aricept®, a treatment for alzheimer’s disease and dementia with lewy bodies, eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. as a pioneer in the field of dementia treatment, eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.

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

biogen safe harbor 

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

these statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of biogen’s drug candidates, including aducanumab; actual timing and enrollment of future studies of aducanumab; the occurrence of adverse safety events and/or unexpected concerns that may arise from additional data or analysis; risks of unexpected costs or delays; the risks of other unexpected hurdles; uncertainty of success in the development and potential commercialization of aducanumab; failure to protect and enforce biogen’s data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab, and other unexpected difficulties or hurdles; product liability claims; and third party collaboration risks. the foregoing sets forth many, but not all, of the factors that could cause actual results to differ from biogen’s expectations in any forward-looking statement. investors should consider this cautionary statement, as well as the risk factors identified in biogen’s most recent annual or quarterly report and in other reports it has filed with the u.s. securities and exchange commission. these statements are based on biogen’s current beliefs and expectations and speak only as of the date of this news release. biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

on october 19, 2019, the “2019 ads beijing” sponsored by eisai china inc. was held in beijing, which is another platform for doctors’ information exchanges. featuring the theme of “let’s build hope together”, the main forum and three sub-forums focused on the latest cutting-edge academic research and clinical practice and development in china and in the world. 37 well-known experts and scholars from china, japan, singapore, spain and other countries, more than 300 on-site guests and nearly 1,000 on-line guests jointly discussed and conducted dialogues and interactions, producing collision of ideas and academic resonance between china and foreign countries.

at the beginning of the summit, mr. zhang jianzhong, vp and head of pharmaceutical business division of eisai china inc., delivered a speech. firstly, mr. zhang gave a warm welcome to all the experts and guests and sincerely thanked them for their strong support to the 2019 ads beijing summit. eisai china inc. will devote itself to building an academic exchange platform for cognitive disorders and continue to increase research and development of new drugs in this field. at the same time, adhering to its business philosophy of hhc (human health care), it will work hand in hand with all walks of life to make contributions in the cognition, prevention and control of diseases, patient care and other aspects.


zhang jianzhong delivered a speech

at this summit, professor jianping jia and professor luning wang were invited to act as chairmen of the summit. both of professor jia and professor wang expressed their thanks to eisai china inc. for setting up such an academic exchange platform to allow experts from many countries and guests to share academic and clinical practice and to jointly explore new modes of control and prevention of diseases in the field of cognitive impairment, and wished the summit a complete success.


a group photo of some experts

in the main forum, experts held academic discussions on issues such as the development of cognitive science, researches on the post-stroke cognitive impairment, researches on self-management of patients with alzheimer’s disease, the comparison of csf and blood biomarkers for alzheimer disease, researches on dlb and pdd drugs, advances and clinical treatment experiences of vad. they also held large-scale discussions on issues such as sleep and cognitive impairment, non-invasive biomarkers, and new target drugs for treatment of alzheimer’s disease, colliding their ideas and benefiting the participants.


photo of main forum

in the “practice” sub-venue, the themes were “measurement”, “observation”, “investigation”, “differentiation “, identification”, “treatment” and “practice”. speeches and case discussions and “on-the-spot consultation” mode discussions were conducted on the clinical applications of neurocognitive assessment, ad picture description, new progress in gene diagnosis of chinese population, truth and falsehood of senile depression “pseudodementia”, sharing of dlb or ad difficult cases, ad whole-process management and rational drug use. in the “field hotspots” sub-venue, from theory to practice, the participants interpreted in detail the “china guidelines for cognitive impairment related to cerebral small vessels (2019)”, “china expert consensus on post-stroke cognitive impairment rehabilitation” and “outpatient management standard for patients with post-stroke cognitive impairment”, and shared their experience and practical theories. in the “care for patients with alzheimer’s disease in all aspects” sub-venue, the participating experts shared and discussed the contents in three aspects: exploring a new management model for alzheimer’s disease, scientific care, and social support. the topics covered the medical care models based on family needs in shanghai, management system for patients with alzheimer’s disease, community two-way referral model, clinical characteristics and care needs of patients with alzheimer’s disease, setting of care plans and case analysis for the mentally retarded elderly, and consideration of long-term care for the elderly by the commercial insurance industry. in the exchanges and collision of opinions, the latest academic frontier progress and clinical practice experience were shared.

based on more than 35 years of drug research and development experience in the fields of alzheimer’s disease and dementia, eisai strives to realize the prevention and treatment of dementia through multidimensional and comprehensive methods. every year, many academic exchange activities sponsored by eisai china inc., such as empowering neurology’s future (enf), peripheral neuropathy summit (pns) and ads beijing summit, have become brands that are recognized and highly praised by doctors. eisai china inc. will always adhere to the philosophy of “hhc (human health care)” that “we give first thought to patients and their families, and to increasing the benefits health care provides. ” while providing disease solutions, it also provides long-term communication and learning platforms for medical professionals, and builds bridges for the exchanges of latest medical information at home and abroad.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today thateisai received a new drug approval for its in-house discovered and developed antiepileptic drug (aed) fycompa® (perampanel) from the china national medical products administration (nmpa) for use in an adjunctive treatment of partial onset seizures (with or without secondarily generalized seizures)in epilepsy patients 12 years of age and older. fycompa was designated for priority review by the nmpa due to itssignificant clinical benefits compared to existing treatments, and was approved in about 12 months since the submission in september 2018.

in china, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60% of whom being affected by partial-onset seizures. about 40% patients with partial-onset seizures require adjunctive treatment.1as approximately30% of patients with epilepsy are unable to control their seizures with currently available aeds, 2this is a disease with significant unmet medical needs.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. administered orally once-daily, it 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 has been approved in over 60 countries around the world as an 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 over 55 countries as an adjunctive treatment 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.

eisai considers neurology including epilepsy, a therapeutic area of focus. with this approval of fycompa in china, eisai pursues our mission to provide “seizure freedom” to a greater number of patients with epilepsy across the world living. eisai seeks to address 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

on october 13, 2019, eisai china inc. responded positively to the “2nd large-scale alzheimer-disease-month memory walk campaign” sponsored by alzheimer’s disease chinese, gave strong support and actively provided volunteer services.


wang li, representative of eisai china, delivered a speech

featuring the theme of “let’s talk about dementia: end the stigma”, this activity aimed to call on patients and their families to calmly face alzheimer’s disease, and to advocate the correct understanding and treatment of the disease and patients. by encouraging different social groups to take part in this activity, more social groups will understand and know about alzheimer’s disease, and the whole society will be called upon to change and abandon the negative and pessimistic views on alzheimer’s disease, and actively treat and pay attention to the disease and patients based on “people-orientation”. in the process of walking, through participating in relevant activities, we popularize knowledge of alzheimer’s disease to the public, spread the diagnosis and treatment methods of alzheimer’s disease and advocate the correct concept of medical treatment, enhance the public’s correct understanding of the disease and concern for alzheimer’s patients, promote the whole society’s understanding and support for the elderly with alzheimer’s disease and their families, say no to discrimination, create a friendly living environment, and encourage patients and their families to hold such an attitude: “let’s talk about dementia: end the stigma”.


a group photo of eisai china volunteers with the sponsor and experts
this activity was mainly divided into two parts, namely, the voice of various social groups, and healthy walking. first of all, the leaders from all walks of life, representatives of different social groups, and patients’ families spoke to express their concern and their heartfelt wishes for the disease, so that all walks of life could hear the understanding and concern about the disease from different groups, that the public can pay attention to the disease, correctly understand it and say no to discrimination. on the following walking route, five sites with the themes of “understand alzheimer’s disease”, “prevent alzheimer’s disease”, “treat alzheimer’s disease”, “care for alzheimer’s disease” and “pay attention to alzheimer’s disease” were set up.  at each site there were 1-2 memory health booths from different units to popularize knowledge about alzheimer’s disease, offer activity experience and medical care and answer questions for residents on the scene.

we are willing to call on all sectors of society to participate, to help people understand the disease in a relaxing and healthy atmosphere, to pay attention to the disease and patients, to promote the development of the field, to build a good medical environment and to establish a sound disease support platform. we are committed to improving the social care and attention for patients with alzheimer’s disease, and cultivating and improving the professional skills of caregivers for the elderly with alzheimer’s disease.

eisai china inc. will always adhere to its business philosophy of hhc (human health care), that we give first thought to patients and their families, and to increasing the benefits health care provides.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and nichi-iko pharmaceutical (headquarters: toyama, president and ceo: yuichi tamura, “nichi-iko”) announced today that they have entered into a comprehensive collaboration agreement (hereinafter, “agreement”) for the generic pharmaceutical business in china.

the chinese pharmaceutical market is the second largest market in the world after the united states, and the generic drugs account for more than 70% of its market in terms of value. also, due to the rapid aging and the government’s policies to promote the generic drug market, the continuous growth of generic drugs is predicted. furthermore, in order to improve the quality of generic drugs, the chinese government is establishing the stable supply system of high quality generic drugs equivalent to the original drugs, such as it introduces the generic quality consistency evaluation system and provides priority response to the government’s centralized procurement system for the generic drugs which have passed its evaluation test.

under this agreement, eisai and nichi-iko aim to enhance their pharmaceutical businesses in china by introducing the high quality generic drugs which nichi-iko maintains the marketing approval in japan. eisai and nichi-iko specifically select the appropriate products for the chinese market needs, and eisai’s subsidiary in china sells the products after nichi-iko obtains the approval for import and sales in china. eisai and nichi-iko will select the first two products in this fiscal year, and subsequently prepare to launch one to two products every year for the continuous launch from fy2024.

due to this agreement, eisai will address a broader range of medical needs in china by further strengthening its chinese generic business since entering in 2015. nichi-iko aims to enter the chinese market leveraging the eisai’s business foundation in china, as part of the strategic imperatives, “business expansion” and “global operation” in the 8th medium-term management plan “nexus∞“.

in march 2018, eisai and nichi-iko has entered into a strategic alliance agreement for the generic pharmaceutical business in japan. by developing the partnership between eisai and nichi-iko in china, eisai and nichi-iko will aim to expand the contribution to patients in china as well as attempt to expand and grow their businesses in china.

the impact of the agreement has no impact on the financial results for fiscal 2019 for either company.

media inquiries

eisai co., ltd.
public relations department
tel: 81-(0)3-3817-5120
fax: 81-(0)3-3811-3077

nichi-iko pharmaceutical co., ltd.
president’s office
tel: 81-(0)76-442-7026
fax: 81-(0)76-415-8710

  


1. about eisai co., ltd.
eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including neurology and oncology.

as a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

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

 

  1. about nichi-iko pharmaceutical co., ltd.

since the establishment of nichi-iko group in 1965, nichi-iko has steadily developed its business to contribute to people’s health and quality of life by manufacturing high-quality, cost-effective pharmaceuticals. we shall excel as the outstanding generic pharmaceutical company, making every effort to continue to serve and deliver our products needed by our patients and their families, pharmacists, doctors, distributors and other pharma companies around the world. in working to fulfil this mission, we seek to earn the trust and respect of all our stakeholders and to be the first choice for our customers.

more patient-friendly, more patient-choice, more high-quality. that is what we mean by premium quality. and premium quality underpins our commitment to evolve into a global comprehensive generic pharmaceutical company.

for more information about nichi-iko pharmaceutical co., ltd., please visit 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and fronteo, inc. (headquarters: tokyo, ceo: masahiro morimoto, “fronteo”) announced today that they have launched the tumbling and falling prediction system coroban® to medical institutions in japan on september 26, 2019. the coroban  predicts inpatients’ tumbling and falling risks in advance and displays alerts.

through the launch of antiosteoporotic agent and insomnia treatment, a pharmaceutical company eisai  has recognized that the preventive measures for tumbling and falling at medical institutions are important. on the other hand, fronteo healthcare, inc., a wholly owned subsidiary of fronteo, is a data analysis corporation focused on healthcare. it has originally developed an artificial intelligence (ai) system called concept encoder® based on natural language processing technique.

eisai and fronteo have started the joint development for the coroban since january 2018. the coroban was introduced to several medical institutions in japan on a trial basis by leveraging eisai’s network with medical institutions, and advancing the improvements of coroban based on needs in the clinical settings has led to the launch of the coroban this time.

according to a survey by the ministry of health, labour and welfare, the number of inpatients aged 65 and over tends to increase to about 960,000 in 2017, therefore, the importance of cares for tumbling and falling in medical institutions is increasing. the coroban learns the nursing records of past inpatients at each medical institution, scores the tumbling and falling risks of individual inpatient from the daily nursing records based on these past records, and displays the information of inpatients with high risks. it is expected to reduce the burden of medical professionals and to make the risk assessment uniform and objective by reflecting the information in individual care and nursing plans for each patient’s tumbling and falling with the coroban.

through the launch of the coroban which supports to establish systems at nursing ward to reduce the tumbling and falling risks of inpatients, eisai and fronteo aim to contribute to the realization of well-being of patients and their families.

 

media inquiries
          eisai co., ltd.                                                    fronteo, inc.
public relations department                                               pr
tel: 81-(0)3-3817-5120                                tel: 81-(0)3-5463-6380

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and tokio marine & nichido fire insurance co., ltd. (head office: tokyo, president: shinichi hirose, “tokio marine nichido”) announced today that the companies have entered into a business alliance agreement for co-existence and prevention of dementia.

under this agreement, the following initiatives are scheduled: (1) “disease awareness initiatives” to dispel the misunderstandings and assumptions and to attempt for a widespread correct understanding of dementia, (2) “environment development” to implement the self-assessment of cognitive function on a daily basis, and (3) “measures to familiarize insurance product” to support people with dementia so they can continue to live their own lives. eisai and tokio marine nichido will work towards co-existence and prevention of dementia by mutually utilizing eisai’s abundant experience and knowledge of medicine creation and disease awareness activities in the field of dementia as well as tokio marine nichido’s expertise and networks cultivated in its insurance products and related services.

as part of dementia disease awareness activities, eisai and tokio marine nichido today began distribution of the booklet “wakaru to kawaru ninchisho – what is dementia?” that  was co-produced based on eisai’s dementia experience and expertise.

 

please visit   to browse or download the booklet “wakaru to kawaru, ninchisho – what is dementia?”. (japanese only)

this booklet simply summarizes the symptoms and types of dementia and progression of alzheimer’s disease. in addition, it includes interviews with specialists and medical staff about the images of dementia and the daily life of patients and their families living with dementia.

“misunderstandings and assumptions, such as people with dementia can’t understand anything or they are not themselves once they develop dementia, create the impression that dementia is terrible and misery. i hope this booklet will help educate people about the the reality of dementia by prodiving accurate information and dispelling misperceptions,” said dr. manabu ikeda, professor, department of psychiatry, osaka university medical school, who supervised this booklet.

the booklet for dementia disease awareness will be serialized and issued continuously.

with the rapid aging of the population, it is predicted that one out of five elderly people over the age of 65 will have dementia in japan. the “outline for promoting the dementia plan” was compiled by the government in june this year. the dementia barrier-free efforts are aimed at co-existence so that those with dementia can continue living the way they want in the communities they are used to living. the initiatives for prevention based on the co-existence foundation are expected to make significant progress.

eisai and tokio marine nichido will collaborate on initiatives for co-existence and prevention of dementia, including dementia disease awareness initiatives. the copmanies aim to contribute to the realization of the well-being of people with dementia and their families by considering collaboration with other companies and organizations that agree with the purpose of eisai and tokio marine nichido.

 

media inquiries
eisai co., ltd.                              tokio marine & nichido fire insurance co., ltd.
public relations department       public relations department
public relations group
tel: 81-(0)3-3817-5120           tel: 81-(0)3-5223-3212

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that a series of abstracts will be presented during the european society for medical oncology (esmo) 2019 congress taking place in barcelona, spain, from september 27 to october 1, 2019. the abstracts highlight updates regarding eisai’s in-house discovered lenvima® (lenvatinib mesylate, the orally available kinase inhibitor, “lenvatinib”), and halaven® (eribulin mesylate, “eribulin”, halichondrin class microtubule dynamics inhibitor).

at the esmo 2019 congress, there will be an oral presentation of results from the final analysis of the endometrial carcinoma cohort of study 111/keynote-146, a phase ib/ii study evaluating the combination treatment of lenvatinib and merck & co., inc., kenilworth, nj., u.s.a.’s anti-pd-1 therapy keytruda® (pembrolizumab) in select solid tumors (abstract no.: 994o). the combination treatment was the first to be approved in the united states, australia and canada under the u.s. food and drug administration’s project orbis in september 2019.

a total of 11 poster presentations are scheduled, including one on the updated results of the lenvatinib plus pembrolizumab combination treatment in unresectable hepatocellular carcinoma in study 116/keynote-524, a phase 1b study (abstract no.: 747p), and the interim analysis evaluating the combination after disease progression after pd-1/pd-l1 immune checkpoint blockade in renal cell carcinoma (rcc) from 111/keynote-146 rcc cohort (abstract no.: 1187pd). in addition, the latest data from a phase i study for an eribulin liposomal formulation in solid tumors (abstract no.: 348p) will be presented.

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

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

 

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

网站地图