news – page 13 – eisai china lnc.-nba直播小9直播

news – page 13 – eisai china lnc.-nba直播小9直播

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.

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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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that presentations on a series of abstracts regarding its in-house discovered lenvatinib mesylate (multikinase inhibitor, product name: lenvima®, “lenvatinib”) and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: halaven®, “eribulin”) will be given at the american society of clinical oncology (asco20 virtual scientific program*), from may 29 to 31, 2020.
* presentation materials will be made available on demand via asco’s website at 8:00 am on may 29th (et).

at this year’s meeting, the final results of two studies will be presented on the combination therapy of lenvatinib with the anti-pd-1 antibody keytruda® (generic name: pembrolizumab, “pembrolizumab”) from merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada). one is the oral presentation of the metastatic renal cell carcinoma cohort (abstract number: 5008) of study 111 / keynote-146, and the other is the poster discussion presentation of the first-line therapy for unresectable hepatocellular carcinoma (abstract number: 4519) in study 116 / keynote-524**.
**this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds and investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

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 franchise area and aims to create innovative drugs that act towards curing cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito) announced today that it has been selected as “most honored company” and has been ranked first place overall in the biotechnology & pharmaceuticals sector of “the all-japan executive team”, released by the us financial information magazine “institutional investor”. this selection is based on eisai’s being ranked first place in “best ceos” and “best cfos”, respectively, in the sector.

this survey is a ranking of the world-famous financial information magazine “institutional investor” that selects japanese companies that perform outstanding ir activities by sector based on the votes of institutional investors and analysts around the world. in 2020, almost 350 investors and analysts from 189 securities firms and financial institutions voted. eisai is highly praised for its high-quality ir activities such as investor conferences and proactive initiatives for esg, while ceo haruo naito is highly praised for his credibility, quality of communication, and leadership.

for details, please refer to the “institutional investor” website.

eisai’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. in order to realize this philosophy, the company will respect the rights of shareholders and investors, ensure fairness and transparency of management, and engage in ir activities that contribute to the enhancement of corporate value.

 

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and seikagaku corporation (headquarters: tokyo, president: ken mizutani, “seikagaku”) announced today that the companies have entered into an agreement for the co-development and marketing alliance in china for si-613 (diclofenac conjugated sodium hyaluronate), a therapeutic agent for osteoarthritis discovered by seikagaku.

on the basis of this agreement, the companies will jointly develop si-613 in china for a treatment of knee osteoarthritis. after obtaining approval, seikagaku will supply products to eisai, and eisai will be responsible for distribution. the companies will cover an equal share of the development cost, and eisai will pay seikagaku the upfront payment, and development as well as sales milestones.

osteoarthritis is a disease caused by the articular cartilage damage due to aging and other factors, leading to inflammation and pain, which result in impaired quality of life (qol). knee osteoarthritis is one of the most frequent cases among thereof, and the number of symptomatic patients with knee osteoarthritis in china is estimated to be approximately 47 million*1, and it is anticipated that the number will continue to increase as the population ages.

si-613 is diclofenac conjugated sodium hyaluronate created by seikagaku using their proprietary drug-binding technology to chemically bond hyaluronic acid and diclofenac (an anti-inflammatory drug). this material has the analgesic and anti-inflammatory effects of diclofenac, which is designed to be sustained-released*2 by a drug delivery system*3, in addition to the joint function improving effect of sodium hyaluronate. hence, it is expected that si-613 rapidly and continuously reduces the pain and inflammation associated with osteoarthritis.

under this agreement, eisai aims to contribute to patients with knee osteoarthritis that is unmet medical needs by utilizing the knowledge and networks that eisai has cultivated through its china business. seikagaku will seek to maximize the value of si-613 in china by leveraging eisai’s business base in china.
through the development and commercialization of si-613, the companies will provide new treatment options in china for knee osteoarthritis and contribute to improving the qol of patients.

references:
*1: for the estimated data regarding the number of patients with knee osteoarthritis
 · data of morbidity prevalence rate – the prevalence of symptomatic knee osteoarthritis in china, arthritis & rheumatology(2016)
· estimated data calculated from united nations world population estimates – world population prospects, url:http://www.un.org/en/development/desa/population/
*2: sustained release is a gradual release of the active pharmaceutical ingredients of a drug to achieve a sustained therapeutic effect.
*3: drug delivery system (dds) is a technology for the controlled release, targeting, and absorption improvement of drugs.

the 6th gastrointestinal & liver disease treatment forum (hereinafter referred to as “give”), which was hosted by eisai china inc. and consisted of two sessions, completed successfully on mar. 20 and mar. 27 separately. in order to avoid people gathering during the epidemic outbreak, the forum was held online innovatively. as one of the biggest annual academic feasts that eisai china inc. held in the field of digestive liver disease, the forum aims to build an academic exchange platform for chinese and overseas experts to deeply analyze the most cutting-edge development trend in the field of digestive diseases. the forum invited experts in the field of infection and digestion to discuss the latest progress in the infection field under the novel coronavirus epidemic situation, the current diagnosis and treatment mode in the digestion field and the development trend. more than 20,000 people watched the live broadcast of the two online sessions. although the epidemic hindered people from getting together, it could not stop the academic exchange and adherence.
 
ms. yanhui feng, president of eisai china holdings ltd. & eisai china inc., is delivering a speech online


in the first session of the give forum held on march 20, ms. yanhui feng, president of eisai china holdings ltd. & eisai china inc., delivered the opening speech, expressing her welcome and thanks to all the experts and colleagues to participate in the online give forum, and giving her gratitudes for their unremitting efforts and contributions to the development of digestive liver diseases during the epidemic period. she also indicated that eisai china inc. always adheres to the corporate philosophy of hhc (human health care) and is committed to promoting the rapid development of the field of digestive liver disease to improve the satisfaction of patients and their families with academic aids, and will create greater value for patients together with the experts and colleagues.


professor minhu chen serves as chairman of the forum in the first session


prof. minhu chen, chairman of the digestive branch of the chinese medical association, was invited as the forum’s chairman in the first session. prof. jifang sheng gave the first speech themed of “infections – treatment of severe patients with novel coronavirus pneumonia”, which generated a surge of online participators with exciting contents. the second topic consisted of “nip the bud – the comprehensive management of medicine-induced gastrointestinal injury” given by professor sha weihong and “better or fitter – the individual treatment of chronic gastritis” by professor li jingnan, which brought the audience a new understanding of medicine-induced liver injury and drug-induced gastrointestinal injury. at last, prof. minhu chen made a concluding speech for the forum, giving it a full recognition and wished it an even better future.  

mr. jianzhong zhang, vp & head of pharmaceutical business division of eisai china inc., is giving a speech

on march 27, mr. jianzhong zhang, vp & head of pharmaceutical business division of eisai china inc., was invited to give a speech at the second session of the give forum. he indicated that the give forum had lasted for six years and had become one of the biggest annual academic feasts in the field of digestion held by eisai china inc. he thanked the experts for their support to the give forum and promised that eisai china inc. would continue to take action to push the development of the digestive liver diseases. prof. duowu zou of shanghai ruijin hospital was also invited to the forum as the chairman and lecturer in the second session. prof. hong tang, director of the infectious disease center of west china hospital, sichuan university, gave a speech on the topic of “infections: the diagnosis, treatment, prevention and control of the novel coronavirus pneumonia”, analyzing the concerned aspects from the perspective of infectious diseases department. prof. duowu zou’s speech, challenges and thoughts on the diagnosis and treatment of gastroesophageal reflux disease, and the speech of prof. ning dai, dean of the medical college of zhejiang university city college, on “the old vs the new: the current situation and diagnosis & treatment of overlapping symptoms of functional gastrointestinal diseases” introduced the latest diagnosis and treatment of gastroesophageal reflux and functional dyspepsia. the three professors shared the latest information about the relevant medical topics, and gave high praise to the forum. 

prof. duowu zou serves as chairman of the forum in the second session


eisai china inc. adheres to the hhc corporate philosophy of “human health care” and is committed to building an international academic exchange platform in the field of digestion, combining rigorous academic theory and clinical practice, exploring clinical diagnosis and treatment ideas, improving the clinical diagnosis and treatment level of difficult cases of digestive system, sharing the latest domestic and international academic information to provide medical professionals more gains and breakthroughs.

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