news – page 22 – eisai china lnc.-爱游戏(ayx)中国官方网站

news – page 22 – eisai china lnc.-爱游戏(ayx)中国官方网站

aug. 4, 2018, china top 100 pharmaceutical enterprises list was released in the 35thchina pharmaceutical industry information annual conference 2018. following the 97th place in 2015, and the 92nd place in 2016, eisai (china) ranked 84th in the top 100 list 2017.


eisai china holdings ltd. ranked 84th in china top 100 pharmaceutical enterprises list

with more than 20 years’ development, eisai has established a development mode consisting of eisai china holdings ltd. for capital control and management, while eisai china inc., eisai (liaoning) pharmaceutical co., ltd. and eisai (suzhou) trading co., ltd. for business support. currently, the total registered capital of eisai in china is usd108.54 million. eisai china specializes in neurology, oncology and gastrointestinal areas, and expands to the generic business. the sales volume reached rmb3 billion yuan in 2017.

“eisai china always keeps to the faith in providing drugs with high quality and reasonable price and addressing the diverse needs of patients and their families. as an important strategy of eway 2025, eisai china will actively expand the market coverage including the low-tier market,” said ms. yanhui feng, corporate officer of eisai co. ltd. and president of eisai china holdings ltd. “eisai china sticks, all the time, to the corporate philosophy that the interests of patients and their families are our priority and we will contribute to improving their well-beings, constantly bringing in high quality drugs, proactively expanding and innovating business mode, serving chinese patients and their families.”

china pharmaceutical industry information annual conference is held by china national pharmaceutical industry information center. based on the annual statistic report of china pharmaceutical industry published by ministry of industry and information technology, china top 100 pharmaceutical enterprises list reflects the status of china pharmaceutical industry, with the final data obtained through the first, second, third and fourth reviews in the materials of pharmaceutical enterprises. according to the data analysis, with the constant expansion of the industrial scale of china’s pharmaceutical industry, the threshold of the top 100 enterprises in china’s pharmaceutical industry has increased year by year, and the lowest threshold of the top 100 enterprises has increased from rmb2.4 billion yuan of main business income in 2016 to rmb2.56 billion yuan in 2017. the overall size of the top 100 companies has continued to grow rapidly.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride (generic name, product name in the united states: belviq®, product name for once-daily formulation in the united states: belviq xr®, “lorcaserin”) in china (including hksa and chinese macao) to cy biotech (headquarters: taipei, chinese taiwan, “cyb”).

under this agreement, eisai will supply cyb with lorcaserin. eisai will receive a one-time contractual payment and milestone payments dependent upon acquisition of regulatory approval. in addition, eisai has the option rights to co-promote lorcaserin with cyb in china (excluding hksa and chinese macao), as well as the option rights to market lorcaserin in hksa and chinese macao.

lorcaserin is a novel chemical entity that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2c receptors in the brain. lorcaserin was approved in june 2012 by the u.s. food and drug administration (fda) 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 was launched in the united states in june 2013. lorcaserin was approved in mexico in july 2016 and in brazil in december 2016, with the same indication as for the united states. in chinese taiwan, lorcaserin was developed by cyb, who obtained approval in july 2017 and launched lorcaserin in chinese taiwan in october 2017.

by entering into this agreement with cyb, which already has a track record in developing and marketing lorcaserin in chinese taiwan, eisai is aiming to accelerate the delivery of lorcaserin to patients in these regions.

 

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

 

[notes to editors]

1. about lorcaserin hydrochloride (product name in the united states: belviq, product name for once-daily formulation in the united states: belviq xr, “lorcaserin”)
discovered and developed by arena pharmaceuticals, inc., lorcaserin is a novel chemical entity that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2c receptors in the brain. activation of these receptors may help a person eat less and feel full after eating smaller amounts of food. lorcaserin was approved in june 2012 by the u.s. food and drug administration (fda) 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 was launched in the united states under the brand name belviq in june 2013 after receiving a final scheduling designation from the u.s. drug enforcement administration (dea). in addition, lorcaserin has been made available in south korea via a third-party distributor from 2015. lorcaserin was approved in mexico in july 2016 and in brazil in december 2016, with the same indication as for the united states. furthermore, belviq xr, a once-daily formulation of lorcaserin aiming to increase convenience of administration for patients, was approved in the united states in july 2016. in january 2017, eisai acquired all of arena’s rights to develop and market lorcaserin.

the most common adverse reactions observed in multiple phase iii clinical studies on lorcaserin were headache, dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycemia, headache, back pain, cough and fatigue in patients with diabetes.

a cardiovascular outcomes trial conducted in multiple countries, including the united states, with 12,000 patients found that long-term treatment with lorcaserin does not increase incidence of mace (major adverse cardiovascular events including myocardial infarction, stroke and cardiovascular death), and the primary safety objective of the trial was met. in addition, regarding the incidence of mace (consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, heart failure or coronary revascularization) which was the primary efficacy endpoint, although statistical superiority to placebo was not met, the results successfully confirmed statistical non-inferiority for lorcaserin. in this trial, lorcaserin also demonstrated an improvement in multiple cardiovascular risk factors including blood pressure, lipids, blood glucose and renal function as well as a reduction in conversion to type 2 diabetes mellitus (t2dm) in patients without diabetes. furthermore, in additional subgroup analyses, on a background of lifestyle modification, it was observed that lorcaserin improved long-term weight loss compared to placebo, including in subpopulations with t2dm and obstructive sleep apnea.

 

2. about cy biotech company ltd.

cy biotech company ltd. (cyb) is a pharmaceutical company established in april 2011 with its headquarters in chinese taiwan. in 2012, cyb launched a wholly-owned subsidiary chuang yi trading limited in shanghai. cyb obtained the exclusive rights for marketing and distributing lorcaserin in chinese taiwan and has been marketing lorcaserin in chinese taiwan since 2017. aiming to be an innovative leader in self-paid pharmaceutical and health products with a wide range of indications, cyb is striving to improve the quality of life (qol) of patients in greater china.

tokyo & kenilworth, n.j., july 31, 2018 – eisai co., ltd. and merck & co., inc. kenilworth, n.j., u.s.a. (nyse:mrk), known as msd outside the united states and canada, announced today that the u.s. food and drug administration (fda) granted breakthrough therapy designation for lenvima® (generic name: lenvatinib mesylate), the orally available kinase inhibitor discovered by eisai, in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda® (generic name: pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (msi-h)/proficient mismatch repair (pmmr) endometrial carcinoma (ec) who have progressed following at least one prior systemic therapy.

the lenvima/keytruda combination therapy is being jointly developed by eisai and merck & co., inc., kenilworth, n.j., u.s.a. as part of the strategic collaboration announced in march 2018. this is the third breakthrough therapy designation for lenvima and the second breakthrough therapy designation for lenvima in combination with keytruda following the breakthrough therapy designation for the combination for advanced and/or metastatic renal cell carcinoma announced in january 2018.

the breakthrough therapy designation is an fda program intended to expedite development and review of medicines for serious or life-threatening conditions. in order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial improvement over currently available therapy on at least one clinically significant endpoint. the benefits of this breakthrough therapy designation include more intensive guidance on an efficient clinical development program, access to senior fda managers and experienced fda staff to help accelerate review time, as well as eligibility for rolling review and potentially priority review.

this breakthrough therapy designation was based on interim results of the ec cohort in study 111/keynote-146, which were presented in june 2018 at the 54th american society of clinical oncology (asco) annual meeting.1,2 study 111/keynote-146 is a multi-center, open-label, single-arm phase 1b/2 basket trial evaluating the efficacy and safety of lenvima in combination with keytruda in patients with selected solid tumors.

“this second breakthrough therapy designation for the lenvima/keytruda combination represents another step forward in our collaboration with eisai and supports the continued evaluation of this combination in more than 11 types of cancer,” said dr. roy baynes, senior vice president and head of global clinical development, chief medical officer, merck research laboratories. “we will continue to work closely with eisai to build on the robust data for the lenvima/keytruda combination in advanced endometrial carcinoma in an effort to offer a new option for these patients and potentially help address a critical unmet need.”

“we designed study 111 to learn as much as we could about the lenvima/keytruda combination as efficiently as possible, driven by a sense of urgency to bring forward a potential new treatment option for patients in need,” said dr. takashi owa, vice president and chief medicine creation officer, oncology business group, eisai. “we are encouraged by the continued activity seen in patients with endometrial carcinoma, and the latest breakthrough therapy designation for lenvima and keytruda has strengthened our commitment, as part of our human health caremission, to expedite the path to ultimately benefitting patients living with endometrial carcinoma as quickly as possible.”

 

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

 

about study 111/keynote-146
study 111/keynote-146 is a multicenter, open-label, single-arm phase 1b/2 basket trial evaluating the combination of lenvima (20 mg/day) with keytruda (200 mg intravenously every three weeks) in patients with selected solid tumors (renal cell carcinoma, ec, non-small cell lung cancer, urothelial cancer, squamous cell head and neck cancer, and melanoma). patients were not preselected based on msi or pd-l1 tumor biomarker status. the primary endpoint of the phase 1b study was to determine the maximum tolerated dose of lenvima and keytruda in combination. the primary endpoint of the phase 2 portion is investigator-assessed objective response rate (orr) at week 24 based on immune-related recist (irrecist). the secondary efficacy endpoints included orr, progression-free survival and duration of response for patients with complete or partial responses. fifty-three patients with previously treated, metastatic ec were evaluated in the ec cohort. currently, the phase 2 part is ongoing as an ec cohort expansion. this study is being conducted under an existing strategic collaboration between the two companies.

a randomized, international, two-arm phase 3 study in recurrent ec is underway (study 309/keynote-775; nct03517449; please visit  for more information).

about endometrial carcinoma

endometrial cancer begins in the inner lining of the uterus (endometrium), and nearly all cancers of the uterus are endometrial carcinomas.3 in 2018, it is estimated there will be approximately 63,230 new cases of uterine cancer, and there will be approximately 11,350 deaths from uterine cancer (with the figures for endometrial cancer being slightly lower than this combined estimate).4 stages of endometrial cancer range from stage 1 through 4.5 the five-year survival rate for women diagnosed with stage 1a endometrial cancer is 88% and drops to 15% for those diagnosed with stage 4b.

 

about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration
in march 2018, eisai and merck & co., inc. kenilworth n.j., u.s.a., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will develop and commercialize lenvima jointly, both as monotherapy and in combination with merck & co., inc. kenilworth n.j., u.s.a.’s anti-pd-1 therapy keytruda. in addition to ongoing clinical studies of the combination, the companies will jointly initiate new clinical studies evaluating the combination to support 11 potential indications in six types of cancer (bladder cancer, endometrial cancer, head and neck cancer, hepatocellular carcinoma, melanoma and non-small cell lung cancer), as well as a basket trial targeting six additional cancer types. the combination of lenvima and keytruda is investigational. the efficacy and safety of this combination has not been established. the lenvima/keytruda combination is not approved in any cancer types today.

 

about lenvima® (lenvatinib mesylate
lenvima, discovered and developed in-house by eisai, is an orally administered receptor tyrosine kinase (rtk) inhibitor with a novel binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors (vegfr1, vegfr2 and vegfr3) and fibroblast growth factor (fgf) receptors (fgfr1, fgfr2, fgfr3 and fgfr4) in addition to other proangiogenic and oncogenic pathway-related rtks (including the platelet-derived growth factor (pdgf) receptor pdgfrα; kit; and ret) involved in tumor proliferation.

currently, eisai has obtained approval for lenvima as a treatment for refractory thyroid cancer in over 50 countries, including the united states, japan, and in europe. additionally, eisai has obtained approval for the agent in combination with everolimus as a treatment for renal cell carcinoma (second-line) in over 40 countries, including the united states and in europe. in europe, the agent was launched under the brand name kisplyx® for renal cell carcinoma.

furthermore, lenvima is approved in japan for use in the treatment of unresectable hepatocellular carcinoma. eisai has submitted applications for an indication covering hepatocellular carcinoma in the united states and europe (july 2017), mainland china (october 2017) as well as chinese taiwan (december 2017).

 

about keytruda® (pembrolizumab) 
keytruda is an anti-pd-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. keytruda is a humanized monoclonal antibody that blocks the interaction between pd-1 and its ligands, pd-l1 and pd-l2, thereby activating t lymphocytes which may affect both tumor cells and healthy cells.

 

about eisai co., ltd.
eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including oncology and neurology.

as a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

for more information about eisai co., ltd., please visit .

 

about merck & co., inc., kenilworth, n.j., u.s.a.
for more than a century, merck & co., inc., kenilworth, n.j., u.s.a., a leading global biopharmaceutical company known as msd outside of the united states and canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. we also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. today, merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, alzheimer’s disease and infectious diseases including hiv and ebola. for more information, visit .

 

forward-looking statement of merck & co., inc., kenilworth, n.j., usa
this news release of merck & co., inc., kenilworth, n.j., usa (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the u.s. private securities litigation reform act of 1995. these statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. if underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the united states and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

the company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 annual report on form 10-k and the company’s other filings with the securities and exchange commission (sec) available at the sec’s internet site ().

 

  1. makker v, et al. lenvatinib pembrolizumab in patients with advanced endometrial cancer: update results. asco meetingabstract, 2018; #5596
    2. makker v, et al. biomarker results and preclinical rationale for combination lenvatinib and pembrolizumab in advancedendometrial carcinoma. asco meeting abstract, 2018; #5597
    3. american cancer society. what is endometrial cancer. .
    4. american cancer society. key statistics for endometrial cancer. .
    5. american cancer society. endometrial cancer stages..
    6. american cancer society. endometrial cancer survival rates, by stage. .

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib) (headquarters: cambridge, massachusetts, united states, ceo: michel vounatsos, “biogen”) announced detailed results from the phase ii study (study 201) with ban2401, an anti-amyloid beta (aβ) protofibril antibody, in 856 patients with early alzheimer‘s disease as part of session dt-01 “recent developments in therapeutics (presentation number: dt-01-07) at the alzheimer’s association international conference (aaic) 2018 being held in chicago, illinois, united states on july 25. this abstract was accepted for late breaking oral presentation at aaic.

study 201 (clinicaltrials.gov identifier nct01767311) is a placebo-controlled, double-blind, parallel-group, randomized phase ii clinical study in 856 patients with mild cognitive impairment (mci) due to alzheimer’s disease or mild alzheimer‘s dementia (collectively known as early alzheimer‘s disease) with confirmed amyloid pathology in the brain. patients were randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo. this study used a bayesian adaptive randomization design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses.

the study assessed changes from baseline to 18 months in biomarkers measuring the underlying disease pathophysiology, including changes in amyloid accumulated in the brain as measured by amyloid pet (positron emission tomography). the clinical endpoints of alzheimer’s disease composite score (adcoms), alzheimer‘s disease assessment scale-cognitive subscale (adas-cog) and clinical dementia rating sum of boxes (cdr-sb)  were also assessed from baseline to 18 months of treatment.

through bayesian interim analyses, the highest doses of 10 mg/kg monthly and 10 mg/kg biweekly were determined to be the treatment dosages with higher efficacy early in the trial, and as a result, the proportion of patients allocated to these treatment arms was greater (placebo: 247 patients, 2.5 mg/kg biweekly: 52 patients, 5 mg/kg monthly: 51 patients, 5 mg/kg biweekly: 92 patients, 10 mg/kg monthly: 253 patients, 10 mg/kg biweekly: 161 patients). following a regulatory request (outside of the united states) in july 2014, the allocation of apoe4 carriers to the 10 mg/kg biweekly treatment arm was restricted, resulting in fewer apoe4 carriers  in this arm and more patients being allocated to the 10 mg/kg monthly treatment arm.

ban2401 demonstrated a dose-dependent reduction in amyloid plaques as measured by amyloid pet, and this reduction was statistically significant at all doses. at the highest dose of ban2401 (10 mg/kg biweekly), an analysis of amyloid accumulated in the brain using standardized pet as measured on the centiloid scale showed an observed mean at baseline of 74.5 and at 18 months of 5.5. using a mixed-effects model with repeated measures (mmrm), the mean reduction in amyloid load was 70 units, which was statistically significant (p<0.0001). in amyloid pet image visual read, ban2401 demonstrated a dose dependent conversion from amyloid positive to negative, and at the highest dose, 81% of patients converted from amyloid positive to negative at 18 months (p<0.0001).

conventional statistical methods on predefined clinical endpoints at the 18 month final efficacy time point confirmed a dose-dependent slowing in cognitive decline from baseline on adcoms. the highest treatment dose of 10 mg/kg biweekly demonstrated a statistically significant slowing of clinical decline of 30% compared to placebo at 18 months (p=0.034). a statistically significant slowing of decline on adcoms was observed as early as 6 months (p<0.05) as well as at 12 months (p<0.05). dose-dependent slowing in cognitive decline from baseline on adas-cog was also observed for ban2401, with the highest treatment dose of ban2401 demonstrating a significant slowing of clinical decline compared to placebo at 18 months (47% slower decline, p=0.017). furthermore, dose-dependent slowing in cognitive decline from baseline on cdr-sb was observed, surpassing the pre-specified difference of 25% over the duration of the study. at 18 months, slowing of clinical decline for the highest treatment dose of ban2401 compared to placebo on cdr-sb was 26%. the rate of clinical decline for the placebo group was consistent with the results of research by the alzheimer’s disease neuroimaging initiative (adni) in the united states.

in a bayesian analysis of adcoms at 12 months, the estimated probability that the highest dose of ban2401 slows clinical decline more than placebo was 98%. while the criteria for early success at 12 months was pre-specified as an 80% or higher estimated probability of demonstrating a clinically significant difference (a 25% or greater slowing in clinical decline) from baseline compared to placebo, the actual probability for this criteria was 64% according to bayesian analysis.

a dose-dependent increase in aβ levels in cerebrospinal fluid (csf) in patients on ban2401 (highest dose at 18 months: p<0.0001) was observed. combined analysis of patients receiving ban2401 at 10 mg/kg (either monthly or biweekly) demonstrated a statistically significant reduction in total tau over time compared to placebo (p<0.05).

ban2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration.  the incidence rate of treatment-related adverse events was 26.5% for the placebo arm, 53.4% for the 10 mg/kg monthly treatment arm and 47.2% for the 10 mg/kg biweekly treatment arm. the most common treatment emergent adverse events were amyloid related imaging abnormalities (aria) and infusion-related reactions. incidence of aria-e (edema) was 9.9% at the highest treatment dose, and not more than 10% in any of the treatment arms. incidence of aria-e in apoe4 carriers was 14.6% at the highest dose. per protocol, all patients presenting with aria-e on mri were discontinued in the study. the incidence rate of serious adverse events was 17.6% for the placebo arm, 12.3% for the 10 mg/kg monthly treatment arm and 15.5% for the 10 mg/kg biweekly arm.

this release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. there is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

biogen safe harbor statement

this press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the private securities litigation reform act of 1995 about results from the phase ii study of ban2401; the potential clinical effects of ban2401; the potential benefits, safety, and efficacy of ban2401 and therapies for other neurological diseases; the clinical development program for ban2401; risks and uncertainties associated with drug development and commercialization; the timing and status of current and future regulatory filings; biogen‘s strategy and plans; the anticipated benefits and potential of biogen’s collaboration arrangements with eisai; and the potential of biogen‘s commercial business and pipeline programs, including ban2401, elenbecestat, and aducanumab. these forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” and other words and terms of similar meaning. drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. you should not place undue reliance on these statements or scientific data presented.

these statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, unexpected concerns that may arise from additional data, analysis, or results obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of biogen’s drug candidates, including ban2401, elenbecestat, and/or aducanumab; the occurrence of adverse safety events; risks of unexpected costs or delays; the risks of other unexpected hurdles; uncertainty of success in the development and potential commercialization of ban2401, elenbecestat, and/or aducanumab, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce biogen‘s data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges; uncertainty as to whether the anticipated benefits and potential of biogen’s collaboration arrangement with eisai can be achieved; product liability claims; and third party collaboration risks.  the foregoing sets forth many, but not all, of the factors that could cause actual results to differ from biogen‘s expectations in any forward-looking statement. investors should consider this cautionary statement, as well as the risk factors identified in biogen‘s most recent annual or quarterly report and in other reports biogen has filed with the u.s. securities and exchange commission. these statements are based on biogen’s current beliefs and expectations and speak only as of the date of this press release.  biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

media inquiries

eisai co., ltd. biogen inc.
 

public relations department
81-(0)3-3817-5120

eisai inc.
patricia_councill@eisai.com
1-201-746-2139

 

public affairs
1-781-464-3260
public.affairs@biogen.com

  1. about ban2401

ban2401 is a humanized monoclonal antibody for alzheimer’s disease that is the result of a strategic research alliance between eisai and bioarctic. ban2401 selectively binds to neutralize and eliminate soluble, toxic aβ aggregates that are thought to contribute to the neurodegenerative process in alzheimer‘s disease. as such, ban2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. eisai obtained the global rights to study, develop, manufacture and market ban2401 for the treatment of alzheimer’s disease pursuant to an agreement concluded with bioarctic in december 2007. in march 2014, eisai and biogen entered into a joint development and commercialization agreement for ban2401 and the parties amended that agreement in october 2017.

  1. about study 201

study 201 is a placebo-controlled, double-blind, parallel-group, randomized phase ii clinical study in 856 patients with mild cognitive impairment (mci) due to alzheimer‘s disease or mild alzheimer’s dementia (collectively known as early alzheimer‘s disease) with confirmed amyloid pathology in the brain. this study used bayesian adaptive randomization design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. the study design included five dose regimens and placebo, and considered the efficacy of ban2401 as an exploratory endpoint as well as dose responsiveness through 16 interim analyses that assessed potential for early success, an analysis based on adcoms at 12 months, and a comprehensive final analysis at 18 months. patients who received treatment with ban2401 were randomized to five dose regimens, 2.5 mg/kg biweekly (52 patients), 5 mg/kg monthly (51 patients), 5 mg/kg biweekly (92 patients), 10 mg/kg monthly (253 patients), or and 10 mg/kg biweekly (161 patients). biomarker endpoints included changes in aβ accumulated in the brain as measured by amyloid pet (positron emission tomography) as well as in cerebrospinal fluid (csf), while adcoms (alzheimer’s disease composite score), clinical dementia rating sum of boxes (cdr-sb) and alzheimer‘s disease assessment scale-cognitive subscale (adas-cog) were measured as efficacy endpoints (clinical).

  1. about adcoms

developed by eisai, adcoms (ad composite score) combines items from the adas-cog (alzheimer’s disease assessment scale-cognitive subscale), cdr-sb (clinical dementia rating sum of boxes) and the mmse (mini-mental state examination) scales to enable a sensitive detection of changes in clinical functions of early alzheimer‘s disease symptoms and changes in memory. this study 201 utilizes adcoms as its key endpoint for assessing clinical symptoms.

  1. about amyloid pet imaging

amyloid pet (positron emission tomography) imaging is a diagnostic method that enables the visualization of amyloid plaque present in the brain as well as the quantitative evaluation of amyloid plaque distribution and accumulation in the brain via administration of a minute amount of pet tracer, which specifically binds to amyloid plaque and marks it with positron. amyloid pet imaging enables the assessment of pathology change and assistance of diagnosis of patients with alzheimer’s-disease including mci, and estimates the clinical effect of disease modifiers based on the amyloid hypothesis. suvr (standard uptake value ratio) calculates the ratio of strength of accumulation of pet tracer in a region of interest in the brain to an area of the brain (reference region) which shows low and stable accumulation of pet tracer. these suvr values can be used to quantitatively compare and evaluate the accumulation of amyloid. when integrating and assessing biomarkers of the change in aβ accumulation measured by different tracers, it is necessary to compensate for the differences in measured values between the pet tracers. this has led to the development of a 100-point scale by the gaain centiloid project, termed “centiloid,” which is an average value of zero in “high certainty” amyloid negative subjects and an average of 100 in “typical” alzheimer‘s disease (ad) patients (klunk et al., 2015). in this study, this centiloid scale was used to standardize suvr measurement values to evaluate the decrease in amyloid burden.

  1. about the joint development agreement between eisai and biogen for alzheimer’s disease

eisai and biogen are widely collaborating on the joint development and commercialization of alzheimer’s disease treatments. eisai serves as the lead in the co-development of elenbecestat, a bace inhibitor, and ban2401, an anti-amyloid beta (aβ) protofibril antibody, while biogen serves as the lead for co-development of aducanumab, biogen‘s investigational anti-amyloid beta (aβ) antibody for patients with alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. if approved, the companies will also co-promote the products in major markets, such as the united states, the european union and japan.

as to ban2401 and elenbecestat, both companies will equally split overall costs, including research and development expenses. eisai will book all sales for elenbecestat and ban2401 following marketing approval and launch, and profits will be equally shared between the companies.

  1. about eisai co., ltd.

eisai co., ltd. is a leading global research and development-based pharmaceutical company headquartered in japan. we define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. with approximately 10,000 employees working across our global network of r&d facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of neurology and oncology.

leveraging the experience gained from the development and marketing of aricept®, a treatment for alzheimer‘s disease and dementia with lewy bodies, eisai has been working to establish a social environment that involves patients in each community in cooperation with various stakeholders including the government, healthcare professionals and care workers, and is estimated to have held over ten thousand dementia awareness events worldwide. as a pioneer in the field of dementia treatment, eisai is striving to not only develop next generation treatments but also to develop diagnosis methods and provide solutions.

for more information about eisai co., ltd., please visit .

  1. about biogen

at biogen, our mission is clear: we are pioneers in neuroscience. biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. one of the world’s first global biotechnology companies, biogen was founded in 1978 by charles weissman, heinz schaller, kenneth murray and nobel prize winners walter gilbert and phillip sharp, and today has the leading portfolio of medicines to treat multiple sclerosis; has introduced the first and only approved treatment for spinal muscular atrophy; and is focused on advancing neuroscience research programs in alzheimer‘s disease and dementia, neuroimmunology, movement disorders, neuromuscular disorders, pain, ophthalmology, neuropsychiatry, and acute neurology. biogen also manufactures and commercializes biosimilars of advanced biologics.

to learn more, please visit .

  1. about bioarctic abbioarctic ab (publ) is a swedish research-based biopharma company focusing on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as alzheimer’s disease and parkinson‘s disease. the company also develops a potential treatment for complete spinal cord injury. bioarctic focuses on innovative treatments in areas with high unmet medical needs. the company was founded in 2003 based on innovative research from uppsala university, sweden. collaborations with universities are of great importance to the company together with our strategically important global partners in the alzheimer (eisai) and parkinson (abbvie) projects. the project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. bioarctic’s b-share is listed on nasdaq stockholm mid cap (sto:bioa b).
thirteen presentations to be given including on phase ii study results of ban2401 and elenbecestat

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announces today that a total of 13 presentations highlighting results from a phase ii clinical study (study 201) of the anti-amyloid beta (aβ) protofibril antibody ban2401 and a phase ii clinical study (study 202) of the oral bace (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: e2609) in addition to the latest data on its alzheimer‘s disease / dementia pipeline including anti-aβ antibody aducanumab, will be given at the alzheimer’s association international conference (aaic) 2018, in chicago from july 22 to 26, 2018. ban2401, elenbecestat and aducanumab are being jointly developed by eisai and biogen inc. (headquarters: cambridge, massachusetts, united states, “biogen”).

as previously announced on july 10, an oral presentation will be given on the results of study 201 (clinicaltrials.gov identifier: nct01767311) on ban2401 in early alzheimer‘s disease (mild cognitive impairment due to alzheimer’s disease or mild alzheimer‘s disease dementia) as a late-breaking abstract. eisai and biogen announced on july 6 that study 201 achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in alzheimer’s disease composite score (adcoms) and on reduction of amyloid accumulated in the brain as measured using amyloid-pet (positron emission tomography). this study was first late-stage study data successfully demonstrating potential disease-modifying effects on both clinical function and amyloid beta accumulation in the brain. the most commonly reported adverse events were infusion reactions and amyloid related imaging abnormalities (aria).

the ban2401 study 201 data presentation will be webcast live. to access the live webcasts, please visit the investors section of eisai‘s website on the day at .

for elenbecestat, a poster presentation will similarly be given as a late-breaking abstract on the results of study 202 (clinicaltrials.gov identifier nct02322021) on elenbecestat in patients with mild cognitive impairment and mild-to-moderate dementia due to alzheimer’s disease. on june 6, 2018, it was announced that from the positive topline results of study 202 at 18 months, elenbecestat demonstrated acceptable safety and tolerability (primary endpoint), as well as a statistically significant effect on aβ levels in the brain as measured by amyloid-pet (exploratory endpoint). a numerical slowing of decline in functional clinical scales of a potentially clinically important difference was also observed, although this effect was not statistically significant. the six most common adverse events observed were contact dermatitis, upper respiratory infection, headache, diarrhea, fall, and dermatitis. elenbecestat is currently being investigated in two ongoing phase iii clinical studies (mission ad1/2) in patients with early alzheimer‘s disease.

in addition, regarding aducanumab, an oral presentation and a poster presentation will be made on the long-term administration of aducanumab from a phase ib clinical study being conducted by biogen. currently, eisai and biogen are advancing two phase iii clinical studies (engage/emerge) on aducanumab.

furthermore, presentations will also be made on the novel phosphodiesterase-9 inhibitor e2027, including an oral presentation on the results of a phase i clinical study as well as poster presentations on non-clinical studies. discovered and developed solely by eisai, e2027 is currently being investigated in a phase ii/iii clinical study as a potential treatment for dementia with lewy bodies.

regarding the investigational sleep-wake agent lemborexant, baseline data from a phase ii clinical study (study 202) in patients with irregular sleep-wake rhythm disorder (iswrd) and alzheimer’s disease will also be presented at aaic 2018. discovered by eisai, lemborexant has been jointly developed with purdue pharma l.p. (headquarters: connecticut, united states, “purdue pharma”) since august 2015.

eisai is aiming to realize prevention and cure of dementia through a holistic approach to dementia drug discovery research based on a foundation of over 30 years of experience of drug discovery activities in the area of alzheimer‘s disease / dementia. eisai is striving to create innovative medicines as soon as possible in order to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.

presentations at aaic2018:

please note aaic embargo policy: all materials submitted to aaic are embargoed for publication and broadcast until the officially scheduled date and time of presentation.

 

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

 

[notes to editors]

1. about ban2401
ban2401 is a humanized monoclonal antibody for alzheimer’s disease that is the result of a strategic research alliance between eisai and bioarctic. ban2401 selectively binds to neutralize and eliminate soluble, toxic aβ aggregates that are thought to contribute to the neurodegenerative process in alzheimer‘s disease. as such, ban2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease. eisai obtained the global rights to study, develop, manufacture and market ban2401 for the treatment of alzheimer’s disease pursuant to an agreement concluded with bioarctic in december 2007.

2. about elenbecestat (generic name, development code: e2609)

elenbecestat is an oral bace (beta amyloid cleaving enzyme) inhibitor currently being investigated in phase ⅲ clinical studies for alzheimer‘s disease discovered by eisai. by inhibiting bace, a key enzyme in the production of aβ peptides, elenbecestat reduces aβ production, which is thought to lead to a reduction in amyloid plaque formations caused by the aggregation of toxic oligomers and protofibrils in the brain. currently, two global phase iii clinical studies (mission ad1/2) of elenbecestat in early alzheimer’s disease including mild cognitive impairment (mci) due to ad/prodromal ad and the early stages of mild ad are underway. in addition, the u.s. food and drug administration (fda) has granted fast track designation for the development of elenbecestat, a process to facilitate development and expedite review by fda for drugs deemed as having potential to treat serious conditions and addressing unmet medical needs.

3. about aducanumab (biib037)

aducanumab is an investigational compound being developed for the treatment of alzheimer‘s disease. aducanumab is a human recombinant monoclonal antibody (mab) derived from a de-identified library of b cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using neurimmune’s technology platform called reverse translational medicine (rtm). biogen licensed aducanumab from neurimmune under a collaborative development and license agreement.
aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of alzheimer‘s disease patients. based on pre-clinical and phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels.
in august 2016 aducanumab was accepted into the european medicines agency’s prime program. in september 2016 the u.s. food and drug administration accepted aducanumab into its fast track program and in april 2017 aducanumab was accepted into the japanese ministry of health, labour and welfare‘s (mhlw) sakigake designation system.
as of october 2017, biogen and eisai entered into a global collaboration agreement to jointly develop and commercialize aducanumab.

4. about the joint development agreement between eisai and biogen for alzheimer’s disease
eisai and biogen are widely collaborating on the joint development and commercialization of alzheimer’s disease treatments. eisai serves as the lead in the co-development of elenbecestat, a bace inhibitor, and ban2401, an anti-aβ protofibril antibody, while biogen serves as the lead for co-development of aducanumab, biogen‘s investigational anti-aβ antibody for patients with alzheimer’s disease, and the companies plan to pursue marketing authorizations for the three compounds worldwide. if approved, the companies will also co-promote the products in major markets, such as the united states, the european union and japan.

5. about e2027
discovered by eisai, e2027 is a selective phosphodiesterase (pde) 9 inhibitor. inhibiting pde9 reduces the degradation of cyclic gmp which is critical to signal transmission among cells. by helping maintain the concentration of cyclic gmp in the brain, e2027 has the potential to be a new treatment for dementia with lewy bodies.

6. about lemborexant (generic name, development code: e2006)
lemborexant, a dual orexin receptor antagonist, is eisai‘s in-house discovered and developed small molecule compound that inhibits orexin neurotransmission by binding competitively to the two subtypes of orexin receptors (orexin receptor 1 and 2). in individuals with sleep disorders, it is possible that the orexin system that regulates sleep and wakefulness is not functioning normally. during normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission. therefore, eisai and purdue have been developing lemborexant as a treatment for multiple sleep disorders.
in addition, a phase ii clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder (iswrd) and mild to moderate alzheimer’s dementia is underway.

tokyo, june 21, 2018 – abbvie gk (headquarters: tokyo, president: james feliciano, “abbvie”) and eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that humira® for subcutaneous injection 20 mg syringe 0.2 ml, a new pediatric formulation of humira ® (generic name: adalimumab [recombinant], “humira”), a fully human anti-tnf-α monoclonal antibody formulation, has been launched today after being listed in the national health insurance reimbursement price list on june 15.

humira has an indication of “treatment of polyarticular juvenile idiopathic arthritis (jia)” that develops in pediatric patients.
humira® for subcutaneous injection 20 mg syringe 0.2 ml is a higher-concentration formulation, which is produced by removing some excipients, and has the same active ingredient as that of, humira® for subcutaneous injection 20 mg syringe 0.4 ml that has been commercially available since september 2011. it has also the same formulation and concentration as those of humira® for subcutaneous injection 40 mg syringe 0.4 ml and humira® for subcutaneous injection 80 mg syringe 0.8 ml that were launched in november 2016. outside of japan, two phase 2, randomized, single- blind, two-period crossover studies were conducted with humira® for subcutaneous injection 40 mg syringe 0.4 ml, to compare injected site-related pain between this higher-concentration formulation and the former formulation, using a visual analog scale (vas). patients with rheumatoid arthritis showed a significantly lower vas pain score after injection of the higher-concentration formulation, as compared with the former formulation.

jia is an autoimmune disease that generally affects children under 16 years of age and is an umbrella term used to define a group of conditions occurring among children that include some form of chronic arthritis. in japan, jia affects 10-15 persons per 100,000 children, and is designated as an incurable disease by the ministry of health, labour and welfare. polyarticular jia is a type of jia which involves five or more joints. symptoms include painful and swollen joints, limping, morning stiffness, decreased activity and the reluctance to use an arm or leg.

abbvie and eisai will continue to promote and provide information on the proper use of humira® while making further contributions to improve the quality of life of patients including children.


grand launching campaign

june 20, 2018, eisai china region held a grand launching campaign for its rk-1000 model a, a new generation of icg clearance meter, in jw marriott hotel shanghai. the staff from merchants department and partners in china region got together witnessing the company’s first clinical diagnosis device hitting the market. the device will be promoted together with indocyanine green for injection, a product of eisai (liaoning) pharmaceutical co. ltd. this is an attempt of eisai china to expend its business to a new field, which will enrich its product line in the treatment of hepatic diseases such as hepatic carcinoma, hepatic injury, hepatic encephalopathy, and etc., greatly improve its market competitiveness and provide better solution of diagnosis and treatment for both doctors and patients in china.


mr. dali wang and mr. ningbo cai introduced the company and the product

eisai china always gives first thought to patients and their families, and contributes to increasing the benefits provided to them. 
mr. dali wang, director of merchants department, indicated in his speech, “as a multi-national company focusing on the r&d of pharmaceutical products, eisai always gives first thought to patients and their families, and contributes to increasing the benefits provided to them; and as a japanese pharmaceutical company in china, we always adhere to our company philosophy, “human health care (hhc)”. in december 2015, through the full acquisition of a local pharmaceutical enterprise, eisai china established eisai (liaoning) to enter the generic pharmaceutical business to expand its existing business focused on new medicines, in a bid to adapt to chinese market. by providing a stable supply of high quality generic pharmaceuticals with reasonable price, eisai china is able to fulfill an even wider range of medical needs in china. this is the mission of eisai, in accordance with the company’s hhc philosophy. the new business in medical devices bears the same philosophy and spirit. we look forward to working together with our partners to better serve medical practitioners and benefit more chinese patients.


grand launching campaign

liver reserve function testing is the technical basis of precise liver resection of the hepatobiliary surgery.
yangqing huang, head of shanghai public health clinical center, introduced the importance of the liver reserve function testing to hepatobiliary surgeons. huang indicated that the liver reserve function testing is the technical basis for the precise liver resection in the hepatobiliary surgery, and icg clearance test, currently a widely used quantitative assay method of the liver reserve function, is regarded as the standard evaluation index in a large number of guiding documents in both china and overseas. preoperative icg clearance test helps assess the safe range of liver resection and reduce the incidence rate of postoperative liver failure and death, while the postoperative icg clearance test can predict the incidence rate of liver dysfunction and severe complications.

in the campaign, the sponsor introduced in detail the clinically applicable departments of liver reserve function testing and the clinical benefits it brings, explained the guide documents, marketing strategies and gave product demonstrations.

liver reserve function testing is applicable to multiple departments including hepatobiliary surgery, liver transplantation, hepatology, intervention, and etc. in the hepatobiliary surgery department it can be used to assess the safe range of liver resection, to reduce the risks of postoperative liver failure and death, and to predict the incidence rate of postoperative liver dysfunction. in the liver transplant department it can be used to evaluate the quality of the donor liver and the success rate of the operation. in the hepatology department it is manly used in the early diagnosis of liver injury and prognosis evaluation of cirrhosis. in the interventional department it can be used to guide the interventional operation plan and to evaluate the prognosis of operation.


rk-1000 model a, a new generation of icg clearance meter

the new generation icg clearance tester rk-1000 model a is a professional liver reserve function testing device with exclusive dynamic calibration technology and continuous spectrophotometric method bringing a lot of advantages such as dynamic, real-time, accurate, convenient test and so on. this device will be sure to bring more benefits to the broad masses of patients and clinical practitioners.

● first presentation of lenvima/keytruda data in patients with unresectable hepatocellular carcinoma (hcc), which aims to be the first systemic combination of a tki and immunotherapy for these patients, as well as squamous cell carcinoma of the head and neck (scchn)
● updated results show antitumor activity with a consistent safety profile in advanced renal cell carcinoma (rcc) and advanced endometrial carcinoma (ec)
● the lenvima/keytruda combination was recently granted u.s. food and drug administration (fda) breakthrough therapy designation for advanced rcc
● phase iii trials underway in advanced rcc (nct02811861) and advanced ec (nct03517449)

tokyo jun 4, 2018 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., kenilworth, n.j., u.s.a. (known as msd outside the united states and canada), announced today that results from presentations of new data and analyses of lenvima® (lenvatinib), an orally available kinase inhibitor discovered by eisai, in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy, keytruda® (pembrolizumab), in four different tumor types: unresectable hepatocellular carcinoma (hcc) (abstract #4076), squamous cell carcinoma of the head and neck (scchn) (abstract #6016), advanced renal cell carcinoma (rcc) (abstract #4560), and advanced endometrial carcinoma (ec) (abstract #5596 and abstract #5597). the data are included in presentations at the 54th annual meeting of the american society of clinical oncology (asco) in chicago from june 1-5. lenvima and keytruda are not approved for use in combination in any cancer types today.

“the data we have observed in the combination studies of lenvima plus keytruda have fueled our commitment to help meet the diverse health care needs of patients living with cancer through clinical studies and research in specific tumor types that are notoriously difficult to treat and continue to have a significant need for new therapeutic options,” said alton kremer, md, phd, chief clinical officer and chief medical officer, oncology business group at eisai. “we are pleased to share the activity observed in clinical studies of the lenvima plus keytruda combination, as well as rationale for the combination in advanced endometrial carcinoma through translational research.”

“with these data at asco, we are continuing to see encouraging overall response rates, as well as a safety profile that supports the scientific rationale of adding lenvima to keytruda,” said dr. roy baynes, senior vice president and head of global clinical development, chief medical officer, merck & co., inc., kenilworth, n.j., u.s.a. “these findings add to the growing body of evidence showing the potential of this combination regimen across a number of tumor types and underscore the strategy behind our collaboration with eisai.”

this release discusses investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced the u.s. food and drug administration (fda) has accepted for review the supplemental new drug application (snda) for eisai‘s antiepileptic drug (aed) fycompa®(perampanel). this application seeks approval for an indication expansion to cover pediatric patients with partial onset seizures and primary generalized tonic-clonic seizures (pgtc) seizures. furthermore, eisai has included a study in this snda requested by the fda in a pediatric written request, and therefore fda has designated this application for priority review, which means the review period will be six months. the fda has assigned a prescription drug user fee act (pdufa) action date of september 28, 2018.

this snda was based on the interim results of a phase iii clinical study (study 311) as well as the results from a phase ii clinical study (study 232). both studies suggested the safety and efficacy of adjunctive treatment with fycompa was similar between pediatric patients and patients 12 years of age and older. the application aims to expand the indication for fycompa in the united states, which currently covers monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older, to the age range down to 2 years of age. based on data accumulated to date, the snda also seeks to expand the pediatric indication to include children 2 years of age and older for the adjunctive treatment of pgtc seizures.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. it is a highly selective, noncompetitive ampa receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic ampa receptors. fycompa has been approved in countries around the world including the united states as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) as well as pgtc seizures in patients with epilepsy 12 years of age and older. in the united states, fycompa has also been approved as monotherapy for the treatment of partial-onset seizures (with or without secondarily generalized seizures). a new oral suspension formulation has also been approved and is available in the united states.

epilepsy affects approximately 2.9 million people in the united states, 1 million people in japan, 6 million people in europe, and approximately 60 million people worldwide. while epilepsy affects people of all ages, incidence is particularly high among children and the elderly. as approximately 30% of patients with epilepsy are unable to control their seizures with currently available aeds,1 this is a disease with significant unmet medical need.

eisai considers neurology including epilepsy, a therapeutic area of focus, and strives to deliver fycompa throughout the world in pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to further contribute to addressing 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]

about study 311
study 311 is a global (united states, europe, japan, asia) multicenter, open-label, single-arm trial with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of fycompa oral suspension when administered as an adjunctive therapy in approximately 160 pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
following the 23 week treatment phase in which patients were titrated to receive 2 to 16 mg of fycompa orally once-daily, long term safety was assessed during an extension phase. in japan, pediatric patients with partial-onset seizures were titrated to receive 2 to 12 mg of fycompa orally once-daily. the adverse events (≥10% in the perampanel arms) observed in study 311 at the time of interim analysis were somnolence, nasopharyngitis, dizziness, and irritability.

about study 232
study 232 was a global (united states, europe), multicenter, open-label, long-term administration clinical study in approximately 63 pediatric patients with epilepsy (ages 2 to less than 12). the study evaluated the pharmacokinetics, safety, tolerability and efficacy of fycompa oral suspension taken at the same time as other aeds. administration of once-daily fycompa was titrated from 0.015 mg/kg to 0.18 mg/kg, and long-term safety was confirmed after 11 weeks of treatment and an extension phase (41 weeks). the most common adverse events (≥10% in the perampanel arms) observed in study 232 were pyrexia, fatigue, vomiting, irritability, somnolence, dizziness, and upper respiratory tract infection.

1. “the epilepsies and seizures: hope through research. what are the epilepsies?” national institute of neurological disorders and stroke, accessed may 24, 2016, 

on may 29, the china human capital forum 2018 was held in china world hotel beijing, announcing that the human resource team of eisai china won the “best hr teams in greater china” of hroot awards 2018 for their outstanding achievements and contributions in pushing the development and innovation of the corporate, building excellent workplaces and promoting business development. mr. yamada koki, head of pharmaceutical affairs division of eisai china, mr. yu ruilong, director of drug affairs & relationship department of eisai china, and ms. wang li, manager of human resource department of eisai china attended the award ceremony. 


mr. yamada koki accepted the award


china human capital forum, sponsored annually by china’s leading hr media – hroot, is a foremost hr summit in the hr field in china region. it seeks to provide senior executives and hr managers with a communicating platform for sharing high-end, forward-looking management concepts and discussing the up-to-date practices. the forum was inaugurated in 2008 and has been successfully operated for 10 years. it attracted nearly 2,000 participators this time, including senior hr executives from 64 state-owned enterprises, 271 fortune global 500 enterprises, and 359 china top 500 enterprises.


eisai china won the best hr teams in greater china” of hroot award 2018


eisai china‘s hr team always dedicates to promoting the “human health care (hhc)” corporate philosophy and rooting it in the hearts of eisai’s employees. hhc is the soul of the eisai employees and is where the significance of their endeavors lie. a half-day hhc activity is specially included in the new employee training in eisai china to better implement and practice this corporate philosophy instead of just introducing it as a terminology. eisai china recommends that all of its employees spend 1% of their business time each year practicing hhc. what‘s more, the corporate carries out over 300 hhc activities each year such as eisai china cognition school, the serving chopsticks action, the yellow wristband action, eisai china scholarships for medical school students, and etc. 


mr. yamada koki, mr. yu ruilong and ms. wang li

in the internet era, working people study in fragmented time and through mobile applications more than ever. eisai china’s employees, of whom 70% are sales & marketing personnel, work in over 40 cities. for better using the existing resources to provide better learning channels for its employees, eisai china‘s hr department established “eisai library (shu-yuan)” platform in 2016, providing both online and offline learning services. this platform includes a real library, “joyful reading room(yue-xiang-ge)”, for offline reading, and gives online book recommendations, book introductions, sofa talks, live broadcasts and masters’ sharing, and etc., which attracted a maximum of 1,274 person-time interactions. in 2018, the eisai library (shu-yuan) was updated to include a comprehensive learning platform – “cloud library (yun-xue-yuan)”, an online sharing community for independent learning – “eisai courses (wei-ke-tang)”, an independent learning community – “talents fusion (da-ren-hui)”, an offline learning salon – “travel-know class (xing-zhi-tang)”, and the offline library “joyful reading room (yue-xiang-ge)” was expanded to eisai china‘s beijing branch.

in 2015, eisai china’s hr department launched eisai management academy, a talent project accelerating the development of the high-potential supervisors and managers and preparing managerial staff for the business expansion of the corporate. to date, 45% trainees of the current 2 sessions have got promotion. what‘s more, the corporate continuously develops cross-function rotations, overseas rotations and the tutorial system to enrich the vocational developments of its employees. currently, 60% management positions were selected from its internal personnel. the project “eisai management academy” won the “top 10 influential events award” of eisai china in fiscal year 2017, and the “top 20 most popular projects award” of ceibs business online in march, 2018.

eisai china always regards the improvements in employees‘capability as one of its long-term strategies. in a bid to strengthen its staff‘s sense of belonging and enhance the cohesive force in the corporate, eisai china has established “honorary staff awards” for the employees who have served the company for 5, 10, 15 and 20 years separately. by the end of march, 2018, eisai has 23 20-year employees, 71 15-year employees, 182 10-year employees and 542 5-year employees. the corporate regards employees’ability improvements and loyalty as the biggest return and a positive response. in eisai china, you have huge vocational development space, and grow together with the corporate. 

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