news – page 18 – eisai china lnc.-pg电子app

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that it provides tanks to supply clean water for the neglected tropical diseases (ntds) measures to the endemic regions in kenya in collaboration with merck (headquarters: darmstadt, germany).

as part of its efforts to improve access to medicines, eisai manufactures diethylcarbamazine (dec) tablets, a treatment for a ntd named lymphatic filariasis (lf), at its visag plant in india and provides these dec tablets free of charge to endemic countries through the world health organization (who) elimination program. as of august 2019, eisai has provided about 1.9 billion dec tablets to 28 endemic countries¹, including kenya.
when lf becomes severe, it causes lymphatic dysfunction that leads to swelling of body parts such as the legs and the affected body parts become susceptible to bacteria. therefore, it is important to keep the affected body parts clean with clean water.

on the other hand, merck provides praziquantel tablets, a treatment for a ntd named schistosomiasis, free of charge to kenya and 45 other endemic african countries. schistosomiasis is caused by parasitic worms (helminths) living in freshwater such as rivers and lakes. humans are infected with schistosomiasis when worm larvae enter through the human skin. therefore, it is very important to supply clean water to prevent infection.

eisai and merck will jointly provide tanks to supply clean water necessary for measures to ntds in the endemic areas, which are designated by ministry of health in kenya and where it is difficult to secure clean water. through this collaboration, eisai and merck will support the elimination of ntds in these endemic areas.

under its human health care (hhc) philosophy, eisai seeks to contribute to the health and welfare of people in developing and emerging countries. once they have recovered their health, they can resume productive activities, which will in turn contribute to economic development and expansion of the middle-income class. eisai considers this to be a long term investment in creating the markets of the future. by accelerating the development of new medicines for infectious diseases endemic in developing and emerging countries via leveraging partnerships, together with implementing activities to improve access to medicines including raising disease awareness locally and implementing price setting models that take income levels into account, eisai strives to further contribute to increasing the benefits for patients and their families worldwide.

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

[notes to editors]
about lymphatic filariasis (lf)
lf is a neglected tropical disease (ntd) transmitted to humans via carrier mosquitoes. lf causes lymphatic dysfunction and can lead to the swelling of body parts such as legs, and cause severe pain, permanent disability and social stigma associated with disfiguring visible manifestations. as a result, patients suffer mental, social and financial losses. it is estimated that 886 million people in 52 countries worldwide, mainly those in developing countries, are exposed to the risk of lf. elimination of lf is possible by stopping the spread of the infection through mass drug administrations (mdas) of three types of lf treatments including dec tablets.

about eisai’s commitment to improving global access to medicines including lf elimination program
in line with its hhc philosophy, eisai is committed to improving global access to medicines over the medium-to-long term through partnership strategies that involve working with governments, international organizations, private entities and non-profit organizations.

in november 2010, eisai agreed to supply a total of 2.2 billion dec tablets to who free of charge by 2020, as there was a global shortage of high-quality dec tablets for use in the mdas. in 2012, eisai became the only japanese company to participate in the london declaration, a coordinated effort to eliminate 10 ntds and the largest public-private partnership of its kind in the field of global health. at the london declaration’s fifth anniversary event held in april 2017, eisai announced its plan to supply dec tablets continuously after 2020, until lf is completely eliminated in all endemic countries where dec tablets are needed.

as of august 2019, eisai has supplied about 1.9 billion tablets 28 countries¹ through who’s elimination program. furthermore, in order to support the smooth implementation of who’s mda programs, eisai is engaging in initiatives to raise public awareness of lf and to support implementation of mda in endemic countries. staff members of eisai group cooperate with the relevant representatives in endemic countries to eliminate lf as early as possible. eisai staff also prepare and distribute leaflets in the local languages on the prevention and treatment of lf.

in addition to the above-mentioned initiatives, eisai is moving ahead with new drug development projects targeting malaria and neglected tropical diseases (ntds) such as chagas disease, mycetoma and lymphatic filariasis, based on partnerships with international non-profit organizations such as the drugs for neglected diseases initiative (dndi) and medicines for malaria venture (mmv), as well as research organizations such as liverpool school of tropical medicine, university of kentucky, and the broad institute.

furthermore, eisai co-established the global health innovative technology fund (ghit fund), japan’s first public–private partnership to advance development of new health technologies for the developing world, is a member of the world intellectual property organization (wipo) re:search consortium, an international joint enterprise for the development of treatments for ntds, malaria and tuberculosis led by wipo, is a signatory to the tuberculosis drug accelerator (tbda) partnership, and is participating in the access accelerated initiative to promote prevention and treatment of non-communicable diseases.

for further information on eisai’s access to medicines initiatives, please visit the access to medicines page on the eisai global website: 

about schistosomiasis
schistosomiasis is a chronic condition and one of the most common and most devastating parasitic diseases in tropical countries. it is estimated that more than 200 million people are infected worldwide and that around 280,000 die from it each year. flatworms transmit the disease. it is widespread in tropical and subtropical regions where large sections of the populations have no access to clean water and sanitary installations. people become infected with the parasite via contact with freshwater, for example while working, swimming, fishing or washing their clothes. the miniscule larvae penetrate human skin, enter the blood vessels and attack internal organs. the infection rate is particularly high among school-aged children. praziquantel is the only active ingredient with which all forms of schistosomiasis can be treated. who has therefore deemed praziquantel, the most cost-efficient solution for the health of patients in need, as the drug of choice.

the merck schistosomiasis elimination program
merck initiated the schistosomiasis elimination program in cooperation with who back in 2007. since then, more than 900 million tablets have been donated, enough to treat 360 million school children. merck has committed itself to maintaining its efforts in the fight against the tropical disease until schistosomiasis has been eliminated. to this end, each year merck is donating up to 250 million tablets to who. the planned annual donation has a value of around us$ 28 million. in addition, merck is supporting awareness programs at schools in africa in order to educate children about the causes of schistosomiasis and ways to prevent it. furthermore, as part of a public-private partnership, the company is researching a new formulation of praziquantel that can also be administered to very young children. to date, the tablets are only suitable for children older than six. at the end of 2014, merck founded the global schistosomiasis alliance together with partners such as the bill & melinda gates foundation, the u.s. development agency usaid, the schistosomiasis control initiative (sci) and world vision international.

¹ american samoa, comoros, dominican republic, egypt, eritrea, fiji, french polynesia, guyana, haiti, india, indonesia, kenya, kiribati, lao pdr, madagascar, malaysia, micronesia (fsm), myanmar, papua new guinea, the philippines, samoa, são tomé and príncipe, sri lanka, thailand, timor-leste, tuvalu, zambia, zimbabwe (alphabetical order)

as potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment

tokyo and kenilworth, n.j.,[july 23, 2019] – eisai (headquarters: tokyo, ceo: haruo naito), and merck & co., inc., kenilworth, n.j., u.s.a. (nyse: mrk), known as msd outside the united states and canada, today announced that the u.s. food and drug administration (fda) has granted breakthrough therapy designation for lenvima, the orally available kinase inhibitor discovered by eisai, in combination with keytruda, merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (hcc) not amenable to locoregional treatment. this is the third breakthrough therapy designation for the lenvima plus keytruda combination. the first two breakthrough therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (msi-h)/proficient mismatch repair (pmmr) endometrial carcinoma, received in january 2018 and july 2018, respectively.

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 therapy may provide substantial improvement over currently available therapy on at least one clinically significant endpoint.

this breakthrough therapy designation is based on interim results from the phase 1b trial keynote-524/study 116. an earlier interim analysis was presented at the 2019 american association for cancer research (aacr) annual meeting.

the combination of lenvima plus keytruda is investigational. the efficacy and safety of this combination has not been established. the lenvima plus keytruda combination is not approved in any cancer types today.

“we are excited that the fda has recognized the importance of the activity seen with lenvima plus keytruda in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this breakthrough therapy designation,” said dr. takashi owa, vice president, chief medicine creation and chief discovery officer, oncology business group at eisai. “we are dedicated to working together with merck & co., inc., kenilworth, n.j., u.s.a. to potentially bring another important option to patients.”

“as part of our ongoing collaboration with eisai, we are committed to evaluating the potential of keytruda plus lenvima across a number of different types of cancer,” said dr. jonathan cheng, vice president, oncology clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “with this breakthrough therapy designation from the fda, we look forward to working with eisai to potentially build upon our existing indications for this difficult-to-treat cancer, so that we can help even more patients through a combination approach.”

eisai co., ltd.                                     merck & co., inc. kenilworth, n.j., u.s.a.
public relations                                media relations                    
81-(0)3-3817-5120                            pamela eisele: (267) 305-3558
kristen drake: (908) 334-4688

investor relations                            investor relations
81-(0)3-3817-3016                            teri loxam: (908) 740-1986
michael decarbo: (908) 740-1807

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., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, 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 evaluating the lenvima and keytruda combination across several different tumor types, including renal cell carcinoma, the companies will jointly initiate new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program, which will evaluate the combination to support 11 potential indications in six types of cancer (endometrial cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and urothelial cancer). the leap clinical program also includes a new basket trial targeting six additional cancer types (biliary tract cancer, triple negative breast cancer, colorectal cancer, gastric cancer, glioblastoma and ovarian cancer). the lenvima and keytruda combination is not approved in any cancer types today.

about eisai 
eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. 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. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit  (for global), (for u.s.) or  (for u.k.), and connect with us on twitter (. and ) and  (for u.s.).

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 & co., inc., kenilworth, n.j., u.s.a. 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  and connect with us on , , ,  and .

merck & co., inc., kenilworth, n.j., u.s.a.’s focus on cancer 
our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. at merck & co., inc., kenilworth, n.j., u.s.a., the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. as part of our focus on cancer, merck & co., inc., kenilworth, n.j., u.s.a. is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. we also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. for more information about our oncology clinical trials, 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 2018 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 ( ).

eisai co.,ltd.(headquarters: tokyo, ceo: haruo naito, “eisai”) announced its latest data of nonclinical research which examined the effect to the synaptic function in the brain by spinal densities^*1 in regard to oral bace (beta-site amyloid precursor protein cleaving enzyme) inhibitor elenbecestat^*2 were presented at the alzheimer’s association international conference (aaic) held in los angeles, california, united states, from july 14 to 18, 2019 (poster presentation no.: p2-064).

bace is a key enzyme in the production of aβ peptides, which inhibits β site of amyloid precursor protein (app). bace inhibitor may decrease the formation of toxic aβ peptide aggregates in the brain, thereby thought to exert disease modifying effects and may have potential to slow the disease progression. on the other hand, in addition to app, the other substrates with physiological role in synapse formation and function are known as a substance (substrate) changed by bace. at this time, the effect to aβ level in csf and synaptic damage were examined after 4 weeks of administration of bace inhibitors using novel preclinical model mouse. for the examination compounds, elenbecestat (in-house discovery), verubecestat, and lanabecestat were used. in addition, the effect to the synapse formation and function were evaluated by setting the numerous spinal densities on dendrite of brain cortex (number of spines per 10 μm of dendrites) and mitochondrial function (mitochondrial oxygen efficiency) of hippocampal synaptosomes (isolated presynaptic terminal) as an index. it is believed that decreases in spinal densities and mitochondrial function damage the synaptic function and deteriorate the cognitive function.

the dose of each base inhibitor was adjusted so as to be equivalent to the dose for clinical study in accordance with exploratory data of lowering effect of aβ in mouse csf.

as a result, elenbecestat did not show significant effects on spinal density and mitochondrial function at dose of 3, 10mg/kg with significant decline of aβ level in csf (p<0.001).

as for the verubecestat, significant decline of spinal density was shown at the dose of 10, 30mg/kg (p<0.05) with significant decline of aβ level in csf (p<0.001).

also, as for lanabecestat, significant decline of spinal density was shown at the dose of 30, 100mg/kg (p<0.05) with the significant decline of aβ level in csf (p<0.001), as well as the significant decline of mitochondrial function was shown at the dose of 100mg/kg (p<0.05).

these results suggest that elenbecestat does not affect the synaptic function in the brain with an effective dose to decline the aβ level in csf.

eisai aims to realize the prevention and cure of dementia through a multi-dimensional and holistic approach with a foundation of over 35 years of experience of drug discovery activities in the area of alzheimer’s disease and dementia. eisai strives to create innovative medicines as soon as possible to further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.

^*1 there are more than 100 billion nerve cells (neurons) in the brain, the information is transmitted by forming each bond, called a synapse. this synapse is formed between the axon terminal (presynaptic neuron) sending information and the neuron dendrite (postsynaptic neuron) receiving information. many supraspinal structures on the neuron dendrite which forms synapse is called spine.

^*2 elenbecestat, is being jointly developed by eisai and biogen inc. (headquarters: cambridge, massachusetts, united states, “biogen”).

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

[notes to editors]
1. about elenbecestat (generic name, development code: e2609)
discovered by eisai, elenbecestat is an investigational next-generation oral candidate for the treatment of alzheimer’s disease (ad) that inhibits bace (beta amyloid cleaving enzyme). by inhibiting bace, a key enzyme in the production of aβ peptides, elenbecestat reduces aβ production, and by reducing amyloid plaque formations in the brain, exerts disease modifying effects of potentially slowing the progression of ad. currently, two global phase iii clinical studies (mission ad1/2) of elenbecestat in early ad including mild cognitive impairment (mci) due to ad or the 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 allowing priority reviews by the fda for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.

2. about joint development agreement between eisai and biogen for alzheimer’s disease
eisai and biogen are 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, and the companies plan to pursue marketing authorizations for the two 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.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has been included in the ftse4good index series for the 18th consecutive year since its initial inclusion in 2002.  the ftse4good index series is a global index series for socially responsible investment.

the ftse4good index series is designed to help investors integrate the global standard factors of environmental, social and governance (esg) into their investment decisions. eisai received particularly high scores in “customer responsibility”, “labor standards”, “corporate governance”, “anti-corruption”, and “climate change”, among others. as of july 2019, a total of 1,034 companies from around the world have been selected for the ftse4good developed index, including 175 companies from japan.

along with being listed in the ftse4good index series, eisai is also listed in the msci japan empowering women index (win), the ftse blossom japan index, the msci japan esg select leaders index, and s&p/jpx carbon efficient index, which are the four esg investment indices for japanese stocks adopted by the government pension investment fund (gpif).

eisai’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. by strengthening its esg initiatives and increasing non-financial value, eisai is striving to sustainably enhance corporate value based on this corporate philosophy.

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