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combination treatment approved for patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
under new fda-initiated program, combination treatment is the first to receive simultaneous review decisions in the u.s., australia and canada

tokyo, and kenilworth, n.j., [september 18, 2019] – eisai (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) approved the combination of lenvima, the orally available kinase inhibitor discovered by eisai, plus keytruda, merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. this marks the first u.s. approval for the combination of lenvima plus keytruda and the first time an anti-pd-1 therapy is approved in combination with a kinase inhibitor for advanced endometrial carcinoma in the u.s. following submission on june 17, this is an accelerated approval reviewed under the fda’s real-time oncology review (rtor) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible. rtor allows the fda to review much of the data earlier, before the applicant formally submits the complete application. this accelerated approval is based on tumor response rate and durability of response. continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. according to the fda, this review was conducted under project orbis, an initiative of the fda oncology center of excellence. project orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. under this project, the fda, the australian therapeutic goods administration (tga) and health canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

the approval was based on data from study 111/keynote-146, a phase 2, multi-cohort, multi-center, open-label, single-arm trial that enrolled 108 patients with metastatic endometrial carcinoma that had progressed following at least one prior systemic therapy in any setting. in the 94 patients with tumors that were not msi-h or dmmr, the lenvima plus keytruda combination demonstrated an orr of 38.3% (95% ci, 29-49), with a complete response rate of 10.6% (n=10) and a partial response rate of 27.7% (n=26). in the patients who had a response as determined by independent review (n=36), at the time of data cutoff, the median dor was not reached (range, 1.2 to 33.1 months), and 69% of these patients experienced responses lasting six months or longer. the most common adverse reactions (≥20%) with the lenvima plus keytruda combination were fatigue, musculoskeletal pain, hypertension, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plantar erythrodysesthesia, dyspnea, cough and rash.

“when diagnosed early, endometrial carcinoma can have a good prognosis; however, for women whose cancer has progressed following prior systemic therapy, there are few fda-approved treatment options,” said dr. vicky makker, medical oncologist, memorial sloan kettering cancer center. “based on objective response rate and the duration of response, this approval of the lenvima plus keytruda combination will help address a significant unmet medical need for patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.”

“today’s approval of the lenvima plus keytruda combination for advanced endometrial carcinoma that has progressed following prior systemic therapy brings the first approved combination treatment to women with this type of cancer whose tumors are not msi-h or dmmr and who are not candidates for curative surgery or radiation, and this demonstrates the potential of our collaboration with eisai,” said dr. jonathan cheng, vice president, oncology clinical research, merck & co., inc., kenilworth, n.j., u.s.a. research laboratories. “merck & co., inc., kenilworth, n.j., u.s.a. is committed to developing this combination through the leap (lenvatinib and pembrolizumab) clinical program, which is under active investigation.”

“at least 75% of endometrial cancer cases are not microsatellite instability-high or mismatch repair deficient, and these women have been in need of new treatment options,” said dr. takashi owa, vice president, chief medicine creation and chief discovery officer, oncology business group at eisai. “we are very pleased that the lenvima plus keytruda combination for patients with advanced endometrial carcinoma that is not msi-h or dmmr, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation has been selected for fda’s rtor pilot program, launched last year, and has been approved approximately three months after the submission. we look forward to providing this combination therapy to women with certain types of advanced endometrial carcinoma.”

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 keytruda plus lenvima combination across several different tumor types, 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. the leap clinical program also includes a new basket trial targeting six additional cancer types.

the pivotal studies evaluating the combination therapy of lenvima plus keytruda in hepatocellular carcinoma (first-line), renal cell carcinoma (first-line), melanoma (first-line and second-line), non-squamous cell lung carcinoma (first-line [all-comer], first-line [pd-l1 positive] and second-line), endometrial carcinoma (first-line and second-line), and bladder carcinoma (first-line) are currently underway.

eisai’s focus on cancer

eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment with experience and knowledge from halaven and lenvima and the driver gene mutation and aberrant splicing leveraging rna splicing platform as areas (ricchi) where real patient needs are still unmet, and where eisai can become a frontrunner in oncology area. eisai will discover innovative new drug with new target and mechanism of action from these ricchi, and aims for contribution to cure cancers.

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.).

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 .

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 .

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 today that it has been selected for a 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). this marks eisai’s sixth selection.

the djsi family was jointly established between robecosam ag (switzerland) and s&p dow jones indices llc (united states) in 1999 and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. the djsi is one of the important investment criteria for the investors around the world who emphasize on corporate initiatives for improving non-financial value focused on environmental, social, and governance (esg).this year, the djsi asia pacific has selected top 148 companies (76 of which are from japan) from among the approximate major 600 companies in the region. eisai received high scores in categories such as innovation management, cost burden addressing, environment policy and management systems, product quality and recall management as well as human rights.

in addition to the djsi asia pacific, eisai has been selected for the ftse4good index series, which is another global benchmark sri index as well as for 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.

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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it received the 33^rd “iia japan chairman’s award” of the institute of internal auditors – japan (chairman: kazuhiko fushiya, “iia japan”).

the iia japan was established in 1957 with the aim of contributing to the sound development of japan’s industry and economy through the internal audits. it also functions as japan’s representative organization of the institution of internal auditors (iia), which plays a role of global leadership in international audits.

“iia japan chairman’s award” was established in 1987, and it is the 33^rd time this year. this award is to commend the corporations and management organizations, which have the fulfilled internal audit system, the active and continuous internal audit activities in long time period, the achieved results, as well as the contribution for spreading and developing the internal audit.
through the review by the review committee (head of committee：nobuo hida), the following initiatives of eisai’s corporate internal audit department for the internal audit activities were highly evaluated, and eisai received the chairman’s award.

emphasis on contribution for achieving the corporate objectives,
implementation of audit by the full consideration of business operation risks and socially focused matters and selecting the theme for audit,
emphasis on cause analysis of problems, and
implementation of regular internal and external evaluations for continuous audit quality improvement.

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. in order to realize this corporate philosophy, eisai will promote our initiatives for internal audit quality improvement, and is striving for further enhancement of corporate governance to improve sustainable corporate value.

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into a business alliance agreement for exclusive development and commercialization of a cognitive function test – cogstate brief battery (cbb) – developed by cogstate ltd. (headquarters: australia, “cogstate”), in japan as a digital tool for self-assessment of cognitive function (classified as miscellaneous goods).

the cbb consists of four tests, each measuring different cognitive domains: psychomotor function, attention, working memory, and learning, and it has been developed and already in use as a digital tool for self-assessment of cognitive function overseas, including the united states.

eisai will aim to raise awareness of cognitive function by developing and making widely available the cbb in japan jointly with cogstate as a simpler digital tool for self-assessment of cognitive function, which can be used at various locations such as at home and community events. with this tool, it is expected to have opportunities to review lifestyle and to consult with specialists and primary care physicians by objectively checking the changes in cognitive function. it is important to note that this tool is not an alternative for medical examination and diagnosis by qualified medical professionals.

in its medium-term business plan, eway2025, eisai is aiming to become a “medico societal innovator” (a company that changes society through creating medicines and providing solutions), promoting various kinds of digitalization such as the analysis of big data, including using real world data to develop an environment for early diagnosis and initiation of treatment and provision of solutions. this also includes creating next-generation treatments primarily in “neurology” and “oncology” that are eisai’s therapeutic areas of focus. through these efforts to partner with cogstate to develop and make widely available the cbb as a digital tool for self-assessment of cognition more easily in japan where aging is progressing and to raise awareness of cognitive function, eisai aims to contribute to the realization of well-being.

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

[notes to editors]
1. about cogstate ltd.
cogstate ltd. (asx:cgs) is a neuroscience technology company headquartered in melbourne, victoria, australia, optimising brain health assessments to advance the development of new medicines and to enable earlier clinical insights in healthcare since 1999. cogstate technologies provide rapid, reliable and highly sensitive computerised cognitive tests across a growing list of domains and support electronic clinical outcome assessment (ecoa) solutions to replace costly and error-prone paper assessments with real-time data capture. the company’s clinical trials solutions include quality assurance services for study endpoints that combine innovative operational approaches, advanced analytics and scientific consulting. for nearly 20 years, cogstate has proudly supported the leading-edge research needs of biopharmaceutical companies and academic institutions and the clinical care needs of physicians and patients around the world. for more information, please visit .

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)

on august 7, 2019, eisai china inc. was invited to participate in a cpc sub-branch co-construction campaign in zhenping organized and arranged by the school of pharmacy of china pharmaceutical university. seventeen people, including shiying zhang, party secretary of school of pharmacy, yan huang, deputy party secretary and other relevant leaders from china pharmaceutical university, ningbang wang, deputy director of jiangning high-tech park administrative committee, wei guo, chief physician and director of the geriatric endocrinology department of shaanxi provincial people’s hospital, wei cui, chief physician and director of department of geriatric endocrinology of first affiliated hospital of xi’an jiaotong university, xiaojing zhang, director of the general practice department and emergency treatment department of second affiliated hospital of xi’an jiaotong university, as well as xiongwei gu party branch secretary and head of internal audit department of eisai china inc., came to zhenping. the co-construction campaign at this time mainly included: the drug donation by eisai china inc., experts’ free clinic services, “rational drug use” lectures, hierarchical diagnosis and treatment, transfer treatment, academic exchanges, etc.

drug donation ceremony of eisai china inc.

at 8: 30 a.m., the co-construction campaign started on time. the drug donation ceremony of eisai china inc. was held first. shiying zhang expressed thanks to eisai china inc. for its strong support to the branch co-construction campaign, and pointed out in particular that in the early communication with president yanhui feng of eisai china inc., she felt the entrepreneurial spirit of “human health care“, and both parties agreed and immediately started the project cooperation. xiongwei gu said at the donation ceremony that eisai china inc. has always adhered to the corporate philosophy of “hhc” (human health care), and actively participated in philanthropic activities and fulfilled corporate social responsibility.

at 9 a.m., the free clinic service and training lectures started on time. prof. wei guo and prof. xiaojing zhao had face-to-face communication with the patients, and provided them with free clinic services. at the same time, prof. wei cui brought a lecture on “rational drug use” to grassroots doctors. after the free clinic services and lectures, relevant heads of the health bureau, zhenping county hospital and transfer treatment office had more in-depth exchanges and communication on hierarchical diagnosis and treatment, strengthening academic exchanges between the hospitals in xi’an and hospitals in zhenping county, transfer treatment co-construction, and joint diagnosis of general practice patients by xi’an and zhenping.

free clinic services

lecture on “rational drug use”

the core of eisai china’s “hhc” corporate philosophy is: we give first thought to patients and their families, and to increasing the benefits health care provides. we advocate that every employee should spend 1% of working time with patients every year, and apply the seci mode (including socialization, externalization, combination and internalization) and carry out hhc. only by contacting and understanding the patients, thinking deeply and producing resonance can they realize the “hhc demand”, that is, “socialization”. only by making mutual exchanges with members, generating new concepts and optimizing ideas for solving problems can they form “hhc ideas”, i.e. “externalization”. only by formulating action plans, continuously improving and revising plans according to opinions and suggestions, and improving the levels of actions, can they realize “hhc innovation”, that is, “combination”. only through effective implementation of the project and continuous revision and optimization, can they get the “hhc knowledge”, i.e. “internalization”. therefore, eisai china attaches great importance to corporate social responsibility and will continue to support various forms of social activities for public good under the leadership of president feng yanhui.

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.
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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 the presentation and discussion about the treatment, including oral beta amyloid cleaving enzyme (bace) inhibitor elenbecestat* research data on alzheimer’s disease (ad), were given in the aaic’s focused topic session “discussion of bacei trial findings: challenges and opportunities” at the alzheimer’s association international conference (aaic) held in los angeles, california, united states, from july 14 to 18, 2019. in addition, eisai held a symposium focused on the rationale and opportunities for drug development for pre-clinical ad.

1. aaic’s focused topic session (discussion of bacei trial findings: challenges and opportunities)

in this session, each company presented information about their own bace inhibitors. eisai gave a comprehensive presentation about the findings from the following nonclinical and clinical studies, as well as the clinical study status in regard to elenbecestat.

the nonclinical study results did not show significant effects on the decrease in spinal density and the impairment of mitochondrial function, relating to the cognitive function deterioration, at dose with significant decline of amyloid beta (aβ) level in csf, as an effect of elenbecestat.
the safety data, including the change in cognitive function in 900 patients with treatment administration for 6 months or more, has been reviewed periodically by the data safety monitoring board (dsmb). in its most recent review the dsmb recommended the continuation of the elenbecestat phase 3 mission ad 1 and 2 studies without modification.
in the clinical phase ii study (study 202), patients with mild cognitive impairment (mci) due to ad, or mild-to-moderate dementia due to ad with confirmed amyloid pathology by positron emission tomography (pet) who were administered elenbecestat 50mg showed a significant reduction in brain amyloid load at 18 months versus the placebo group with amyloid pet.
elenbecestat 50mg total group showed less worsening of clinical assessment using clinical dementia rating sum of boxes (cdr-sb) and alzheimer’s disease composite score (adcoms) at 18 months compared to placebo group. in study 202, elenbecestat suggested the acceptable tolerability.
elenbecestat has been selected by the alzheimer’s clinical trials consortium (actc) as treatments to be evaluated in upcoming clinical studies targeting primary prevention (a3 study) and secondary prevention (a45 study) of ad, and the screening will start in 2020.

2. eisai sponsored symposium (target therapy for preclinical alzheimer’s disease)

in this symposium, a presentation including issues and expectations for a biological definition, molecular pathways, and early treatment of ad were given by academic pioneers, and a lively discussion followed.

cerebral aβ accumulation, which is the causable substance of ad, begins one to two decades before the onset of memory symptoms in ad, therefore, the diagnosis and categorization based on pathology, not on the clinical symptoms, are required. in the latest ad classification atn (amyloid, tau, neurodegeneration / neuronal injury), the concept that ad is a disease that changes with a sequence of events in the alzheimer’s continuum was explained. with the progress of biomarkers (blood, csf, imaging), the current status, which enables determination of the stages of ad, including preclinical ad were introduced. according to the progress in these diagnosis technologies, it was indicated that therapeutic intervention in the preclinical ad is possible. reducing production of toxic aβ species through pathway-based targeted therapy is a rational approach in researching methods to arrest ad pathogenesis. in addition, the expectation for study design innovations, use of combination therapy, and establishment of the simplified blood-based diagnosis in the future were discussed.

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.

^* 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 that data relating to a new anti-tau antibody e2814*¹ was 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.: p4-696).

neurofibrillary tangles composed of aggregated tau protein is one of the pathological features of alzheimer’s disease (ad). during the course of the disease, tau is believed to spread throughout the brain via synaptically-connected pathways. the propagation of this pathology is thought to be mediated by tau species (“seeds”) containing the microtubule binding region of tau (mtbr). e2814 is designed to target mtbr containing tau species, preventing build-up and spreading of tau seeds, and thus may slow the course of the disease.

the data presented describes a method for quantification of mtbr-containing tau fragments mtbr in cerebrospinal fluid (csf) from patients with ad. in addition, an e2814 target engagement biomarker assay is binding to fragments including mtbr of e2814 target with this assay in the clinical study.

the results confirmed that mtbr-containing tau species can be quantified in human csf and there was a significant increase in mtbr in csf of patients with ad (caucasian aged between 64 and 84, mmse: 13-26) in comparison with healthy adults (caucasian aged between 46 and 75) (p<0.0001). furthermore, mtbr-containing tau species in the csf of ad patients was well correlated with phosphorylated tau (r² = 0.8849) rather than total tau (r² = 0.7811), maybe indicating the pathological species for tau propagation.

in vitro experiments using csf from patients with ad spiked with e2814, showed that e2814 was able to bind the majority of mtbr-containing tau in the samples. additionally, in vivo experiments in non-human primates demonstrated dose-dependent binding of e2814 to mtbr-containing tau fragments in csf samples and a concomitant reduction in free mtbr-containing tau species.

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 e2814 is the first clinical candidate discovered as part of a research collaboration with university college london in uk.

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

[notes to editors]
1. about e2814
an investigational anti-tau monoclonal antibody. e2814 is being developed as a disease modifying agent for alzheimer’s disease and other tauopathies, phase i clinical studies are under preparation. the clinical candidate was discovered as part of the research collaboration between eisai and university college london. e2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.

eisai co.,ltd.(headquarters: tokyo, ceo: haruo naito, “eisai”) announced its latest research on evaluation about correlation of amyloid beta (aβ) in plasma and in cerebrospinal fluid (csf) by high precision measurement with the newly developed automated protein assay system, jointly developed with sysmex corporation (headquarters: hyogo, chairman and ceo: hisashi ietsugu, “sysmex”), using full-automated immunoassay system hiscl^tm*1 series for creating the simplified diagnosis of alzheimer’s disease (ad) with blood was 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.: p4-548)

aβ is a peptide consisting of amino acid residues, which is generated by excision from the amyloid precursor protein. aβ_1-40 consisting of 40 residues is dominant substance, and aβ_1-40does not significantly fluctuate with progression of ad. on the other hand, as for the aβ_1-42 consisting of 42 residues, the aggregability is high and the reduction in aβ_1-42is detected from the early stage of ad. the absolute value of aβ has individual differences and intra individual variabilities, therefore, aβ_1-42/aβ_1-40 ratio in csf is used for the diagnosis of amyloid positive or negative.

in this research, the correlation between aβ_1-42/aβ_1-40 ratio in plasma and aβ_1-42/aβ_1-40 in csf were investigated for creating a simple blood diagnostic for ad by the automated protein assay system using full-automated immunoassay system hiscl™series. this assay system enables the automated immune assay in 17 minutes with small volume samples such as 10-30µl, and aβ assay in plasmas is possible with enough sensitivity and the high reliability. the samples from elderly person with normal cognition and patients with mild cognitive impairment (mci) and ad were used for investigation with hiscl™series. results show a correlation (spearman’s rank correlation coefficient (r_s) *² =0.502, p<0.001) between aβ_1-42/aβ_1-4ratio in plasma and aβ_1-42/aβ_1-40 ratio in csf; therefore, it may be possible to understand the pathological processes in the brain condition by measuring aβ_1-42/aβ_1-40 ratio in plasma. to further assess clinical utility, eisai aim to check the correlation between aβ_1-42/aβ_1-40 ratio in plasma and amyloid pet.

eisai aims to realize the prevention and cure of dementia including establishment of new diagnostics by 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 further contribute to addressing the unmet medical needs of, as well as increasing the benefits provided to, patients and their families.

^*1 hiscl™ is a trademark of sysmex corporation.

^*2 the correlation coefficient indicates the strength of the relationship between the two data from the two quantitative data distributions. in this analysis, spearman’s rank correlation coefficient (r_s) which is an index of correlation obtained from rank data is calculated.

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

[notes to editors]
1. about collaboration between eisai and sysmex
eisai and sysmex have entered into a comprehensive non-exclusive collaboration agreement aimed at the creation of new diagnostics in the field of dementia in february, 2016. leveraging each other’s technologies and knowledge, the two companies aim to discover next-generation diagnostics that will enable early diagnosis, selection of treatment options and the regular monitoring of the effects of treatment for dementia.

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