news – page 25 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that it has submitted applications to the us food and drug administration (fda) and the european medicines agency (ema) for its in-house discovered and developed anticancer agent lenvatinib mesylate (lenvatinib) for the treatment of hepatocellular carcinoma (hcc). this follows the application in japan. lenvatinib for the treatment of hcc is designated as an orphan drug by the fda.

this application is based on the results of the reflect study (study 304), a multicenter, open-label, randomized, global phase iii trial comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for hcc, as a first-line treatment for 954 patients with unresectable hcc.

in the reflect study, lenvatinib met the primary endpoint and demonstrated an overall survival (os) treatment effect by the statistical confirmation of non-inferiority compared to sorafenib. developing first-line treatments for hcc is challenging, and over the past 10 years, four previous first-line phase iii studies investigating other agents compared to sorafenib have failed to achieve this endpoint in os.

additionally, lenvatinib showed highly statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr). in this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

liver cancer is the second leading cause of cancer related death and is estimated to be responsible for 750,000 deaths per year globally (27,000 per year in the us, 62,000 per year in europe), with 780,000 cases newly diagnosed each year (30,000 per year in the us, 63,000 per year in europe). hcc accounts for 85% to 90% of 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.

lenvatinib is approved as a treatment for refractory thyroid cancer in over 50 countries, including the united states, japan, and in europe, under the brand name lenvima®. additionally, lenvatinib in combination with everolimus is approved for the treatment of renal cell carcinoma (rcc) in over 35 countries, including the united states and in europe. in europe, lenvatinib was launched under the brand name kisplyx® for rcc.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai is committed to exploring the potential clinical benefits 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.

primary endpoint achieved and statistically significant improvement of secondary endpoints compared with sorafenib

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the results of a phase iii trial (study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) against the comparator sorafenib as first-line treatment for unresectable hepatocellular carcinoma, will be orally presented during the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. in this study, lenvatinib was the first agent to demonstrate statistical non-inferiority against sorafenib in the primary endpoint of overall survival (os) and showed statistically significant and clinically meaningful improvements in the secondary endpoints of progression free survival (pfs), time to progression (ttp), and objective response rate (orr), doubling sorafenib‘s median values and ratios.

according to the results of the study, lenvatinib (13.6 months) met the statistical criteria for non-inferiority in the primary endpoint of median os compared to sorafenib (12.3 months). (hazard ratio [hr] 0.92, 95% confidence interval [ci] = 0.79-1.06)
additionally, lenvatinib showed statistically significant improvements in the three secondary endpoints compared to sorafenib: median pfs (lenvatinib 7.4 months versus sorafenib 3.7 months, hr 0.66, 95% ci = 0.57-0.77, p<0.00001), median ttp (lenvatinib 8.9 months versus sorafenib 3.7 months, hr 0.63, 95% ci = 0.53-0.73, p<0.00001) and orr (lenvatinib 24% versus sorafenib 9%, p<0.00001).
furthermore, when overall quality of life (qol) was evaluated based on the eortc qlq-c30 questionnaire, it was found that lenvatinib helped to delay deterioration of qol, such as pain and diarrhea, compared to sorafenib (nominal p-value < 0.05).
in this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of lenvatinib.

based on the results of this study, eisai will submit regulatory applications for lenvatinib for the treatment of hepatocellular carcinoma in japan, the united states, and europe during the first half of fiscal 2017, and china within fiscal 2017.

liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for 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. hepatocellular carcinoma accounts for 85% to 90% of primary liver cancer cases. early stage hepatocellular carcinoma is treatable by a wide variety of means, including surgery, radiofrequency ablation, ethanol injection, and chemoembolization therapy, but treatment opinions for unresectable hepatocellular carcinoma are limited and the prognosis is very poor, meaning that this is an area of high unmet medical need.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced the first results for metastatic endometrial carcinoma obtained from a phase ib/ii study (study 111) of its in-house developed multi-kinase inhibitor lenvatinib mesylate (product names: lenvima® / kisplyx®, “lenvatinib”) in combination with the msd (known as merck & co., inc, kenilworth, nj, usa in the united states and canada) anti-pd-1 antibody pembrolizumab (brand name: keytruda®^*), during a presentation at the 53rd annual meeting of the american society of clinical oncology (asco), taking place in chicago, the united states. the two companies are collaborating to develop this combination therapy. study 111 is being conducted to evaluate the activity of the lenvatinib/pembrolizumab combination in select solid tumors.

the presentation covers an analysis of a combined total of 23 endometrial carcinoma patients over both the phase ib and phase ii parts of the study, who had previously undergone at least one chemotherapy regimen. after being treated with a combination of lenvatinib and pembrolizumab, the results of the analysis showed the primary endpoint of objective response rate was 52.2% (95% confidence interval [ci] = 30.6 – 73.2) based on an independent radiologic review (irr) and 47.8% (95% ci: 26.8 – 69.4) by investigator review.
the secondary endpoints of clinical benefit rate^** were 65.2% (95% ci: 42.7 – 83.6) by irr and 73.9% (95% ci: 51.6 – 89.8) by investigator review. disease control rate^***were 91.3% (95% ci: 72.0 – 98.9) by irr and 95.7% (95% ci: 78.1 – 99.9) by investigator review. median progression-free survival was 9.7 months (95% ci: 4.2 – ne) based on investigator assessment and was not reached by irr. median duration of response was not reached at the time of analysis.
anti-pd-1 antibodies are generally more effective in patients with a high frequency of microsatellite instability (msi), a biomarker that results in dysfunctional dna mismatch repair, and less effective in other patients. however, in this study, the combination therapy resulted in tumor response regardless of the state of their msi.
the most frequently observed adverse events for the combination regimen (top 5) were hypertension, fatigue, arthralgia, diarrhea, and nausea.

endometrial cancer is the sixth most common cancer in women worldwide, with 320,000 new cases diagnosed in 2012. in the united states, it is estimated that approximately 60,000 women will be newly diagnosed with endometrial cancer, and approximately 10,000 women will die from the disease in 2017. therefore, this remains a disease with significant unmet medical needs and necessitates the development of new treatments.

eisai positions oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. 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.

* keytruda® is a registered trademark of merck sharp & dohme corp., a subsidiary of merck & co., inc. kenilworth, nj, usa.
** clinical benefit rate: percentage of patients who had complete response, partial response, or maintained disease stability for 23 weeks or longer.
*** disease control rate: percentage of patients who had complete response, partial response, or maintained disease stability for 5 weeks or longer.

eisai commits funding to the 2nd phase of global health innovative technology fund activities

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it will grant a total of 500 million yen to the global health innovative technology fund (“ghit fund”) to fund the second phase of its activities, which will take place in the five-year period from fy 2018 to fy 2022. the ghit fund is a public-private partnership, co-established in april 2013 by multiple japanese pharmaceutical companies (including eisai), the japanese government, and the bill & melinda gates foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in japan and overseas.

in order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (ntds) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. it is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. the key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.

eisai is proactively collaborating with academia and research organizations and has participated in 11 joint research projects to develop new medicines and vaccines for malaria, chagas disease, leishmaniasis, and filariasis, with the support of the ghit fund.
currently, eisai is conducting a phase ii clinical trial of its in-house developed agent e1224 (generic name: fosravuconazole) for the treatment of chagas disease in partnership with the non-profit organization drugs for neglected diseases initiative(dndi). eisai is also conducting a phase i clinical trial of antimalarial agent sj733 in collaboration with non-profit public-private partnership medicines for malaria venture (mmv) and the university of kentucky. furthermore, several pre-clinical stage projects are underway, including joint research with the broad institute and mmv to develop an antimalarial agent with a new mechanism of action, which has been newly adopted by the ghit fund this year.

in accordance with its human health care (hhc) philosophy, eisai will continue to proactively engage in initiatives which contribute to improving the health and welfare of people in developing and emerging countries. eisai considers this to be a long term investment in economic growth and the expansion of the middle-income class.

on april 19, 2017, eisai china inc. (hereinafter referred to as: eisai (china)) was invited to attend the “health to countryside” activity held in yudu county, jiangxi province by the national committee for education, science, culture, health and sports of chinese people’s political consultative conference (cppcc), and donated medicines worth rmb540,000 yuan to the local hospitals. according to the statistics, eisai (china), practicing the philosophy of hhc (human health care) all along, donated medicines worth rmb450,000, rmb490,000, rmb500,000 and rmb540,000 respectively to this activity from the year 2014 to 2017, with the total worth of medicines reaching up to rmb1.98 million yuan.

eisai (china) donated medicines worth rmb540, 000 yuan to the “health to countryside” activity.

the “health to countryside” is an important and traditional activity annually organized by the national committee for education, science, culture, health and sports of cppcc, implementing cppcc’s articles of association. this activity not only delivers doctors, medicines, concepts, technologies and management to the grassroots, but also narrows the distance between the committee members, the experts and the masses. it coincides with what eisai (china) has always been pursuing – the hhc philosophy. eisai (china) advocates that every year every eisai staff shall spend about 1% of their working hours on practicing hhc with patients, for the simple fact that only with the empathy of patients’ feelings and pains can eisai provide better services as well as products in need to earn the trust from patients and their families. eisai (china) will, led by its president mr. kaneko norio and the general manager ms. feng yanhui (fendy feng), continuously contribute to the medical and health services in poor areas by donating medicines to the “health to countryside” activity.

the donation certificate granted to eisai china inc.

on the donation ceremony, the chinese hospital association’s president mr. huang jiefu, the deputy secretary of cpc yudu county committee, the director of yudu county health and family planning commission and other leaders made their speeches. mr. xue xiaolin, the executive vice president of chinese hospital association, signed an agreement of donation with yudu county health and family planning commission. after the ceremony, president huang jiefu, executive vice president xue xiaolin and other leaders praised eisai (china)’s years of participation in this activity and expressed their high recognition for eisai’s hhc philosophy. finally, president huang jiefu said that the “health to countryside” activity would continue and more medical and health institutions would be welcomed to join the team for more contributions to the development of medical and health services.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that, approaching the 65^th anniversary of its chocola bb brand, it will launch chocola bb® gold rich (designated quasi-drug), a supplement drink recommended to relieve fatigue, on monday, april 17.

chocola bb gold rich is a luxurious combination of 16 active ingredients, the highest number in the chocola bb series. it contains active ingredients including b-complex vitamins and taurine 1500mg to help a fatigued body produce energy, and six natural herbs carefully selected by female developers to please female consumers, including angelica acutiloba, ginseng, and royal jelly. the bergamot orange flavor, which is also used in earl grey tea and other products, is easy to drink, and the gold and pink packaging is elegantly designed to give off a sense of luxury. this boxed supplement drink from the chocola bb brand has been designed to be approachable for female consumers.

in recent years, along with the increasing social advancement of women, the market catering to female supplement drink consumers is also growing. additionally, consumers drink different products depending on their level of fatigue. this product is designed to respond to the needs of women who want a high performance drink. chocola bb gold rich is a speedy fatigue reliever perfect for busy women in the office or at home.

the chocola bb supplement drink series includes chocola bb® light 2 for day-to-day fatigue, chocola bb® royal 2 for extreme fatigue, and chocola bb® hyper for weak constitutions, all of which are marketed as designated quasi-drug products designed to help relieve fatigue.

through the chocola bb brand, eisai will continue to respond to the diverse needs of female consumers and support an ever-growing number of people to achieve health and beauty in their everyday lives.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and meiji seika pharma co., ltd. (headquarters: tokyo; ceo: daikichiro kobayashi, “meiji”) announced today that they have entered into a license agreement for the commercialization of safinamide (development code: me2125) for the treatment of parkinson’s disease in japan and asia. safinamide is currently under clinical development by meiji in japan.

under the agreement, eisai will obtain exclusive rights to safinamide to market in japan and to develop and market in asia (seven countries*). meiji will continue the clinical trials that it is currently conducting and submit a manufacturing and marketing authorization application for the drug in japan. meanwhile, eisai will conduct clinical trials for seeking regulatory approval, and make the applications in asia. meiji will manufacture and supply the product of safinamide to eisai for japan and asia.
furthermore, meiji will receive an upfront payment from eisai, as well as developmental milestone and sales royalty payments under the agreement.

parkinson’s disease is a neurodegenerative disease which causes motor impairment, including shaking in the limbs, muscular rigidity and brachybasia. it is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain.
according to a survey by the ministry of health, labour and welfare, the number of patients suffering from parkinson’s disease in japan numbered 163,000 in 2014, with the number of patients increasing due to the aging of the population.

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 (“on” time) decreases, and there are cases of parkinson’s disease symptoms returning before the next dose (“wearing-off” phenomenon). to prevent the “wearing-off” phenomenon, combination therapy with a drug that has a different mechanism of action to levodopa is administered.

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. global clinical trials of safinamide in combination with levodopa for the treatment of mid- to late-stage parkinson’s disease showed extended “on” time, and an improvement in motor function.

safinamide was discovered and developed by newron pharmaceuticals s.p.a. (headquarters: italy, milan, “newron”). in 2011, newron entered into a licensing agreement with meiji, granting meiji exclusive rights to development, manufacture and commercialize the drug in japan and asia. safinamide is marketed under the name “xadago” in eleven countries in europe, and on march 21, 2017, was approved by the u.s. food and drug administration. in japan, meiji is currently conducting phase ii/iii trials for safinamide in combination with levodopa.

through this agreement, eisai and meiji will make further contributions to address the diversified needs of, and increase the benefits provided to, parkinson’s disease patients and their families.

* south korea, chinese taiwan, brunei, cambodia, laos, malaysia, and the philippines

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has presented the latest research data regarding a mechanism of action that led to increased anti-tumor activity in mouse models which had been dosed with a combination of the in-house developed anticancer agent lenvatinib mesylate (lenvatinib) and an anti-mouse pd-1 antibody, at the american association for cancer research (aacr) 108th annual meeting.

the results presented at the aacr meeting showed that when syngeneic model mice inoculated with mouse liver cancer, melanoma or colon cancer cell lines were dosed with a combination of lenvatinib (10 mg/kg, once daily) and an anti-mouse pd-1 antibody (500 g/mouse, twice a week), lenvatinib alone or an anti-mouse pd-1 antibody alone, a substantial inhibitory effect on tumor growth was observed in mice that had been dosed with the combination therapy compared to the single treatments.
additionally, an increased number of mice in the combination therapy group showed complete response (cr) of tumor compared to the single treatment group. specifically, in the combination therapy group, 7 out of 30 mice showed cr (colon cancer models: 2/10, melanoma models: 2/10, liver cancer models: 3/10), whereas in each single treatment group, 1 out of 30 mice showed cr (colon cancer models: 1/10, melanoma models: 0/10, liver cancer models: 0/10).

furthermore, in the liver cancer mouse model, even when identical cancer cell lines were re-inoculated into mice with complete tumor remission, no in vivo growth was observed.

rna analysis of the cancer tissue and other tests confirmed a reduction in immunosuppressive tumor associated macrophages, a reduction in immunosuppressive signal receptors, and an increase in the ratio of memory t cells in model mice dosed with lenvatinib.

this non-clinical research suggested synergistic anti-tumor activity when combining lenvatinib with an anti-mouse pd-1 antibody in the mouse models, based on an immunostimulatory response due to the reduction in tumor associated macrophages and the enhancement of the ratio of memory t cells by lenvatnib.

eisai has positioned oncology as a key therapeutic area of focus and remains committed to providing further evidence for 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai” ) announced today that the german federal joint committee (g-ba) has confirmed the additional benefit of in-house developed anticancer agent kisplyx^® (lenvatinib mesylate) in combination with everolimus for the treatment of advanced renal cell carcinoma (rcc) compared to everolimus alone in its assessment for insurance reimbursement. based on this additional benefit assessment, price negotiations with the head association of german sick funds (gkv-sv) will be conducted, and a reimbursement price has to be agreed.

the g-ba’s assessment was based on a phase ii clinical study (study 205) that evaluated the safety and efficacy of kisplyx in combination with everolimus in patients with unresectable advanced or metastatic rcc following one prior vascular endothelial growth factor (vegf) targeted therapy. from the results of the study, the kisplyx plus everolimus group demonstrated a significant extension in the study’s primary endpoint of progression free survival (pfs) compared to the everolimus alone group. furthermore, the kisplyx plus everolimus group demonstrated an extension in median overall survival (os) compared to the everolimus alone group.
the most common treatment-emergent adverse events (teaes) reported in the kisplyx plus everolimus group were diarrhea, decreased appetite and fatigue. the most common teaes of grade 3 or higher (common terminology criteria for adverse events) were diarrhea, hypertension and fatigue

the number of patients with renal cancer is estimated to be approximately 115,000 in europe in 2012. renal cell carcinoma comprises more than 90% of all malignancies of the kidney, and originates from malignant cells in the lining of the tubules of the kidney. the incidence of renal cell carcinoma in people over 55 years of age is rising, and it is more likely to affect men than women. for advanced or metastatic rcc that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy. however, with low 5-year survival rates, rcc remains a disease with a significant unmet medical need.

in europe, lenvatinib mesylate has been designated as an orphan drug for thyroid cancer and is marketed as lenvima^® for this indication.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai remains committed to expanding access to kisplyx and maximizing value of the drug 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into a marketing and distribution agreement with orion corporation (headquarters: espoo, finland; ceo: timo lappalainen, “orion”) concerning its parkinson’s disease treatments comtan®(entacapone) and stalevo®(levodopa/entacapone/carbidopa combination agent) in china.

under the terms of the agreement, eisai acquired from orion the exclusive rights to market the two products in china, and began distribution and promotion through its chinese subsidiary eisai china inc. (location: suzhou, jiangsu province).

eisai has a diverse range of neurology products in china, including parkinson’s disease treatment eldepryl® (monoamine oxidase inhibitor), anti-alzheimer’s agent aricept® and the peripheral neuropathy treatment methycobal®. through the addition of comtan and stalevo, eisai has strengthened its product lineup for parkinson’s disease treatment, and is now able to provide multiple treatment options with different mechanisms of action for patients with parkinson’s disease in china (approx. 1.7% of the population aged 65 years and over)1.

parkinson’s disease is thought to be caused by a shortage of dopamine, a neurotransmitter in the brain. levodopa is used to treat parkinson’s disease by transforming into dopamine inside the brain. by replenishing the brain’s supply of dopamine, parkinson’s disease symptoms are alleviated. metabolic enzyme inhibitors are widely used to prevent peripheral metabolism of levodopa, helping it to move to the brain more efficiently.

comtan, which is used in combination with levodopa, is an agent that helps levodopa reach the brain by inhibiting peripheral metabolism by catechol-o-methyltransferase (comt).
stalevo is a combination agent consisting of levodopa, and two other compounds which help levodopa reach the brain, namely entacapone and carbidopa (a decarboxylase inhibitor). combining the compounds into a single tablet reduces the burden on patients who have difficulty swallowing, and is expected to improve drug compliance.

eisai defines neurology as a therapeutic area of focus, and through this marketing agreement for parkinson disease’s treatments, eisai seeks to make further contributions to address the diversified needs of and increase the benefits provided to patients suffering from neurological diseases including parkinson’s disease in china.

news – page 25 – eisai china lnc.-pg电子app

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