news – page 27 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its u.s. subsidiary eisai inc. has launched belviq xr® 20mg tablets, a new once-daily formulation of belviq® (generic name: lorcaserin hydrochloride) for chronic weight management in the united states.

belviq xr is an extended release formulation proven to be slowly absorbed in the body and to last throughout the day. the availability of once-daily belviq xr (20mg) in a single tablet provides patients with another dosing option in addition to the conventional twice-daily belviq (10mg).

approval for twice-daily belviq was obtained in the united states 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 from the u.s. food and drug administration (fda) in 2012 by arena pharmaceuticals, inc. (headquarters: california, united states, president and ceo: amit d. munshi, “arena”), whom eisai and eisai inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride, and was launched in june 2013. once-daily belviq xr was approved with the same indication by the fda in july 2016.

“eisai is committed to efforts in research and development, disease awareness as well as other activities in order to address the diverse needs of to those living with obesity – a chronic, progressive disease that has serious health consequences,” said paul hawthorne, senior vice president, americas neurology business unit, neurology business group, eisai inc. “we are excited to offer patients a once-daily option for chronic weight management that may help them achieve and sustain their weight loss goals.”

through the launch of belviq xr, eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.

simultaneous development of two combination therapies lenvatinib/everolimus and lenvatinib/pembrolizumab

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the initiation of a global phase iii clinical study (study 307, clear study) of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in respective combination regimens with the anticancer agent everolimus and the anti-pd-1 antibody pembrolizumab as a potential first-line treatment for advanced renal cell carcinoma.

the clear (comparison of the efficacy and safety of lenvatinib in combination with everolimus or pembrolizumab versus sunitinib alone in first-line treatment of subjects with advanced renal cell carcinoma) study is a multicenter, randomized, open-label phase iii clinical study to compare the efficacy and safety of lenvatinib/everolimus and lenvatinib/pembrolizumab versus sunitinib alone in first-line treatment in patients with advanced renal cell carcinoma. the primary outcome measure will be progression-free survival.

non-clinical research into the combination of lenvatinib and everolimus suggested synergistic enhancement of antiangiogenic activity and a stronger antitumor effect than either monotherapy in renal cell carcinoma models through the respective inhibition of signaling pathways which facilitate tumor angiogenesis, upstream (vascular endothelial growth factor receptor [vegfr] and fibroblast growth factor receptor [fgfr]) with lenvatinib and downstream (mammalian target of rapamycin [mtor]) with everolimus. furthermore, non-clinical research into the combination of lenvatinib and anti-pd-1 antibody suggested that the combination has a mechanism of action in which lenvatinib enhances the antitumor activity of the anti-pd-1 antibody by reducing immunosuppressive cells.

the number of patients with renal cancer is estimated to be approximately 338,000 worldwide, including approximately 115,000 in europe, 58,000 in the united states and 17,000 in japan. renal cell carcinoma comprises more than 90% of all malignancies of the kidney, and occurs when malignant cells are found 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 renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

currently lenvatinib has been approved in over 45 countries including the united states, japan and in europe as a treatment for refractory thyroid cancer. in may 2016, lenvatinib was approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy by the u.s. food and drug administration in the united states. furthermore, lenvatinib was approved in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy in europe in august 2016.

eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. eisai remains committed to providing further clinical evidence for lenvatinib 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 a series of abstracts highlighting the latest clinical and pre-clinical data on lenvatinib mesylate (selective inhibitor of receptor tyrosine kinases (rtks) with a novel binding mode, product name: lenvima®/kisplyx®, “lenvatinib”) and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: halaven®, “eribulin”) will be presented during the european society for medical oncology (esmo) congress 2016, taking place in copenhagen, denmark, from october 7 – 11.

for lenvatinib, six abstract poster presentations (including health economics and outcome research data) are to be given at the meeting with the main presentations featuring the latest data from a phase ib trial of lenvatinib in combination with the immune checkpoint inhibitor pembrolizumab in patients with selected solid tumors as well as an analysis of the responses in specific metastases following treatment with lenvatinib from the results of the phase iii select study.

for eribulin, an abstract poster presentation on a subgroup analysis in leiomyosarcoma (lms) patients from a phase iii study (study 309) in patients with advanced liposarcoma (lps) and lms is also scheduled to be given at the meeting.

eisai positions oncology as a key franchise area. 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 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 that its european regional headquarters eisai europe ltd. (location: u.k.) has received license from the european commission for anticancer agent kisplyx® ▼ (generic name: lenvatinib mesylate, “lenvatinib”) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (vegf) targeted therapy. following the united states, europe marks the second region where lenvatinib has been licensed for the advanced renal cell carcinoma indication.

this license was based on a phase ii clinical study (study 205) that evaluated the safety and efficacy of lenvatinib in combination with everolimus in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vegf-targeted therapy. from the results of the study, the lenvatinib plus everolimus group (n=51) demonstrated a significant extension in the study′s primary endpoint of progression free survival (pfs) compared to the everolimus alone group (n=50) (median pfs for the lenvatinib plus everolimus group: 14.6 months vs median pfs for the everolimus alone group: 5.5 months; hazard ratio (hr) 0.40 [95% ci: 0.24-0.68], p=0.0005). furthermore, updated median overall survival in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus alone group (hr 0.59 [95% ci: 0.36-0.97]). the most common treatment-emergent adverse events (teaes) reported in the lenvatinib 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 338,000 worldwide, including approximately 115,000 in europe, 58,000 in the united states and 17,000 in japan. 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 renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

in europe, lenvatinib has been designated as an orphan drug for thyroid cancer and is marketed as lenvima® for this indication. in europe, renal cell carcinoma does not meet the criteria for orphan drug designation. accordingly, under european regulations, any licensed medicine that previously received orphan drug designation for an indication and subsequently receives license for a non-orphan indication must be marketed under a different trade name. as such, lenvatinib will be marketed as kisplyx® ▼ in the european union for the indication covering renal cell carcinoma.

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 providing further clinical evidence for lenvatinib 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 been selected for a fourth consecutive year of membership in the dow jones sustainability asia pacific index (djsi asia pacific), the asia pacific version of the dow jones sustainability indices (djsi), which are a family of premier global indices for socially responsible investment (sri).

the djsi family was jointly established between robecosam ag (switzerland) and s&p dow jones indices llc (united states) in 1999 as the first global sri indices in the world and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. this year, the djsi asia pacific has selected 146 companies leading the way in sustainability (68 of which are from japan) from among the region’s top 615 companies. eisai received high scores particularly in categories such as corporate governance, product quality and recall management, human capital development, occupational health and safety as well as strategy to improve access to drugs or products.

in addition to the djsi asia pacific, eisai has been selected for the 15th consecutive year since 2002 as a member of the ftse4good index series, another global benchmark sri index.

the eisai group’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. guided by this philosophy, eisai will continue to develop innovative new drugs and make them available to patients around the world as early as possible to fulfill its social responsibility and secure the trust of stakeholders.

on september 3rd 2016, the peripheral neuropathy forum is successfully held by eisai china inc. in changsha, china.

feng yanhui, pu chuanqiang, liu zhongjun, zhu dalong

on the forum, ms. feng yanhui, general manager of eisai china (holding) co., ltd and eisai china inc., firstly delivered a welcome speech. she said, “welcome to our forum, all my keynote speakers and fellows, honorable gusts and friends, eisai china is committed to promoting the development and progress of the field of neuroscience in china, hoping to get together with the country’s elite, to harvest more cutting-edge academic achievements, and to harvest more profound friendship. at the same time, ms. feng stressed that, we should consider all kinds of patients and their families in different health needs, as our primary task is to meet these needs; in order to meet the different needs of health, eisai china is committed to being a valuable and “human health care” company.

ms. feng delivers her speech.

the forum invited more than 400 experts from home and abroad, including kols, academics and medical doctors, to study and discuss more advanced, more authoritative and professional academic ideas. professor liu zhongjun from the people’s liberation army general hospital, professor zhu dalong from no.3 hospital of peking university and professor pu chuanqiang from nanjing gulou hospital jointly served as chairmen of the main forum, to organize a number of well-known experts to present with multi angles and to discuss various cases of clinical practices with the participants, from the research history and the development of the peripheral neuropathy disciplines, the new progress in diagnosis and treatment of the disease, the sensory neurons: from animal models to the clinical syndrome, the identification to intermittent claudication related diseases, the diagnosis and treatment of diabetic peripheral neuropathy and etc.

main forum photo

at the same time, the forum set up four special sub-seminars, including internal neurology seminar, orthopedics seminar, endocrine seminar and ophthalmic seminar, to carry out the academic speeches discussing and sharing practical experiences in fields such case studies of the peripheral neuropathy, the treatment of spinal degenerative diseases and the surgery strategies, advances in the screening of diabetic peripheral neuropathy, the diabetic neuropathy, the group consultation among the diabetes endocrine, the neurological and the ophthalmic, the guide to the interpretation of glaucoma, the diabetic retinopathy and clinical experiences, and so on.

it is understood that eisai china has opened several activities accordingly, such as, the universal detectives: difficult cases of peripheral neuropathy, the super swordsmen: ddd difficult disease meeting, the eef elite edition: diabetic peripheral neuropathy “big consultation”, the eyeshot precedents: ophthalmic difficult cases sharing, and etc., which have been recognized by medical doctors and highly praised the eisai’s brand, and also those are the best practices of “hhc” (human health care) philosophy and promote the development for the field of neuroscience in china.

for the starry night by van gogh, the bright nebula will always shine brightly in the history of art. for classics, it can cross the river of history, for people to collect and read. just as the field of neuroscience, it has made the immortal classics. eisai always gives the first thought to patients and their families, and to increasing the benefits health care provides. and it guides eisai for the health with the medical researchers, promotes the academic innovation; it is particularly bright on the academic study of the peripheral neuropathy.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it will launch “chocola bb® mouth ulcer repair shot” (third-class otc drug) for mouth ulcers in japan on thursday, august 25. the product is the first oral care spray to be marketed under the chocola bb brand.

mouth ulcer is a general term that refers to any inflammation of the mucous membrane in the mouth. in many cases, it is thought that nutritional imbalances, lifestyle changes and/or stress lead to a decrease in the mucous membrane’s ability to regenerate, allowing bacteria to penetrate the membrane and cause an ulcer to form.

chocola bb mouth ulcer repair shot is a medicated spray that is effective for mouth ulcers and soothing pain caused by inflammation in the throat. containing antiseptic cetylpyridinium chloride (cpc) that keeps the mouth clean, as well as azulene which acts to repair the mucous membrane, the spray alleviates the symptoms of mouth ulcers by allowing the active ingredients to be directly applied into the mouth. it also comes in a compact form making it portable and easy to use anywhere without having to directly touch the affected area.

centered around the signature otc product chocola bb® plus® (third-class otc drug) for the relief of skin trouble, acne and mouth ulcers, eisai has been expanding the chocola bb brand to suit the needs and lifestyles of its customers such as chocola bb® royal 2 (quasi-drug), a nutritional drink for invigoration when physically fatigued, and chocola bb® joma, a soft drink that contains vitamin b6 (food with nutrient function claims).

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that, at its recent meeting with the u.s. food and drug administration (fda), the fda confirmed there was sufficient data to support the advancement of its novel investigational oral beta-secretase cleaving enzyme (bace) inhibitor e2609 into phase iii clinical studies. e2609 was discovered by eisai and is being jointly developed by eisai and biogen inc. (headquarters: massachusetts, united states, ceo: george a. scangos, “biogen”) for early alzheimer’s disease.

based on the clinical and pre-clinical data presented to the fda at the study 202 end of phase ii meeting, the fda confirmed that the data package was sufficient to commence phase iii studies, and acknowledged the outlines of the two phase iii clinical study protocol designs. the study protocol will be a placebo-controlled design in patients with early alzheimer’s disease where the treatment group will be administered a dosage of 50 mg/day of e2609 with the primary outcome endpoint assessed at 24 months. the primary endpoint will be the clinical dementia rating sum of boxes (cdr-sb), with routine safety assessment.

following this discussion with the fda on the phase iii clinical study designs, eisai and biogen intend to have similar discussions with the regulatory authorities in japan and the eu, and to conduct the study as a global, multicenter study.

study 202 was a multicenter, randomized, double-blind, placebo-controlled parallel-group study to evaluate the safety of e2609 administered in patients with early to moderate alzheimer’s disease (including prodromal alzheimer’s disease) with confirmed accumulation of amyloid beta (aβ) by pet (positron emission tomography) screening. the study included three doses of e2609: 5, 15, and 50mg/day. plasma and cerebrospinal fluid (csf) aβ (aβ1-x)* levels were measured in patients prior to receiving e2609 and during the study.

the results of an analysis of study 202 presented at the end of phase ii meeting suggested favorable safety at all doses of e2609 and that total aβ levels in the plasma and csf were reduced in a dose-dependent manner. furthermore, according to an analysis of safety and pharmacokinetic/pharmacodynamic data from pre-clinical studies as well as study 202 and phase i clinical studies overall, the optimal dose of e2609 was identified as 50 mg/day.

lynn kramer, m.d., chief clinical officer and chief medical officer of eisai neurology business group commented, “we believe that the phase iii clinical study design outline agreed upon will enable us to efficiently conduct studies on bace inhibitors aimed at realizing preemptive medicine, and will accelerate the development of e2609. we are striving to deliver e2609 to patients around the world as soon as possible, and contribute to increasing the benefit for patients.”

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its european regional headquarters eisai europe ltd. (location: u.k.) has received a positive opinion from the european medicines agency’s committee for medicinal products for human use (chmp) on anticancer agent lenvatinib mesylate (generic name, “lenvatinib”) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (rcc) following one prior vascular endothelial growth factor (vegf) targeted therapy. if approved, lenvatinib will be launched under the brand name kisplyx^® for this indication.

the chmp’s positive opinion was based on a phase ii clinical study (study 205) that evaluated the safety and efficacy of lenvatinib in combination with everolimus in patients with unresectable advanced or metastatic renal cell carcinoma following one prior vegf-targeted therapy. from the results of the study, the group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival, the study’s primary endpoint, as well as a higher objective response rate compared to the everolimus alone group. the most common treatment-emergent adverse events (teaes) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. the most common teaes of grade 3 or higher were diarrhea, hypertension and fatigue.

the number of patients with renal cancer in europe is estimated to be 115,000, and renal cell carcinoma comprises more than 90% of all malignancies of the kidney. for advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

currently lenvatinib has been launched in countries including the united states, japan and in europe under the product name lenvima^® as a treatment for refractory thyroid cancer. furthermore, in may 2016, lenvatinib was approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior vegf-targeted therapy by the u.s. food and drug administration in the united states.

eisai positions oncology as a key therapeutic area, and is aiming to discovery revolutionary new medicines with the potential to cure cancer. eisai remains committed to providing further clinical evidence for lenvatinib 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 the u.s. food and drug administration (fda) has approved a new drug application (nda) for belviq xr^®, a once-daily formulation of lorcaserin hydrochloride (generic name, u.s. brand name: belviq^®) for chronic weight management. belviq xr is scheduled for launch in autumn 2016.

belviq xr is a sustained release formulation which enables once-daily treatment, increasing the convenience of administration compared to twice-daily belviq tablets. this approval was based on clinical data that confirmed bioequivalence of once-daily 20 mg belviq xr with twice-daily 10 mg belviq tablets. eisai believes belviq xr will offer patients the potential benefits of the full fda approved 20 mg dose in a simple once daily tablet.

this approval was obtained by arena pharmaceuticals, inc. (headquarters: california, united states, president and ceo: amit d. munshi, “arena”), whom eisai and its u.s. subsidiary eisai inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride.

belviq was approved by the 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 july 2016, lorcaserin hydrochloride was approved in mexico under the brand name venespri^®.

through obtaining approval for belviq xr, eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.

news – page 27 – eisai china lnc.-pg电子app

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