Last ¥6,242 JPY
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eisai co ltd (4523) Details

Eisai Co., Ltd. manufactures and sells pharmaceutical products worldwide. The company offers oncology-related products, such as Halaven, an anticancer agent; Aloxi, an antiemetic agent; and Fragmin, an injectable anticlotting agent, as well as Symbenda/Treakisym, a treatment for low-grade non-Hodgkin's lymphoma and other types of lymphatic cancer. It also provides Aricept, an anti-Alzheimer's agent; Pariet/AcipHex, a proton-pump inhibitor; and Humira, a human anti-TNF-a monoclonal antibody. In addition, the company offers epilepsy products comprising Zonegran, Zebinix, and Fycompa, which are antiepileptic agents; and Inovelon/BANZEL for the treatment of Lennox-Gastaut syndrome, as well as consumer healthcare (over-the-counter) products, which include vitamin B2 preparation Chocola BB Plus. Further, it provides Methycobal, a peripheral neuropathy treatment; Warfarin, an oral anticoagulant; Actonel, an osteoporosis treatment; Selbex for the treatment of gastritis/gastric ulcer; BELVIQ, an antiobesity agent; Stronger Neo-Minophagen C/Glycyron tablets for liver disease/allergic disease treatment; Lyrica, a treatment for postherpetic neuralgia; and Lunesta, a treatment for insomnia. Additionally, the company is involved in the research and development of various products under the areas of oncology, vascular and immunological reaction, gastrointestinal and hepatic disorders, and neurology. It has strategic partnerships with Quintiles Inc.; SFJ Pharma Ltd.; Biogen Idec, Inc.; BioArctic Neuroscience AB; FORMA Therapeutics, Inc.; Epizyme, Inc.; PRISM BioLab Co., Ltd.; and Verastem, Inc. for the discovery and development of various products. The company was formerly known as Nihon Eisai Co., Ltd. and changed its name to Eisai Co., Ltd. in 1955. Eisai Co., Ltd. was founded in 1941 and is headquartered in Tokyo, Japan.

10,419 Employees
Last Reported Date: 06/20/14
Founded in 1941

eisai co ltd (4523) Top Compensated Officers

Chief Executive Officer, Representative Corpo...
Total Annual Compensation: ¥115.0M
Chief Clinical Officer of Eisai Product Creat...
Total Annual Compensation: ¥84.0M
Compensation as of Fiscal Year 2014.

eisai co ltd (4523) Key Developments

Eisai Announces Phase III Trial of Anticancer Agent Halaven® (Eribulin) in Soft Tissue Sarcoma Shows Overall Survival Benefit in Primary Endpoint

Eisai announced that in the Phase III trial (Study 309) of Halaven® (eribulin) in patients with soft tissue sarcoma, eribulin demonstrates a statistically significant extension in overall survival (OS) over the comparator treatment dacarbazine, the primary endpoint of the study. No other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a Phase III study. Eribulin, as a single agent, now demonstrates overall survival benefit in two distinct solid tumour types (advanced breast cancer and soft tissue sarcomas), following two prior regimens in the advanced setting. Eisai will seek to present these data at an upcoming peer review forum as soon as possible. Soft tissue sarcomas are cancers that develop from cells in the soft, supporting tissues of the body such as fat, muscle, nerves, fibrous tissues and blood vessels. Study 309 was a randomised, open-label multicentre Phase III study comparing the efficacy and safety of eribulin in 452 patients (aged 18 or over). Treatment was administered on days one and eight of a 21-day cycle versus dacarbazine to patients with one of two subtypes: adipocytic or leiomyosarcoma locally advanced or relapsed and metastatic soft tissue sarcoma who showed disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. The primary endpoint of the study was to compare overall survival between both treatment arms, and the additional endpoints include progression free survival and quality of life. In this study, the most common adverse events observed in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation, which is consistent with the known profile of eribulin. Eisai intends to submit applications during the first half of the fiscal year of 2015 to the regulatory authorities in multiple countries which include the United States, Europe and Japan seeking an expansion of the indication for eribulin including soft tissue sarcoma.

FDA Approves Eisai's LENVIMA (Lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Eisai Inc. announced that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA(lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). LENVIMA was approved following a priority review by the FDA, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition. LENVIMA demonstrated a statistically significant progression-free survival prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine therapy. In the Phase 3 SELECT trial, which included 392 patients, LENVIMA demonstrated a highly statistically significant improvement in PFS in patients with RAI-R DTC compared with placebo. The median PFS, or delay in the length of time during and after treatment in which the disease did not worsen, with LENVIMA and placebo was 18.3 months and 3.6 months, respectively (HR 0.21; 95% CI: 0.16-0.28; p<0.001). In addition, an overall response rate, the sum of partial and complete response rates, of 65% was seen in patients treated with LENVIMA versus 2% with placebo, which included a complete response achieved in 2% of patients treated with LENVIMA versus 0% with placebo. Based on RECIST v1.1 criteria, a partial response is defined as a minimum 30% decrease in the sum of diameters of target lesions and a complete response is defined as a complete disappearance of tumors. Serious risks seen in patients in the Phase 3 SELECT clinical trial were hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, proteinuria, renal failure and impairment, gastrointestinal perforation and fistula formation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhagic events, impairment of exogenous thyroid suppression and embryofetal toxicity. The most common adverse reactions observed in greater than or equal to 30% of LENVIMA-treated patients, in order of decreasing frequency, were: hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia. The most common serious adverse reactions (at least 2%) were pneumonia (4%), hypertension (3%), and dehydration (3%). It is important for doctors to know that when treating with LENVIMA, they may modify the dose as needed according to the recommendations provided in the prescribing information. Management of some adverse reactions may require the dose of LENVIMA to be withheld, reduced or discontinued. Upon resolution/improvement of an adverse reaction, treatment may be resumed at a reduced dose as suggested in the prescribing information. In the clinical trial, adverse events led to dose reductions in 68% of patients who received LENVIMA and 5% of patients who received placebo. Some patients will need to discontinue treatment for serious adverse reactions. In the trial, 18% of patients treated with LENVIMA and 5% who received placebo discontinued treatment. The most common adverse reactions (at least 10%) that resulted in dose reductions of LENVIMA were hypertension (13%), proteinuria (11%), decreased appetite (10%), and diarrhea (10%). The most common adverse reactions (at least 1%) resulting in discontinuation of LENVIMA were hypertension (1%) and asthenia (1%). Eisai is committed to ensuring patients have access to medicines from which they may benefit and is dedicated to working to ensure that products are available to those who need them. Once LENVIMA is available, Eisai will provide reimbursement support programs for eligible patients.

Eisai Co., Ltd. Reports Lenvatinib Phase III Results

Eisai Co., Ltd. announced the Pivotal results from the Phase III SELECT LEnvatinib in Differentiated Cancer of the Thyroid) trial of lenvatinib (E7080) in the treatment of radioiodine-refractory differentiated thyroid cancer (RR-DTC) demonstrate that lenvatinib significantly extended progression-free survival (PFS) by a median of 14.7 months (Hazard Ratio (HR)=0.21, [99% CI, 0.14-0.31]; p[1] Further results from the study. The pivotal SELECT study is a randomised, double-blind, multicentre trial for people with progressive radioiodine-refractory differentiated thyroid cancer (n=392).[1] Results demonstrate that PFS is significantly prolonged with lenvatinib versus placebo (median 18.3 months versus 3.6 months, respectively; hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, P40%, all grades) were hypertension (67.8%), diarrhoea (59.4%), fatigue (59.0%), decreased appetite (50.2%), decreased weight (46.4%), and nausea (41.0%). Adverse effects were managed with dose reductions and standard interventions and were greater with lenvatinib, and include six (2.3%) treatment-related deaths.[1] Differentiated thyroid cancer is the most common form of thyroid cancer and accounts for approximately 90% of all thyroid cancers.[2] Currently there are very few effective therapies for radioiodine-refractory differentiated thyroid cancer in Europe. Lenvatinib is an oral molecular targeted agent that selectively inhibits the activities of several different molecules including vascular endothelial growth factor receptors (VEGFR), fibroblast growth factor receptors (FGFR), RET, KIT and platelet-derived growth factor receptors (PDGFR). It simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumour angiogenesis and proliferation of thyroid cancer. This potentially makes lenvatinib the first TKI that simultaneously inhibits the kinase activities of FGFR 1-4 as well as VEGFR 1-3.[3],[4],[5] In addition, lenvatinib has been confirmed through X-ray crystal structural analysis to be the first compound to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid and potent inhibition of kinase activity. lenvatinib discovered and developed by Eisai.


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