news – page 24 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that aricept® (donepezil hydrochloride, brand name in china: ) has been approved for the additional indication of severe alzheimer‘s disease in china. aricept is the first alzheimer’s disease treatment with a broad indication that covers mild to severe alzheimer‘s disease in china.

the approval of the additional indication was based on the results of a phase iii clinical study (study 339) in china. study 339 was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of aricept 10 mg per day in 313 chinese patients with severe alzheimer’s disease. in this study, aricept demonstrated a statistically significant improvement in total severe impairment battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. in the study, the four most commonly observed adverse events in the aricept arm were bradycardia, anorexia, qt interval prolongation, and dizziness.

in china, it has been estimated that approximately 6 million people suffer from alzheimer‘s disease. furthermore, with the progressive aging of the population, the number of patients with dementia is expected to greatly increase in the future. eisai launched aricept in china in september 1999, and in collaboration with various stakeholders including government, hospitals and non-government organizations, is actively promoting dementia disease awareness initiatives for civilians as well as support for establishing memory clinics and other initiatives.

with the approval of this indication covering severe alzheimer’s disease, eisai strives to further contribute to increasing the quality of life of patients with alzheimer‘s disease in china, and as the originator of aricept, continues to make comprehensive contributions in dementia such as improving treatment and care, increasing public awareness of the disease and discovering new treatment methods.

results of subpopulation analysis of patients from greater chinese region (mainland china, hksa, and chinese taiwan)

additionally, lenvatinib’s safety profile for the greater chinese region subpopulation was consistent with previous studies.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions. specifically, in china, there are approximately 395,000 new cases and 380,000 deaths per year, accounting for approximately 50% of cases worldwide. hcc accounts for 85% to 90% of primary liver cancer cases. treatment options for unresectable hcc are limited and the prognosis is very poor, making this an area of high unmet medical need.

following submissions in japan (june 2017), the united states and europe (july 2017), eisai will submit a regulatory application for lenvatinib in hcc in china within the latter half of fiscal 2017. eisai remains committed to generating scientific evidence aimed at maximizing the value of lenvatinib as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

on september 15, 2017, china population welfare foundation, alzheimer’s disease chinese (adc) and eisai china inc. (eci) jointly kicked off the “yellow bracelet” activity for caring the patients with alzheimer‘s disease. in line with the corporate philosophy of “human health care (hhc)” and according to the actual situation of chinese patients, eisai introduced into china the experiences for the treatment and care of the aging people of japan in hope of continuously enhancing the attention of the whole chinese society to the alzheimer’s disease and improving the grim situation of china‘s insufficient treatments and care concerning this disease through upgrading the entire solution that covering recognition, trainings and care. chairman hao linna of china population welfare foundation, professor wang luning from alzheimer’s disease chinese, professor xie hengge from the general hospital of people‘s liberation army of china, professor wang huali from peking university sixth hospital (institute of mental health), professor liu xueyuan from the tenth people’s hospital affricated to tongji university, professor he jincai from the first affiliated hospital of wenzhou medical college, mr. kaneko norio, the president of eci and ms. feng yanhui, the general manager of eci attended the conference and delivered speeches. the guests jointly kicked off the “alzheimer‘s care” activity and witnessed the important moment.

since the establishment of the company, eisai made “hhc” as its mission and the criterion of the company’s operation and charity activities. “in eisai, every employee gives first thought to patients and their families, and to increasing the benefits that health care provides them. every year the eisai employees spend 1% of their working time practicing the hhc mission together with the patients, experiencing their sufferings in a bid to provide better services for them. eisai carries out extensive health activities according to the needs of different countries. for example, eisai opened clinics and provided free clinical services, patient-care services and doctor educations in india, thailand, philippines, britain, canada, and etc. in india, eisai has provided over 1,000 free clinic services for patients with alzheimer‘s disease. the amount of patients with alzheimer’s disease got treatments there increased about 6 times in 5 years since eisai opened memory clinics there and trained relevant medical staff. eisai also brings this mission to china,” said mr. kaneko norio, the president of eci when talking about the original purpose of the “hhc” activities.

the “world alzheimer report 2016” indicated that the figure of patients with alzheimer‘s disease showed a rapid growth in china and the country saw a stark contrast of the huge patient amount to the insufficient treatment and care. only a few patients accepted standard diagnosis, and a considerable proportion of patients were mistaken for experiencing a natural part of the aging process and missed the best treatment time. what’s more, the coverage rate of professional medical care resources was obviously insufficient. based on the current situation, the “alzheimer‘s care” activity will establish a community-centered, comprehensive, hierarchical diagnosis and treatment system and a professional home-care platform, which help combat the disease with 5 practical measures as follow:

firstly, to strengthen the education to potential patients
distribute yellow bracelets to more elderly and help them better use it. enhance the technology of the yellow bracelet and enrich the relevant functions to reduce the risk of old people from getting lost;

secondly, to give full play to the power of yellow bracelet in wechat platform
rely on the wechat platform to promote the early diagnosis and treatment of the elders with alzheimer’s disease, give them early cognitive tests, recommend them the nearby memory clinic, show them care-introducing videos and provide them better caring methods;

thirdly, to explore and promote the community care model
make communities and pension institutions as the centers to establish home-care training platforms and livable environments. eisai plans to pilot this model in 6 chinese cities for the first batch;

fourthly, to carry out professional training in caring skills
to learn the global advanced caring experiences, design and develop standard courses to conduct professional trainings to improve the skills of medical staff.

fifthly, to strengthen the guidance on public awareness
carry out propaganda and education of disease-related knowledge and construct social environment that encourages respecting, loving and caring the elderly.

japan is a country with serious aging problem and experienced at elderly care. as a leading japanese pharmaceutical company, considering alzheimer‘s disease as a focus area for the long-term, eisai has introduced aricept® to china, made all efforts for its accessibility, and continuously increased the investments in the research and development of new drugs. what’s more, since 2012, eisai china began to support the yellow bracelet project, which helps prevent the elderly with alzheimer‘s disease from getting lost; eisai china has conducted a series of projects – “remember that i love you” patient-care activities, and has supported over 100 free clinical services, distributed 245,000 yellow bracelets and provided free drugs to 136 families. “the ’alzheimer‘s care’ activity is an upgrade of eisai‘s former hhc activities. based on the 20-year experiences in serving chinese families and communities, eisai china joins hands with institutions in different fields to help more patients get standard treatments at early stage, and to guide their families in taking care of the patients. eisai would like to introduce health management experiences accumulated for years through charitable organizations and academic institutions, and to protect the happiness of chinese families with the comprehensive alzheimer-treatment solutions,” said ms. feng yanhui, the general manager of eci.

eisai co., ltd. (headquarters: bunkyo-ku, tokyo, ceo: haruo naito, “eisai”) and ono pharmaceutical co., ltd. (headquarters: chuo-ku, osaka, representative director and president: gyo sagara, “ono”) have announced that they have entered into a collaboration agreement to jointly develop the combination therapy of eisai‘s multi-kinase inhibitor, lenvima® (lenvatinib mesylate) and ono’s human anti-human pd-1 (programmed cell death-1) monoclonal antibody, opdivo® (nivolumab) for the treatment of hepatocellular carcinoma (hcc).

based on this agreement, eisai and ono will swiftly implement a phase ib clinical trial in japan to investigate the safety, tolerability, and efficacy of the combination of lenvima and opdivo in patients with hcc. details relating to the financial and other conditions of this agreement are confidential.

liver cancer is the second most common cause of cancer related deaths, with an estimated 750,000 deaths per year globally. additionally, 780,000 cases are newly diagnosed each year, about 80% of which occur in asian regions, including japan and china. hcc accounts for approximately 85% to 90% of liver cancer cases. it is estimated that there are approximately 42,000 hcc patients in japan, with 26,000 deaths per year. treatment options for unresectable hcc are limited and the prognosis is very poor, so this remains an area with high unmet medical needs.
eisai submitted an application for an additional indication of lenvima for the treatment of hcc in japan in june 2017. ono is currently conducting a phase iii clinical trial of opdivo for the treatment of hcc in japan.

dr. takashi owa, vice president, chief medicine creation officer, oncology business group, eisai, commented, “our non-clinical research has demonstrated synergistic antitumor activities in the lenvima and anti-pd1 antibody combination, which are considered to be a result of an immunostimulatory response through a reduction in immunosuppressive tumor-associated macrophages and an increase in cytotoxic t lymphocytes by lenvima. through the development of a combination therapy that has the potential to produce synergistic effects between lenvima and nivolumab, both drugs of japanese origin, we anticipate being able to further contribute to addressing the high unmet medical needs of hcc patients and their families and improving their benefits.”

hiroshi awata, vice president executive officer / executive director, clinical development, ono, commented, “we have been actively engaged in the development of opdivo not only in monotherapy, but combination therapies with other agents. as we believe that the combination therapy may exert more excellent therapeutic efficacy compared to the monotherapy, we are very pleased to pursue the potential for developing the combination therapy of opdivo with lenvatinib. we expect that the combination therapy with opdivo and lenvatinib will be a new treatment option for the patients with hepatocellular carcinoma.”