news – page 14 – eisai china lnc.-开元游戏大厅app版本合集

news – page 14 – eisai china lnc.-开元游戏大厅app版本合集

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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has submitted in japan a marketing authorization application of the anticancer agent denileukin diftitox (genetic recombinant) (generic name, development code: e7777) for relapsed or refractory cutaneous t-cell lymphoma (ctcl) and peripheral t-cell lymphoma (ptcl).

this application is based on data from a multicenter, open-label, single-arm phase ii clinical study (study 205) conducted in japan for patients with relapsed or refractory ctcl or ptcl to evaluate the efficacy and safety of this agent.

this study achieved the primary endpoint and exceeded a predetermined threshold with statistical significance: the objective response rate (orr) of ctcl and ptcl patients in total (n=36) was 36.1% (95% confidence interval (ci): 20.8-53.8). the orrs of each subtype were 31.6% (95% ci:12.6-56.6) for ctcl (n=19) and 41.2% (95%ci: 18.4-67.1) for ptcl (n=17).

the five most frequent adverse events observed in this study were increased aspartate aminotransferase (ast) (89.2%), increased alanine aminotransferase (alt) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%).

denileukin diftitox (genetic recombinant) is a fusion protein of the receptor-binding portion of interleukin-2 (il-2) and diphtheria toxin that specifically binds to the il-2 receptor on the surface of tumoral lymphocyte. the antitumor effect of denileukin diftitox depends on the intracellular delivery of diphtheria toxin which inhibits protein synthesis and induces cell death. the agent has been evaluated as a drug with high medical need by the “study group for unapproved drugs/off-label drugs for high medical needs”*, and eisai has been requested to develop it by the ministry of health, labour and welfare.

eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. eisai 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 china inc. kicked off the empowering neurology’s future (enf) successfully on mar. 22, 2020. to avoid people gathering during the epidemic period, the forum is held innovatively online to start a brand-new enf season, which will last from march 22ndto april 28th in seven sessions, one session per week. the peripheral neuropathy session, as the first session of the enf online forum, was held on march 22 and attracted 2,645 participators to its e-meeting, as well as 17,000 audients to the live-broadcast on the www.yxj.org.cn website. though the epidemic limits our steps, it cannot prevent the participants from yearning for and adhering to the academic learning.


the 2020 enf (online) live-broadcast was watched by 17,000 people

the summit invited prof. yan chuanzhu from qilu hospital of shandong university, vice chairman of the neurology branch of chinese medical association, as its chairman, prof. chen xiangjun of huashan hospital affiliated to fudan university as the comment expert, and 4 young doctors who gave outstanding performance in the “pn difficult cases-sharing competition”, namely dr. zhao yawen from peking university first hospital, dr. wang yiqi from zhejiang people’s hospital, dr. tai hongfei from beijing tiantan hospital affiliated to capital medical university and dr. zhou xiajun from renji hospital affiliated to shanghai jiaotong university school of medicine, to share 4 difficult cases of peripheral neuropathy including hereditary pressure sensitive peripheral neuropathy, familial amyloid peripheral neuropathy, anti-caspr1 igg4 positive cidp and mitochondrial neuro-gastrointestinalencephalomyopathy. the exciting contents and the powerful expert team attracted a large number of neurologists to participate.


prof. yan chuanzhu from qilu hospital of shandong university, vice chairman of the neurology branch of chinese medical association, is in live broadcast
always sticking to the company philosophy of hhc (human health care), eisai china inc. presents and shares abundant disease management experiences and cutting-edge academic progresses by building a platform for academic exchange. eisai china inc. considers neurology as a priority disease area and is committed to pushing the development of this field in order to promote the satisfaction of patients and their families by introducing better medical treatment based on the academic power and providing new solutions to satisfy the diverse needs of patients and their families.


the comment expert is in live broadcast in the “2020 enf” online)

 
the “2020 enf” (online) has finished its first stop successfully, with participating doctors speaking highly of its content and effect. let’s look forward to the same wonderful academic feast in the following days.

 

attached (schedule of the next six sessions):
march 28 – cognitive impairment
april 7 – epilepsy
april 11 – parkinson’s disease
april 18 – headache
april 25 – vertigo
april 28 – inheriting classics and looking ahead (an conclusion to the enf)

in the face of the epidemic of covid-19, a large number of patients with normal medical needs can not go to hospital to seek medical treatment, and their diseases can not be treated well, which seriously decreases the quality of life of patients. eisai china holdings ltd. is joining hands with all sectors of society to fight against the epidemic, and escorting people to tide over the crisis.

since the outbreak of the epidemic, on the one hand, we have actively raised all kinds of anti-epidemic materials through overseas channels as many as possible to offer more security to the majority of medical personnel fighting in the frontline, on the other hand, suzhou plant of eisai china inc. and eisai (liaoning) pharmaceutical co., ltd. have actively organized the resumption of work and production to ensure the production and supply of drugs in accordance with the requirements of the local government and on the premise of ensuring the health and safety of employees, especially to ensure the production of drugs donated by eisai (liaoning) pharmaceutical co., ltd., the demand statistics of epidemic prevention drugs and the logistics during the epidemic period, so as to win this white war. as of march 2, 2020,eisai china holdings ltd. has donated 1 million yuan to the wuhan charity federation, more than 10-million-yuan worth of drugs to protect and improve the self-immunity of medical personnel and more than 750,000-yuan worth of medical protective masks, goggles, forehead thermometers, disinfection supplies and other materials that have been urgently raised from overseas and other channels, and its donation work is still in progress.

meanwhile, in order to ensure the physical and mental health of its employees, eisai has, on the one hand, purchased masks and relevant disinfection and protection articles through various channels at home and abroad, and reimbursed for those purchased by employees themselves, on the other hand, actively used the online system to organize and carry out various internal communication and training activities, launched a campaign featuring “eisai supports hubei” for those employees in the affected areas, so as to relieve the pressure of such employees during the epidemic period, exchange anti-epidemic experience, enhance confidence and enrich the life of such employees.

during the epidemic prevention and control period, eisai china inc. has actively cooperated with third-party platforms to carry out online public welfare activities, such as “boyuntang anti-epidemic special session”, “expert network lecture: ct early signs and differential diagnosis of covid-19”, “special session for famous orthopedists providing free diagnosis of neck, shoulder, low back pain”, “cervical spondylosis special session” and “online free clinic services from 30 provinces for neurological diseases”, actively carried out public welfare activities such as “care for cancer patients” and “protect you with long-term prescriptions from epidemic”, and provided patients with free medical help, guidance on home isolation, as well as suggestions on transfer and treatment, so as to better solve practical problems for patients in medical treatment and diagnosis, such as difficulty in seeing a doctor, difficulty of diagnosis, difficulty in consultation, difficulty in dispensing, and difficulty in follow-up.

ms. feng, yanhui, president of eisai china, said that we have been rooted in china for past 29 years and have maintained a sound, healthy and rapid growth. our development can hardly do without the efforts, devotions and love for china of every employee of eisai. upholding the corporate philosophy of “hhc“, we hope that all employees will work together with the public and win the battle against covid-19.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and fuji yakuhin co., ltd. (headquarters: saitama, ceo: masayuki takayanagi, “fuji yakuhin”) announced today that they have concluded a license agreement concerning dotinurad (generic name), a treatment for hyperuricemia and gout discovered by fuji yakuhin, for development and distribution in china.

based on this agreement, eisai will acquire exclusive development and marketing rights for dotinurad in china from fuji yakuhin. fuji yakuhin will retain responsibility for manufacturing the formulation of dotinurad, and supply to eisai. eisai will be responsible for a new drug application for dotinurad  in china and pay fuji yakuhin upfront payment, development milestone and sales milestone.

hyperuricemia is the second most common metabolic disease after diabetes mellitus in china. in addition, hyperuricemia is known to be associated with various diseases in the urinary system, endocrine system, metabolic system, cardio-cerebrovascular system etc., including gout. furthermore, it is estimated that currently in china, the number of patients with hyperuricemia is approximately 190 million and the number of patients with gout is approximately 16 million.1 it is expected that the number of patients will further increase in the near future due to changes in lifestyle and dietary preferences in accordance with socioeconomic development in china.
dotinurad is a new therapeutic agent for gout and hyperuricemia discovered by fuji yakuhin. dotinurad suppresses uric acid reabsorption and lowers blood uric acid levels, by selectively inhibiting the urate transporter (urat1) related to reabsorption of uric acid in the kidney.

under this agreement, eisai will proceed with the development of dotinurad in china. following commercialization, eisai will aim to contribute to patients with hyperuricemia that is unmet medical needs by utilizing the knowledge and networks that eisai has cultivated through its china business. fuji yakuhin anticipates maximizing the value of dotinurad in china by leveraging eisai’s business base as the first step in the global expansion of dotinurad. through the development and commercialization of dotinurad, eisai and fuji yakuhin will provide new treatment options for hyperuricemia and gout in china and contribute to improving the quality of life of patients.

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

references:
1 for the estimated data regarding the number of patients with hyperuricemia as well as the number of patients with gout:data of morbidity prevalence rate – rui liu et al., prevalence of hyperuricemia and gout in mainland china from 2000 to 2014: a systematic review and meta-analysis, biomed research international, volume 2015, article id 762820
estimated data calculated from united nations world population estimates – world population prospects, url:

for its contributions towards patients with liver disease through the eisai-originated orally available kinase inhibitor lenvima®

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it received the president’s award at the 8th technology management and innovation awards held by the japan techno-economics society (jates)*. the award was presented to eisai for its discovery of the orally available kinase inhibitor lenvima®(generic name: lenvatinib mesylate) and its contributions towards patients with liver disease.

the technology management and innovation awards was established in 2012 with the aim of contributing to the development of japan’s economy, social transformation, and global competitiveness by introducing a wide range of outstanding innovations originating in japan. this year marks the 8th anniversary of the award.
this award symbolizes high evaluation for eisai’s creation of the new treatment lenvima in japan, the expedition of contributions towards patients through its strategic collaboration with merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada) to globally co-develop and co-promote lenvima, and eisai’s efforts to support patients with liver disease based on its corporate philosophy.

lenvima was discovered at eisai’s tsukuba research laboratories. it is an orally administered multiple receptor tyrosine kinase (rtk) inhibitor that selectively inhibits the kinase activities of proangiogenic pathway-related rtks. eisai obtained approval of manufacturing and marketing in japan for lenvima indicated for the treatment of unresectable thyroid cancer in march 2015. in march 2018, lenvima received its first approval worldwide with additional indication for unresectable hepatocellular carcinoma (hcc) in japan. lenvima thus became the first systemic therapy to be approved in japan for front-line treatment of hcc in approximately 10 years. eisai has also established its own liver disease support site** to realize contributions to patients that cannot be achieved with drugs alone. the support site aims to help patients with hepatitis, cirrhosis, and liver cancer to resolve the anxiety they face in treatment and recuperation, as well as to foster a positive mindset towards treatment and an active lifestyle.

eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards healing cancer. in addition to innovation in drug development based on cutting-edge cancer research, eisai aims to build an oncology ecosystem including prediction and prevention of cancer. eisai will make continuous efforts to meet the diversified needs of, and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

* institute founded in october 1966 to research technology, management, and economics and facilitate exchange among sectors thereof, to promote industrial activities (japanese only): 
** eisai’s liver disease support site (japanese only): 

 

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched the in-house developed anticancer agent halaven® (product name in china: 海乐卫®, generic name: eribulin mesylate) in china.

halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. in addition to its mechanism of action of inhibiting the growth of microtubule dynamics, non-clinical studies showed halaven’s unique actions on the tumor microenvironment such as increasing vascular perfusion and permeability in tumor cores,1 promotion of the epithelial state and decrease in the capacity of breast cancer cells to migrate.2 in a phase iii clinical study (embrace) of halaven versus treatment of physician’s choice (tpc) in 762 patients with advanced or recurrent breast cancer previously treated with an anthracycline and a taxane, halaven showed an extended overall survival compared to tpc.3 for use in the treatment of breast cancer, halaven is currently approved in over 70 countries worldwide, including the united states, japan and countries in europe and asia. the most common adverse events (incidence 25% and higher) in the halaven arm of this study were asthenia (fatigue), neutropenia, alopecia, peripheral neuropathy, nausea and constipation.

in china, halaven received new drug approval for the use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including and an anthracycline and a taxane in july 2019 based on the results of study 304,4 which was a phase iii clinical study in 530 women with locally recurrent or metastatic breast cancer, previously treated with chemotherapy regimens, including an anthracycline and a taxane. halaven demonstrated a statistically significant extension of progression-free survival over the comparator treatment vinorelbine. the five most common adverse events observed in the halaven arm of this study were white blood cell count decreased, neutrophil count decreased, increased aspartate aminotransferase, increased alanine aminotransferase and anemia.

the number of women diagnosed with breast cancer in china has increased in recent years,5 with an estimated 370,000 new cases of breast cancer and 100,000 related deaths in 2018.6 breast cancer is now the most frequently diagnosed cancer in chinese women.6

eisai positions oncology as a key therapeutic area, and is aiming to create revolutionary new medicines with the potential to cure cancer. lenvima® has been available in china as a treatment of patients with unresectable hepatocellular carcinoma who have not received prior systematic therapy since november 2018.* with this approval of halaven, eisai seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in china.

*eisai and merck & co., inc., kenilworth, n.j., u.s.a’s chinese subsidiary msd china have been providing information about lenvima in china.

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


1. about halaven (generic name: eribulin mesylate)
halaven is in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. structurally, halaven is a simplified and synthetically produced version of halichondrin b, a natural product isolated from the marine sponge halichondria okadai. halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. in addition, non-clinical studies showed halaven’s unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores,1 promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate,2 and etc.

halaven was first approved as a treatment in the united states in november 2010 for patients with metastatic breast cancer. halaven is currently approved for use in the treatment of breast cancer in over 70 countries worldwide, including japan, china and countries in europe, the americas and asia. furthermore, halaven was first approved as a treatment for soft tissue sarcoma in the united states in january 2016, and is approved in over 65 countries including japan and in europe and asia. furthermore, halaven has been designated as an orphan drug for soft tissue sarcoma in the united states and japan.

specifically, halaven is approved for the following indications.

in the united states for the treatment of patients with:

  • metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
  • unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

in japan for the treatment of patients with:

  • inoperable or recurrent breast cancer, soft tissue sarcoma

in europe for the treatment of adult patients with:

  • locally advanced or metastatic breast cancer who have received a prior anthracycline-containing regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
  • unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

1 funahashi y et al., eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. cancer sci., 2014; 105, 1334-1342
2 yoshida t et al., eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (emt) to mesenchymal-epithelial transition (met) states. br j cancer, 2014; 110, 1497-1505
3 cortes j et al., eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (embrace): a phase 3 open-label randomised study lancet, 2011; 377, 914-23
4 yuan p et al., eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: a randomized clinical trial eur j cancer, 2019; 112, 57-65
5 lei f et al., breast cancer in china. the lancet oncology, 2014; 15(7), e279–e289
6 ferlay j, et al., (2018). global cancer observatory: cancer today. lyon, france: international agency for research on cancer. , as of january 10, 2020

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched the in-house discovered and developed antiepileptic drug (aed) fycompa®, (product name in china: 卫克泰®, generic name perampanel) for use in adjunctive treatment of partial onset seizures (with or without secondarily generalized seizures) in epilepsy patients 12 years of age and older.

in china, it is estimated that there are approximately 9 million patients with epilepsy, approximately 60% of whom are affected by partial-onset seizures. about 40% patients with partial-onset seizures require adjunctive treatment1. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds2, this is a disease with significant unmet medical needs. fycompa was designated for priority review by the national medical products administration due to its significant clinical benefits compared to existing treatments after the submission in september 2018 and was approved on september 29, 2019.

fycompa is a first-in-class aed and a once-daily tablet discovered at eisai’s tsukuba research laboratories. in the united states and europe, a new oral suspension formulation has been approved and is being marketed. the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes.

fycompa has been approved in over 65 countries around the world as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. in addition, fycompa has been approved in over 60 countries as an adjunctive treatment for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older.

eisai considers neurology including epilepsy, a therapeutic area of focus. with this launch of fycompa in china, eisai pursues our mission to provide “seizure freedom” to a greater number of patients with epilepsy across the world. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

 

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

[notes to editors]
1. about fycompa (perampanel)
fycompa is a first-in-class aed discovered and developed by eisai. with epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. fycompa is available in tablet form to be taken once daily orally at bedtime. in addition, an oral suspension formulation has been approved and marketed in the united states and in europe. to date, fycompa has been used to treat more than 270,000 patients worldwide across all indications.

fycompa is currently approved in more than 65 countries and territories, including the united states, japan, in europe and in asia as adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. in addition, fycompa has been approved in more than 60 countries, including the united states, japan, in europe and in asia for treatment as an adjunctive therapy for primary generalized tonic clonic seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa is also indicated for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. in japan, a supplementary new drug application has been filed seeking approval of fycompa for use as monotherapy for partial-onset seizures, treatment for partial-onset seizures in pediatric patients aged 4 years and older, as well as a fine granule formulation. in europe, an application has been submitted seeking the additional approval of fycompa for adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures in pediatric patients with epilepsy.

furthermore, eisai is conducting a global phase iii clinical study (study 338) for the agent in patients with seizures associated with lennox-gastaut syndrome.

2. about epilepsy
epilepsy affects approximately 9 million people in china, 6 million people in europe, 3.4 million people in the united states, 1 million people in japan, and approximately 60 million people worldwide. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds2, 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 clinical guideline 2015 in china.
2 “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”) today announced that the u.s. food and drug administration (fda) approved the new drug application for its in-house discovered and developed orexin receptor antagonist dayvigotm(lemborexant). dayvigo was approved for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults1. in the united states, dayvigo will be commercially available in 5 mg and 10 mg tablets following scheduling by the u.s. drug enforcement administration (dea), which is expected to occur within 90 days.

the mechanism of action of lemborexant in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance 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 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 with stronger inhibition effect to ox2r*.

the approval was based on the results of a clinical development program that included two pivotal phase iii studies (sunrise 2 and sunrise 1), which evaluated dayvigo versus comparators for up to one month and dayvigo versus placebo for six-months, respectively, in a total of about 2,000 adult patients with insomnia. from these studies results, dayvigo demonstrated statistically significant superiorities on sleep onset and sleep maintenance compared to placebo in both subjective and objective evaluations.

across sunrise 2 and sunrise 1, dayvigo was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following dayvigo discontinuation at either dose. in addition, the development program included multiple safety studies evaluating effects on postural stability, cognition, driving performance and respiratory safety.

  • 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. 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 patient-reported (subjective) sleep onset latency (ssol), defined as the estimated minutes from the time that the subject attempted to sleep until falling asleep. pre-specified secondary efficacy endpoints were change from baseline to end of treatment at six months for patient reported sleep efficiency (sse; defined as the proportion of time spent asleep during time in bed) and subjective sleep onset and sleep maintenance (swaso; defined as the minutes of wake from the onset of persistent sleep until lights on). the primary and pre-specified 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 sse and swaso.1
  • sunrise 1 was a short-term (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 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 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 pre-specified secondary efficacy endpoints in sunrise 1 were the mean change from baseline to end of treatment (day 29/30) in sleep efficiency (se) 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.1

the most common adverse reaction (reported in 5% or more of patients treated with dayvigo and at least twice the rate of placebo) in sunrise 2 (the first 30 days) and sunrise 1 was somnolence (dayvigo 10 mg, 10%; dayvigo 5 mg, 7%; placebo, 1%).

in addition to these pivotal trials, eisai conducted a number of studies to further evaluate the safety of dayvigo, including a study that assessed the effect of dayvigo on postural stability and cognitive performance and a next-morning driving study.

  • middle of the night safety (study 108): the effect of dayvigo on middle of the night safety was evaluated in a randomized, placebo- and active-controlled trial in healthy female subjects ≥ age 55 or male subjects ≥ age 65. postural stability, the ability to awaken in response to a sound stimulus, and attention and memory were assessed following a scheduled awakening four hours after the start of the eight-hour time in bed. nighttime dosing of dayvigo 5 and 10 mg resulted in impairment of balance (measured by body sway area) at four hours as compared to placebo. there were no meaningful differences between dayvigo (5 or 10 mg) and placebo on ability to awaken to sound. dayvigo was associated with dose-dependent worsening on measures of attention and memory as compared to placebo.1
  • effects on next-day postural stability and attention and memory (sunrise1 and study 108): the effects of dayvigo on next day postural stability and attention 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 (5 or 10 mg) and placebo on next-day postural stability, or memory compared to placebo. 1
  • effects on driving (study 106): a randomized, double-blind, placebo- and active-controlled, four-period crossover study evaluated the effects of nighttime administration of dayvigo on next-morning driving performance approximately nine hours after dosing in 24 healthy elderly subjects (≥65 years old, median age 67 years) and 24 adult subjects (median age 49 years). although dayvigo at doses of 5 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 dayvigo.

“insomnia disorder is a chronic condition that has a variety of potential negative impacts and long-term consequences for health and well-being,”2 said russell rosenberg, phd, d.absm, a principal investigator in the dayvigo clinical studies and former chairman of the board of the national sleep foundation. “the clinical trials provide evidence that dayvigo may improve patients’ ability to fall asleep and stay asleep.”

“we believe the approval of dayvigo is particularly exciting because it is the first fda-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study,” said lynn kramer, md, chief clinical officer, neurology business group, eisai. “we look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia.

eisai has submitted new drug applications seeking approval of this agent for use in the treatment of insomnia in japan (march 2019) and canada (august 2019).

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.2,9 insomnia is one of the most common sleep-wake disorders with high prevalence. approximately 30% of adults worldwide have symptoms of insomnia,7,8 and many of them remain months to years. as a result, insomnia causes various social losses such as long absences and reduced productivity.

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

*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). when activated, the role of ox1r is to suppress rem sleep, and the role of ox2r is to suppress both non-rem sleep and rem sleep. lemborexant enables sleep by preventing activation of ox1r and ox2r.
**dsm-5: diagnostic and statistical manual of mental disorders, fifth edition (american psychiatric association)

 

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 a and orexin b to receptors ox1r and ox2r is thought to suppress wake drive.
as a result of clinical studies, the effect of lemborexant are suggested not only for primary insomnia but also for insomnia which is associated with other diseases, such as depression, (sunrise-1 and sunrise-2).
in addition to the indication of insomnia, a phase ii clinical study of lemborexant in patients with iswrd associated with mild to moderate alzheimer’s dementia is underway.

2. about sleep-wake disorders and insomnia
sleep-wake disorders consist of disease categories such as insomnia, 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, that can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.2,9
good quality sleep is essential for good health including brain health,11 and studies suggest an optimal sleep duration between seven and eight hours.12 poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke, dementia, as well as adverse effects on mood and behavior.2,10
women are 1.4 times more likely than men to suffer from insomnia.13 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.14 

3. sunrise 2 (study 303)4
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 aes in the lemborexant arms were somnolence, nasopharyngitis, headache and influenza.

4. sunrise 1 (study 304)3
sunrise 1 is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group phase iii study of the efficacy and safety of lemborexant in 1,006 patients 55 years and older (45% of all patients were aged 65 years and older) with insomnia disorder conducted in north america and europe. sunrise 1 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 30-day treatment period and a two-week period without treatment prior to the end-of-study-visit. in this study, patients were administered placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem er 6.25 mg).
the primary objective for sunrise 1 was to demonstrate using polysomnography that lemborexant  at either the 5 mg or 10 mg dose is superior to placebo on objective sleep onset, as measured by latency to persistent sleep after the last two nights of one month of treatment. key secondary endpoints included change from baseline in sleep efficiency for both lemborexant  doses compared to placebo, wake after sleep onset (waso) for both lemborexant  doses compared to placebo, and waso in the second half of the night (waso2h) for both lemborexant  doses compared to zolpidem er, after one month of treatment, measured objectively by polysomnography.
the results of the study showed that lemborexant  had statistically significant improvement compared to zolpidem er 6.25 mg and placebo in sleep parameters evaluated in primary and key secondary endpoints. the common adverse events (aes) in the dayvigo arms were headache and somnolence.

5. about study 1065
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 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 1086
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 zolpidem er 6.25 mg. the primary endpoint assessed postural stability when awakened by an alarm approximately four hours after administration of lemborexant compared to zolpidem er, as measured by stabilometer.

while there was a statistically significant increase in body sway for both doses of lemborexant compared with placebo, zolpidem er increased body sway at a magnitude almost three times more than lemborexant. this increase with zolpidem was three times that, which is associated with a blood alcohol content (bac 0.05 percent) near the legal driving limit.

the next morning, shortly after the end of eight hours in bed, unlike zolpidem er, neither dose of lemborexant had statistically significant residual effects on this measure of postural stability as compared to placebo.

1 eisai inc. dayvigo full prescribing information. 2019.
2 institute of medicine. sleep disorders and sleep deprivation: an unmet public health problem. washington, dc: national academies press. 2006.
3 eisai inc. a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of the efficacy and safety of lemborexant in subjects 55 years and older with insomnia disorder. (e2006-g000-304). (clinicaltrials.gov identifier nct02783729). 2018. unpublished data on file.
4 eisai inc. a long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (e2006-g000-303). (clinicaltrials.gov identifier nct02952820). 2018. unpublished data on file.
5 eisai inc. a randomized, double-blind, placebo- and active-controlled, 4-period crossover study to evaluate the effect of dayvigo versus placebo on driving performance in healthy adult and elderly subjects. (e2006-e044-106). (clinicaltrials.gov identifier nct02583451). 2017. unpublished data on file.
6 eisai inc. a randomized, double-blind, placebo-controlled and active-comparator, 4-period crossover study to evaluate the effect of dayvigo versus placebo and zolpidem on postural stability, auditory awakening. (e2006-a001-108). (clinicaltrials.gov identifier nct03008447). 2017. unpublished data on file.
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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 cappuccio fp, et al. sleep and cardio-metabolic disease. curr cardiol rep. 2017;19:110.
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 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.
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 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.
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