news – page 26 – eisai china lnc.-pg电子app

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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito) announced today that, in association with its u.s. pharmaceutical subsidiary eisai inc. (collectively, “eisai”), it has reached an agreement with arena pharmaceuticals, inc. (headquarters: california, united states, president and ceo: amit d. munshi) to revise the november 2013 marketing and supply agreement it concluded with arena’s wholly owned subsidiary, arena pharmaceuticals gmbh (collectively, “arena”), for the chronic weight management treatment lorcaserin hydrochloride (generic name, u.s. brand name: belviq® / belviq xr®, “belviq”). under the new agreement, eisai acquires all of arena’s rights to develop and market belviq.

under the latest agreement, eisai becomes solely responsible for all decision-making and implementation related to global development and submissions for regulatory approvals, as well as global marketing for belviq. the previously negotiated financial terms such as purchase price based on net sales and regulatory and sales milestones to arena have also been reduced and modified. in addition, a technology transfer will take place to allow eisai to participate in the manufacture of belviq. eisai will also assume arena’s exclusive distribution agreements with third-parties to develop and market belviq in south korea, chinese taiwan and israel. eisai will now serve as the third parties’ exclusive supplier and receive income in the form of payment for the supply of product to the distributors.

belviq was approved by the u.s. food and drug administration (fda) in 2012 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (bmi) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition, and has been available to patients in the united states since june 2013. in addition, belviq has been made available in south korea via a third-party distributor contracted by arena from 2015. in 2016, lorcaserin was approved in both brazil and mexico, and will be launched in mexico under the brand name venespri®. in addition, belviq xr, a once-daily formulation of lorcaserin was approved in the united states in 2016.

by seeking to further the development of belviq and to expand its availability to more patients, eisai anticipates that the new agreement will give it greater freedom in its development and submission strategy, support its goal of making contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families worldwide.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the anticancer agent treakisym® (generic name: bendamustine hydrochloride) has been approved in japan for an additional indication as first-line treatment for low-grade b-cell non-hodgkin′s lymphoma and mantle cell lymphoma (mcl). treakisym is the subject of a licensing agreement concluded between eisai and symbio pharmaceuticals limited (headquarters: tokyo, representative director, president & ceo: fuminori yoshida, “symbio”). through the approval of this additional indication, treakisym will now be available for adjunctive use with rituximab for untreated low-grade b-cell non-hodgkin′s lymphoma and mcl.

treakisym was initially approved in japan in october 2010 as monotherapy for relapsed or refractory low-grade b-cell non-hodgkin′s lymphoma and mcl. under the licensing agreement concluded between the two companies, eisai has been marketing the product since december 2010. in august 2016, treakisym was approved in japan for an additional indication of chronic lymphocytic leukemia. for this approval of the indication for first-line low-grade b-cell non-hodgkin′s lymphoma and mcl, this indication met the development requests set by the japanese ministry of health, labour and welfare′s council on unapproved drugs/off-label use, and symbio submitted a supplemental new drug application in december 2015.

non-hodgkin′s lymphoma is a general term that refers to lymphocytes within white blood cells that have mutated into lymphomas, except for hodgkin′s lymphoma, and represent the majority of lymphomas diagnosed in japan. non-hodgkin′s lymphoma is categorized by progression speed, which means lymphoma progressing annually is low-grade, monthly is mid-grade and weekly is high-grade. in addition, non-hodgkin′s lymphoma can be further categorized by which cells have become cancerous (such as b-cells) and how mature the cells are. as low-grade b-cell non-hodgkin′s lymphoma and mcl are difficult to cure completely, they are both diseases with high unmet medical needs.

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 maximizing the value of treakisym as well as its in-house developed anticancer agents including halaven® and lenvima®, seeking to contribute further to addressing the diverse needs of patients with cancer and their families.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the results of an interim analysis of a phase ib/ii clinical study (study 218) of its in-house discovered and developed anticancer agent eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: halaven®, “eribulin”) in combination with the anti-pd-1 antibody pembrolizumab developed by merck & co., inc., kenilworth, nj, usa (known as msd outside the u.s. and canada), in patients with metastatic triple-negative breast cancer have been presented at the 39th annual san antonio breast cancer symposium held from december 6 to 10, 2016. development of this combination regimen is being conducted jointly under the cooperation of both companies.

study 218 is a phase ib/ii clinical study which examined the activity and safety of eribulin in combination with pembrolizumab in 95 patients with metastatic triple-negative breast cancer previously treated with 0 – 2 lines of chemotherapy in the metastatic setting. the primary objective of the phase ib part was safety and tolerability, and the primary objective of the phase ii part was objective response rate (orr).

this presentation reported on the results of an interim analysis of 39 evaluable patients out of the 89 patients enrolled in the study as of july 2016. eribulin (1.4 mg/m²intravenously on day 1 and day 8) and pembrolizumab (200 mg intravenously on day 1) were administered to patients over 21 day cycles. from the results of the study, orr was 33.3% (1 patient experienced a complete response and 12 patients experienced a partial response). in addition, the orr was similar between pd-l1 positive and negative cohorts.

in this study, the most common treatment-emergent adverse events (incidence greater than or equal to 35%) in patients treated with the combination regimen were fatigue, nausea, peripheral neuropathy, neutropenia and alopecia, with grade 3 or higher treatment-emergent adverse events (teaes) observed in 66.7% of patients. the most common grade 3 or higher teaes (incidence greater than or equal to 7%) observed were neutropenia (30.8%) and fatigue (7.7%).

eribulin is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. recent non-clinical studies showed that eribulin is associated with increased vascular perfusion and permeability in tumor cores.¹ eribulin promotes the epithelial state and decreases the capacity of breast cancer cells to migrate and invade.² it was first approved for use in the treatment of metastatic breast cancer in the united states in november 2010, and is currently approved for use in the treatment of patients with breast cancer in over 60 countries including japan and countries in europe, the americas and asia.

eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. as exemplified by this combination regimen, eisai remains committed to providing further clinical evidence for eribulin aimed at 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 presented the latest two clinical trials (study 202 and study 006) data on its in-house discovered oral bace (beta amyloid cleaving enzyme ) inhibitor elenbecestat (development code: e2609) at the 9th clinical trials on alzheimer’s disease (ctad 2016) held from december 8 to 10 in san diego, the united states.

study 202 is a multicenter, randomized, double-blind, placebo-controlled parallel-group phase ii clinical study to evaluate the safety of elenbecestat and the change from baseline in cerebrospinal fluid (csf) amyloid beta aβ(1-x)* level in patients with mild cognitive impairment (mci) due to alzheimer’s disease or mild to moderate dementia due to alzheimer’s disease with confirmed accumulation of amyloid beta (aβ) by pet (positron emission tomography) screening. patients are administered 5, 15 or 50 mg of elenbecestat daily. the change in aβ(1-x) level is evaluated by analyzing the concentrations of aβ(1-x) in plasma and csf before and after elenbecestat administration. the presentation highlighted the results from a preliminary analysis of pharmacokinetic and pharmacodynamics data of study 202 at the ctad 2016 (poster presentation number: p3-28).
in study 202, the pharmacokinetic profile of elenbecestat was similar to the results obtained from phase i studies in healthy volunteers. a correlation between plasma concentration of elenbecestat and the decrease in csf aβ(1-x) was observed, which overlapped with exposure-response models combining data from this study and phase i clinical study data (figure 1).
* aβ(1-x) refers to aβ peptides of all lengths

furthermore, a dose-response model was established to explain the relationship between dosage of elenbecestat and the decrease in csf aβ(1-x) using the same dataset. this model was able to describe the decrease in csf aβ(1-x) in study 202 well. the predicted median reduction in csf aβ(1-x) at 50 mg/day dose of elenbecestat was 70% (figure 2). based upon these results, a global phase iii clinical study (mission ad) is currently underway to confirm efficacy and safety of elenbecestat at a dosage of 50 mg/day.

study 006 was a bridging study (phase i clinical study) of elenbecestat to investigate similarity of the pharmacokinetics, pharmacodynamics and safety profiles between japanese and white healthy subjects (poster presentation number: p3-27). the study was conducted as a randomized, double-blind, placebo-controlled study. single oral doses of 5, 50 or 200 mg/day of elenbecestat were administered in healthy adult japanese and 50 mg/day of elenbecestat in white subjects, respectively.
from the results of the study, a dose-dependent decrease in plasma aβ(1-x) level was observed in japanese subjects. pharmacokinetic and pharmacodynamics profiles were similar between japanese and white subjects. there were no specific racial differences in safety findings.

discovered in-house by eisai, elenbecestat is an investigational oral bace inhibitor currently being investigated in a phase iii clinical study for alzheimer’s disease. by inhibiting bace, a key enzyme in the production of aβ peptides, elenbecestat decreases the formation of these peptides which can aggregate into toxic oligomers and protofibrils and eventually form amyloid plaques in the brain. it is believed that decreasing the formation of these plaques may potentially slow disease progression. elenbecestat is being jointly developed by eisai and biogen inc. (headquarters: massachusetts, united states, ceo: george a. scangos, “biogen”). in addition, the u.s. food and drug administration has granted fast track designation for the development of elenbecestat.

eisai considers dementia a therapeutic area of focus and is committed to new drug such as elenbecestat development in this field. eisai is striving to bringing promising therapies to patients worldwide as early as possible.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that a series of abstracts highlighting the latest clinical data on its in-house developed halichondrin class microtubule dynamics inhibitor eribulin mesylate (product name: halaven®, “eribulin”) will be presented at the san antonio breast cancer symposium (sabcs2016) taking place in san antonio, the united states, from december 6 to 10.

three abstract poster presentations (including outcome research data) are to be given at the meeting, with the main presentation featuring the results of an interim analysis of a phase ib/ii trial (study 218) of eribulin in combination with the immune checkpoint inhibitor pembrolizumab in patients with metastatic triple-negative breast cancer.

eisai positions oncology as a key franchise area and is aiming to discover revolutionary new medicines with the potential to cure cancer. the company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and to increase the benefits provided to, patients and their families as well as to healthcare providers.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that the latest data on its antiepileptic drugs (aed) perampanel (product name: fycompa®) and rufinamide (product name: inovelon®, u.s. product name: banzel®) will be presented at the 70th american epilepsy society (aes) annual meeting to be held from december 2 to 6 in houston in the united states.

for this year’s aes meeting, poster presentations will be given on eight abstracts for perampanel which include the results of phase ii trials (study 231, study 233) of adjunctive perampanel in japanese patients with refractory partial-onset seizures. regarding rufinamide, a poster presentation will be given on the safety and cognitive development effects of adjunctive rufinamide in pediatric subjects with inadequately controlled lennox-gastaut syndrome (lgs) from the final results of study 303. along with three poster presentations on health economics and outcome research, a total of 12 poster presentations will be given.

perampanel 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 postsynaptic ampa receptors. the agent is currently approved in more than 50 countries and territories as an adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) in adult and adolescent patients with epilepsy 12 years of age and older. in addition, perampanel is approved in more than 40 countries as an adjunctive treatment of primary generalized tonic-clonic (pgtc) seizures in patients with epilepsy 12 years of age and older.

furthermore, eisai has submitted a supplemental application to the u.s. food and drug administration for a partial label change for perampanel as monotherapy for treatment of partial-onset seizures in patients with epilepsy 12 years of age and older.

rufinamide is believed to exert its antiepileptic effects by regulating activity of voltage-gated sodium channels in the brain involved in the overexcitement of neurons that potentially causes seizures, so as to prolong their inactive state. the agent is approved as an adjunctive therapy to other aeds in the treatment of seizures associated with lgs in europe and the united states. in japan, the agent is approved as an adjunctive therapy to other aeds in the treatment of tonic and atonic seizures associated with lgs when therapy with other aeds is considered inadequate. rufinamide is currently approved in more than 30 countries worldwide.

eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to perampanel and rufinamide as part of an extensive epilepsy product portfolio, eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

news – page 26 – eisai china lnc.-pg电子app

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