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

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

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

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

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

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

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

 

■ virtual oral presentation:

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

    

■ virtual poster presentation:

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

 

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

 

[notes to editors]

1. about lemborexant

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

 

2. about sunrise 2study 303

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

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

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

 

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

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

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

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

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

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

 

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

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


1. about lenvima® (generic name: lenvatinib mesylate)
lenvima, discovered and developed by eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (fgf) receptors fgfr1-4, the platelet derived growth factor receptor alpha (pdgfrα), kit, and ret. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells. currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 65 countries including japan, the united states, in europe and in asia, and for unresectable hepatocellular carcinoma in over 65 countries including japan, the united states, in europe, china and in asia. additionally, it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 55 countries, including the united states, in europe (where it was launched under the brand name kisplyx® for renal cell carcinoma) and in asia. in addition, it is approved in combination with keytruda® (generic name: pembrolizumab) as a treatment for advanced endometrial cancer that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in countries including the united states, australia, and canada. continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

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

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

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

3. about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration
in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as a monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda® (generic name: pembrolizumab).

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

4. about eisai co., ltd.
eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. eisai defines our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care(hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, eisai takes that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit  (for global), (for u.s.) or  (for europe, middle east, africa), and connect with us on twitter ( and ) and  (for u.s.).

5. about msd
for more than 125 years, msd has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. msd is a trade name of merck & co., inc., with headquarters in kenilworth, n.j., u.s.a. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, msd continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit  and connect with us on , and .

eisai dementia platform easiit commences

 

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

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

 

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

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

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

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

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

 

the brain performance app “easiit app”

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

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

planned functions moving forward

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

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

 

commentary from persons in charge of operations in both companies

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

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

 

[notes to editors]

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

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

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

 

2. summary of easiit app details

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

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

 

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

easiit website: 

 

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

3. about the dementia ecosystem business

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

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

 

4. about eisai co., ltd.

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

 

5. about dena’s healthcare initiatives

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

 

6. about dena co., ltd.

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

 

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

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

preventing medical infrastructure collapse by a monitoring system linked to line

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

the selected study and development project is as follows:

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

representative organization: allm inc.

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

(reference) amed website (japanese only)

 

■summary of the experimental study

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

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

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

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

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

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

■ about mysos

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

■ about team

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

■ about allm

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

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

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

 

■ about tokyo medical and dental university

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

 

■ about eisai

eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of neurology and oncology. as a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

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

 

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

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

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

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

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

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

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

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

for additional information please visit: 

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

[notes to editors]

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

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

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

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

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

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

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

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

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

 

biogen safe harbor 

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

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

research activities commence

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

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

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

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

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

 

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

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

 

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched a new fine granule formulation of its in-house-discovered antiepileptic drug (aed) fycompa® (perampanel hydrate) in japan on july 6, 2020. eisai received marketing and manufacturing approval for this formulation on january 23, 2020, and the fine granule formulation was added to japan’s national health insurance drug price list on april 23 of the same year.

in japan, it is estimated that there are approximately 1 million patients with epilepsy. while epilepsy is a disease that may occur regardless of age, it is said that incidence is particularly high in children and the elderly. this newly launched fine granule formula was developed so that even patients who have difficulty taking tablets such as children or those who have difficulties in taking tablets due to reduced swallowing ability may take this drug. additionally, greater ability to adjust dosage to match patients’ symptoms becomes possible.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories and was developed in-house. it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic ampa receptors. in japan, fycompa is currently approved 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, as well as adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

with the launch of this fine granule formulation in japan, eisai will continue to prioritize the provision of safety information. furthermore, eisai will pursue its mission of delivering “seizure freedom” to as many patients as possible, and seek 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

[notes to editors]
1. product information
1) product name

fycompa® fine granules 1%

2)
 generic name

perampanel hydrate

3) indications 
    partial-onset seizures (including secondarily generalized seizures)
adjunctive therapy with antiepileptic drugs for tonic-clonic seizures below in patients with epilepsy showing inadequate response to other antiepileptic drugs

4) price 
fycompa fine granules 1%: 1,068.90 yen per 1g containing 1% (package price: 106,890 yen)

5) packaging
bottles of 100 g

6) product image


2. about fycompa (perampanel hydrate)

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 drug form to be taken once daily orally at bedtime. an oral suspension formulation and tablet have been approved in the united states and europe.

fycompa is currently approved in more than 65 countries and territories, including japan, the united states, china, and other countries 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 japan and the united states, fycompa is approved 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 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. to date, fycompa has been used to treat more than 300,000 patients worldwide across all indications.

eisai is conducting a global phase iii clinical study (study 338) for the agent in patients with seizures associated with lennox-gastaut syndrome. in addition, eisai is conducting development of an injection formulation.

 

3. about epilepsy

epilepsy affects approximately 1 million people in japan, 3.4 million people in the united states, 6 million people in europe, 9 million people in china, and approximately 60 million people worldwide. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds1, this is a disease with significant unmet medical need.

epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. in a partial-onset seizure, an abnormal electrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain, becoming a generalized seizure (known as a secondarily generalized seizure). in a generalized seizure, abnormal electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physical symptoms manifested throughout the whole body.

 

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that eisai korea inc., eisai’s subsidiary in south korea, has received marketing approval of parkinson’s disease treatment equfina® (safinamide mesilate, “safinamide”) for the indication of treatment of idiopathic parkinson’s disease as adjunctive therapy with levodopa-containing products in patients with end of dose motor fluctuations from the regulatory authority in south korea (ministry of food and drug safety). the marketing authorization application for safinamide in south korea was submitted in july 2019, and through the approval of this application, south korea became the first country in asia outside of japan to grant marketing approval for safinamide.

this approval is primarily based on a double-blind, placebo-controlled, phase iii study (settle study) in overseas countries, including south korea, to evaluate the efficacy and safety of 24-week oral administration of the once-daily safinamide as an add-on to levodopa in patients with parkinson’s disease with motor fluctuations.1
in the settle study, the primary endpoint was the change in mean daily “on” time (period of time in which parkinson’s disease symptoms are suppressed) from baseline to 24 weeks of the treatment phase. regarding the primary endpoint, safinamide increased the “on” time by 0.96 hours (95% ci: 0.56, 1.37, p<0.001) more than placebo, showing a statistically significant extension in “on” time. the most common three adverse drug reactions observed with patients with safinamide were dyskinesia, nausea and somnolence.

under the license agreement signed between eisai and meiji seika pharma co., ltd. (headquarters: tokyo, “meiji”) in march 2017, eisai obtained exclusive marketing rights for safinamide in japan, as well as development and marketing rights in asia. meiji obtained manufacturing and marketing approval for safinamide in japan in september 2019, and eisai launched safinamide in japan in november 2019.

the estimated number of patients with parkinson’s disease is approximately 150,000 in south korea. parkinson’s disease has high unmet medical needs because of inadequate symptom control using current medications, necessitating new treatment options. this disease is designated as a rare intractable disease in south korea.

together with providing equfina as a new treatment option for parkinson’s disease to patients in south korea, eisai will make further contributions to address the diversified needs of and increase the benefits provided to parkinson’s disease patients and their families in japan and asia.

 

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

 

[notes to editors]

1. about equfina (safinamide mesylate “safinamide”)

safinamide is a selective monoamine oxidase b (mao-b) inhibitor, which reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such has potential as a new parkinson’s disease treatment which possesses both dopaminergic and non-dopaminergic mechanisms.

safinamide was discovered and developed by newron pharmaceuticals s.p.a. (headquarters: milan, italy, “newron”). in 2011, newron entered into a licensing agreement with meiji, granting meiji exclusive rights to develop, manufacture and commercialize the drug in japan and asia. eisai has exclusive rights for marketing in japan, as well as for development and marketing in asia* based on a licensing agreement signed between eisai and meiji. safinamide mesilate is marketed under the name “xadago” in 15 countries in europe, the united states and australia, and under the name “onstryv” in canada.

* south korea, chinese taiwan, brunei, cambodia, laos, malaysia, the philippines, indonesia, thailand, vietnam, myanmar, singapore, hksa, and chinese macau

 

2. about the clinical phase iii study (settle study)1

the settle study was a placebo-controlled, double blinded, and parallel group clinical phase iii study conducted in overseas countries. the efficacy and safety of 24-week oral administration of once-daily safinamide as add-on to levodopa in patients with parkinson’s disease with wearing-off phenomena of motor fluctuations were compared to placebo. administration started with 50mg in safinamide group, and increased to 100mg as tolerated. the primary endpoint was the change in mean daily “on” time (period of time in which parkinson’s disease symptoms are suppressed) from baseline to 24 weeks of the treatment phase, and verified the superiority of safinamide over placebo. regarding the primary endpoint, safinamide increased the “on” time by 0.96 hours (95% ci: 0.56, 1.37, p<0.001) more than placebo, showing a statistically significant extension in “on” time. the adverse drug reactions (adr) incidence rates in this study were 27.6% for placebo and 28.5% for safinamide. the most common three adrs observed with patients with safinamide were dyskinesia, nausea and somnolence.

 

3. about parkinson’s disease

parkinson’s disease is a neurodegenerative disease which causes motor impairment, with symptoms including tremors in the limbs, muscular rigidity and shuffling gait. it is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. the estimated number of patients with parkinson’s disease is approximately 150,000 in south korea (eisai’s internal estimates). the number of patients suffering from parkinson’s disease is approximately 3 million patients in asia,2 and 200,000 patients in japan.the number of patients is increasing due to aging of the population.4 levodopa is widely used to treat parkinson’s disease by replenishing the brain’s supply of dopamine. however, as the disease progresses, levodopa’s duration of effect decreases, and there are cases of parkinson’s disease symptoms returning before the next dose (“wearing-off” phenomenon). to prevent the “wearing-off” phenomenon, a combination therapy with a drug that has a different mechanism of action than that of levodopa is used.

 

1 schapira ah et al. assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with parkinson disease and motor fluctuations: a randomized clinical trial. jama neurol. 2017;74(2):216-224
2
 e ray dorsey et al. global, regional, and national burden of parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016 lancet neurol. 2018;17:939–53
3
 japanese society of neurology. treatment and management guideline 2018 for parkinson’s disease
4
 japan intractable diseases information center: 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its u.s. subsidiary eisai inc. has launched its in-house discovered orexin receptor antagonist dayvigo™ (lemborexant) civ for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance in the u.s. on june 1, 2020.

discovered at eisai’s tsukuba research laboratories and developed in-house, dayvigo is a small-molecule compound. the mechanism of action in the treatment of insomnia is presumed to be through antagonism of orexin receptors1. the orexin neuropeptide signaling system plays a role in wakefulness1. blocking the binding of wake-promoting neuropeptides orexin a and orexin b to orexin receptors ox1r and ox2r is thought to suppress wake drive. lemborexant binds to orexin receptors ox1r and ox2r and acts as a competitive antagonist (ic50 values of 6.1 nm and 2.6 nm, respectively).

dayvigo was approved in the u.s. by the u.s. food and drug administration (fda) based on findings from the lemborexant clinical development program, which included two pivotal phase 3 studies2 (sunrise 1 and sunrise 2) in nearly 2,000 adult patients with insomnia.

sunrise 1 was a one month, randomized, double-blind, placebo- and active-controlled multi-center, parallel-group clinical trial in adult female subjects age 55 and older and male subjects 65 years and older who met dsm-5 (the diagnostic and statistical manual of mental disorders – 5th edition) criteria for insomnia disorder. the primary efficacy endpoint was the mean change in latency to persistent sleep (lps; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (day 29/30), as measured by overnight polysomnography (psg) monitoring. the secondary efficacy endpoints in sunrise 1 were the mean change from baseline to end of treatment (day 29/30) in sleep efficiency (sef) and wake after sleep onset (waso) measured by psg. in sunrise 1, dayvigo 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, lps, compared to placebo. dayvigo 5 mg and 10 mg demonstrated statistically significant improvement in se and waso compared to placebo and active-controlled.

sunrise 2 was a long-term (six month), randomized, double-blind, placebo-controlled, multi-center, trial in adult patients age 18 or older who met dsm-5 criteria for insomnia disorder. the primary efficacy endpoint was the mean change from baseline to end of treatment at six months for patient-reported (subjective) sleep onset latency (ssol), defined as the estimated minutes from the time that the subject attempted to sleep until sleep onset. pre-specified secondary efficacy endpoints for sleep maintenance were change from baseline to end of treatment at six months for patient reported sleep efficiency (ssef; defined as the proportion of time spent asleep per time in bed) and wake after sleep onset (swaso; defined as the minutes of wake from the onset of sleep until wake time). the pre-specified primary and secondary efficacy endpoints were measured using a sleep diary. in sunrise 2, dayvigo 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, ssol, compared to placebo. dayvigo 5 mg and 10 mg also showed statistically significant superiority in ssef and swaso.1

analyses in both studies suggested dayvigo was not associated with rebound insomnia, and there was no evidence of withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to one year. dayvigo is the first fda-approved insomnia medication with safety data over a 12-month treatment period and with sleep onset and sleep maintenance efficacy data over a six-month treatment period in a pivotal clinical study.

the most common adverse reaction (reported in 5% or more of patients treated with dayvigo and at least twice the rate of placebo) in the sunrise1 and sunrise2 (sunrise2 was initiated 30 days after first dosing) studies was somnolence (dayvigo 10 mg, 10%; dayvigo 5 mg, 7%; placebo, 1%).

in a special safety study (study 106)3, dayvigo at 5 mg and 10 mg doses did not cause statistically significant impairment in next morning driving performance in healthy adult or elderly subjects (compared with placebo). impairment was seen in some people taking the 10 mg dose. patients using the 10 mg dose should be cautioned about the potential for next-morning driving impairment because there is individual variation in sensitivity to dayvigo. additional special safety studies (study 108)4evaluated middle-of-the-night safety, next morning postural stability and memory. the effects of dayvigo on next day postural stability and memory were evaluated in two randomized, placebo and active-controlled trials in healthy subjects and insomnia patients age 55 and older. there were no meaningful differences between dayvigo and placebo on next-day postural stability or memory at either dose. patients should be cautioned about the potential for middle-of-the-night postural instability as well as attention and memory impairment.

dayvigo (5 mg, 10 mg tablets) received approval from the u.s. fda in december 2019, and was designated as a schedule iv controlled substance by the u.s. drug enforcement administration (dea) in april 2020. according to this schedule iv designation, individuals with a history of abuse or addiction to alcohol or other drugs may be at an increased risk for abuse and addiction to dayvigo and such patients should be followed carefully. eisai received manufacturing and marketing approval for dayvigo as an insomnia treatment in japan in january 2020, and was included in japan’s national health insurance drug price list in april 2020. it is being prepared for launch in japan. eisai has also submitted a new drug application seeking approval of this agent for use in the treatment of insomnia in canada in august 2019.

insomnia is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep5, 6. insomnia is one of the most common sleep-wake disorders with high prevalence. approximately 30% of adults worldwide have symptoms of insomnia7, 8, and many of them persist for months to years.

with the launch of dayvigo and through its continuing research and development efforts focusing on orexin biology, eisai aspires to improve the lives of patients suffering from sleep disorders.

 

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

 

[notes to editors]
1. about (lemborexant)
lemborexant is eisai’s in-house discovered and developed small molecule that binds to orexin receptors, ox1r and ox2r (ic50 values of 6.1 nm and 2.6 nm, respectively) and acts as a competitive antagonist with stronger inhibition effect to ox2r. in individuals with insomnia, it is possible that orexin signaling regulating wakefulness is not functioning normally.

the orexin neuropeptide signaling system plays a role in wakefulness.2 blocking the binding of wake-promoting neuropeptides orexin a and orexin b to receptors ox1r and ox2r is thought to suppress wake drive. dayvigo is being prepared for launch in japan. eisai has also submitted a new drug application seeking approval of this agent for use in the treatment of insomnia in canada in august 2019.

for further information on dayvigo in the united states, including important safety information (isi), please visit the dayvigo website ().

2. about sleep-wake disorders and insomnia
sleep-wake disorders consist of disease categories such as insomnia, irregular sleep-wake rhythm disorder (iswrd), hypersomnia and breathing-related sleep disorders. among the sleep-wake disorders, insomnia is the most common with persistent insomnia symptoms experienced by approximately 30 percent of the adult population worldwide.7,8 insomnia disorder is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep.5,6

diagnostic criteria in the u.s. for insomnia disorder include if the sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral or other important areas of functioning, occurs at least three nights per week and is present for at least three months.

sleeping well is essential for good health9, and studies suggest an optimal sleep duration between seven and eight hours.10 poor sleep is associated with a wide range of health consequences.5,12

women are 1.4 times more likely than men to suffer from insomnia.11 older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.12

3. about sunrise 1 (study 304)2
sunrise 1 is a one-month trial in adult female patients age 55 and older and male patients 65 years and older who met dsm-5 criteria for insomnia disorder. patients were randomized to placebo (n=208), dayvigo 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly. the primary efficacy endpoint was the mean change from baseline to end of treatment at days 29/30 in latency to persistent sleep (lps; the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness). secondary efficacy endpoints were the mean change from baseline to end of treatment at days 29/30 in sleep efficiency (sef) and wake after sleep onset (waso). these endpoints were measured by overnight polysomnography monitoring.

4. about sunrise 2 (study 303)2
sunrise 2 is a six-month placebo-controlled treatment trial with a 6-month parallel-group extension period including adult patients age 18 or older who met dsm-5 criteria for insomnia disorder. patients were randomized to placebo (n=325), dayvigo 5 mg (n=323), or dayvigo 10 mg (n=323) once nightly. the primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (ssol; the estimated minutes from the time that the patient attempted to sleep until sleep onset). secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (ssef; the proportion of time spent asleep per time in bed) and wake after sleep onset (swaso; the minutes of wake from the onset of sleep until wake time). these endpoints were measured by sleep diary.

5. about study 1063
study 106 was a randomized, double-blind, placebo- and active-controlled, four period, crossover phase i study to evaluate the effect of lemborexant in 48 healthy adults and elderly volunteers (23 to 58 years of age, mean: 58.5 years old) to evaluate on-road driving performance. volunteers (65 years and older: 24, 23 to 64 years old: 24) were treated at bedtime with two out of three dose levels of lemborexant (2.5, 5 or 10 mg) and placebo for eight consecutive days. zopiclone 7.5 mg as an active control was administered on days one and eight only, with placebo given for the six days in between. the primary endpoint was to evaluate change of standard deviation of lateral position (sdlp) during an on-road driving test conducted after the first (in the morning of day 2) and last day (in the morning of day 9) of treatment administration after 9-hour dose.

in the on-road test, the volunteers drove a specially instrumented vehicle for about one hour over 100km (approximately 60 miles) primary highway circuit, accompanied by a licensed driving instructor. the task was to drive with a steady lateral position between the delineated boundaries of the slower traffic lane, while maintaining a constant speed of 95km/h.

although lemborexant at doses of 5 mg and 10 mg did not cause statistically significant impairment in next-morning driving performance in adult or elderly subjects (compared with placebo), driving ability was impaired in some subjects taking 10 mg lemborexant.

6. about study 1084
study 108 was a randomized, double-blind, four period crossover phase i study to evaluate the effect of lemborexant on postural stability, auditory awakening threshold, and cognitive performance in 56 healthy volunteers 55 years and older. participants were treated at bedtime with a single dose of placebo, lemborexant 5 mg, lemborexant 10 mg, or active control. there was a statistically significant increase in body sway for both doses of lemborexant compared with placebo. the next morning, shortly after the end of eight hours in bed neither dose of lemborexant had statistically significant residual effects on this measure of postural stability as compared to placebo.
references
1 scammell te, winrow cj. orexin receptors: pharmacology and therapeutic opportunities. annu rev pharmacol toxicol. 2011;51:243266.
2
 eisai inc. dayvigo full prescribing information. 2020.
3
 vermeeren a, et al. on-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. sleep. 2019 42 (4): zsy260.
4 murphy p, et al. safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening, j. clinical sleep medicine. 2020: 16(5):765-773.
5
 institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
6
 ohayon mm, et al. epidemiology of insomnia: what we know and what we still need to learn. sleep med rev. 2002;6(2):97-111.
7
 ferrie je, et al. sleep epidemiology – a rapidly growing field. int j epidemiol.2011;40(6):1431–1437.
8
 roth t. insomnia: definition, prevalence, etiology and consequences. j clin sleep med. 2007;3(5 suppl):s7–s10.
9
 cappuccio fp, et al. sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. sleep. 2010;33(5):585-592.
10
 pase mp, himali jj, grima na, et al. sleep architecture and the risk of incident dementia in the community.  neurology. 2017;89(12):1244-1250.
11
 roth t, et al. prevalence and perceived health associated with insomnia based on dsm-iv-tr; international statistical classification of diseases and related health problems, tenth revision; and research diagnostic criteria/international classification of sleep disorders, second edition criteria: results from the america insomnia survey. biol psychiatry. 2011;69:592– 600.
12
 crowley k. sleep and sleep disorders in older adults. neuropsychol rev. 2011;21(1):41-53.

abbvie gk (headquarters: minato-ku, tokyo; president: james feliciano, hereafter “abbvie”) and eisai co., ltd. (headquarters: tokyo; ceo: haruo naito, hereafter “eisai”) today announced an approval of partial changes in the marketing approval of humira® (generic name: adalimumab [recombinant], hereafter “humira”), a fully human anti- tnfα monoclonal antibody, for additional dosage and administration, specifically, to add an 80mg every-other-week (q2w) regimen as a treatment option for patients with hidradenitis suppurativa (hereafter “hs”) after the first 4 weeks of treatment.

previously, the recommended dose of humira for hs patients was 160 mg in week 0, followed by 80 mg two weeks later, administered by subcutaneous injection. starting at week 4, humira should be administered at a dose of 40mg once weekly (qw). today, a 80mg q2w regimen has been newly added as a treatment option with efficacy and safety equivalence to those of the 40mg qw regimen. 80mg q2w is expected to contribute to reducing patients’ burden of injection by reducing the number of administrations by half* and extend the administration interval in comparison to 40mg qw.

*when humira subcutaneous injection 80 mg syringe 0.8 ml or humira subcutaneous injection 80 mg pen 0.8 ml is used.

this approval was supported by the results of efficacy and safety evaluations at 80mg q2w for humira in a japanese phase iii study (study m15-573) and the results obtained by simulation with data in clinical pharmacokinetic studies. the japanese phase iii study was a multi-center, open-label, single-arm study to evaluate the efficacy and safety of humira in japanese patients with moderate to severe hs.

humira was designated as an orphan drug for the indication of hs in 2017 and was approved for the first time in japan for the indication of hs on february 21, 2019. currently, humira is the only drug that has an indication for hs in japan.

hs is a painful, inflammatory skin disease with a chronic course which typically presents after puberty. inflammatory symptoms are frequently observed in the axillary, inguinal, breast-fold, and gluteal regions. the main symptom is red, swollen boil-like lumps, and the progression of symptoms leads to formation of nodules, abscesses, and even fistulas. repeated recurrence causes thickening of the affected areas, resulting in scarring. severe symptoms may limit the patients’ daily activities and sometimes force them to stop working. the epidemiology data in japan is unknown, and the prevalence outside japan is reported to be 1%. since the disease is poorly recognized and difficult to diagnose, overseas reports indicate that the average time to definitive diagnosis is seven years, which is longer than that of psoriasis and other inflammatory skin diseases, and patients with hs visit hospitals more often.

abbvie and eisai are committed to further contribute to the improvement of qol of many more patients by making efforts to promote the appropriate use of humira, including its use for this indication, and to provide information on humira.

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