Environmental and Social Report 2013 - Eisai Inc.

Striving to be a human health care company

Satisfying diverse healthcare needs around the world

Eisai supports the World Health Organization’s programme to eliminate lymphatic filariasis.

Environmental and Social Report 2013

Eisai’s Corporate Philosophy

1.

The Company’s corporate concept is to give first thought to patients and their families, and to increase the benefits that healthcare provides. Under this concept, the Company endeavors to become a human health care (hhc ) company.

2.

The Company’s mission is the enhancement of patient satisfaction. The Company believes that revenues and earnings will be generated as a consequence of the fulfillment of the mission. The Company places importance on this positive sequence of the mission and the ensuing results.

3.

Positioning compliance, the observance of legal and ethical standards, as a core in all business activities, the Company strives to fulfill corporate social responsibilities.

4.

The Company’s principal stakeholders are patients, customers, shareholders and employees. The Company seeks to foster a good relationship with stakeholders and to enhance their value through making the following efforts:

⑴ Satisfying unmet medical needs, ensuring stable supply of high quality products, and providing useful information of safety and efficacy.

⑵ Timely disclosure of corporate managerial information, enhancement of corporate value, and proactive return to shareholders.

⑶ Ensuring stable employment, offering challenging and fulfilling duties,

and providing full opportunities for the development and enhancement of employees’ capabilities. Excerpt from the Articles of Incorporation, Chapter I, Article 2

Eisai Co., Ltd.

Contents 2 MESSAGE FROM THE PRESIDENT To the Readers of the Environmental and Social Report 2013 Philosophy Eisai–A human health care (hhc ) Company hhc 4 6 Eisai’s Business Activities Addressing Diverse Healthcare Needs around the World 8 Feature: Access to Medicines Working to Improve Access to Medicines in Emerging and Developing Countries

12 16 20 24 28

Increasing Patient Satisfaction Research and Development Striving to Improve Patients’ Quality of Life Stable Supply of Products Building a Global System Based on the Patients’ Perspective Providing Information Engaging with Patients Through Information Quality Assurance from the Patients’ Perspective Opinion from a Global Health Expert

29 30 32 36

Eisai’s Social Activities Crisis Management Corporate Governance and Compliance Talent Development Social Contribution Activities

38 40 41 42 44 46 47 48 50 51 52

Eisai’s Environmental Activities Efforts to Ensure Coexistence with the Global Environment Resource Input and Environmental Impact Environmental Costs Environmental Management Formation of a Low-Carbon Society Establishment of a Recycling-Oriented Society Management of Chemical Substances Environmental Protection Efforts at Group Companies outside Japan Air Pollutant Emissions and Pollutant Load in Wastewater Resource Input and Environmental Impact (Group Companies outside Japan) Opinion from an Environmental Expert

The Annual Report 2013, which provides an overview of Eisai’s financial performance and business strategy, is also available. To view the report, please visit the following website. Website: http://www.eisai.com/ir/annual/index.html Inquiries: Investor Relations Department, Eisai Co., Ltd. +81-3-3817-5327

53 Social Responsibility Index and Distribution of Added Value Editorial Policy This report focuses on Eisai’s activities in fiscal 2012 by describing our human health care (hhc) corporate philosophy, involvement with stakeholders, and environmental protection efforts. The report on each initiative offers a representative example of how the hhc philosophy has been put into practice, introduces the basic approach behind that initiative and provides a detailed activity report. This report also includes the opinions of Eisai stakeholders (see pages 28 and 52) with the aim of exploring their evaluations and expectations of Eisai and reflecting their feedback in the Company’s future activities.

● Scope of reporting This report primarily focuses on the activities of Eisai Co., Ltd., although some content also covers information on the activities of Eisai Group companies. ● Period covered The data covers business performance from April 1, 2012 to March 31, 2013. However, some sections may include information on activities as recent as June 2013. ● For inquiries regarding this report, please contact: Eisai Co., Ltd. Public Relations Department Tel: +81-3-3817-5120 Fax: +81-3-3811-3077 General Affairs and Environmental & Safety Affairs Department Tel: +81-3-3817-5118 Fax: +81-3-3811-9982

In the development of this report, we have referred to the Environmental Report Guidelines (2007 edition) issued by Japan’s Ministry of the Environment and the Global Reporting Initiative (GRI) Sustainability Reporting Guidelines (2006 edition). In addition, we have included, to the greatest extent possible, performance data and examples of activities for which data can be continually obtained. Moreover, in order to reduce our environmental impact, this report has been prepared solely for publication on the Eisai Global Website.

Overview of Eisai Co., Ltd. (as of March 31, 2013) Company Name: Date Established: Headquarters: Capital: Number of Employees:

Eisai Co., Ltd. December 1941 4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan, 112-8088 44,985 million yen 10,495 (consolidated), 4,050 (nonconsolidated)

(The nonconsolidated number of employees includes staff on loan to Eisai Co., Ltd. from external organizations, and excludes Eisai Co., Ltd. employees seconded to external organizations.)

Sales Offices in Japan: 65 communication offices nationwide (Please refer to pages 6 and 7 for detailed information on overseas sales offices, production plants and research facilities.)

A more detailed company profile is available on the Eisai Global Website: http://www.eisai.com


1

MESSAGE FROM THE PRESIDENT

To the Readers of the Environmental and Social Report 2013

Fiscal 2012 witnessed a growing sense of uncertainty in the global economy owing to issues such as the fiscal problems in Europe and the United States and decelerating growth in China and other emerging economies. Amid this unsteady global economy, the world pharmaceutical market is undergoing a major transition toward an era of great globalization characterized by slowing growth in industrialized countries and expanding growth opportunities in emerging and developing countries. In the Japanese economy as well, a crucial issue will be to implement growth strategies through innovation promotion policies. I believe the pharmaceutical industry has a major role to fulfill in leading this growth. The Eisai Group’s corporate philosophy is to give first thought to patients and their families and to increase the benefits that health care provides. Eisai’s mission is to quickly deliver innovative pharmaceutical products that satisfy unmet medical needs to the patients around the world who need these medicines. To realize this goal, Eisai is proactively strengthening its innovation capabilities and building a new business model that helps improve access to medicines in emerging and developing countries.

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Eisai Co., Ltd.

Strengthening Innovation Capabilities I believe the driving forces for spurring innovation in new drug creation are the ability to create therapeutic hypotheses based on human biology and having contemporary synthesis technology capabilities that link these therapeutic hypotheses with the creation of compounds. The Eisai Group is working to realize new product creation routes generated by research in human biology fields such as research on iPS (induced pluripotent stem) cells and genetic codes involved with diseases. The Eisai Group’s greatest strengths are its abilities to synthesize and create a wide range of compounds, from small molecules to natural products and biologics, which validate therapeutic hypotheses. With these two abilities serving as closely connected pillars, the novel anticancer agent Halaven®, which is derived from a natural product, was discovered in-house. Halaven has received approval in over 40 countries, including Japan, the United States and European countries. Additionally, Fycompa®, an antiepileptic agent with a novel mechanism of action, was

discovered in-house by Eisai and has received approval in Europe and the United States. Eisai is also focusing on developing therapeutic agents in oncology fields based on human biology as well as next-generation therapeutic agents for Alzheimer’s disease as a pioneer in the field of dementia.

Initiatives for Improving Access to Medicines The Eisai Group is taking on the challenge of improving access to medicines for numerous diseases suffered by patients in countries around the world. One category of such diseases is Neglected Tropical Diseases (NTDs), which flourish in impoverished regions. Many of the regions where NTDs flourish are developing countries that face problems with access to medicines, whereby essential drug products do not reach patients who need these due to poverty and inadequate healthcare systems. These kinds of global health issues should not be tackled by pharmaceutical companies alone. Rather, these issues need to be addressed with all-out efforts in unified partnership with local governments, international organizations, non-profit organizations (NPOs) and other stakeholders. The Eisai Group is making proactive efforts in this area based on the belief that improving health and welfare and access to medicines in these countries will lead to economic growth and expansion of middle-income classes and represents a long-term investment in the formation of future markets. The Eisai Group will manufacture about 2.2 billion diethylcarbamazine (DEC) tablets, a therapeutic agent for the treatment of lymphatic filariasis, one of these NTDs. The DEC tablets, which are in short supply around the world, are being manufactured at our Vizag Plant in India and will be supplied to the World Health Organization (WHO) at price zero over a seven-year period from 2013. Additionally, in April 2013 Eisai participated in the establishment of the Global Health Innovative Technology Fund (GHIT Fund), a public–private partnership for promoting Japan-based new drug creation for infectious diseases prevalent in the developing world. Meanwhile, to deliver innovative pharmaceutical products such as Aricept® and Halaven® to patients in emerging and developing countries, Eisai is setting affordable prices tailored to the economic circumstances and health insurance systems in each country to allow patients to easily purchase medicines. Through these initiatives, Eisai aims to build a sustainable business model by quickly delivering new medicines to patients and significantly expanding the number of patients our products help.

Toward the Realization of a Sustainable Society Global pharmaceutical production volume is expected to increase in the future along with the ongoing aging of societies in industrialized countries and growth in pharmaceutical markets in emerging and developing countries. At the same time, global environmental problems such as increases in energy usage and waste that accompany production activities are becoming an issue of critical importance. As a global company that contributes to the health care of numerous people around the world, Eisai recognizes its important mission of reducing the environmental impact at each stage of its business operations, including in pharmaceutical R&D, production, distribution, sales, usage and disposal. The process leading up to the delivery of high-quality pharmaceuticals to patients requires the consumption of large amounts of energy. At the research and production stages in particular, energy is used for operating airconditioning systems to comply with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. Moreover, product transportation and storage also consume considerable amounts of energy that could cause increased CO2 emissions. In responding to these issues, the Eisai Group in Japan decided to compile and implement a medium-term CO2 reduction plan while it routinely promotes energy savings. We are also steadily cutting the use of chemical substances with an adverse environmental impact, reducing waste for the formation of a recycling-oriented society, implementing green purchasing for preferential purchases of products and services with low environmental impacts and introducing fuel-efficient and low-emission hybrid vehicles for sales activities. The Eisai Group will continue to undertake environmentally conscious business activities and contribute to the creation of a sustainable society. The Group, as a good corporate citizen, will continue to increase the benefits that health care provides to patients around the world based on its human health care (hhc ) philosophy while working to earn the trust of stakeholders. We look forward to your continued support and understanding.

Haruo Naito President (Representative Corporate Officer) and CEO


3

hhc Philosophy

Eisai–A human health care (hhc ) Company The Eisai Group’s corporate philosophy is to “give first thought to patients and their families, and to increase the benefits that healthcare provides” and to address diverse healthcare needs worldwide. Guided by this philosophy, all corporate officers and employees are working as one to ensure that the Eisai Group fulfills its role as a group of human health care (hhc ) companies capable of making a meaningful contribution under any healthcare system. * The Group’s Philosophy Logomark combines inspiration from the life and dedication of Florence Nightingale (1820–1910), who made enormous contributions to the development of the nursing profession and public health, with our own Eisai hhc philosophy. As such, the script for the logo is modeled on the signature of this prominent figure.

Realizing the hhc Philosophy The Eisai Group aspires to realize the hhc philosophy. hhc is the motivating force for achieving the Eisai Group’s business objective of enhancing patient value. To this end, we have built a corporate culture that encourages our entire global workforce to put the hhc philosophy into practice in their daily work. The Knowledge Creation Department is a dedicated organization for the fulfillment of the hhc philosophy. The department undertakes a range of activities with a special focus on promoting knowledge creation and fostering an organizational climate that encourages innovation. One such example is the in-house awards program that promotes “hhc Driven Innovation Activities” at an organizational level or on a project basis, and which recognizes those activities that have made outstanding contributions to patients. The department is focused on nurturing talent capable of empathizing with patients and engaging in daily business activities that contribute to patients.

to spend time with patients. For example, as part of the Field Experience Training Program, employees visit medical settings and nursing care facilities to learn about the reality of contemporary medical and nursing care, and to gain firsthand insight into the perspectives of patients as well as health and nursing care providers. In addition, we are conducting the Nursing Care Simulation Experience Training Program, where employees attend a vocational school to learn basic nursing care skills while practicing those skills on each other. The Elderly Simulation Program is part of new employee training in which participants put on special gear such as ankle and wrist weights as well as elbow and knee supports that simulate the lowered physical functions of an elderly person and enable them to experience age-related psychological changes. The Group also provides opportunities for employees to spend time with patients by planning seminars and plant tours for patient support groups as well as exchange programs at support facilities for the disabled.

Sharing Knowledge through the hhc Initiative Understanding Patient Needs and Business Purpose by Spending Time with Patients At the Eisai Group, we believe that it is important for employees to spend considerable time with patients in order to better understand their true needs. We urge our entire global workforce to spend 1% of their work hours, or about two days per year, with patients. As such, the Knowledge Creation Department provides a range of opportunities for employees

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Eisai Co., Ltd.

The Eisai Group holds the annual hhc Initiative to acknowledge outstanding innovations from among the more than 500 hhc Driven Innovation Activities carried out globally, as well as papers submitted in the Group essay contest. Award winners and top management from Group companies around the world gather together at this event to present their best practices and share collective knowledge. This event promotes global fulfillment of the hhc philosophy.

Examples of Award-Winning hhc Driven Innovation Activities Award-Winning Activities 1 Aquarium Trip with Psycho-Oncologist Support (Germany) Psycho-oncologists, who specialize in the psychological well-being of patients with cancer and their loved ones, play a significant role in improving the quality of life (QOL) of people living with the disease. Although there are many clinics in Germany where psycho-oncological services are available, there are few patients who use these services. To address this issue, Eisai GmbH (Germany) planned and initiated a day trip to an aquarium to make it easier for patients living with breast cancer who have young children to seek advice from a psycho-oncologist. In October 2012, the first day trip took place at an aquarium in Munich. Several patients with metastatic breast cancer and their children attended with a psycho-oncologist. In addition to psychological support, the patients were able to benefit from sharing their fears and concerns with other patients during the trip. Going forward, the Eisai Group will continue to work hard to support people living with cancer. Patients and their families who joined the tour

Award-Winning Activities 2 Contribution to Pediatric Patients through Pediatric Clinical Trials (Japan) In Japan, juvenile idiopathic arthritis (JIA) is designated as a chronic pediatric disease. Manifesting itself in children before the age of 16, it is of unknown etiology and is estimated to affect one in every 100,000 children. Eisai Co., Ltd.’s first clinical trial for JIA in children was conducted in collaboration with Abbott Japan Co., Ltd.* and the disease was approved as the six indication of the antibody treatment drug Humira® in Japan in July 2011. Since then, we have been delivering hope for the future to over 150 pediatric patients. There has also been a case of a young person who, after returning to a normal life thanks to Humira, has gone on to enter medical college to pursue a career as a doctor. We will continue aiming to realize hhc so that as many pediatric patients as possible are brought up with brighter hope for the future. * Currently AbbVie GK

Award-Winning Activities 3 Epilepsy Education through Drawing Activities and Distribution of Educational Picture Book (France, Spain) Getting children to draw pictures is one method used in the medical field to encourage them to express their feelings. In 2010, the Eisai Group initiated a project in which children in France who have epilepsy draw their experiences and incidents related to the disease. In order to help neurologists who treat epilepsy to more deeply understand the feelings of children with epilepsy, we exhibit the drawings at epilepsy-related conferences and clinics and have also compiled and are distributing the drawings in booklet form. In Spain, we created a children’s picture book that explains epilepsy and summarizes basic advice on first aid in the event that an epileptic seizure occurs. The book is being distributed to schools in an effort to deepen understanding of epilepsy. By continuing to expand these projects, we aim to spread understanding of epilepsy to the friends, classmates and wider community of children living with epilepsy.

Drawing by a child with epilepsy (France)

Picture book aiming to educate children about epilepsy (Spain)

Award-Winning Activities 4 Worldwide Campaign to Make Breast Cancer Patients Smile: Activity at Kashima Plant in Ibaraki (Japan) Eisai’s Kashima Plant is striving to enhance production capacity of the pharmaceutical ingredient eribulin for the anticancer agent Halaven® in order to bring a smile to the faces of patients with breast cancer worldwide. The production process for eribulin, which has a complex chemical structure, requires significant and precise control. In order to enhance production capacity, the Kashima Plant tackled “repetitive manufacturing,” where part of the production for two lots* is carried out simultaneously, with the aim of ensuring the stable and efficient synthesis of the complex eribulin. Based on a shared vision of making patients smile, we leveraged our know-how in research and development as well as commercial production and took creative measures in quality control. As a result, we were able to achieve success in just one year. * Lot: Smallest unit of production volume in manufacturing process


5

Eisai’s Business Activities

Addressing Diverse Healthcare Needs around the World Asia

EMEA

Research centers Eisai Knowledge Centre, India (Andhra Pradesh, India), Eisai Clinical Research Singapore Pte. Ltd. (Singapore) Production sites Suzhou Plant (Jiangsu, China), Tainan Plant (Tainan, Taiwan), Bogor Plant (West Java, Indonesia), Vizag Plant (Andhra Pradesh, India) Sales offices China, Hong Kong, South Korea, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Philippines, India

(Europe, the Middle East and Africa)

Fiscal 2012 Net sales

¥25.8 billion

Asia Fiscal 2012 Net sales

¥41.3 billion

EMEA (Europe, the Middle East and Africa) Research centers European Knowledge Centre (Hertfordshire, United Kingdom) Production sites Hatfield Plant (Hertfordshire, United Kingdom) Sales offices United Kingdom, Germany, France, Netherlands, Spain, Italy, Switzerland, Sweden, Portugal, Belgium, Austria, Australia

Other businesses 4.3% ¥24.4 billion

Products Supplied in Fiscal 2012

Pharmaceuticals business 95.7% ¥549.2 billion Pariet ®

Other products 42.1% ¥241.5 billion

Humira® 5.1% ¥29.0 billion Humira® is a fully human anti-TNF-alpha monoclonal antibody that neutralizes the activity of TNF-alpha, a type of cytokine that plays a central role in inflammatory reactions in patients with autoimmune diseases. In Japan, Humira is indicated for rheumatoid arthritis (including inhibition of structural damage), psoriasis, Crohn’s disease, ankylosing spondylitis, juvenile idiopathic arthritis, intestinal Behçet’s disease, and ulcerative colitis.

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Eisai Co., Ltd.

(U.S. brand name: AcipHex®)

18.9% ¥108.4 billion

Total sales

¥573.7 billion

Aricept ®

16.4% ¥94.3 billion

Aricept® is an Alzheimer’s disease treatment that contributes to improvement in the quality of life (QOL) of patients in more than 70 countries worldwide. As a pioneer in the treatment of dementia, we are also taking active steps to develop new formulations and expand existing indications.

The proton pump inhibitor Pariet® is marketed in more than 80 countries around the world for use in the treatment of reflux esophagitis, gastric ulcers, duodenal ulcers and other acid-related diseases.

Oncology-related products 17.5% ¥100.4 billion Eisai has been conducting research in oncology since 1986. Halaven®, an anticancer agent developed in-house, today continues to grow into a truly global product. We provide a range of oncology-related products that includes not only anticancer agents but also supportive cancer therapy drugs while continuing to develop our extensive investigational pipeline to further enhance our oncology franchise.

Americas

Japan

Research centers Eisai Inc. (New Jersey, United States), Andover Research Institute (Massachusetts, United States), Research Triangle Park (North Carolina, United States), H3 Biomedicine Inc. (Massachusetts, United States), Morphotek Inc. (Pennsylvania, United States) Production sites North Carolina Plant (North Carolina, United States) Sales offices United States, Canada, Brazil, Mexico

Fiscal 2012 Net sales

¥328.8 billion

Americas Fiscal 2012 Net sales

¥153.3 billion

Japan Research centers Koishikawa Knowledge Center (Tokyo), Tsukuba Research Laboratories (Ibaraki), KAN Research Institute (Hyogo), Kawashima Laboratory (Gifu), Kashima Plant (Ibaraki) Production sites Kashima Plant (Ibaraki), Misato Plant (Saitama), Kawashima Plant (Gifu), Honjo Facility (Saitama), Sannova Co., Ltd. (Gunma) Sales offices Japan (prescription drugs, generic drugs, diagnostics, over-the-counter drugs)

Around the world there are still many diseases for which no effective treatments exist and many patients who do not have adequate access to the medicines they need. As a global network of pharmaceutical companies working to address these unmet medical needs, the Eisai Group is committed to making contributions to health care for patients and their families around the world. Working together under our hhc philosophy, the Group’s more than 10,000 employees in Japan, the United States, Europe, Asia and other parts of the world continue to conduct business operations with the aim of achieving “the enhancement of patient satisfaction” as set out as the goal of all corporate activities of the Group. To fulfill this shared mission, the Group seeks to contribute to patients through new drug creation by strengthening innovation capacities and the expansion of our operations in each region based on local characteristics, particularly in regard to our active engagement in initiatives aimed at addressing issues in access to medicine in emerging countries.

■Accelerating drug development by focusing on specific

research areas Since its foundation, the Eisai Group has consistently pursued unique research and development activities. We are particularly concentrating on two key therapeutic areas, neuroscience and oncology, where unmet medical needs are especially high. By specializing in these areas, the Group is able to ascertain cutting-edge technologies and medical trends, resulting in more effective research and development (R&D). At the same time, we are also actively investing in R&D activities, with R&D expenditure in fiscal 2012 reaching ¥120.4 billion, accounting for 21.0% of the Eisai Group’s total net sales.

Research centers Production sites Sales offices

■Initiatives to improve access to medicines

As part of the Eisai Group’s current midterm strategic plan “HAYABUSA,” which ends in fiscal 2015, we aim to expand our operations into each of the world’s top 20 markets and increase the number of countries where Eisai’s products are available to 114 in order to effectively make contributions to some 500 million patients worldwide. With the Group’s Vizag Plant in India playing a major strategic role in the expansion of our operations into emerging countries and the developing world, we aim to realize the stable supply of pharmaceutical products in each country by setting affordable prices that reflect local social, economic and medical conditions.


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Feature: Access to Medicines

Working to Improve Access to Medicines in Emerging and Developing Countries Many emerging and developing countries around the world are faced with the problem of access to medicines, where required medicines are not reaching the patients who need them due mainly to poverty and inadequacies in the medical system. The Eisai Group is working actively and continuously to resolve such issues in access to medicines and is making a long-term investment for this purpose, as underpinned by our hhc philosophy.

More than one billion of the estimated 2.7 billion impoverished people in the world suffer from NTDs.

Global Health and Access to Medicines “Global health,” one of the major areas of contributions made to emerging and developing countries by the Eisai Group in our capacity as a pharmaceutical company, refers to the concept of rectifying health disparities across national borders with regard to worldwide healthcare issues. For many emerging and developing countries, health insurance coverage is limited compared with industrialized countries. Moreover, the average purchasing power of people in these countries remains relatively low, which has led to the current situation where people cannot sufficiently receive the medical care they require. The overall ability to access essential health care and medicines in this sense is referred to as “access to medicines.” The spread of neglected tropical diseases (NTDs) in many of these countries constitutes a serious issue and it is estimated that more than one billion of the world’s poorest 2.7 billion people suffer from NTDs. The problems of access to medicines, public health and disease are some of the causes of poverty since they significantly hinder economic development.

■ Global prevalence of the 10 NTDs designated for elimination under the London Declaration on Neglected Tropical Diseases Disease Blinding trachoma Leprosy Human African trypanosomiasis Dracunculiasis (Guinea-worm disease) Lymphatic filariasis Chagas disease Leishmaniasis Onchocerciasis (river blindness) Schistosomiasis Soil-transmitted helminthiasis (referring to ascariasis, trichuriasis and hookworm infection)

Global prevalence 84 million 400,000

Population at risk Approx. 600 million −

300,000

60 million

10,000

−

120 million 8-9 million 12 million 37 million 207 million

Approx. 1.3 billion 25 million 350 million 90 million Approx. 800 million

Approx. 800 million (for ascariasis)

Approx. 4.2 billion (for ascariasis)

Source: Hotez, et al. NEJM357: 1010-1027, 2007.

The parts in orange * control or eliminate.

represent diseases that Eisai is currently working to

●エーザイ製品が入手可能な国の数

（単位：百万人）

500+

114

2

アフリカ 13

Public–private–academia partnerships in the

欧州 37

Three Ds (discovery, development, delivery)

3

200+ Through partnerships with governments, the private sector, non23 governmental organizations (NGOs) and non-profit organizations (NPOs), the Eisai Group is implementing various strategies 22 and plans to improve access to medicines. Since it is difficult to resolve the issue of access2006∼ to medicines by phamaceutical 2006∼ 2011∼ 2010年度 2010年度 companies alone, it is necessary that2015年度 we collaborate with public, （社内推計） private and academic institutions in an ongoing manner. There are three important elements to improving access to medicines (the “Three Ds” model). Specifically, better access can be achieved by having all public, private and academic

中東 10 中南米 12

The “Three Ds”: The Keys to Improving Access 10 to Medicines 6 66 2倍以上

北米 2

are important for improving access to medicines. アジア・オセアニア 40

institutions working together on an integrated approach to the Ds, namely, the discovery of medicines and treatments for diseases prevalent in the developing world, the development of such interventions, and the delivery of those newly discovered and developed interventions and medicines together with patient education to promote their usage.

2011∼ 2015年度 three

■ The Three Ds in the comprehensive approach for improving access to medicines

Research

Discovery

Product development

Regulatory processes

Development

Introduction strategy

Scaled-up effective use

Impact on Im Ac Access to M Medicine

Delivery Reference: Christopher J. Elias

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Eisai Co., Ltd.

Overview of Eisai’s Activities to Improve Access to Medicines

Nov.

2007

■Training in Quality Control Provided to Staff from Cambodia’s Ministry of Health We organized a tour of our plants for staff from Cambodia’s Ministry of Health and provided them with lectures and practical training in the analysis of products and raw materials as well as atomic absorption spectrometry (AAS) for activities such as wastewater processing at plants. We also provided training given by an expert in counterfeit medicines.

Apr.

2010

in Indonesia ■Implementation of Affordable Pricing for We secured over 40% market share by revising prices and in two years increased the amount delivered by approximately four times compared with the amount prior to the revision. We have therefore significantly increased access to this medicine for patients in Indonesia. Aricept ®

2005

■Implementation of Affordable Pricing and Launch of Activities to Raise Awareness of Alzheimer’s Disease in India We began providing Aricept® at an affordable price in India in line with social, economic and medical conditions. At the same time, we established “Memory Clinics,” and are initiating educational and awareness programs for this disease. There were 69 Memory Clinics in India as of March 2013, with the number of patients receiving treatment gradually rising to 550,000.

Sep.

Aug.

■Acceptance of First TDR Fellow from a Developing Country A doctor from Nigeria, Eisai’s first TDR* Fellow, is involved in three drug development projects for Chagas disease, cerebral malaria and invasive fungal infections, respectively. *TDR: Special Programme for Research and Training in Tropical Diseases

Nov.

■Signing of Joint Statement of Intent with WHO for the “Price Zero” Supply of Medicine for the Treatment of Lymphatic Filariasis

We agreed to produce a total of approximately 2.2 billion tablets of the therapeutic agent diethylcarbamazine (DEC) in accordance with the high quality standards of the World Health Organization (WHO) and to supply them to WHO at price zero. We are producing the tablets at our Vizag Plant in India. More information is available in the article on page 11.

Signing of the agreement (Margaret Chan, Director-General of WHO (left) and Eisai’s President Naito (right))

Jan.

2012

■Participation in the London Declaration on Neglected Tropical Diseases

As one of the world’s 13 leading pharmaceutical companies, we cooperated with the Bill & Melinda Gates Foundation, WHO, the U.S. and U.K. governments, the World Bank and governments from NTD-endemic countries to build the largest ever international public–private partnership in a coordinated effort to eliminate 10 NTDs by 2020. More information is available on the Eisai Global Website: ●http://www.eisai.com/company/atm/activities/15.html

Jul. ■Partnership with Sabin Vaccine Institute to Develop Vaccines for NTDs Eisai entered into a partnership agreement to supply the Sabin Vaccine Institute with E6020, an in-house developed vaccine adjuvant as well as relevant information pertaining to the compound. E6020 stimulates the body’s immune system via TLR4 (Toll-like receptor 4), a receptor that plays a key role in the body’s immune system, and is expected to be used in a broad range of antigen vaccines to enhance vaccine efficacy. More information is available on the Eisai Global Website:

●http://www.eisai.com/news/news201265.html

Jan.

Under this agreement, Eisai and the Fundacão Oswaldo Cruz (Fiocruz) select development projects and conduct joint research and development for therapeutic agents for malaria and NTDs targeting compounds internally developed by Eisai. For the first collaboration, we began joint research and development of E6446 and analogs, which are TLR9 (Toll-like receptor 9) antagonists, as therapeutic agents for cerebral malaria. More information is available on the Eisai Global Website:

2011

■Trial of PPP Business Model in India In India, we implemented a pilot public–private partnership (PPP) program for Alzheimer’s disease and depression from diagnosis to treatment and care in cooperation with Apollo Hospitals and HelpAge India.

Jun. ■Acceptance of Second TDR Fellow from a Developing Country A doctor from Colombia, our second TDR Fellow, was involved in the Phase II trial for the treatment of Chagas disease, which was conducted by DNDi using drug candidates discovered by Eisai. It is expected that this study will be directly applicable to his clinical practice and clinical research work in Colombia.

Oct. ■Participation in the WIPO-Sponsored Global Consortium for NTD Research and Development Member organizations of the World Intellectual Property Organization (WIPO) Re:Search consortium provide intellectual property and research and development expertise and information for drugs and candidate compounds to treat NTDs, malaria and tuberculosis free of charge by way of a public database. Researchers and institutes from around the world share the database to promote open innovation toward the development of new therapeutic agents. The Eisai Group has provided information on seven candidate compounds to the consortium’s database. More information is available on the Eisai Global Website: ●http://www.eisai.com/company/atm/activities/13.html

Dec. ■Establishment of an Access to Medicines Advisory Board Eisai established the Access to Medicines Advisory Board by bringing together several experts in international policy and development. In order to provide ongoing solutions to patients and their families, the Board provides recommendations and advice to Eisai on what kind of activities are necessary to ensure the most cost-effective and meaningful results.

Oct. ■Agreement with Fiocruz to Develop Drugs for Malaria and NTDs

2009

■Cooperation in the Development of New Medicines to Treat Chagas Disease We entered a collaboration and licensing agreement with DNDi (Drugs for Neglected Disease initiative) for the clinical development of a new therapeutic agent for the treatment of Chagas disease. E1224, a compound developed by Eisai, was shown to have good disposition and safety during its Phase I trials, and we are currently conducting a Phase II trial for this agent.

Apr.

2013

■Co-establishment of GHIT Fund Eisai co-established the Global Health Innovative Technology (GHIT) Fund to advance the development of new medicines from Japan to fight infectious diseases in emerging countries and the developing world. More information is available in the article on page 10.

●http://www.eisai.com/news/news201275.html


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Feature: Access to Medicines

The Eisai Group is doing all that it can to tackle many of the diseases that patients are suffering from around the world. The development and supply of therapeutic agents to fight infectious diseases such as neglected tropical diseases (NTDs) prevalent in poorer regions has become a major issue from the perspective of access to medicines. We are striving to make improvements in this regard in cooperation with a variety of partners based on the three Ds (discovery, development, delivery).

Discovery and Development: New Drug Development via International Public–Private Partnerships ■Utilization of Global PDPs (Product Development Partners) Specializing in the Development of Medicines to Fight NTDs The development of new medicines to fight infectious diseases prevalent in emerging and developing countries such as NTDs requires expertise in research and development, which is limited in many of the countries where the diseases are most prevalent. In addition, the difficulty of clinical trials in these countries and the issue of financing make it an arduous task for a single pharmaceutical company to carry out a series of new drug development activities. This means there are still a number of diseases that require effective new medicines. The Eisai Group is pushing ahead with the development of new medicines to combat these diseases through joint research via product development partnerships (PDPs) with international organizations boasting experience and a proven record in the development of therapeutic agents to fight the three major infectious diseases–malaria, tuberculosis and HIV. The table on the right provides a list of PDPs under which the Group has already commenced joint research in recent years. As part of this joint research, Eisai provides compounds and scientific expertise as well as test drugs for clinical trials, while our PDP partners take responsibility for conducting basic research and clinical research.

Eisai pursues the development of new drugs to fight NTDs and malaria through

International public–private partnerships.

Targeted diseases

PDPs DNDi (Drugs for Neglected Disease initiative )

Fundacão Oswaldo Cruz (Fiocruz)

Sabin Vaccine Institute

Eisai compounds

Chagas disease Anti-fungal agent E1224

Year agreement entered 2009

Malaria and NTDs

Active TLR9 antagonist E6446 and analogs, etc.

2012

Chagas disease and leishmaniasis

Vaccine adjuvant E6020

2012

Chagas Disease: The “Silent Disease”

Leishmaniasis: The disease causing ulcer or death

●Changas disease is caused when the protozoan Trypanosoma cruzi is transmitted to humans through the bite of an infected triatomine bug. ●There are few symptoms in the initial period following infection, but in rare cases the disease can lead to death through acute myocarditis or acute meningoencephalitis in combination with cardiac arrest. ●During the incubation period, which can be from several years to several decades, the symptoms are “silent” but in 20% to 40% of infected persons this infectious disease may progress to a chronic condition and lead to sudden death caused by cardiac arrest or cardiac arrhythmia.

●Leishmaniasis is a parasitic disease in which leishmania parasites are transmitted to humans through the bite of a certain species of sand fly. ●Approximately 12 million people are infected in over 90 countries worldwide, with 350 million at risk of infection. It is thought that 2 million people are newly infected every year. ●Leishmaniasis consists of cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which causes fever and anemia. Visceral leishmaniasis affects the bone marrow, liver, spleen and lymph nodes, in particular, and if not treated can lead to death.

■Aiming to Develop New Medicines from Japan That Contribute to Global Health The Eisai Group participates in the Global Health Innovative Technology (GHIT) Fund, which was established in April 2013 to advance the development of new medicines from Japan to fight infectious diseases in emerging countries and the developing world. The GHIT Fund was set up through the cooperation of Eisai and four other Japanese pharmaceutical companies, the Government of Japan and the Bill & Melinda Gates Foundation with the aim of eliminating infectious diseases prevalent specifically in the developing world, including HIV/AIDS, tuberculosis, malaria and NTDs. The GHIT Fund will facilitate global PDPs and fund promising research programs in order to realize advances in new health technologies by Japanese pharmaceutical companies and

academic and research institutions possessing strengths in drug creation, with the aim of utilizing those technologies effectively in emerging countries and the developing world.

Representatives from member organizations at a press event on June 1, 2013

● More information on access to medicines is available on the Eisai Global Website: 　 http://www.eisai.com/company/atm/index.html

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Eisai Co., Ltd.

Delivery: Provision of Therapeutic Agents through International Public–Private Partnership ■Efforts to Help Eliminate Lymphatic Filariasis

Eisai will provide WHO 2.2 billion DEC tablets at price zero

Lymphatic filariasis, an NTD, is a parasitic disease that is transmitted to humans by the bite of carrier mosquitoes. The Eisai Group will produce 2.2 billion tablets of diethylcarbamazine (DEC), a therapeutic agent for lymphatic filariasis that is in short supply worldwide, at the Vizag Plant in India, and provide it to the World Health Organization (WHO) at price zero over a seven-year period from 2013 to 2020. This amount of tablets is required to eliminate the disease in endemic areas. This is the first case of a partnership between a Japanese pharmaceutical company and WHO to combat a global health issue. Based on our hhc philosophy, the Eisai Group will not only provide medicines but also work to enhance awareness of the disease among sufferers, the general public and doctors in an effort to eliminate it effectives.

over a seven-year period from 2013 to treat lymphatic filariasis.

■Eisai will supply 2.2 billion DEC tablets from our Vizag Plant in India to approximately 250 million people at risk of contracting lymphatic filariasis in 24 countries

DEC tablets (diethylcarbamazine)

WHO East Mediterranean Region ●Egypt

WHO Americas Region

WHO Southeast Asia Region

●Brazil ●Dominican ●Guyana ●Haiti

●Indonesia ●Bangladesh

●Myanmar ●Nepal ●Timor–Leste

WHO Africa Region ●Gambia ●Kenya ●Comoros

●Madagascar ●São Tomé and ●Zambia ●Zimbabwe

Eisai Head quarters

Republic

WHO West Pacific Region

Príncipe Vizag Plant, India

●Fiji ●French Polynesia ●Laos ●Malaysia

●Papua New ●Philippines ●Samoa

Guinea

Lymphatic filariasis: Lower extremities that swell up to resemble those of an elephant ●Lymphatic filariasis is a parasitic disease in which microfilariae are transmitted to humans through carrier mosquitoes. ●It is estimated that 120 million people have been infected in 73 countries worldwide. The disease existed in Japan from the Heian Period (794–1185) but was eliminated in the latter half of the 1970s. ●It causes lymphatic dysfunction that leads to other serious physical disabilities such as elephantiasis, a condition in which a patient’s lower extremities swell up to resemble those of an elephant. ●Lymphatic filariasis is one of the leading causes of physical disability in the world, and the economic loss resulting from persons unable to work is said to be as much as several hundred billion yen.

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Realizing Affordable Pricing in Non-endemic Areas to Provide New Medicines to as Many Patients as Possible

The Eisai Group realizes affordable pricing in consideration of income level and medical systems in order to supply Eisai products as quickly as possible to emerging markets where huge growth opportunities are forecasted on the back of a rapidly expanding middle class. We already provide Aricept®, an Alzheimer’s disease treatment, in Indonesia and Revovir®, a treatment for patients with chronic hepatitis B, in the Philippines at an affordable price, thereby significantly increasing the number of patients that these medicines help. In fiscal 2013, we plan to introduce tiered pricing in sales of the anticancer agent Halaven® and will set the price at several levels in accordance with the income level of patients within the same country. Through this, we aim to realize a low-margin, high-volume sustainable business model by supplying innovative new medicines to more patients around the world at affordable prices.


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Increasing Patient Satisfaction

Research and Development

Striving to Improve Patients’ Quality of Life Patient-Oriented R&D activities The Eisai Group defines its R&D activities as “product creation” under the belief that R&D is a cornerstone to ensuring that innovative drugs demonstrated to improve patients’ quality of life (QOL) are delivered to patients as early as possible. The Group’s R&D organization, Eisai Product Creation Systems (EPCS), strives to create innovative drugs based on an understanding of the emotions and realities of patients so as to effectively address unmet medical needs.

Drug Development Based on Innovation There are two key factors that are fundamental to generating innovation: creating therapeutic hypotheses that lead to the treatment of diseases, and having the modern chemistry capabilities to translate these hypotheses into viable compounds for use as therapeutic agents. In order to create hypotheses for optimal disease targets from rapidly progressing research on genome informatics and other information based on human biology, EPCS continues to bolster its external network of worldleading research institutes and scientists. Through collaborations with leaders in each field, the Group is increasing the possibility of obtaining candidates for disease targets and accurate validity assessments of those targets. Moreover, the creation of compounds for each therapeutic hypothesis is crucial for delivering valid hypotheses to patients in the form of actual innovative treatments. At EPCS, we are working to enhance our technological platform for creating compounds by expanding

our diverse, unique compound library while also increasing our capacity to create not only small compounds and natural products but biologics as well. ■Eisai’s Drug Creation Activities Innovation Therapeutic hypothesis

＋

＝

Innovative pharmaceutical product

Modern chemistry

Initiatives to Shorten Development Timelines and Advance Personalized Medicine ●開発期間の短縮 ●臨床研究の

バイオマーカーの活用成功確立の向上

Improving success rates in clinical development and shortening development timelines are crucial to being able to create new medicines for patients as early as possible, and EPCS is promoting the thorough operation of large-scale international clinical trials in this regard. We are also focused on the

advancement of personalized medicine, from biomarker discovery to the development of companion diagnostics (CoDx) used in their measurement in order to maximize patient benefits such as high therapeutic value and reducing the risk of side effects.

■Contribution to patients through personalized medicine Stratifying homogeneous patient subsets

Same disease, diverse patient population

Selecting patient subsets with specified characteristics

Efficacy （−） Side effects（＋）

Efficacy （−） Side effects（−）

Efficacy （＋） Side effects（＋）

Efficacy （＋） Side effects（−）

(Biomarkers and CoDx)

Patients with the same disease can have different constitutions and disease etiologies

Existing medicines ●

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Same treatment for all patients

Eisai Co., Ltd.

Role of companion diagnostics (CoDx) ・To select patients with a particular cause of the

disease (e.g., a genetic mutation) for a particular treatment

・To remove individuals believed to be at risk of adverse side effects during treatment

Personalizing patient treatment through CoDx in terms of treatment efficacy and risk of side effects

Personalized medicines ● ●

High therapeutic value Reduction of risk of side effects

● ●

コンパニオン個別化医療

Research and Stable Supply Development of Products

How a New Medicine Is Developed

Providing Information

Quality Assurance

Developing new pharmaceutical products is a long and complex process. From discovery research to identification of candidate pharmaceutical substances, clinical studies, regulatory application and review, there are many steps to ensuring the creation of safe, efficacious drugs.

Discovery research (2 to 3 years)

Identifies and creates candidate substances that have the potential to become new medicines. In this step, various chemical methods are used, including extraction from plants, microbes and other natural substances, as well as organic synthetic chemistry and biotechnology.

Nonclinical studies (3 to 5 years)

Involves studying the efficacy and safety of candidate compounds using animal or other nonhuman subjects. Tests are conducted to evaluate the safety, quality and pharmacokinetics (absorption, distribution, metabolism and excretion) of candidate substances.

Clinical studies (3 to 7 years)

Confirms the efficacy and safety in humans of those candidate compounds. Clinical studies are also sometimes referred to as clinical trials. Phase I studies:

The drug is assessed for safety and phamacokinetics in a small group of healthy adults or patients.

Phase II The drug is tested in a small group of patients to assess its studies: safety and efficacy and appropriate dose. Phase III The drug is administered for treatment in a large group of patients and tested in a manner similar to that of a real-life studies: treatment setting to confirm its efficacy and safety.

Regulatory application and review (1 to 2 years)

After confirming the efficacy, safety, and quality of the compound, an application is submitted to the regulatory authorities in each country to obtain approval to market it as a medicine. In Japan, applications are submitted to the Ministry of Health, Labour and Welfare for review by the Pharmaceutical Affairs and Food Sanitation Council and other bodies comprised of experts with relevant knowledge and experience.

Approval and sales

After the regulatory review is completed, the medicine is approved for manufacture and sales. While the prices of prescription drugs vary from one country to another, there are many countries in which the government decides the price. In Japan, prescription drugs are covered under the National Health Insurance system, and their prices are regulated in accordance with established standards.

Postmarketing commitments and studies

Involves gathering information continuously on adverse drug reactions that can only be discovered once the drug is actually used by patients, and on its proper use. Such information often provides good insights that lead to further product improvements or the development of new medicines.

Reference: Japan Pharmaceutical Manufacturers Association website


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Shaping Our Minds: Turning Knowledge into Action—Activities Report Contributing to Patients’ Well-Being with Anticancer Agent Halaven® Halaven® is an anticancer agent that was discovered by the Eisai Group and is currently approved for the treatment of metastatic breast cancer in over 40 countries, including Japan, the United States and in Europe. Working to ensure that Halaven is made available to patients around the world, the Group is also seeking approval for the agent in countries in South America and Asia. Halaven is a non-taxane, microtubule dynamics inhibitor with a novel mechanism of action and is a totally synthesized derivative of a natural product known as halichondrin B, which is extracted from the marine sponge Halichondria okadai . The Group received the Pharmaceutical Society of Japan (PSJ) Award for Drug Research and Development ’13 in recognition of its achievement in developing the drug, particularly for the ingenuity of the research theme, its innovativeness as a medical treatment, and the establishment of a method for bulk manufacture with an extremely difficult process control that enables high-precision stereocontrol over 64 sequences.

Launch of Fycompa® and Inovelon® in Epilepsy Area The Eisai Group positions epilepsy as a therapeutic area of focus. Among patients with epilepsy, there are still many individuals who cannot completely control seizures with existing antiepileptic drugs, and thus new drugs are required. Fycompa®, developed in-house, possesses a novel mechanism of action that exerts an antiepileptic effect by antagonizing AMPA-type receptors and thus inhibiting neuronal hyperexcitation. It is currently approved in more than 30 countries, including the United States and in Europe and since its launch in the United Kingdom in September 2012 has contributed to patients with epilepsy as a new treatment option. Furthermore, Inovelon®, a therapeutic agent for the rare disease Lennox-Gastaut syndrome (LGS), is approved and has been launched in Japan. LGS is one of the most severe and intractable forms of childhood-onset epilepsy, and the agent has been granted orphan drug designation by Japan’s Ministry of Health, Labour and Welfare for treatment of the disease.

Fycompa® in Europe Award ceremony for the researchers at the Pacifico Yokohama on March 27

Seeking to Create a New Treatment for Alzheimer’s Disease The Eisai Group has pioneered in the treatment of dementia through its creation of the anti-Alzheimer’s disease agent Aricept® and in this role is working to create dementia drugs based on new treatment concepts. One of the causes of Alzheimer’s disease is thought to be the deposition in the brain of a protein known as betaamyloid. According to a prevalent therapeutic hypothesis, it is expected that reducing beta-amyloid will slow progression of the disease. At the Alzheimer’s Association International Conference held in fiscal 2012, Eisai presented the results of its research to date, which showed that E2609, an agent being

developed in-house, significantly reduced beta-amyloid in the body (in cerebrospinal fluid and plasma). E2609 is thought to reduce the overall amount of beta-amyloid by inhibiting the beta-site amyloid precursor protein-cleaving enzyme (BACE). In addition, we have been conducting clinical trials of the novel monoclonal antibody BAN2401 targeting for soluble aggregates of beta-amyloid protofibrils, based on the concept of achieving early detection and early treatment of Alzheimer’s disease. Eisai is also consistently striving to create new Alzheimer’s disease treatments through its focus on both small compounds and biologics.

Contributing to Patients with Cancer in Japan Eisai continues to enhance its oncology product portfolio in Japan, launching Gliadel® in January 2013. Gliadel is the third anticancer agent to be launched in the country, following the launch of TREAKISYM® and Halaven®. Gliadel is a wafer formulation approved for intracranial implantation. It contains carmustine (generic name) distributed in a biodegradable polymer matrix and is used following surgical removal of malignant glioma. In April 2013, the vascular embolization device DC Bead® received approval for use in transcatheter arterial embolization (TAE) therapy in patients with hepatocellular carcinoma. Furthermore, lenvatinib mesylate (generic name), which is undergoing clinical development as a treatment for thyroid

14

Eisai Co., Ltd.

cancer with the aim of filing an application, has been designated as an orphan drug not only in Japan but in the United States and Europe as well.

Gliadel® in Japan



Quality Assurance

Consumer Healthcare Business in Japan Our Consumer Healthcare Business is responsible for over-the-counter (OTC) drugs available through pharmacies and drugstores as well as quasi-drugs, foods with nutrient function claims and other products sold in convenience stores that are designed to improve the health and well-being of consumers. Our Consumer Healthcare Business is the one business that allows us to get up-close and personal with consumers. We always make certain that we listen to the feedback provided to us by customers, pharmacists, and drugstore employees alike and utilize this information to ensure the development and improvement of high-quality products that benefit patients and enhance their quality of life (QOL).

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Chocola BB® Hyper contains 13 active ingredients effective in combatting symptoms of fatigue (designated quasi-drug)

Morphotek Inc. Plant Receives 2013 Facility of the Year Award for Sustainability

U.S. subsidiary Morphotek Inc. was designated as the 2013 Facility of the Year Awards (FOYA) Category Winner in Sustainability for its recently opened pilot plant for the production of antibodies. The FOYA program is dedicated to celebrating technological innovation and accomplishments in facility design, construction and operation in the global pharmaceutical industry. The plant’s construction was selected as the Sustainability Category Winner for (1) building on a brownfield site, (2) minimizing the amount of energy used for shipping building materials, and (3) using Building Information Modeling (BIM) software to optimize the design process.

Morphotek Inc. Plant

● For more information on the award, please visit our corporate website: http://www.eisai.com/pdf/others/e20130205.pdf

R&D Activities Based on International Rules and the hhc Philosophy Fairly and properly conducted research activities are a basis of the Eisai Group’s corporate activities. The Group complies with the various regulations concerning research and development of pharmaceuticals in each of the countries in which we operate, as well as with international guidelines for safe and ethical research and development such as Good Laboratory Practice (GLP, for implementation of nonclinical drug safety tests) and Good Clinical Practice (GCP, for implementation of clinical trials). Our research activities are underpinned by faithful compliance with these international regulations and guidelines, as well as the high ethical principles at the core of Eisai’s hhc philosophy. Clinical studies from the patient’s perspective At Eisai, we believe that the highest priority must be given to protecting the rights, safety and welfare of patients who participate in clinical studies. The Eisai Group's Code of Conduct stipulates that our research activities comply faithfully with all relevant regulations (including GCP, GLP) in each country, and with high regard for ethical principles. The Group also has established global standard procedures to assure ethical conduct in the implementation of clinical studies, which stipulate that the Group shall investigate ethical issues and scientific adequacy prior to starting any clinical study. Furthermore, to enhance the transparency of its clinical studies, the Group accurately discloses information on clinical studies that meet certain conditions at the appropriate time, to make it easier for healthcare professionals and patients to gain access to information. Animal testing that takes into account animal welfare Eisai believes that animal testing is a necessary and required part of verifying safety and efficacy in the development of new drugs.

The Group carries out research and development in compliance with the relevant rules and regulations for animal testing. In Japan, we have established in-house guidelines in accordance with the Fundamental Guidelines for Proper Conduct of Animal Experiments and Related Activities as laid down by the Japanese Ministry of Health, Labour and Welfare (MHLW) and comply with national laws and applicable government agency and ministry guidelines. Animal testing is monitored and controlled by the Institutional Animal Care and Use Committee, which includes outside experts, in order to ensure the dignity of the animals involved and to comply with the 3R* principles for animal testing. At the Tsukuba Research Laboratories, we carry out self-monitoring and evaluation of animal tests to verify that each test is conducted appropriately. The initiatives for these animal tests are evaluated as accurately implementing animal testing based on the MHLW’s guidelines mentioned above, and in March 2009 and March 2012 (revised) we have received certification from the Health Science Center for Accreditation of Laboratory Animal Care and Use of the Japan Health Sciences Foundation. Furthermore, our Andover Research Institute in the United States has received the accreditation of AAALAC International, which is a global, third-party evaluation organization.

*

3R: reduction in the number of animals used, replacement with nonanimal experiments whenever possible, and refinement to alleviate animal suffering

● For more information on animal testing that takes into account animal welfare, please visit our corporate website. http://www.eisai.co.jp/social/research/index.html


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Stable Supply of Products

Building a Global Production System Based on the Patients’ Perspective We deliver a stable supply of high-quality medicines at affordable prices to patients worldwide “The quality of every single tablet, capsule, and ampoule that we produce is integral to the life of patients.” This is the general policy on product quality upheld by the Eisai Group. We believe that as long as there are people around the world in need of medicines, it is our mission and responsibility to continue ensuring a stable supply of high-quality pharmaceutical products. To attain this objective, we work to assure quality through an outstanding structure covering all processes ranging from formulation research to production and distribution.

Product Supply Structure That Realizes Patient Satisfaction Since fiscal 2010, the Production Department has carried out production activities aimed at increasing patient satisfaction under the Eisai Demand Chain Systems (EDCS) along with its shift from being a supply-driven organization to one driven by demand. A demand chain is a structure that not only produces and supplies pharmaceutical products but that also actively ascertains the needs of patients and promotes production activities and product improvements. The environment surrounding the pharmaceutical industry is evolving rapidly owing to such factors as increasing demand in emerging countries, the problem of access to medicines, and responses to biologics and other new technologies. As these changes unfold, we further reformed EDCS to deliver products to patients that accurately meet their needs. Specifically, in October 2012 we transitioned from a production structure emphasizing optimization of each production site to a global structure for implementing end-to-end production activities, from raw materials procurement to manufacturing, packaging and shipment, in each product lineup. Implementing

end-to-end production will enable us to grasp patients’ true needs in a timely manner and quickly deliver products that realize patient satisfaction. Under the new structure, business units organized according to product lineup will ascertain the needs of patients in each product domain, strive to provide formulations that meet these needs and improve the convenience of packaging to create products that lead to Customer Joy. Additionally, the structure features quality assurance and sub-contracted production management functions as functions for supporting these production activities. With the collaboration of all functions, we will provide stable supplies of high-quality pharmaceutical products at affordable prices. Through the operation of our global independent demand chain “for all patients and their families as well as members of the wider public,” we will continue responding quickly and flexibly to diverse patient needs throughout the world and provide stable supplies of high-quality pharmaceutical products that realize ever-greater patient satisfaction.

■Shift from a “production structure focused on production sites” to a “structure that aims to increase patient value” in each product lineup

Kashima Plant

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Eisai Co., Ltd.

API Formulation

Formulation

Packaging

Packaging

Vizag Plant

Misato Plant Kawashima Plant Sannova Co., Ltd. Hatfield Plant North Carolina Plant Tainan Plant Bogor Plant Suzhou Plant

Global production structure that implements end-to-end production in each product lineup

Biologics

Procurement

API

Formulation

Packaging

Anticancer agents

Procurement

API

Formulation

Packaging

Procurement

API

Formulation

Packaging

Products for global markets

Procurement

API

Formulation

Packaging

Products for Japan and Asia

Procurement

API

Formulation

Packaging

New products

(other than biologics and anticancer agents)

Patient satisfaction

API

Units based on product lineup

Patient needs

Production structure emphasizing optimization of each production site


How a Pharmaceutical Product Is Manufactured


Quality Assurance

It takes several production processes and quality tests to produce safe, high-quality pharmaceutical products before delivering them reliably to patients. This flow chart explains the manufacturing process for tablets and capsules.

① Receiving and Dispensing Raw Materials

Precise Dispensing Ensures the Efficacy of Every Granule Pharmaceutical products are produced in plants from active pharmaceutical ingredients (APIs) created through a long research and development process. Ingredients are dispensed in precise amounts to ensure the proper effect. Binders and other excipients are added, and the mixture is blended to form granules containing a uniform amount of APIs.

② Granulation and Milling

Automated transport is used to prevent human error.

③ Encapsulation and Tableting

Shaped into Medicines on Clean, Automated Production Lines Granules are pressed into a tablet shape (granules are compressed and formed into tablets) or filled into capsules while undergoing strict quality checks directly.

④ Coating and Printing

Making Medicine Easy to Use for Healthcare Professionals and Patients

Printing on both sides

After tablets are formed, coating is applied when necessary to mask the bitterness of the medicine. Additionally, the coated medicine in tablet or capsule form is imprinted with letters, numbers and symbols identifying the name of the medicine. Each tablet and capsule is then visually inspected for shape and size irregularities. Front

Back

⑤ Packaging

Making Packaging Easy to Use for Healthcare Professionals and Patients

Blister packaging

Outer package

The medicines are packaged in blister packaging in which the medicine contained in plastic cavities is pressed through an aluminum foil blister board backing or containers such as bottles, inspected yet again, and then packed in boxes with a package insert listing product information.

A single line handles the process from blister package filling to packing in cardboard boxes.

⑤ Packaging

Delivery to Patients Now in product form, the medicine undergoes further inspection before finally being delivered to the patient. The Eisai Group has built a global manufacturing and distribution system designed to provide patients with a stable supply of high-quality medicine.


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■Overview of Our Global Production Structure The Eisai Group currently has four production sites in Japan and six production sites overseas. We have established a structure that enables the products we supply globally to be produced

at multiple production sites and are building a structure that ensures stable supplies of high-quality pharmaceutical products to people throughout the world even during emergencies.

●Hatfield Plant (U.K.)

Suzhou Plant (China)● Vizag Plant (India)●

Kawashima Plant (Gifu) Misato Plant (Saitama)

● Kashima Plant (Ibaraki)

●

Sannova Co., Ltd. (Gunma)

North Carolina Plant (U.S.)

●Tainan Plant (Taiwan)

●Bogor Plant (Indonesia)

Shaping Our Minds: Turning Knowledge into Action—Activities Report Eisai’s Initiatives for Achieving a Safe Healthcare Environment Attaching IC Tags to Vial Labels With the aim of preventing medical accidents resulting from the mishandling of medicines administered in operating rooms and at bedsides in hospitals, we are working to establish IC tag attachment technologies for individual dispensing packages and have attached IC tags to the backside of vial labels (attached to the backside of the picture barcode). The product code, manufacturing number, expiration date, and serial number are recorded on the IC tags, and each and every vial can now be properly managed. Besides reading information, it is now also possible for medical institutions to write necessary information. In the future as well, we will continue to contribute to the realization of safe healthcare environments.

Front

Side

Realizing Affordable Pricing through Vizag Plant Operations The realization of affordable pricing is crucial for improving access to medicines, which is an aim of the Eisai Group. The Vizag Plant is one manufacturing site that plays a central role in the achievement of affordable pricing. This plant has obtained approval from Japan, the United States and India as a manufacturing plant for active pharmaceutical ingredients (APIs) and formulations as well as approval from European countries and South Korea as a manufacturing plant for APIs. In this manner, it is establishing a structure as a production plant serving the entire world, including emerging countries. To date, the Vizag Plant has manufactured and exported Myonal® 50mg tablets, Aricept® 5mg tablets, and Pariet® 20mg tablets to Japan. Additionally, in fiscal 2013, diethylcarbamazine (DEC) 100mg tablets, one of the medicines for lymphatic filariasis, will be manufactured at the Vizag Plant and provided at price zero to the World Health Organization (WHO). We will continue to supply high-quality products at affordable prices to patients around the world.

IC tag (on backside label)

Vizag Plant formulation wing

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Eisai Co., Ltd.


Column 1

Socialization* with Patients

Spending time with patients and other members of the wider public provides an invaluable opportunity to acquire an understanding of their hopes and to generate new ideas. It also helps instill a sense of responsibility and mission among our employees tasked with creating pharmaceuticals. In order to create such opportunities, our production plants in Japan invite patients and their families to tour the facilities. In August 2012, the Kawashima Industrial Park invited two patient association groups, consisting mainly of children, to tour its production facilities. Visitors had a chance to voice their own views on medicines through their participation in activities such as the plant tour, scientific experiments and a lunch gathering. The occasion also served as an opportunity for employees to think about what they need to do to fulfill the hhc mission. Similar tours were also held at the Misato Plant. As in the case of the Kawashima Industrial Park, in addition to being shown the production process, hands-on programs such as chemistry experiments were provided. While participants enjoyed themselves by taking part in the tours, there were also sessions for patients to voice what they expect of a pharmaceutical company and to


Quality Assurance

* Activities for understanding the emotions of patients by spending time together with them

exchange views on the hhc activities being undertaken at each plant. At the same time, in order to gain insight into the everyday lives of patients and the wider public, employees visit the places where patients and the general public live and gather. By visiting medical institutions, nursing homes for the elderly and facilities for persons with intellectual disabilities, employees learn about the sincere hopes of patients and other users of the facilities and about what they expect of pharmaceutical companies. In addition, it is an opportunity for employees to get a feel for the high aspirations of all the people working on the frontlines of medical care, caregiving, nursing care and welfare, and for them to reaffirm their own mission and responsibilities. We are also extending these activities to our overseas plants. The Suzhou Plant (China) has arranged opportunities for interacting and communicating with patients through a program called Listen to the Voice of the Customer. The Bogor Plant (Indonesia) is also implementing similar activities. Through these activities, we will continue to gain an understanding of the realities that patients face and take steps toward fulfilling the hhc mission.

Left: Observation tour at the Misato Plant (manufacturing process) Center: Observation tour at the Misato Plant (scientific experiments) Right: Relay for Life 2012 Kawagoe

Column 2

Provisions for Major Disasters and Pandemics

The Eisai Group has a business continuity plan (BCP) to enable a stable supply of products even in the event of a major disaster or other emergency situation. In fiscal 2012, under a Group-wide policy that encompasses the Eisai Network Companies, Eisai systematized and upgraded various functions and regional BCPs and established a system for making consistent responses globally. Moreover, each at operational site has carried out repeated drills aimed at enabling activities to be started for minimizing human damage and the quick resumpition of business operations in the event of a major disaster. Also, to prepare for outages of commercial power sources, Eisai installed in-house power generators in all domestic plants to assure necessary electric power. While enhancing the individual BCPs maintained by

each production site and developing a global system capable of responding to diverse risks, we are currently building a stronger and more flexible structure for ensuring stable supplies through such initiatives as establishing multiple sites for supplying raw materials.

In-house power generator installed at the Kashima Plant


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Engaging with Patients through Information Provision of Accurate Information on Medicines and Collection of Information for Future Use The Eisai Group gives first thought to patients and undertakes its business activities with the aim of providing products that satisfy patients’ needs. For various problems that cannot be solved only by providing medicines, Eisai strives to increase the benefits that health care provides to patients and their families by carrying out informationproviding and information-gathering activities from the perspective of the patients. Without the provision of accurate information, such as on the appropriate dose, side effects, indications and usage, pharmaceuticals might not be used effectively and safely. The Group believes the keys to realizing true hhc are gathering opinions from patients and healthcare

professionals, understanding the latent needs of patients and responding to their feelings and concerns. Eisai’s information-providing and information-gathering activities are carried out mainly through three channels, namely, medical representatives (MRs), its call center and websites. We are also bolstering our structure for properly conveying higher-quality information as we undertake our marketing activities in countries around the world. Moreover, by undertaking activities to promote awareness of various diseases, beginning with Alzheimer’s–type dementia, we are providing related information to patients and their families, caregivers, and the general public at large.

Three Channels of Information Provision: Example in Japan Patients and their families Product information Disease-related information

Inquiries Feedback Eisai’s Three Channels Call Center

Medical Representatives (MRs)

Website

Role of MRs

Call Center “hhc Hotline”

Website “eisai.jp”

The main role of MRs is to provide information on pharmaceuticals to medical institutions and pharmacies, including information on a drug’s efficacy and side effects. MRs also gather information on side effects and other matters pertaining to products from the medical institutions they visit and share that information with relevant departments within Eisai.

The hhc Hotline is a toll-free service that handles inquiries and suggestions from customers 365 days a year. The hotline provides simple yet thorough explanations on the most essential basic information. Moreover, the feedback and inquiries we receive are shared among related departments as the “Customers’ Voice” and are used for improving medicines and providing even better information.

Eisai uses its Japanese portal site (http://eisai.jp) to provide information to patients and healthcare professionals. From prevention to cure, the site covers information on all products available in Japan, including prescription drugs, consumer healthcare products and information on diseases. There is also a section where specialists from various therapeutic disciplines answer questions on minor health-related matters.

Information is shared among related departments. Provision of information Support for scientific seminars

Collection of information

Inquiries Feedback

Healthcare professionals

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Eisai Co., Ltd.

Product information Disease-related information



Quality Assurance

Role of MRs Working as an MR requires broad knowledge that goes beyond product information to encompass medicine, pharmacology and pathology. To ensure that MRs are knowledgeable in such areas, Japan has a standard certification test system for MRs that applies throughout the pharmaceutical industry. In addition, Eisai Co., Ltd. organizes periodic training opportunities for all of our MRs. In the medical world, where advances are being made each and every day, it is extremely important to hold conferences on diseases and treatments, and to have occasions for healthcare professionals to exchange information with one another. Eisai’s MRs work closely with medical associations, pharmacist associations and government agencies to organize forums with the aim of promoting disease awareness and medical seminars for doctors, and also serve as a liaison between health professionals while strictly complying with ethics and compliance regulations.

The Four Main Roles of MRs Provide Information Provide information on pharmaceuticals to medical institutions and pharmacies, including information on a drug’s efficacy and side effects as well as information on related diseases.

Gather and Share Information Gather information on side effects and other matters pertaining to products from the medical institutions they visit and share this with relevant departments within Eisai.

Provide Academic Support Support medical seminars and explanation sessions for doctors, pharmacists and other healthcare professionals to provide them with information.

Promote Disease Awareness Carry out activities for promoting disease education and awareness among the general public by holding public courses and forums and distributing printed materials.

Eisai Group in Japan: Creation of two hhc Units in Japan The healthcare environment surrounding patients and their families is changing dramatically due to changes in Japan’s healthcare and nursing care policies. Within this changing environment, the Eisai Group in Japan, which undertakes the Group’s pharmaceuticals business in Japan, has restructured its organization into two groups based on a renewed focus on the actions and thoughts of patients in order to respond more closely to patients’ needs. One of the newly established groups is the Integrated Community hhc Unit. This unit will satisfy the needs of patients and their families, such as patients with dementia, who live their lives within the medical districts of each community as they deal with their disease over the long term. The second group is the Oncology hhc Unit. This unit strives to meet the needs of patients who are facing more serious and more critical circumstances, such as those afflicted with cancer and who are thus involved in an even broader domain of health care within their medical district. Activities of the Eisai Group in Japan focus not only on each pharmaceutical category and health care segment but also emphasize medical districts based on patients’ health consultation behavior as we work toward increasing patient satisfaction and creating hope.

■Integrated Community hhc Unit Community-oriented medical districts based on patients’ health consultation behavior

Approximately

35 districts

1,400 MRs

■Oncology hhc Unit Broad medical districts centering on specialist facilities

Approximately

4 districts

120 oncology MRs


21


Shaping Our Minds: Turning Knowledge into Action—Activities Report “Customer Hotline” Becomes the “hhc Hotline” In April 1990, Eisai Co., Ltd. established the Customer Hotline, the industry’s first such hotline, for the purpose of promptly responding to inquiries and suggestions from patients and healthcare professionals. With such appealing features as toll-free access 365 days a year, making easy for customers to call in, the hotline has responded to over 1.57 million inquiries to date. In fiscal 2012, the Customer hotline handled a total of 108,298 inquiries. In April 2013, the Customer Hotline marked its 23rd year of operation and in keeping with our goal of further implementing hhc , the name of the hotline was changed to the hhc Hotline. We will continue to utilize the valuable opinions of our customers to improve quality and our products as we aim to realize Customer Joy.

Other: 1% Consumer healthcare products:

26％

Among these: 77% from the general public 21% from pharmacies and drugstores 2% from others

108,298

inquiries

Prescription drugs:

73％

Among these: 75% from hospitals and health insurance pharmacies 11% from patients and their families 14% from others

Number and breakdown of inquiries in fiscal 2012

Disseminating Information on Proper Usage Based on Opinions Received through the Hotline The hhc Hotline receives inquiries not only from healthcare professionals but also from many patients. (In fiscal 2012, there were 9,117 inquiries regarding prescription drugs.) The most frequently received inquiry, particularly on Saturday, Sunday and holiday mornings, was: “I forgot to take Actonel®. What should I do?” Actonel is an osteoporosis treatment available in three types that are taken once per day, once per week or once per month, respectively, depending on the lifestyles of the patients. Based on opinions received from customers, for Actonel taken once per week and once per month, we adopted packaging that combines a cardboard backing for inscribing the drug administration dates and an easy-to-understand explanation of the drug administration method. Additionally, the hotline also receives calls from pharmacists at clinical sites about questions asked by patients. To meet the needs of these pharmacists, we created printed materials with frequently asked questions providing various information and disseminated them accordingly.

Packaging for Actonel ® taken once per month

Utilizing the Opinions of Health Insurance Pharmacies at Drug Administration Guidance Locations Eisai Co., Ltd. held dementia workshops for pharmacists in regions throughout Japan to respond to the latent concerns and questions of pharmacists at health insurance pharmacies who interact with dementia patients on a daily basis. These workshops provided training on specific ways of interacting with elderly dementia patients and their families and caregivers as well as on care procedures. These also featured exchanges of opinions among the pharmacists about difficulties they had regularly experienced for counseling patients on the use of Aricept® and good measures they have adopted to address such difficulties. This information has been compiled into “patient information leaflets” (pamphlets that contain information on diseases and points for caution in administration for providing Aricept to patients) as well as in the aptly titled Aricept Information . This material was provided to health insurance pharmacies via our MRs; it was also introduced in product presentations at hospital meetings, and has been put to good use in providing instructions on the use of Aricept to patients and family members.

22

Eisai Co., Ltd.

A discussion at a dementia workshop for pharmacists



Quality Assurance

Providing Audio Information for the Visually Impaired Patient information leaflets are used as a tool for patients to deepen their own knowledge about a disease and its treatment and to enhance communication with healthcare professionals. Eisai Co., Ltd.’s patient information leaflets include audio codes that allow the patient to listen to the printed information by using an audio code reader, which reads up to 1,000 characters of Japanese text that has been pre-recorded in a

barcode the size of a stamp. Currently Eisai provides around 30 such information leaflets with these audio codes. We will continue to promote barrier-free access to pharmaceutical information that is easy to read and understand for all patients, including the estimated 300,000 visually impaired persons in Japan.

Searchable, Map-Based Dementia Patient Community Support Directory on e-65.net Website Eisai Co., Ltd. redesigned our dementia awareness promotion website e-65.net and established a searchable, map-based dementia community support directory (http://sasp.mapion.co.jp/b/e-65/). The directory is a service that allows people to search the area they live for nearby “comprehensive support” community centers that provide consultation on dementia as well as for healthcare institutions that offer diagnosis and treatment for the disease. This site helps people to easily arrange consultations at such community centers and healthcare institutions in their neighborhood should they have questions about their own possible dementia symptoms or those of members of their family, and this is expected to facilitate early diagnosis and responses to dementia. The directory can be accessed at the e-65.net website (http://www.e-65.net).

Main page of the redesigned e-65.net website

Column

Launch of Antiobesity Agent BELVIQ® (lorcaserin HCl) CIV Tablets in the United States

BELVIQ® was launched in the United States in June 2013 as the first new treatment to be approved in 13 years for overweight or obese patients with a weight-related medical condition. Eisai Inc., a U.S. subsidiary, established the product website BELVIQ. com to coincide with the launch in order to create fuller opportunities for providing product information. The site features information for physicians about BELVIQ and obesity including maps from the U.S. Centers for Disease Control and Prevention that outline obesity statistics in different U.S. states, as well as patientoriented content that includes information about the agent, a Body Mass Index (BMI) calculator and other content. Sales team members at Eisai Inc. are required to have passed a certification test on their knowledge of BELVIQ. Rather than solely focusing on product knowledge, a workshop was held during which representatives were able to develop a better understanding of obesity by listening to presentations from patients who took part in the clinical trials for BELVIQ and doctors who addressed the

challenges they face in working with individuals who are struggling with obesity.Eisai will continue to actively engage in the provision of accurate information in order to address antiobesity treatment needs worldwide. ● BELVIQ product website (in English)　　　 http://www.belviq.com/ About BELVIQ® (lorcaserin HCl) BELVIQ is a new chemical entity that was discovered and developed by Arena Pharmaceuticals and is approved by the U.S. Food and Drug Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of 30 kg/ m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. The use of BELVIQ in combination with other products for weight loss has not been established, and its effectiveness on cardiovascular morbidity and mortality has not been established. For further information on BELVIQ, including important safety information (ISI), please visit the BELVIQ product website. According to the U.S. Centers for Disease Control and Prevention, over two-thirds of adults in the United States are either overweight or obese and the percentage of obese people is currently more than double that of 30 years ago. Furthermore, being obese or overweight may be accompanied by other comorbid conditions such as diabetes, hyperlipidemia and hypertension. The increase in the obese and overweight population in the United States also constitutes a major social problem. 　BELVIQ is a registered trademark of Arena Pharmaceuticals GmbH.


23


Quality Assurance

Quality Assurance from the Patients’ Perspective Quality That Extends up until the Time a Product Is Taken Correctly A stable supply of high-quality medicines is essential for realizing the human health care (hhc ) mission. Maintaining quality is important, extending from the quality design of a pharmaceutical product, to production and distribution, and right up until the time that product is taken correctly by the patient with its proper efficacy and safety intact. The Eisai Group has built a global framework for quality assurance in compliance with Good Manufacturing Practice (GMP) standards, the international guidelines for pharmaceutical production and quality management. At the same time, the Group is pursuing ever-greater levels of quality that leads to Customer Joy (CJ) through meeting the latent wants and needs of patients. Quality Assurance from the Patients’ Perspective The Eisai Quality Advisory Board (EQAB) carried out quality assurance activities over a three-year period as an attempt to view Eisai’s quality not from the perspective of a pharmaceutical manufacturer, but from the perspective of patients and customers. EQAB is an advisory board made up of outside experts set up for identifying quality issues and assessing and reviewing big-picture issues such as employee attitudes toward quality as well as corporate culture and organizational structures and has ensured that these efforts lead to the building of new organizations (EDCS and CJ* Department) and also worked to instill the importance of quality from the patient’s perspective in employee attitudes (experiencing the emotions of patients and their families, and pursuing Customer Joy). * CJ: Customer Joy

Building Systems for Global Quality Assurance and Safety Monitoring The Eisai Group has built systems for global quality assurance (QA), setting up a quality Core Function Unit (CFU) under the Eisai Demand Chain Systems (EDCS). Based on an underlying framework comprised of quality assurance officers in charge of QA functions in the Group’s sales regions around the world– Japan, the Americas, EMEA and Asia as well as QA functions at the plants responsible for production, the Group guarantees the supply of high-quality products while complying with the different regulatory requirements of each country and region. The Group has established an international standard operating procedure (SOP) for monitoring drug safety with due consideration to the regulations in each country around the world. We gather and evaluate information worldwide on the safety of our global products (including compounds in clinical development), and implement appropriate measures in response to any issues that are identified. Moreover, the Eisai Global Safety Board (GSB), which is comprised of experts from each region who specialize in monitoring drug safety, discusses product safety issues, including compounds in clinical development, and makes decisions in order to promote the safe and appropriate use of drugs, such as proposals for revisions to package inserts.

Quality Concept In this model, quality is divided into three levels: primary quality, to be met by all products as a matter of course; secondary quality, measured by customer satisfaction; and tertiary quality, which attempts to generate Customer Joy by fulfilling latent needs. Eisai, which works to evaluate and enhance quality based on the degree to which we fulfill our hhc mission, is pursuing Customer Joy in the form of this tertiary quality.

24

Eisai Co., Ltd.

Tertiary Quality (Customer Joy)

Secondary Quality (Customer Satisfaction)

Primary Quality (Basic Quality)



Quality Assurance

Activities of Our Dedicated Department to Create Customer Joy

Product complaints

Inquiries from patients and consumers

for in nursing homes or in their own private homes in order to better understand the potential or latent needs of our customers. Correlations are then drawn between observations made through these efforts and the feedback received from customers. These are shared with relevant departments, and applied to specific quality and product improvements. nursing care training programs, either at medical facilities * Onsite or in a home setting in order to better understand the realities and potential needs of our customers

Employee–patient socialization at medical and nursing care facilities

Understand latent needs

Inquiries from medical institutions

Gather information on overt desires

The CJ Department is engaged in proactive efforts based on the Declaration of Customer Joy: We strive not only to understand the latent needs of our customers through the socialization process*, but also to generate Customer Joy by providing products, information, services and networks as a package that meets these needs. Since the establishment of the CJ Department, we have promoted employee–patient socialization by having personnel visit hospitals, clinics and health insurance pharmacies, as well as spending time with patients who are being nursed and cared

Provision of products, information and services that generate Customer Joy

Examples of Improvements Aimed at Creating Customer Joy Reducing the Size of Aricept® D 10mg Tablets Aricept®, an Alzheimer’s disease treatment, is offered in an orally disintegrating tablet (ODT) formulation called “D tablets” that dissolves with saliva or small amounts of water so as to be easily taken by elderly patients. Among the various D tablets, we reduced the size of the previously large-size 10mg tablets to enable patients to take these tablets more easily. Changing the size of these tablets

has also yielded other benefits, such as reducing breaking and chipping during preparation. It has also enabled smallersize sheets and boxes, which improves ease of handling by healthcare institutions. Because half-quantity dosages are sometimes used depending on the condition of the patient, we also added tablet-splitting lines on both sides of the 10mg tablets.

Tablet after improvement

Tablet before improvement 9.5mm

8.0mm

(Front)

(Back)

(Side)

●Diameter changed from 9.5mm to 8.0mm. ●Splitting lines were inserted.

(Front)

(Back)

(Side)


25

Increasing Patient Satisfaction Examples of Improvements Aimed at Creating Customer Joy Colorless and Transparent Blister Sheet for Warfarin® 0.5mg Tablets The oral anticoagulant Warfarin® hinders blood coagulation and prevents thrombus. Warfarin tablets are available in 0.5mg, 1mg types, among others. Because Warfarin’s ingredients have properties making it susceptible to degradation in light, redcolored plastic, which blocks light, was used as a sheet. Nevertheless, red is a visually strong color that made it difficult to identify tablet color or lettering from outside the sheet. Accordingly, we received comments from healthcare institutions such as, “The sheets look similar, which makes it

difficult to identify differences in tablet content volume.” In response, we considered the use of colorless and transparent sheets that could still block light and then adopted this sheet for our 0.5mg tablets after confirming that quality could still be maintained. By making this improvement, the color of the 0.5mg tablets are now clearly visible from outside the sheet, making it easy to distinguish between 0.5mg tablets and 1mg tablets, which still use red-colored plastic sheets.

Previous sheet Back

Front

Back

We made the pockets transparent.

Front

New sheet

Blister Sheet Design Change for Nitorol® Tablets

26

Eisai Co., Ltd.

New sheet (back)

The expiration date is now displayed for each tablet.

Previous sheet (back) The expiration date was displayed across two tablets.

Nitorol®, a drug for ischemic heart disease, has a rapid action for relieving symptoms during an occurrence of angina and is thus used in its treatment. Because many patients frequently carry this drug with them over a long time period, we have imprinted expiration dates on the back of the sheet to ensure that patients can use Nitorol with a sense of reassurance. Previously, we printed the year and month on the back of the sheet, which covered two tablets. We have now changed the sheet design so that the dates are displayed for each individual tablet, making it easier for patients to know the expiration date and enable them to safely take this drug with peace of mind.


In addressing complaints about quality from customers, Eisai Co., Ltd. investigates the cause of each individual complaint and takes necessary steps to make improvements. As a result of a Company-wide effort to reduce complaints, the number of product complaints received in fiscal 2012 was 939, declining 8% from fiscal 2011. The Company had been receiving a number of persistent complaints on unresolved matters before the EQAB began its initiative to decrease the number of such complaints. About 50% of these persistent complaints arose after products had been shipped from the production plant, and involved product handling either during distribution or during use by medical institutions and patients. Previously, our understanding was that there was a limit to improvements that could be made at the production plant level to address persistent complaints arising during the distribution stage. That awareness changed, however, when we realized the importance of our role in resolving issues faced by our customers, and we worked toward addressing countermeasures. As a result, we learned that we could indeed make improvements in regard to issues once considered impossible to address, and that this perceived difficulty had, in fact, stood in the way of us making such improvements. Going forward, we will continue our efforts to resolve complaints from the customer’s perspective.

■Trend in the Number of Complaints 1,600 1,400 1,200 1,000

First half

1,438 1,178

767

800

538

200 0

Second half

If an issue about the quality of a product should arise, this could lead to quality concerns among medical institutions that would prevent them from administering the product to patients. The Eisai Group believes that giving appropriate explanations and quickly providing alternative products leads to peace of mind and trust in our products. We promptly collect and send back any products that are the subject of a complaint to the plant, where an investigation into the cause of the problem is carried out. Those results are then explained to the customer. We regard reducing the number of days required for this response, from the time of initial customer contact to final explanation, as an important aspect of Customer Joy and have worked to improve this response time. We began by getting all persons who came into contact with any products that were the subject of a complaint to share in the understanding that reducing the response time is important, and then looked at how each individual task could be shortened. As a result, we successfully shortened total response times from 26.7 days in fiscal 2009, when the CJ Department was launched, to 20.4 days in fiscal 2012. In the future, we will work to further shorten the number of days needed for responses after MRs obtain information and following the investigation of causes. We will prepare written responses and reference materials that are easy for MRs to understand and explain as well as proper written responses that can be easily understood by customers as part of efforts to provide customers with a sense of reassurance. ■Response Time in Handling Complaints (including Saturdays and Sundays) (Days)

1,082

511

600 400

Quality Assurance

Efforts to Reduce Complaint and Claim Response Times

Efforts to Address Persistent Complaints

(Complaints)


1,016

30

939

510

484

25

26.7

23.3

20

20.1

20.4

2011

2012

15 10

671

640

571

506

455

2008

2009

2010

2011

2012

5 (FY)

0

2009

2010

(FY)

Ensuring That Our Products Are Delivered Safely to Patients: Global Product Security In recent years, it has been reported that the risks of counterfeit medicines* have been rising not only in emerging and developing countries, but in industrialized countries as well. It is also a fact that the spread of the Internet has made it easy to carry out illegal distribution activities. In response, besides our ordinary quality assurance activities, the Eisai Group also promotes global product security activities so that our high-quality products reach patients safely and securely. In collaboration with regulatory authorities, other companies in the industry and industry organizations, we closely watch for counterfeit and illegally distributed medicines and also actively work on developing and implementing preventive measures. If actual cases are detected, we take swift action, including conducting investigations, taking legal action and securing a stable supply of genuine products. Specific measures for preventing an influx of counterfeit medicines include the use of counterfeit-proof labels utilizing hologram technology and the adoption of barcodes that enable the identification of individual

packaging of pharmaceutical products, and these measures are implemented in accordance with the risk for each product category and region. Today, global momentum is gathering for the introduction and strengthening of Good Distribution Practice (GDP), a standard for the distribution of pharmaceuticals. The Eisai Group will monitor these trends carefully and implement appropriate measures that meet the needs of the times. The knowledge thus obtained will be utilized by sharing it with bases around the world that are involved in the development, production and marketing of our products.

* Counterfeit medicines are pharmaceutical products that are deliberately forged or fraudulently produced, either in whole or in part, and include medicines that have been mislabeled with respect to their product name, manufacturer and/or distributor. They include products that appear in imitation packaging as well as those that may contain no active ingredients or may contain incorrect amounts of ingredients, and it is often difficult to distinguish them from genuine products at first glance.


27


Opinion from a Global Health Expert

Eliminating Lymphatic Filariasis and Other Neglected Tropical Diseases (NTDs) by 2020 Dr. Kazuyo Ichimori Scientist, World Health Organization (WHO) Headquarters, Geneva Dr. Ichimori has been a scientist at the WHO since 1992. After working on control of filariasis, malaria, dengue and other vector-borne diseases at country and regional levels, she was appointed in charge of Integrated Vector Management, the Department of Control of Neglected Tropical Diseases at the WHO Headquarters in Geneva. Since 2010, she is responsible for the Global Programme to Eliminate Lymphatic Filariasis in the same department. Her previous work with the WHO has seen her involved in various initiatives to control and eliminate vectorborne diseases in Africa, Central and South America, and island nations in the Pacific.

Firsthand Experience Is the First Step in Eliminating Tropical Diseases Although I am currently working at the World Health Organization (WHO) Headquarters in Geneva, I have worked as a scientist at WHO for over 20 years and in that time have been involved in various projects to eradicate tropical diseases, including mosquito-borne communicable diseases such as lymphatic filariasis and malaria. What has always struck me as particularly important when carrying out these initiatives is that we are able to see and experience local conditions firsthand. Actually setting foot in the areas where the disease is endemic affects us more directly on an emotional level and as a result we are often better able to get to the heart of the matter in terms of accomplishing the task at hand. WHO is currently supporting endemic countries to implement mass drug administration-based campaigns for entire endemic populations in 53 out of 73 countries where lymphatic filariasis remains, with the aim of interrupting transmission of this disease. Nevertheless, convincing 500 million people from a wide diversity of ethnic backgrounds, belief systems and cultures to consent to taking the medicine is no simple feat. It is only natural to have doubts when faced with the decision of whether or not to accept medication from a stranger. For an individual to be willing to take the medicine tends to rest heavily on whether the good intentions and sense of conviction on the part of the ones providing the medicine are adequately conveyed. Even then, to be able to feel at ease after taking the tablets, too, further depends on the establishment of mutual trust. It is being able to understand each other on this point that becomes so crucial for these projects to succeed. Ultimately, for people who may not be accustomed to the practice of taking medicine in their day-today lives, there is no other way than to appeal to their humanity. As people, I think, we all want to reduce the suffering in our lives as much as possible; no matter what the country or cultural background of the individual, I think that this is something to which we can all relate and that we all share as human beings. In the Republic of Kiribati, an equatorial nation in the Pacific Ocean, I remember asking a patient who had developed elephantiasis due to lymphatic filariasis if I could take his photograph for use in a disease education poster. Full of joy, he told me how happy he was that he, someone who was unable to walk unassisted and who was entirely dependent on those around him, might help somebody out there by having his picture taken. The experience reaffirmed my belief that

28

Eisai Co., Ltd.

no matter who we are, being able to contribute to others and play a meaningful role in our community offers us hope. The desire to rid our society of disease for the sake of the next generation, I think, is something universal.

Encouraging More Japanese to Openly and Proactively Show Their Support for Our Cause In the late 1970s, Japan became one of the first countries in the world to successfully eliminate lymphatic filariasis. The worldwide program that continues to be implemented by the WHO today is the heritage of those initial seeds planted and nurtured by Japanese, including Japan’s own success in eradicating the disease as evidence that the vision is indeed attainable and the country’s ongoing support for numerous initiatives to eradicate communicable diseases ever since. Among these, the development and supply of reliable medicines play a vital role and I am delighted to think that Eisai, a Japanese pharmaceutical company, is providing DEC tablets toward eliminating this disease. I would love to see more industry–government–academia partnerships being established in Japan based on the initiative of Japanese and a more open show of support from groups and individuals in that country to better raise public awareness for this cause. Japan has played such a pioneering role in the planting of those seeds and I believe that now is the time for us to participate in what could be called the “harvest period” in terms of combating lymphatic filariasis worldwide. I urge all supporters in Japan to continue to actively participate in the program and play a greater role in harvesting the fruits of what is also our own labor as Japanese. There are still many people suffering from lymphatic filariasis around the world, with an estimated more than 120 million people currently infected in emerging and developing countries. Japan possesses the technology to eliminate this disease and so it follows that we also share the responsibility to contribute. It was this belief that first led me to become involved in the fight against tropical diseases. I cannot imagine anything more wonderful than to be able to change the current situation to one where, in the next generation, people will be able to look at a photograph of a patient with elephantiasis and say, “So in the past, people had to go through life suffering from diseases like filariasis....” * Elephantiasis: See related information on page 11.

Mass drug administration for lymphatic filariasis ©WHO/DEC Bangladesh

Eisai’s Social Activities

Crisis Management Eisai’s Approach to Global Crisis Management The Eisai Group has established a Crisis Management Committee and outlined the basic approach to crisis management and preparations that must be taken for dealing with an emergency situation in the ENW* Crisis Management Policy. Pursuant to this policy, we plan to complete disaster response investments to meet antiseismic standards in all of our facilities in Japan and to minimize damage in the event of an emergency by fiscal 2013. Further, we are working to make continuous improvements toward enhancing intangible aspects, such as incorporating action that individuals should take in an emergency in the Emergency Response Manual and formulating the Crisis Response Headquarters Manual aimed at ensuring efficient initial response by members of the Crisis Response Headquarters. In addition, the ENW Business Continuity Plan (BCP) has been established and shared globally to ensure contributions to patients are not interrupted even in the event of an emergency. * Eisai Network Companies: Eisai Co., Ltd. and all Group companies in and outside Japan

Effective Initial Response in an Emergency Each unit (division) and sales region (business territory) has created a crisis management structure according to its function and scope of business as well as regional characteristics, and is creating and continually striving to improve regulations and manuals concerning initial response that place priority on the safety of employees in the event of an emergency.

Enhancing Crisis Responsiveness through Training and Drills Based on the lessons learned from the Kamaishi Miracle*, evacuation drills with all personnel participating and Crisis Response Headquarters training are conducted. As a rule, each type of training is conducted at least twice a year to foster crisis awareness and improve the ability of all employees to respond to a crisis in the event of an emergency. * Kamaishi Miracle: During the Great East Japan Earthquake, the elementary and junior high school students of Kamaishi City in Iwate Prefecture diligently followed what they had learned in drills and escaped on their own to high ground. Despite the school buildings being significantly damaged by the tsunami, all enrolled students were confirmed safe, hence the name.

Efforts to Continue Critical Business Activities We establish specific BCPs to ensure the continuation of critical business activities such as the stable supply of pharmaceuticals and ongoing product creation (R&D activities). The BCPs are constantly verified and reviewed through training.

ENW Business Continuity Plan (BCP) Basic Policy 1. Place the highest priority on initiatives for securing the safety of all employees 2. Protect the surrounding environment thoroughly by preventing the spread of disaster 3. Place “contributing to patients” as the most important of all critical business activities, even in an emergency; continue hhc activities and strive for a speedy recovery in the aftermath of an emergency 4. Develop and implement permanent disaster countermeasures in pursuit of assured business continuation 5. Internalize the principle of “self-help” and “mutual help” in all employees, and foster an awareness of crisis through implementing various kinds of repeated drills for all employees

Business Continuity Response Overseas All local affiliates as well as research facilities and production plants are required to create a crisis management structure that includes the establishment of a route for information related to crisis. The aim of creating such a structure is to ensure that crisis information is channelled swiftly from the local affiliate overseas to members of the Crisis Management Committee at the headquarters so that precise instruction can be provided in the event of an emergency. In order to conduct effective R&D activities and realize a stable supply of pharmaceuticals, we are aiming to create a BCP that is globally consistent. With this in mind, we are proceeding with the establishment of regulations and manuals that cover aspects from initial response to continuing critical business activities and recovery for respective sites of each company as well as revising content through training and drills.

Example of Business Continuity Response Overseas When Hurricane Sandy struck the East Coast of the United States at the end of October 2012, it caused widespread blackouts and gasoline shortages, resulting in the offices of a U.S. subsidiary in New Jersey closing for a week. At the time, the subsidiary managed to minimize the impact on business mainly through recovery of the IT environment. Learning a lesson from this, we are pushing ahead with further optimization to ensure a means for communication as well as a substitute office in the event of an emergency. Going forward, efforts will be made to strengthen the crisis management structure, including swift confirmation of employee safety, and to ensure business continuity throughout R&D, production and sales in the Eisai Group anywhere in the world.


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Corporate Governance and Compliance For Fair and Transparent Management Eisai Co., Ltd. continually pursues optimum corporate governance and makes ongoing efforts for its enhancement. In order to build a long-lasting relationship of trust with our stakeholders, we are working continuously to strengthen corporate governance and our global system of internal control, and strive to ensure observance of legal and ethical standards based on the recognition that compliance serves as the foundation for corporate survival.

Corporate Governance System The central aspect of the Eisai Group’s corporate governance system is the clear separation of supervision of management and execution of business by fully utilizing the fact that we have adopted a Company with Committees System. The presence of independent and neutral outside directors, who account for the majority of the 11 members of our Board of Directors, supports the effective operation of the Company’s corporate governance system. The Board of Directors carries out supervision of management by inspecting the validity of processes and decisions made in the execution of business from the perspective of shareholders and society. By broadly entrusting Corporate Officers with the authority to make decisions related to management to the extent permitted by law, the Company aims to promote flexible management. At the same time, the appointed Corporate Officers provide and ensure autonomy through internal control to enhance management vitality and stimulate the vitality of corporate management. Furthermore, in order to achieve a clear separation between management supervision and business execution, an outside director is appointed as Chair of the Board of Directors. The Chair of the Board of Directors ensures that the selection

of agendas and the establishment of annual themes are scrutinized in order to enable the Board of Directors to make fair and appropriate judgments on behalf of shareholders and other stakeholders. Sufficient time is also spent to confirm the content of proposals presented to the Board of Directors. The Board of Directors’ Secretariat is supervised to explain the content of the proposals to each director in advance of meetings. Furthermore, the proceedings of the meetings of the Board of Directors are carried out in ways that enable directors, with their diverse backgrounds, to express their opinions on the basis of their varied knowledge.

Execution of High-Quality Internal Audits Under the supervision of the Corporate Officer Responsible for Internal Control, Eisai’s Corporate Internal Audit Department collaborates with the internal audit staff of Eisai Group companies to carry out internal audits. The Corporate Internal Audit Department objectively evaluates whether business activities are being carried out properly and efficiently on the basis of the hhc philosophy and compliance standards.

■Eisai’s Corporate Governance System General Meeting of Shareholders

Management Audit Department

Wide delegation of Company management decisions to Corporate Officers Supervision of the execution of business

Collaboration

Audit Committee

Audit Committee 5 members (3 outside, 2 internal) Chair: Outside Director

Audit Committee

Board of Directors: 11 members (7 outside, 4 internal) Chair: Outside Director

Nomination Committee 3 members (All Outside)

Compensation Committee 3 members (All Outside)

Independent Committee of Outside Directors 7 members (All Outside)

Board of Directors’ Secretariat

Executing Divisions President (Representative Corporate Officer) and CEO

Accounting Auditor

Executive Committee

Accounting Audits Corporate Officer Responsible for Internal Control Corporate Internal Audit Department

Internal audits

Corporate Officers Individual divisions/ subsidiaries inside and outside Japan Development and operation of the internal control system

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Furthermore, it continuously confirms the extent of improvements that have been made in regard to issues identified through internal audits. With the criticality of risks in mind, the Corporate Internal Audit Department formulates internal audit plans as well as ensures the quality of internal audits by carrying out auditing activities in accordance with prescribed methods. Furthermore, it strives to execute high-quality internal audits that meet global standards through continuous improvement as well as regular external assessment.

Risk Management Promotion System Every year, the Corporate Compliance and Risk Management Department implements a Control Self-Assessment (CSA) at all Eisai Group companies in an effort to reduce risks in day-today operations. In doing so, we aim to stimulate the risk management cycle (identification, assessment, control and monitoring of risks), while at the same time supporting internal control activities. The Group has also either established a regional management organization or appointed a regional manager in Japan, the Americas, EMEA, Asia and other regions, respectively, to promote CSA, and is promoting the global development of internal controls by supporting risk management.

Compliance Promotion System The Eisai Group regards internal control as “the systems and processes established and managed internally to ensure proper and efficient operations” and is promoting the establishment of global internal controls under the Corporate Officer Responsible for Internal Control. The Eisai Group’s compliance system is presided over by the Chief Compliance Officer. Under this system, the Corporate Compliance and Risk Management Department has established compliance departments in each region and is working with the compliance personnel in each ENW company to promote compliance globally. The Group’s compliance activities are periodically assessed on a regular basis by the Compliance Committee, an advisory organization consisting primarily of outside legal experts such as lawyers and consultants from inside and outside Japan. The Committee conducts an objective review of the Group’s compliance activities and offers necessary advice and recommendations to the Chief Compliance Officer.

Promoting Compliance Awareness ■Compliance Handbook To ensure that all officers and employees adhere to the same standards of compliance, the Group has established the Eisai Network Companies Charter of Business Conduct, which serves as the basis of its business activities, and the Eisai Network Companies Code of Conduct, which lays out the concepts. The Compliance Handbook , which includes both the charter and code, is available in 18 languages, including Japanese, English and Chinese, and helps to instill all officers and employees with the Group’s compliance mindset. The Group also distributes the Compliance Guidebook for Managers to managers at all Group companies in order to provide them with knowledge and tools to guide and supervise their subordinates when implementing compliance activities within their own organization. ■Compliance Cards All Eisai Group corporate officers and employees must carry a card entitled the “Eisai Network Companies Compliance Test” at all times. The card serves as a reminder to constantly selfexamine and check their behavior in light of the three questions printed on the card: “Could you openly tell your family what you did?”, “Do you think the only way to avoid a problem is to not to tell anyone what you did?” and “How would you feel if you read a report of your behavior in the news media?” ■Compliance Training The Eisai Group conducts various training programs on compliance, including seminars for top management, programs focusing on a particular department or specific type of employee such as newly appointed managers or newly hired employees, as well as an Internet-based e-learning program. Eisai also distributes a weekly, compliance-focused email magazine to all officers and employees in Japan. ■Compliance Counter In April 2000, Eisai established the Compliance Counter to serve as an accessible in-house compliance consultation service for employees to utilize whenever they are having difficulty making compliance-related decisions, such as interpreting the law, or have compliance concerns about their own conduct or that of their supervisors or colleagues. The counter fields inquiries on a diverse range of matters, including personal information protection, copyrights and the Public Service Ethics Code. In addition, external consultation services staffed by outside lawyers and counselors have also been established, thereby creating an environment that encourages compliance.


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Talent Development Increasing Benefits for Patients through Diverse Human Resources (Realizing hhc) The Eisai Group seeks to have all of our employees make our Corporate Philosophy their own and work towards implementing the hhc philosophy every day, on the job. We have positioned employees as important stakeholders in our Articles of Incorporation and are determined to work toward ensuring stable employment, providing rewarding careers, and offering opportunities for the development and enhancement of employees’ capabilities. In addition, employees are deemed valuable assets of the company who can realize the Corporate Philosophy of their own accord, and we refer to human resources as “talent” to reflect this.

Leverage Diversity to Realize Provision of Required Pharmaceuticals and Services In order to meet a wide range of needs around the world, respond flexibly to changes and contribute to advancements in healthcare, it is necessary to make use of the values of a vastly diverse array of personnel and reflect these in our pharmaceuticals and services. For that purpose, the Eisai Group is working to ensure diversity across the board and is aiming to create value that fulfills the needs of individual patients at an even higher level. To make diversity into a driving force for business expansion, it is essential that we have a common goal as a pillar of our operations. Eisai’s “pillar” is none other than our hhc philosophy, which has been put into practice and

embodied resolutely over the years. We take the patient into consideration in everything we do in our business and we will continue striving to make sure that each employee understands the emotions and realities of the patients. Promoting innovation in our talent has been a constant endeavor based on the hhc philosophy, which is shared by all employees globally, and this has formed the foundation to reflect diverse values in our business activities. By maximizing the value of each and every employee going forward, we aim to enhance the comprehensive strength of all employees who support corporate growth.

Developing Talent to Fulfill the hhc Philosophy The Eisai Group believes that giving first thought to patients and their families and understanding their emotions and realities is the starting point of all our business activities. We recommend that all of our employees spend 1% of their working hours, a total of around two days each year, together with patients to reflect this idea. We hope to bring joy, hope and peace of mind to patients by having our employees spend time with them and learn about the patients’ thoughts, concerns and true needs firsthand and through doing so create higher-quality products and services. Employees with diverse backgrounds (such as in regard to nationality, gender and age) work hard to improve their own skills based on our “pillar” of realizing the hhc philosophy. We emphasize the importance of employees thinking for themselves about what they can do for patients and their families, and also how they can apply that mindset to their day-to-day work. One example of this is in-field experience training. Employees visit healthcare facilities for the elderly and facilities

for persons with intellectual disabilities and come into close contact with the residents of the facility as well as the staff in an effort to empathize with patients, their families and care providers. Once the training is completed, employees have the opportunity to discuss their experiences with each other, which provides motivation for new hhc activities as they reflect on their daily work. We also offer opportunities for employees to spend time with patients who have dementia or epilepsy, and organize tours of our production plants and research facilities for patient groups. All of these efforts represent some of the opportunities we create in order to nurture personnel who are capable of working towards the fulfillment of our Eisai’s Nursing Care Simulation hhc philosophy. Experience Training Program

Awareness and Promotion of Diversity Using Intranet and Pamphlet In October 2012, the Group released the “Eisai Diversity Declaration.” We also issue PLEDGE , a pamphlet on diversity, each quarter and are striving to increase awareness among employees and foster a corporate culture in which diversity is respected and integrated. In July 2013, we set up a diversity-related intranet as a new endeavor. On this site, we introduce those employees viewed as role models who take the initiative and continue to play an active part in the Company, including women who both work and raise children. This aims to motivate employees to try to develop their career on their own initiative.

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Homepage of the intranet site

PLEDGE pamphlet

Promoting Active Roles for Women ■Diversity Committee　 Inauguration of Women’s Work Role Promotion Group Our vision for promoting the role of women is to help them to follow their dreams, develop a career and find a good work–life balance as well as take into consideration their perspectives as a means to support them. We aim to create an environment that supports career development so that motivated and highly capable female employees continue to work with us for many years.

■Nurturing Young Female Leaders

The Eisai Group is working hard to nurture young female leaders through our E-STAR program, which targets young employees and aims to develop selected leaders. In fiscal 2012, a total of 28 female employees (approximately 40% of all participants) took part in the program.

■Membership in NPO J-WIN

Eisai Co., Ltd. has become a member of the non-profit organization (NPO) J-WIN (Japan Women’s Innovative Network), which aims to develop female leaders, form an external network and gather external cases of measures taken to promote the role of women. Through this program, approximately 260 women from around 90 member companies from diverse industries, occupations and corporate cultures come together to brainstorm, extend their network and implement activities that broaden perceptions and horizons.

■Introduction of Women’s MR Support System

In April 2013, Eisai Co., Ltd. introduced a flextime system for medical representatives (MRs) who are taking shortened hours. We aim to ensure a system that better supports our female MRs so that they can continue to work while having and raising children.

Participants of the E-STAR program held in fiscal 2012

Support for Global Talent Development The Eisai Group conducts talent development to enhance the capabilities of each employee so that they can implement the hhc philosophy at the global level. We offer leadership development programs with the goal of nurturing global talent who will be able to lead Eisai in the future. E-GOLD is a program offered to senior management in each business area and region, while E-elite is a program conducted regionally for managers in Japan, the United States, Europe and Asia with the goal of fostering “intrapreneurship.” In addition to these, E-STAR is a leadership development

program for young employees and E-smile is a program that offers short-term internships with the aims of facilitating the transnational exchange of knowledge and strengthening the Group’s global network. The total number of participants in these leadership development programs and our support system for studies in foreign and domestic MBA programs currently includes over 750 leaders. Many of these individuals are now active in globally based functions or hold key regional positions.

■ Interview with Chief Talent Officer Okada (Executive Vice President) Building a Corporate Culture That Integrates Diverse Values and Nurturing Independent Individuals It is important to promote an employee composition that brings together employees irrespective of gender, age and nationality as well as a corporate culture and structure that ensures the diversity of the organization. The Eisai group makes every effort to achieve its goals of building a structure that enables diverse global talent to play active roles in a professional capacity and establishing an organization that respects and accepts diverse values based on a flexible mindset. Closely connected to the establishment of this kind of environment and system are individual independence and a change in mentality. A career is not something that is received from the Company. The Company merely offers an opportunity to play a role and a place to grow. The individual decides how his or her career will then develop. The Eisai Group endeavors to foster independent individuals and to build an environment that encourages people to change the way they think about their career.


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Ensuring a Motivating Workplace Environment That Offers a Sense of Security Eisai Co., Ltd. defines employees as principal shareholders in Article 2 of the Articles of Incorporation. Embodying this idea is the fact that we have positioned employees as the most valuable assets of the Company since our founding. For this reason, we aim to create a workplace environment that encourages each employee to practice the hhc philosophy and challenge oneself so that Eisai can have a future vision and hope as well as develop and grow over the long term, and so that each person can keep working with a sense of security. We offer an array of options to employees such as flexible work styles that are tailored to certain jobs, including flextime and a discretionary labor system, as well as a system that allows employees to take leave or work shorter hours to care for their children and other family members. In addition, we have established various leave systems that exceed legal requirements such as leave for volunteers and donors to encourage social contribution among employees. We are also striving to ensure the mental and physical well-being of employees such as by assisting them in obtaining mental and physical health care from industrial physicians.

Against this backdrop, it is necessary to look at each individual and respond in light of changes to the social setting of the moment and the actual conditions facing the Group in order to create a working environment that boosts the collective strength of the organization. To achieve this, we introduced a system in April 2012 in which employees retire at 65. This enables them to fully exercise the skills and experiences they have accumulated over the years and realize a workplace where employees can work with a sense of security until the age of 65. In April 2013, we introduced a system for MRs who are often away from the office. MRs who select shortened work hours are allowed to adopt flextime options that fit their individual needs. In this way, we have provided an environment in which employees with a strong desire to keep working at Eisai Co., Ltd. can make full use of the skills and experiences they have accumulated and continue working. Going forward, we will promote initiatives that aim to build a better working environment and that take into consideration the changes occurring around us.

Respecting Human Rights in the Workplace

Initiatives to Establish a Working Environment That Embraces Change Social demands and individual employee needs regarding the working environment are diverse and change with the times. In addition, the business climate in recent years has posed increasingly difficult hurdles to future growth in the form of an increasingly intense and complex competitive environment along with rapid globalization.

The Eisai Group in Japan carries out regular human rights training, including via an online e-learning system designed to foster a comfortable workplace where human rights are respected and no discrimination or harassment occurs. Our human rights training is centered on the theme of human rights in the workplace. Programs cover examples of various behaviors that are considered prejudiced or discriminatory and that may lead to feelings of alienation or different types of harassment. At the same time, the programs stress the importance of respecting oneself and others, and of listening attentively.

■Main Benefits Offered by Eisai Co., Ltd. Company housing Company housing for transferees and for transferees their families

Employee stock ownership plan

Encourages employees to build up their assets and secure a stable livelihood

Dormitories for single employees

Asset-building savings

Encourages employees to build up their assets and secure a stable livelihood

Nursing care leave

Allows employees who need to provide care to take a certain period of time off

Short-term nursing care leave

Allows employees to take up to five days of leave per year (10 days per year for families of more than two people) to care for family members

Dormitories for single employees up to the age of 35

Company housing available to Company housing employees for their first five years of for newlyweds marriage Employee cafeterias

Lunch provided to employees by cafeterias at operational sites

Recreational facilities

Directly managed recreational facilities and many affiliated facilities across Japan

Health clinics

Fully equipped medical offices at the headquarters office, research facilities, and plants (with regularly available doctors)

Shorter working hour system for nursing care

Allows employees who need to provide care to work shorter hours for a certain period

Subsidies provided for loans and recreation, etc.

Childcare leave

Allows employees to take leave to focus on child-raising up until the child’s third birthday

Mutual welfare association

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Shorter working hour system for childcare

Allows employees to work shorter hours to focus on child-raising up until March 31 following the child’s ninth birthday

Recuperative leave system

Allows employees to attain two weeks of consecutive leave at 40 and 50 years old

Organ donor leave

Allows employees to obtain leave when they donate bone marrow

Volunteer leave

Allows employees to obtain leave if they volunteer for multiple days

Nursing leave system

Allows up to five days per year of leave (10 days per year for employees with two or more children) to attend to sick children

■Enhancement of Leave Systems Supporting Diverse Styles of Work

Leave Systems

Diverse Needs and Purposes Health

Leisure and reduced working hours

Social contribution

Family

Maternal protection

Work

Disaster

Menstrual leave

Recuperative leave system

Organ donor leave

Congratulatory or condolence leave

Maternity leave

Relocation leave

Disaster victim leave

Long-term sick leave

Summer vacation

Volunteer leave

Nursing leave system

Morning sickness leave

Leave to return to one’s country

Nursing care leave

Pregnancy outpatient leave

Special leave

Legal leave Eisai leave

Occupational Health and Safety The Eisai Group established the Eisai Network Companies Safety & Health Policies based on the principle of undertaking corporate activities with respect for human dignity, with first priority placed on safety and health. The policies stipulate a code of conduct for health and safety in seven areas and we prepare a Safety and Health Management Plan every year in accordance with the policies. Five of the main production and research sites of the Eisai Group in Japan and two overseas sites have obtained OHSAS18001 certification and have established occupational safety and health management systems. These sites are also coupling their systems with the PDCA*1 cycle to independently and continually upgrade their systems, which helps improve the level of occupational safety and health. All our employees have a shared understanding of the basic principles of health and safety, and the Group carries out its health and safety activities with the aim of ensuring a workplace where no one gets injured and no one falls ill.

In fiscal 2012, the Eisai Group*2 focused its health and safety related efforts on the following six areas.

● Promotion of occupational health and safety activities

through information sharing and active idea exchange, such as on past cases and measures taken to date ● Enhancement of health and safety education and training ● Prevention of recurring accidents by eliminating similar kinds of potential risk ● Maintaining and improving the mental and physical health of employees ● Reinforcement of chemical substance management *1 A method for continually improving management operations by repeating the plan-do-check-act (PDCA) cycle. *2 Eisai Co., Ltd. and Group companies in Japan

Eisai Network Companies (ENW*) Safety & Health Policies Fundamental Safety & Health Policy Eisai and its Group companies (hereafter ENW) place safety and health as a top priority and promote business operations respecting human life and dignity. Safety & Health Guidelines 1. ENW places safety and health as a top priority in all business operations and continuously pursues a policy of no accidents, injuries or disasters. 2. ENW places safety and health as a top priority at all stages of corporate activities from research and development, production, distribution, sales to product usage and disposal. 3. ENW constructs and operates a safety and health management system and promotes this in all operations. 4. ENW complies with all applicable laws, regulations, and agreements concerning safety and health, and each company implements voluntary standards that exceed the minimum standards set forth in the applicable laws, regulations, and agreements. 5. ENW actively introduces advanced technology to be at the forefront of safety technology. 6. ENW shares the fundamental safety and health policy and implements educational training to strengthen specialties at each workplace progressively and continuously. 7. ENW actively discloses information on policies, objectives, programs and results concerning safety and health. * Eisai Network Companies: Eisai Co., Ltd. and all Group companies in and outside Japan


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Social Contribution Activities Contributing to Society as a human health care (hhc ) Company It goes without saying that the Eisai Group contributes to the lives of patients through its products, but the Group also works to earn the trust of all members of society as a good corporate citizen. As hhc companies, we strive to contribute to society beyond the scope of our business operations, by undertaking programs that contribute to the advancement of medical science and interaction with the local community.

The Naito Museum of Pharmaceutical Science and Industry The Naito Museum of Pharmaceutical Science and Industry was established in 1971 by Eisai’s founder, Toyoji Naito, as the first general museum in Japan dedicated to medicine. At present, the collection includes around 65,000 items related to medicine and some 62,000 pieces of literature, of which approximately 2,000 are on display. In February 2009, the museum was designated as a Heritage of Industrial Modernization by Japan’s Ministry of Economy, Trade and Industry, in recognition of the numerous historical materials it archives, including medicine placards and advertisements, pharmaceutical manufacturing equipment, measuring tools, pharmaceutical products and hygiene equipment. Admission to the museum has been made free of charge, with the aim to promote research into medicine and the education of visitors from the wider public about pharmaceuticals. Each display is differentiated by a theme color, with items positioned to maximize ease of viewing, and all explanatory text in Japanese has been supplemented with English text. In addition, 600 varieties of medicinal plants and trees are grown in the attached Medicinal Herb Garden, which is also open to the public. Approximately 40,000 people visited the museum in fiscal 2012. Special Exhibition “Medicine and Healthcare–by exploring the old, discover new wisdom: The origins of Chinese herbology in East Asia and Japan’s medical industrial modernization heritage” Each year, the Naito Museum of Pharmaceutical Science and Industry holds a special exhibition. With traditional Chinese medicine returning to the spotlight in recent years, the Museum’s fiscal 2013 exhibition, co-hosted with The Naito Foundation, introduces literature as well as other historical artifacts tracing back the history of Chinese herbology from China, to South Korea, and finally to Japan.

The Naito Foundation The Naito Foundation was established in 1969 with donations from Eisai and its founder, Toyoji Naito. Its goal is to promote research in the natural sciences related to the prevention and treatment of diseases, and contribute to the advancement of academic research and human welfare. As part of its activities, the Foundation provides financial support to leading researchers each year. In fiscal 2012, the Foundation’s Merit Award for the Advancement of Science, the Natural Science Scholarship, and other grants were provided to 237 researchers, who collectively received a total of ¥501.23 million in support. In addition, the Foundation also holds several sessions of the “Naito Conference” each year, at which scientists from Japan and overseas who are leaders in specified research fields present their latest findings. Eisai supports the Foundation, and continues to offer donations and cooperate in its management. ● The Naito Foundation　　　 https://www.naito-f.or.jp/en/

The Health Care Science Institute The Health Care Science Institute was established in 1990 as one of the events commemorating the 50th anniversary of Eisai Co., Ltd.’s establishment. The Institute aims to contribute to the advancement of medicine and human welfare in Japan by highlighting the state of health care and the proper role of the pharmaceutical industry, and by promoting interdisciplinary surveys and research focused on medicine and related sciences. Specifically, in addition to independent research and educational training of researchers, the Institute gives back to society through the publication of the Journal of Health Care and Society , and at the 23rd Health Care Science Institute Symposium held in September 2012, hosted a discussion on “Applicability of Health Technology Assessment (HTA) in policy decision-making: Current situations in foreign countries and issues in Japan.” As with The Naito Foundation, Eisai supports the Institute and continues to offer donations and cooperate in its management. ● The Health Care Science Institute　　　 http://www.iken.org/english/misson.html

Health and Medical Care Contributions Awards The Naito Museum of Pharmaceutical Science and Industry Address: Kawashima-takehaya 1, Kakamigahara City, Gifu Prefecture Opening Hours: 9:00-16:30 Closed: Mondays and over the New Year holidays Admission: Free Tel: 0586-89-2101 http://www.eisai.co.jp/museum/english/index.html

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As a means of making an important contribution to society in accordance with our hhc philosophy, Eisai Co., Ltd. has co-sponsored the Health and Medical Care Contributions Awards (sponsored by the Yomiuri Shimbun newspaper, and

supported by Japan’s Ministry of Health, Labour and Welfare and Nippon Television Network Corporation) since 1986. The awards are dedicated to people who have achieved outstanding accomplishments while providing medical services over many years in challenging environments. In fiscal 2012, 15 people were presented with the award in the Japan category for their long-standing commitment to regional health care, having braved harsh natural conditions to provide medical services on remote islands and in mountainous areas, including regions with heavy snowfall, in affected regions following the Great East Japan Earthquake. Furthermore, three people received the award in the overseas category, including a nursing care provider who worked for 21 years in Ethiopia, an advocate for the visually impaired in Nicaragua, and a noted contributor to regional healthcare services in Nepal.

Eisai USA Foundation Inc. Eisai USA Foundation Inc. was established in 2008 as part of Eisai’s commitment to be a responsible corporate citizen and contribute to the good of society in which it does business. The Foundation focuses its charitable giving in four areas: healthrelated initiatives for patients and caregivers, disaster relief efforts, innovation in medical and pharmaceutical sciences, and community activities in areas where the Group’s U.S. employees live and work.

American Red Cross (New Jersey, United States) officials (center left and center right) with the vice presidents of Eisai USA Foundation Inc. (far left and far right)

● 41st Health and Medical Care Contributions Awards　　　 http://www.eisai.co.jp/social/award/award41.html

Walking Mileage Plus Program Eisai Co., Ltd. provides employees and their spouses the opportunity to participate in the Walking Mileage Plus program. The aim of Walking Mileage Plus is to prevent lifestyle diseases and to maintain and increase health by encouraging participants to incorporate exercise in the form of walking into their daily routines. Employees and their spouses who choose to participate in the program are given pedometers that can be connected to a computer and that enable them to enjoy their daily walking activities. Eisai Co., Ltd. then makes donations in accordance with the number of steps walked by employees each year as a form of social contribution. A donation equivalent to the steps walked by each participant is given to one of seven organizations of the walker’s choosing. Organizations include NPOs that support cancer patients and promote preventative exercise, and an environmental conservation group. In fiscal 2012, a total of approximately ¥2.16 million was donated. The program has two complementary goals, namely, to promote health while also contributing to society, and at present there are over 3,000 employees and spouses participating in the program.

■Disaster Relief Support for Hurricane Sandy Survivors In 2012, Eisai Inc. donated US$100,000 to the Hurricane Sandy New Jersey Relief Fund and US$50,000 to the American Red Cross through Eisai USA Foundation Inc. as relief for the victims of Hurricane Sandy, with the aim of supporting efforts to not only assist the survivors of the disaster, which caused extensive damage on the eastern coast of North America and in various Caribbean nations, but to also contribute to the recovery of devastated areas. ■Long-Term Support Base for Cancer Patients through Conquer Cancer Foundation In May 2013, Eisai USA Foundation Inc. began its donation of what will be a total of US$1 million over a span of four years to the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO). Eisai USA Foundation Inc. is committed to supporting initiatives to advance knowledge, research and patient care, particularly in oncology, a long-standing area of focus for the Eisai Group. In that light, the donation primarily focuses on funding research, professional education and information, and international programs and initiatives that seek to increase access to and improve the quality of patient care. The work of the Conquer Cancer Foundation aligns with the Eisai Group’s human health care (hhc ) mission to help make a difference in the lives of patients and Eisai is proud to support its vision of a world free from the fear of cancer. In order to realize this and other hhc objectives, Eisai USA Foundation Inc. will continue to collaborate with academia and oncology research organizations in the fight to conquer cancer.


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Eisai’s Environmental Activities

Efforts to Ensure Coexistence with the Global Environment The Eisai Group conducts business operations emphasizing protection of the global environment based on the Eisai Network Companies (ENW) Environmental Protection Policy. By quantitatively assessing resource input and environmental impact, we strive to reduce our burden on the environment and promote environmental protection activities.

Fulfilling Our Social Responsibilities Is an Important Duty Today, the sustainability of society is regarded as a major issue not only from an economic perspective but also from an environmental standpoint. The Eisai Group recognizes that fulfilling our social responsibilities is an important duty in conducting business operations based on the hhc philosophy and also actively promotes initiatives for solving problems from an environmental perspective. During fiscal 2012 also, the halt to nuclear power generation led to a nationwide power shortage. The Eisai Group in Japan continued to promote efforts to reduce power consumption and held the amount of power usage to the same level as in fiscal 2011. From fiscal 2013, the Eisai Group in Japan will implement planned reductions in CO2 emissions, and these efforts will include the participation of Eisai Co., Ltd.’s production plants and research facilities in the Commitment to a Low Carbon Society initiated by the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ).

The Eisai Group in Japan achieved “zero emissions,” or a ratio of waste sent to landfill to total waste of less than 1.0%, for the fifth consecutive year, while curbing the total volume of waste generated to below the volume in fiscal 2011. We are also steadily promoting initiatives for recycling waste into resources. Furthermore, in terms of observance of the law, we conduct a wide range of self-monitoring, including of air, water, noise, vibrations and offensive odors as well as carry out proper and reliable management in order to comply with environmental regulations, ordinances and agreements with local governments. At relevant production plants and research facilities, we are promoting reliable responses to the revised law concerning water pollution control, which was enforced in fiscal 2012. We will also continue to take into account protection of the natural environment around our operational sites and are undertaking business operations with an emphasis on coexistence with the regional environment.

Eisai Network Companies (ENW) Environmental Protection Policy Fundamental Environmental Protection Policy Eisai and its Group companies (hereafter ENW) place global environmental protection as an important component of business operations and strive to maintain the environment.

Environmental Protection Guidelines 1. ENW is aware of the “dignity and importance of nature” and adopts measures to maintain the global environment in all business operations. 2. ENW places environmental protection as a top priority at all stages of corporate activities from research and development, production, distribution and sales, to product usage and disposal. 3. ENW constructs and operates an environmental management system and promotes environmentally protective operations. 4. ENW complies with all applicable laws, regulations, and agreements concerning environmental protection, and each company implements voluntary standards that exceed the minimum standards set forth in the applicable laws, regulations and agreements. 5. ENW actively introduces advanced environmental technology to be at the forefront of reducing environmental impacts. 6. ENW reduces usage of resources and energy as well as reduces or recycles waste products in all business operations. 7. ENW reduces usage and promotes the removal of chemical substances that cause environmental pollutant emission and prevents environmental pollution. 8. ENW shares the fundamental policy on environmental protection and implements educational training to strengthen specialties at each workplace progressively and continuously. 9. ENW actively discloses information on policies, objectives, programs and results concerning environmental protection.

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■Fiscal 2012 Environmental Protection Initiatives and Results Theme

Targets

Enhancement and smooth operation of management systems Enhancement of environmental management

Planning and implementation of environmental education

Implementation of environmental communication

Reduction of average CO2 emissions between fiscal 2008 and 2012 to their fiscal 1990 level (calculated using generating-end electricity carbon emissions coefficient)

Energy conservation and combating climate change

Power-saving goals: ・15% reduction in summer peak power compared with fiscal 2010 ・7% reduction in winter peak power compared with fiscal 2010

Management of chemical substances

Air pollution and water pollution prevention measures

Evaluation Pages

・Proper application of the PDCA cycle ・Periodic and renewal inspection of ISO 14001*1 certification (Kawashima Plant, Misato Plant, Kashima Plant, Sannova Co., Ltd., EIDIA Co., Ltd. Ibaraki Plant, and Eisai Seikaken Co., Ltd.) ・Interim and renewal inspections of EA21*2 certification (Sunplanet Co., Ltd., Eisai Distribution Co., Ltd.) Internal training sessions: 64; external training sessions: 9 ・Publication of the Environmental and Social Report 2012 ・Local community meetings (Kawashima Plant, Misato Plant), administrative committee meetings (Kashima Plant) CO2 emissions: 91,311 tons (receiving-end electricity carbon emissions coefficient) 85,409 tons (generating-end electricity carbon emissions coefficient) (0.8% reduction from fiscal 2011 and 65% increase from fiscal 1990) ・Reduced summer peak power by 8%–20% from fiscal 2010 ・Reduced winter peak power by 7%–19% from fiscal 2010 (All results are for Eisai Co., Ltd.’s five operational sites.)

○

ー

○

P42

○

P43

×

P44

△

P45

Promotion of the replacement of sales vehicles with hybrid vehicles (Eisai Co., Ltd.)

Adoption rate for all sales vehicles: 42% (9% increase from fiscal 2011) Adoption rate for company-owned vehicles: 77%, adoption rate for privately owned vehicles: 25%

○

P41

Purchase of wind-generated green power

Purchase of 965,000 kWh from Japan Natural Energy Co., Ltd.

○

P41

・Reduction of waste generated ・Reduction of waste sent to landfill ・Increase in recycled waste

・Amount of waste generated: 6,289 tons (14.4% decrease from fiscal 2011) ・Amount of waste sent to landfill: 19 tons (42% decrease from fiscal 2011) ・Amount of recycled waste: 2,271 tons (11% decrease from fiscal 2011) ・Recycling rate: 36.1% (1.5% increase from fiscal 2011)

○

P46

Ratio of waste sent to landfill to total waste < 1%

・Eisai Co., Ltd.: 0.18% ・Group companies in Japan: 0.78% ・Eisai Group in Japan: 0.30%

○

P46

Waste reduction

Resource conservation

Results

Implementation of onsite inspections based on the Waste Management and Public Cleansing Law

Implemented onsite inspections based on the Waste Management and Public Cleansing Law at more than 100 sites nationwide; confirmed that waste is being disposed of legally and in a proper manner

○

P46

Promotion of awareness-raising activities and education to encourage green purchasing

Green purchasing rate: 28.8% (2.2% decrease from fiscal 2011) Investigated causes and strengthened re-enlightenment and education from the second half of the fiscal year

△

ー

Response to PRTR*3 system and proper management of designated substances

Proper management based on an understanding of amounts of substances subject to the PRTR system that were handled, emitted and transferred

○

P47

Reduction in usage of dichloromethane

Amount used: 385 tons (53% decrease from fiscal 2011)

○

P47

Proper management of fluorocarbons

Change to hydrofluorocarbons and non-fluorocarbons, and regular inspection of equipment and facilities

○

ー

Compliance with Air Pollution Control Act, Water Pollution Control Act and pollution control agreements

Regular measurements showed that the amounts of pollutant emissions into the atmosphere and water systems were below standard values

○

P50

○

P43

Held regular cleanup activities of areas around each operational site and affiliated company and within industrial parks

○

ー

・Request to cut down trees (Kawashima Plant, Eisai Distribution Co., Ltd.) The relevant trees were pruned or cut down to solve problems of insufficient sunlight, radio interference and fallen leaves. ・Ground dust (Misato Plant) Dispersed water on windy days

×

ー

Compliance with environment-related laws (noise, vibrations, offensive odors, soil contamination) Involvement with local community Conservation of the local environment No complaints made by neighboring residents

・Regularly measured levels of noise, vibrations and offensive odors to confirm compliance

*1 ISO 14001: an international standard for environmental management issued by the International Organization for Standardization *2 EcoAction 21: an environmental management system certification for small- and medium-sized enterprises issued by Japan’s Ministry of the Environment *3 Acronym for Pollutant Release and Transfer Register, a system for understanding, collecting and publicly disclosing information on the extent to which chemical substances involving environmental risk are either released into the environment or are contained in waste matter and transferred from operational sites


39


Resource Input and Environmental Impact ■Resource Input and Environmental Impact Data—Eisai Group in Japan

Resource Input Energy Eisai Co., Ltd.

Water

Group companies in Japan

Total

105,975

19,601

125,577

102

12

114

11,553

1,347

12,900

Kerosene (kl)

0

61

61

Light oil (kl)

2

0

2

76

19

95

40,496

0

40,496

4

0

4

129

0

129

Electric power (MWh) LPG (tons) Processed natural gas (1,000 Nm3)

Fuel oil A (kl) Industrial steam (GJ) Hot water (GJ) Cold water (GJ)

Substances Subject to the PRTR System Total amount handled (including unreported amount) (tons)

Eisai Co., Ltd.


Total

513

53

566

Water consumption (1,000 m3) Clean water (1,000 m3) Industrial water (1,000 m3) Ground water (1,000 m3) Desalinated water (1,000 m3) Wastewater (reused water) (1,000 m3)

Eisai Co., Ltd.


Total

3,031

108

3,139

464

93

557

6

15

21

2,468

0

2,468

5

0

5

88

0

88

Other Eisai Co., Ltd.

Recycling of containers and packaging materials (obligatory recycling amount) (tons) Copy paper purchased (10,000 sheets)


Total

1,335

23

1,358

3,136

633

3,769

INPUT Environmental Impact Exhaust Gas from Vehicles

Waste Eisai Co., Ltd.


Total

Amount generated (tons)

4,989

1,299

6,289

Wastewater discharge (1,000 m3)

2,629

80

2,709

Amount recycled (tons)

1,948

323

2,271

BOD (tons)

6.4

0.5

6.9

Nitrogen (tons)

4.1

0.3

4.4

9

10

19

COD (tons)

1.7

0.5

2.2

Phosphorous (tons)

0.1

0.1

0.2

Substances subject to the PRTR System (off-site transfer as waste) (tons)

210

1

211

Substances subject to the PRTR System (release into water bodies) (tons)

0.1

0.0

0.1

Amount sent to landfill (tons)

CO2 emissions from sales vehicles (tons) CO2 emissions from business-use vehicles other than sales vehicles (tons)

Eisai Co., Ltd.


3,862

189

4,051

38

146

184

Total

Atmospheric Emissions Eisai Co., Ltd.


CO2 (tons)

78,728

12,583

91,311

SOx (tons)

1.7

0.0

1.8

NOx (tons)

9.8

2.0

11.8

Soot and dust (tons)

0.7

0.0

0.7

35.2

0.2

35.4

Substances subject to the PRTR System (release into the atmosphere) (tons)

Total

OUTPUT

40

1) Due to rounding, the sum of “Eisai Co., Ltd.” and “Group companies in Japan” may not correspond to “Total” for some items. 2) CO2 emissions are those from energy use only. 3) The transportation and delivery of Eisai products manufactured in Japan is managed by Eisai Distribution Co., Ltd., which is primarily responsible for logistics management and management of distribution facilities, with actual transportation and delivery being conducted by external operators. Vehicles belonging to Eisai Distribution Co., Ltd. are used for internal purposes only and are never used for delivery.

Eisai Co., Ltd.

Environmental Costs Since fiscal 2004, the Eisai Group in Japan has used a standardized form for assessing environmental costs to tabulate any discernible investments and expenses relating to environmental protection and has been effectively promoting environmental protection activities. Going forward, we will seek to identify the economic effects of environmental protection measures and make improvements to increase the form’s usefulness as a management index.

Results for Fiscal 2012 Investments related to environmental protection

¥81 million (up 17% year on year)

Costs related to environmental protection

¥4,164 million (down 7% year on year)

Economic effect of measures

¥31 million (down 38% year on year)

Basic Approach With reference to the Environmental Accounting Guidelines 2005 issued by the Japanese Ministry of the Environment, the Eisai Group in Japan aggregates its environmental costs to enable it to confirm the environmental costs of environmental protection activities and the associated effects (outcomes).

Environmental costs are recorded separately as capital investments and expenses, with the associated effects generally being regarded in terms of the quantitative effect of environmental protection.

Future Targets and Issues With reference to the Environmental Accounting Guidelines 2005 , rather than just identifying the environmental protection costs (investments and expenses), we will also identify the

economic effect of the environmental protection measures so that they can be implemented efficiently and effectively.

■Environmental protection costs in fiscal 2012 (In “major implementation items,” ○ indicates investment and △ indicates expense.) (million yen) Main category

Subcategory 1. Environmental management systems

Major implementation items

○ △ Investment Expense

△ ISO 14001 regular and recertification inspections

○ Renewal of through-flow boilers 2. Energy conservation and ○ Introduction of high-efficient amorphous transformers measures to address △ Introduction of hybrid cars for sales and marketing purposes climate change △ Purchase of green power

A. C osts to achieve objectives

3. Resource conservation activities

△ Maintenance of wastewater treatment system △ Green purchasing

4. Air pollution prevention measures

○ Renewal of packaged air-conditioner △ Boiler repair and inspection △ Atmospheric analysis

5. Management of chemical substances 6. Waste reduction activities

△ Purchase of database for chemical substance

management

△ Entrustment of waste disposal

7. Product design 1. Waste disposal

△ Management of waste treatment facilities*

0

6

32

2

1

Major results/outcomes ・Promotion of environmental protection activities ・Reduced CO2 emissions by 218 tons (down 5% year on year) ・965,000 kWh (equivalent to 447 tons of CO2 emissions)

・Wastewater (reused water: 88,000 m3) 3,482 ・Promotion of purchasing environmentally friendly products and packaging materials

Pages P42 P39 P44-45

ー

20

28

・Prevention of air pollution

0

1

・Promotion of appropriate management of chemicals

P47

181

・Amount of waste generated increased by 1,057 tons ・Recycled amount increased by 274 tons ・Amount sent to landfill increased by 14 tons

P46

0

P43,53

ー

0

0

2

77

・Compliance with related laws and regulations

P43

16

248

・Prevention of contaminant discharge

P43

○ Renewal of monitoring control system for wastewater

treatment

B. C osts to comply with environmental regulations

2. Pollution prevention measures

○ Repair of oil retaining wall at tank yard △ Cleaning of drainage tanks △C leaning and inspection of septic tanks △ Repair and inspection of wastewater treatment

facilities

△W astewater, noise, vibration and odor measurements

C. Environmental administration costs

3. Soil contamination

△ Inspection costs for fuel oil A leakage

0

0

・Prevention of soil and groundwater contamination

P43

4. Recycling of containers and packaging

△S ubcontracting of container and packaging recycling

0

20

・Compliance with the Containers and Packaging Recycling Act

ー

10

120

・Promotion of business activities that coexist with nature ・Improved communication

ー

81

4,164

Environment-related costs △ Greenery maintenance and management costs excluding A and B △ Publication of the Environmental and Social Report Total

* Includes depreciation costs

■Economic Effect of Environmental Protection Measures Item

Details

(million yen) Amount

Sales of by-products

Proceeds from selling recyclable items

13

Reduction in synthetic solvent expenses through recycling

Reduction in synthetic solvent expenses through distillation of waste solvent in the production process

18

Total

31

Scope of calculations: Eisai Group in Japan Period of data collection: April 1, 2012 through March 31, 2013 Notes: 1) Figures are rounded to the nearest million yen. 2) Since fiscal 2004, personnel costs have included only the subcontractors’ commissions.


41


Environmental Management Environmental Management System Eisai Co., Ltd. established the Company-Wide Environment and Safety Committee as a decision-making body for deliberation of important environmental issues. As a consultative body promoting the environmental activities of the Eisai Group in Japan, the Company also established the Environment and Safety Conference of Group Companies in Japan to share future plans and past experiences. Furthermore, as venues for deepening discussions among persons at the working level, we regularly convene on various projects to examine the issues facing the Eisai Group in Japan as well as associated solutions

and measures. At the same time, each operational site in Japan also holds regular environment-related meetings to promote its own management and implementation of environmental activities. Eisai’s main production sites in Japan have all acquired ISO 14001 certification, while Sunplanet Co., Ltd. and Eisai Distribution Co., Ltd. have acquired EA21 certification. Moreover, each operational site has established its own unique management system and strives for continual improvement by rotating the (plan-do-check-act) PDCA cycle.

■Environmental Management System (Fiscal 2012) Corporate Officer Responsible for General Affairs, Environmental & Safety Affairs

Eisai Co., Ltd. Operational sites / Headquarters office complex*1 Communication offices*2

Company-Wide Environment and Safety Committee

Environment-related meetings

Specific Projects ・Energy Conservation Study Meeting ・Waste Processing Study Meeting General Affairs and Environmental & Safety Affairs Department

Environment and Safety Conference of Group Companies in Japan

Group Companies in Japan

Group Companies outside Japan

Environmental Education In order to promote environmental protection activities ensuring coexistence with the global environment, it is important that all employees have a proper understanding of the relationship between their daily work and environmental problems, and that they make efforts to enhance their own individual awareness for problem-solving. At the Eisai Group in Japan, in addition to Group-wide education and training, independent education programs are also established at each operational site and Group company, with education provided in accordance with the business characteristics and issues of each location. In addition to education targeted at all workers, education is also provided for various levels of employees, from new recruits, transferees and managers, to short-term employees, along with further efforts to improve the learning content. Furthermore, for the purpose of training and further developing environmental educators and publicly qualified employees, we also actively promote participation in both internal and external professional training courses. During fiscal 2012, a total of 73 environmental education and training sessions were conducted across the Eisai Group in Japan.

42

Eisai Co., Ltd.

Environment-related meetings *1 The Eisai Co., Ltd. oﬃce complex that serves as the corporate headquarters for the Eisai Group *2 The 65 domestic sales oﬃces of Eisai Co., Ltd.

Internal Audits Environmental internal audits are handled by the Corporate Internal Audit Department. The department makes efforts to undertake objective audits from an independent standpoint, and the audits cover all Group companies in and outside of Japan. Audit results for fiscal 2012 indicated that there were no urgent or serious issues. Meanwhile, regular inspections and patrols are carried out by site managers at each operational site in Japan. External inspections are also carried out once a year at those operational sites that have adopted ISO 14001 or EA21, to confirm the validity of their environmental management systems. During fiscal 2012, no serious material issues were identified by external auditing organizations. Furthermore, these certified operational sites also educate their own internal auditors, seeking to raise the level of their audits through training. The results of each annual independent internal audit are reflected in the ongoing improvement of the Group’s environmental management system, thus leading to the enhanced quality of our environmental protection activities.

Environmental Communication

Environmental Risk Management The Eisai Group in Japan has summarized its methods for responding to environmental incidents in its Disaster and Accident Response Manual and the Industrial Accident Reporting and Compilation Standards . The aim of both guidelines is to minimize any damage by collecting accurate information and taking swift and appropriate action, as well as to ensure that accidents and other such incidents that occur are not repeated. At production plants and research facilities in particular, we have been preparing for a state of emergency by regularly conducting emergency drills assuming, for instance, the leak of hazardous chemical substances from wastewater, exhaust gas or effluents, as a situation that significantly affects the environment. In fiscal 2012, drills were conducted based on the following hypothetical situations.

● Leak of organic solvent during the manufacture of active

pharmaceutical ingredients or drug formulation

● Leak of synthetic effluents during the manufacture of

active pharmaceutical ingredients

● Anomaly in the treatment of sewage due to an operational

malfunction at a wastewater treatment facility

● Release of air pollutant due to anomaly in boiler combustion

equipment Compliance with Laws and Regulations The Eisai Group in Japan is committed to observing environmental regulations, ordinances and agreements with local governments. In particular at production plants and research facilities, we regularly measure the environmental burden of causative agents in air pollution and water pollution to check that there are no problems. Also, from the perspective of protecting the neighboring environment, we conducted regular measurements of noise, vibrations and offensive odors at production plants and research facilities and confirmed that these were all below the regulatory values. Moreover, we also submitted each type of environmental notification to the relevant authorities without delay. During fiscal 2012, there were no administrative dispositions or lawsuits related to the environment.

In promoting our business activities, mutual understanding and cooperation with the local community is extremely important. This is why the Kawashima Plant and the Misato Plant hold local community meetings as a platform for sharing information and enhancing communication in each region. At these meetings, we introduce the production activities and environmental protection initiatives of the production plants, and also listen directly to participants’ viewpoints and requests regarding these production plants. With participation of neighborhood representatives and government officials, these meetings have been held every year at the Misato Plant since 2001 and at the Kawashima Plant since 2008. A total of 12 people took part in the local community meeting held at the Kawashima Plant in December 2012. Following an overview of the Kawashima Industrial Complex and an introduction to its environmental initiatives, participants visited the onsite production and environmental facilities as well as the Japanese garden. This enabled members to learn about how drugs are manufactured and about our efforts to protect the environment, including wastewater treatment and waste disposal. Numerous participants expressed their view that the meetings helped deepen mutual understanding. Members also submitted requests for continued proper monitoring of wastewater to maintain the water quality of a nearby river. The Misato Plant also held a community meeting in December. In addition to introducing environmental activities centering on energy-saving and waste disposal initiatives, the Misato Plant provided explanations about its emphasis on the safety of vehicles used for commuting to work and about the Eisai Group’s crisis management. During a plant tour, we also introduced in-house power generating facilities. In the spirit of harmony and coexistence with the local community, Eisai Co., Ltd. will continue to actively expand its interaction with local residents, such as through these local community meetings and plant tours.

Environmental Incident Report ■Environmental Incidents Identified in Fiscal 2012 Environmental incident

Operational site/ company

Discharge

Sunplanet Co., Ltd.

Discharge of fuel oil A onto a road on the north side of the production research building

Fuel oil A was fed into the boiler system and discharged through a ventilation pipe due to a malfunction of a solenoid valve during test operation adjustments for an emergency power generator. Discharge into the soil or side ditch was prevented by early detection and recovery using absorption sheets and neutral detergent. The solenoid valve was replaced with a new one.

Leakage

Ibaraki Plant of EIDIA Co., Ltd.

Refrigerant fluorocarbons leaked from Chiller No. 1 used for producing chilled water

A crack developed in a pipe connection component of a refrigerant cooling coil due to the vibration of a compressor. This was caused by aging degradation. The component was replaced and an incident report was filed with Ibaraki Prefecture.

Details

Response


43


Formation of a Low-Carbon Society Formulation of Next CO2 Emissions Reduction Target The Eisai Group in Japan is promoting initiatives for the formation of a low-carbon society to help solve the problem of climate change. Up to fiscal 2012, we promoted efforts to reduce CO2 emissions in line with the Japan Business Federation’s Voluntary Action Plan on the Environment. During this time, we achieved a certain volume of reductions in CO2 emissions by switching to alternative fuels, introducing high-efficient equipments and developing new technologies. However, since 1990, production volume of pharmaceutical products increased significantly, and because of this, we were unable to attain our numerical target of “reducing the average value of CO2 emissions for the period from fiscal 2008 to fiscal 2012 to the fiscal 1990 level.” In view of this result, the Eisai Group in Japan formulated its own effective and unique medium-term plan that states “the Eisai Group in Japan will achieve a 23% reduction in CO2 emissions from the fiscal 2005 level by fiscal 2020.” Under the plan, initiatives for attaining this target will commence in fiscal 2013. With energy policies in Japan remaining uncertain, from fiscal 2013 Eisai Co., Ltd.’s production plants and research facilities will also participate in the Commitment to a Low Carbon Society initiated by FPMAJ and will work to reduce the volume of CO2 emissions. The Eisai Group in Japan has established a feasible medium-term CO2 reduction target that considers the prerequisites of this commitment and is also considering the outlook for business expansion and capital investments within the Group.

■Eisai Group in Japan CO2 emissions*1 2008

2009

2010

0

2011

5,000

（t）

2012

10,000 15,000 20,000 25,000 30,000

Eisai Co., Ltd. Kawashima Plant

26,091

Misato Plant (including Honjo Facility)

21,049

Kashima Plant

7,707

Tsukuba Research Laboratories

20,345

Headquarters office complex

1,873

Communication offices

1,663

Group companies in Japan Sannova Co., Ltd. Sunplanet Co., Ltd.

8,095 590

Eisai Distribution Co., Ltd.

Magnified scale 200

2,009 0

Eisai Seikaken Co., Ltd.

400

（t） 1,000

800

271

KAN Research Institute, Inc.

568

Bracco-Eisai Co., Ltd.

107

Elmed Eisai Co., Ltd.

126

Eisai Food & Chemical Co., Ltd. Palma Bee’Z Research Institute Co., Ltd.

600

65 31

EIDIA Co., Ltd.

720

Note: Palma Bee’Z Research Institute Co., Ltd. was dissolved on March 31, 2013.

CO2 Emissions in Fiscal 2012 CO2 emissions for the Eisai Group in Japan during fiscal 2012 totaled 91,311 tons, a 0.5% decrease from fiscal 2011 (right chart). Eisai Co., Ltd. accounted for 86.2% of the emissions within the Eisai Group in Japan, of which 95.5% were emissions from production plants and research facilities. During the fiscal year, no large-scale energy-saving facilities were introduced and factors causing an increase in energy usage included the construction of a new building and seismic reinforcement work at the Kawashima Plant and base-isolating and seismic reinforcement work at the Tsukuba Research Laboratories. Each operational site carried out earnest energy-saving activities that included improving steam loss and reviewing facility operation methods. We also focused on power-saving measures due to the continued nationwide power supply shortage resulting from the halt of nuclear power generation. Among Group companies in Japan, annual power usage increased at Eisai Distribution Co., Ltd. Power usage increased along with the operation of air-conditioning systems due to a change in temperature control conditions for storing products based on a request from customers.

44

Eisai Co., Ltd.

■Eisai Group in Japan CO2 emissions*1 (t)

100,000

Eisai Co., Ltd.

91,611

91,797 81,153

80,000


79,470

91,311

82,082

(CO2/

100,000 80,000

60,000

60,000 40,000

40,000

20,000

20,000

0 0

2005

2008

2009

2010

2011

2012 (Fiscal year)

*1 The carbon emissions coefficient based on power usage utilizes the coefficient in the notification from the Federation of Electric Power Companies of Japan (FEPC). From fiscal 2012, this has been changed from generating-end coefficient to a receiving-end coefficient and tabulations have been revised accordingly.

CO2 emissions originating from production plants and research facilities at Group companies outside Japan during fiscal 2012 totaled 62,088 tons, a 2.7% decrease from fiscal 2011 (above right chart). Since fiscal 2008, the number of overseas production plants and research facilities as well as production volume have increased and consequently CO2 emissions have also been trending upward. In fiscal 2012, Eisai Knowledge Centre, India set optimal power usage targets for each area and worked to reduce power consumption. Additionally, operation of an active pharmaceutical ingredient plant was temporarily halted along with the introduction of new facilities. As a result, Eisai Knowledge Centre, India reduced power consumption by 16.1% from fiscal 2011 and this led to the decrease in total CO2 emissions originating from overseas production plants and research facilities. CO2 emissions for the entire Eisai Group during fiscal 2012 totaled 153,399 tons, a 1.4% decrease from fiscal 2011. The proportion of emissions accounted for by overseas operational sites has risen to 40.5% (bottom right chart). In recent years, the Eisai Group’s emissions have mildly trended upward along with increased emissions by overseas operational sites. In the future, we forecast that CO2 emissions from overseas operational sites will increase if overseas production volume rises due to global business development. The overseas CO2 emissions coefficient accompanying power usage is larger than that in Japan. The emissions coefficients for emerging countries and developing countries are particularly high. We will progress with the optimization of energy usage percentages and promote energy saving as we work to reduce CO2 emissions in Japan and overseas.

■Overseas operational sites CO2 emissions*2 (CO2/t)

70,000

62,955

63,781

2010

2011

60,000 50,000

62,088

49,891 42,523

40,000 30,000 20,000 10,000 0

2008

2009

2012

(Fiscal year)

*2 The carbon emissions coefficient is based on power usage utilized figures from the following source. IEA: CO2 EMISSIONS FROM FUEL COMBUSTION Highlights (2012)

■Eisai Group CO2 emissions (CO2/t)

200,000

Eisai Group in Japan

150,000 123,698

129,361

145,037

(CO2

Overseas operational sites

155,578

100,000

153,399

80,000

60,000

100,000

40,000 50,000 20,000 0

Efforts to Reduce Power Consumption During fiscal 2012, the nationwide power shortage continued as a consequence of the halt of operations at Japan’s nuclear power plants. Therefore, in the Eisai Group in Japan, operational sites and offices worked in unison to reduce power consumption during summer and winter. Based on the same initiatives undertaken in fiscal 2011 that included reducing the number of fluorescent lights in use, turning off these lights when not in use and controlling the temperature of air-conditioning systems, we continued to install demand controllers to control peak power as well as controlled room temperature at sales offices using temperature loggers. We also focused on raising employee awareness of reducing power by implementing regular energy saving patrols and posting actual power savings results on the Eisai intranet. Our first target was to reduce summer and winter peak power by 15% and 7%, respectively, compared with fiscal 2010. As our second target, we set a common target for both summer and winter of realizing power savings, including power consumption, exceeding the power savings achieved in fiscal 2011. As a result of these efforts, the five operational sites of Eisai Co., Ltd., which is a large user, achieved reductions in summer peak power ranging from 8% to 20% and reductions in winter peak power ranging from 7% to 19% compared with fiscal 2010 levels. The Headquarters office complex reduced

2008

2009

2010

2011

2012

0

(Fiscal year)

summer power consumption by 32% (a 2% reduction from fiscal 2011) and winter power consumption by 20% (a 12% reduction from fiscal 2011).

Chairperson’s Award Received from the Kanto Regional Committee for the Rational Use of Electricity The Tsukuba Research Laboratories won the Excellence Award at the Kanto Regional Committee for the Rational Use of Electricity Chairperson’s Awards 2012. This award system recognizes production plants, operational sites and individuals for outstanding achievements in promoting the rational use of electricity, such as promoting effective use of electricity and improving the load factor. By widely publicizing these achievements throughout society, it also strives to build greater awareness of the rational use of electricity. The Tsukuba Research Laboratories received an overall high evaluation and judging was made from multiple perspectives that included organizational operation, power management, facilities management, promotion of streamlining and other special factors.


45


Establishment of a Recycling-Oriented Society Waste Reduction Results in Fiscal 2012

Initiatives for Recycling Resources

In fiscal 2011, the Eisai Group in Japan launched a new plan to continue to gradually reduce the amount of waste generated, increase the amount of recycled waste and decrease the amount of waste sent to landfill while also maintaining zero emissions. Every year, numerical targets are set for each operational site and Group company, and efforts are made to reduce waste. In fiscal 2012, the total amount of waste generated by the Eisai Group in Japan amounted to 6,289 tons, a significant decline of 14.4% compared with fiscal 2011. This decrease 15000 was due mainly to marked declines in the amounts of waste acid, waste alkali and waste oil accompanying a decrease in production of pharmaceutical 12000 products. Also, the amount of waste sent to landfill decreased for the first time in three years, declining 42% from fiscal 2011 to 19 tons. The ratio of waste 9000 was 0.30%, a 0.14 % decrease sent to landfill to total waste compared with fiscal 2011, meaning that we achieved zero emissions for the fifth consecutive year. Meanwhile, the 6000 recycling rate was 36.1%, a 1.5 % increase from fiscal 2011, which reaffirms the progress of activities based on the Waste Reduction Plan. Going3000 forward, we will continue to promote waste reduction activities toward the establishment of a recycling-oriented society. 0 ■Total Waste and the Ratio of Waste Sent to Landfill to Total Waste （％）

(tons)

15,000

2.5

Total waste (Eisai Co., Ltd.)

In order to reduce waste, it is essential to reduce the amount of waste generated in addition to reusing resources such as metal, glass, waste oil and paper products and recovering resources from waste. Based on this perspective, we actively promote the sale of equipment and devices to be reused as well as the recycling of scrap metal, glass bottles and waste oil. To reduce waste paper, we are devising better ways to distribute materials for meetings and to copy documents to reduce the amount of waste generated, while also promoting the sale of wastepaper. In fiscal 2012, the amount of copy paper used by Eisai Co., Ltd. decreased 6.9% from fiscal 2011. Furthermore, we also reuse organic solvents, such as those used in the chemical synthesis of active pharmaceutical ingredients, and sell these as auxiliary fuel. In fiscal 2012, the Misato Plant further segmentalized its sorting method for waste plastics produced in the manufacturing process and promoted the recycling of these back into reusable raw materials. The Misato Plant’s ratio of recycling waste back into reusable raw materials was 41% in fiscal 2012, up from 20% in fiscal 2010. Meanwhile, the Tsukuba Research Laboratories progressed with the use of environmentally conscious products that included switching to 100% recyclable resin treatment containers for infectious waste. Our “contributions to reducing the amount of waste emissions and promoting recycling” through initiatives implemented in recent years were highly acclaimed and in recognition of these contributions, Eisai Co., Ltd. Head Office was presented with a certificate of appreciation by Bunkyo City in Tokyo.

Total waste (Group companies in Japan)

12,000

2.0

Ratio of waste sent to landfill to total waste (Eisai Group in Japan)

1.5

9,000 7,095 5,725

6,000 0.49

3,000

1,178

0

2008

6,001

5,288

2010

2011

0.5

0.30

1,345

1,280

1,060

2009

0.44

0.35

0.23

1.0

4,989

1,299

0.0 2012 (Fiscal Year)

■Change in Amount of Waste Sent to Landfill and Recycled Waste for the Past Five Fiscal Years Change in Amount of Waste Sent to Landfill and Recycled Waste of Eisai Co., Ltd. FY2008 Waste sent to landfill Amount recycled

FY2009

FY2010

FY2011

26

8

15

12

9

2,771

2,431

2,421

2,021

1,948

Change in Amount of Waste Sent to Landfill and Recycled Waste of Group Companies in Japan FY2008 Waste sent to landfill Amount recycled

46

Eisai Co., Ltd.

(tons) FY2012

FY2009

FY2010

FY2011

(tons) FY2012

12

8

8

21

10

372

418

467

523

323

Onsite Inspections of Waste-Processing Companies The Eisai Group in Japan has been conducting intensive onsite inspections of its waste disposal contractors for the purpose of checking that waste is being disposed of properly. For potential new contractors, rigorous onsite inspections are conducted under the supervision of Eisai Co., Ltd.’s General Affairs and Environmental & Safety Affairs Department. New contracts with Eisai Co., Ltd. are only signed after deliberation by and approval of the Company-Wide Environment and Safety Committee. Contracts for waste disposal are mostly given to those companies that have received certification as an excellent industrial waste processing company. We make regular onsite inspections of our waste disposal contractors to confirm that waste is being disposed of properly. Inspections are carried out once a year for contractors engaged in the collection, transport and intermediate processing of waste and once every three years for contractors handling the final treatment. During fiscal 2012, over 100 onsite inspections were conducted by the Eisai Group in Japan at sites around the country, and it was confirmed that waste is being disposed of in an appropriate manner.

Management of Chemical Substances Management of Substances Subject to the PRTR System Chemical substances that are used in the research and development and production of pharmaceutical products include some substances subject to the PRTR System that could have an impact on the environment. The amounts of these substances handled, released into the environment and transferred as waste need to be understood and properly managed. Therefore, in addition to using our unique reagent management system to monitor the usage of reagents by the Eisai Group in Japan, we are also striving to reduce our usage of PRTR designated substances and to control their release into the environment. The amount of chemical substances used depends largely on the volume of pharmaceutical products produced. To maintain the quality of active pharmaceutical ingredients, it is not easy to change manufacturing conditions after entering the commercial production phase. Therefore, we actively reduce the amount of substances used and utilize alternative solvents from the R&D stage. The total amount of PRTR designated substances handled by the Eisai Group in Japan during fiscal 2012 decreased 36% from fiscal 2011 to 566 tons. This was mainly due to a significant decrease of 47% in the usage of dichloromethane from fiscal 2011. The total amounts handled during the year of toluene

and isophytol, which are used in the manufacture of vitamin E, decreased 17% and 27%, respectively, from fiscal 2011. During fiscal 2012, notifications were made to authorities for 13 substances, one more substance (formaldehyde) than in fiscal 2011. The Eisai Group in Japan recovers dichloromethane and toluene for recycling use or sale and tries to keep any release of these solvents into the atmosphere to a minimum. Furthermore, we also promote the use of alternative substances to hexane. Going forward, we will continue to strive to reduce environmental risks. ■Actual Use of Substances Subject to the PRTR System (tons)

1,000 900 800 700 600 500 400 300 200 100 0

Amount handled

Amount released

885 675

656

Chemical name

Number of Substance operational no. sites

Amount handled

Into the atmosphere

326

301 3.6

12

18

2008

2009

2010

（tons） As waste

1

2

30.729

0.000

0.067

0.065

0.000

Acrylamide

2

1

7.987

0.000

0.000

0.000

0.000

Acetonitrile

13

3

22.429

0.094

0.000

22.335

0.000

Ethylbenzene

53

1

4.086

0.000

0.000

0.881

0.000

Dichloromethane (also known as methylene chloride)

186

1

210.237

29.779

0.000

57.818

0.000

N,N-Dimethylformamide

232

1

8.850

0.000

0.000

8.850

0.000

Isophytol

269

1

125.856

0.000

0.000

0.000

0.000

Water-soluble copper salts (excluding complex salts)

272

1

2.499

0.000

0.001

0.000

0.000

Toluene

300

2

63.642

4.362

0.024

57.060

0.000

Hexane

392

2

58.960

0.646

0.000

58.314

0.000

Boron and boron compounds

405

1

1.592

0.000

0.001

0.000

0.000

Formaldehyde

411

1

1.080

0.067

0.000

0.297

0.000

Manganese and manganese compounds

412

1

21.256

0.000

0.001

0.000

0.000

Groundwater is a valuable source of fresh water. Once groundwater becomes contaminated, however, it is difficult to restore this resource to its original condition and identifying the source of and removing the contamination is not an easy task. With the aim of preventing groundwater contamination, the Water Quality Pollution Control Act was amended and the revised act enforced on June 1, 2012. To ensure that operational sites possessing research facilities and production and storage facilities are firmly responding to the revised law, the Eisai Group in Japan is proceeding quickly with checks and investigations of facilities and equipments. We are steadily progressing with strict compliance with standards concerning structures and with the establishment of usage and inspection methods.

210

70

35

2011

2012

(FY)

■Dichloromethane Usage (tons)

To sewage

Water-soluble zinc compounds

Response to the Water Pollution Control Act

263

196

Transfer

Into water bodies

566

469

■Fiscal 2012 PRTR Data (Releases and Transfers Reported to Authorities) Release

Transfers

1,000

818

800 600 400

615

200 0

385

365

108 2008 2009 2010 2011 2012

(FY)

Note: The amount used includes recycled dichloromethane.

Proper Management of PCB Waste We have quickly completed registrations for polychlorinated biphenyl (PCB) waste with the Japan Environmental Safety Corporation and are subsequently progressing with detoxification processing. In fiscal 2012, Eisai Co., Ltd.’s Head Office treated six high-concentration capacitors. As a result, we have completed the treatment of high-concentration PCB waste at the Head Office. A breakdown of the remaining PCB waste within Eisai Co., Ltd. is as follows: This waste exists at the Kawashima Plant, Honjo Facility, Head Office and sales offices, and we give notification without delay to the relevant prefecture Stored equipment Volume High-pressure oil based on the Law Concerning Special 4 units circuit breakers Measures Against PCB Waste. We store High-voltage transformers 8 units PCB waste under proper management High-voltage capacitors 11 units that includes installing locks, enclosures Fluorescent lamps 585 units and signs around storage areas as well as taking measures to prevent vaporization, Low-voltage condensers 4 units scattering or effluence. PCB ampule formulation 37.5 g PCB attached materials

3 pouches


47


Environmental Protection Efforts at Group Companies outside Japan The Eisai Group carries out corporate activities that emphasize protecting the earth’s environment in accordance with the Eisai Network Companies (ENW) Environmental Protection Policy. Accordingly, we steadily promote environmental protection activities at our overseas operational sites, which undertake business activities in various regions of the world.

Actively Undertaking Environmental Protection Activities as a Global Production Site Eisai Knowledge Centre, India (India)

Andover Research Institute (U.S.)

Eisai Knowledge Centre, India is a production site for providing stable supplies of high-quality pharmaceutical products that patients can purchase at easily affordable prices. This site proactively works to reduce the environmental impact associated with its business activities and three years after its establishment, in March 2012, obtained ISO 14001 certification.

The Andover Research Institute engages mainly in R&D activities under Eisai Product Creation Systems (EPCS). It also handles naturally derived substances and operates a pilot plant that supplies clinical compounds.

With many of its operations requiring the handling of chemicals, Eisai Knowledge Centre, India deploys scrubbers during work processes and minimizes the dissipation of acidic gasses and organic solvents. Additionally, it has established a system for the closedsystem transportation of volatile organic solvents or compounds containing these solvents. The Centre has also introduced a system for the surveillance of volatile organic compounds (VOC) contained in air currents within its plant and focuses on air pollution prevention in concert with regularly scheduled air inspections. Waste generated from processes and laboratories is placed in various types of waste containers and stored in specialized locations. Plant wastewater is sorted into wastewater with high concentrations of dissolved matter and wastewater with low concentrations, and the treatment of both types of wastewater is commissioned to respective outside wastewater treatment plants. Furthermore, Eisai Knowledge Centre, India promotes tree-planting activities to raise the environmental awareness of employees. Tree planting also includes the participation of students from nearby neighborhoods and visitors to the plant. To date, 175 mango trees, 31 night jasmine (Cestrum nocturnum ) trees and 136 other trees have been planted. In fiscal 2012, Eisai Knowledge Centre, India was selected from more than 100 South Indian companies to receive first place in two categories at the Environment, Health & Safety (EHS) Excellence Awards 2012 from the Confederation of Indian Industry based on the high acclaim for its proactive initiatives in areas related to the environment, health and safety.

Tree-planting activity within the Centre’s grounds

48

Raising the Waste Recycling Rate through a “Single Stream Recycling” System

Eisai Co., Ltd.

Awarding of first place at the EHS Excellence Awards 2012

The Environmental Health and Safety Department is responsible for assuring the safety of all employees at their workplaces, reducing the environmental impact associated with business activities and complying with laws concerning health, safety and the environment. The department consists of the Safety Committee, Green Team and the Operations Team and executes its duties concerning health and safety as well as environmental conservation. Over the years, the department has promoted initiatives for energy saving and waste reduction. As energy-saving measures, it introduced a variable air volume system for drafts and air conditioning and is also conserving electricity for lighting and reducing energy consumption during non-business hours. Since fiscal 2008, it has reduced the amounts of natural gas and electricity usage by 20% and 6%, respectively, and over a five-year period following the base year of fiscal 2007, it has reduced CO2 emissions by a total of 9,200 tons. Although the volume of waste generated in fiscal 2012 rose 6% over the amount of fiscal 2011, the recycling rate was 26%, an increase of 11% over fiscal 2011. The increase in the recycling rate was due mainly to the introduction in fiscal 2011 of a “Single Stream Recycling” system that has expanded the scope of items that can be recycled. Of particular note, 50% of waste derived from research laboratories, which was previously incinerated, can now be recycled. Additionally, the Andover Research Institute is increasing the functions of its air discharge monitoring system to reduce the discharge of VOC from the pilot plant.

Reducing the Environmental Impact While Achieving Cost Reductions North Carolina Plant (U.S.) The North Carolina Plant manufactures prescription drugs and carries out formulation research as well as supplies Halaven®, a global product worldwide. At the same time, it supplies Aricept® and AcipHex® in the U.S. market. The plant continuously pays full attention to reducing the environmental impact accompanying its business activities. While making efforts to reduce costs, the plant also pursues initiatives for saving resources and protecting nature. In fiscal 2012, the plant installed an economizer to reuse waste heat from a natural gas fired boiler. As a result, the plant achieved a 7.5% reduction in fuel consumption during steam production while at the same time it lowered the amounts of NOX and CO generated annually by 0.20 tons and 0.17 tons, respectively. With the aim of more accurately ascertaining amounts of wastewater, the plant is progressing with plans for installing Parshall Flume type drainage. The plant expects installation to be completed in the first half of fiscal 2013 and believes this will also help reduce wastewater treatment costs. The plant is also considering utilizing a subsidy by a local government body for using treated wastewater. The plant currently utilizes potable water for irrigation and cooling towers and the use of treated wastewater could thus lead to large reductions in the consumption of potable water.

Boiler with attached economizer

Rotating the PDCA Cycle and Steadily Promoting Environmental Protection Activities Suzhou Plant (China) The Suzhou Plant engages mainly in the manufacture and packing of prescription drugs for China. The plant has obtained ISO 14001 certification and precisely operates an environment management system based on the PDCA cycle. The Suzhou Plant is focusing on environmental education for employees and in fiscal 2012 held training a total of 28 times. Environmental awareness at the plant is rising as evidenced by such activities as the establishment of a “No Car Day” with the participation of 76% of its employees. As energy conservation measures, room temperatures are set at between 26–28℃ for air conditioning and between 20–22℃ for heating. Also, turning off lights and power-source switches for OA equipment when not in use is becoming a regular practice. In fiscal 2012,

the Suzhou Plant reduced electricity consumption by 50% throughout the plant district by switching to induction type lights for toilet and room lighting and outside street lights. Waste is sorted and collected according to the categories of general waste, hazardous waste and recyclable waste. Recyclable waste is further sorted into pallets, wood, metals and plastic drums. The plant is also proceeding with the forprofit sale of cardboard boxes. In fiscal 2012, the amount of waste generated and the amount recycled at the Suzhou Plant expanded by 50% and therefore the recycling rate, at 78.2%, was virtually the same as in fiscal 2011. In addition, measurements for the release of pollutants into the air and wastewater as well as for noise and soil Renewal inspection for ISO 14001 certification contamination were below legal standard values.

Environmental Protection Initiatives That Support Knowledge Creation European Knowledge Centre (U.K.) The European Knowledge Centre possesses research, clinical development, manufacturing and sales organizations all within a single location. By promoting mutual interchanges, the Centre pursues further advances in its business activities through knowledge creation. The European Knowledge Centre was established in 2009 using contemporary materials and advanced technologies. It also features enhanced facilities that include leading-edge equipment. For several years following its establishment, the Centre collected various data while establishing facility operation procedures in its role as an operational site. In recent years, however, the Centre has also been actively undertaking activities to reduce the environmental impact. As energy-saving initiatives, in 2011 the Centre improved the combustion efficiency of its boilers using modulating burners and thereby reduced annual consumption of natural gas by 18%. Moreover, through an analysis by its engineer team, in 2012 the Centre optimized the air handling unit usage within the production building, leading to a 7% annual reduction in electricity consumption. The Estates Department has worked on enabling all general waste to be processed by thermal recycling from fiscal 2012. Because incinerated ash is used for construction blocks, the European Knowledge Centre has reduced to zero the amount of waste sent to landfill.

Waste materials separation box From left: confidential documents, bottles and cans (recyclables), general waste, paper (recyclables)


49


Air Pollutant Emissions and Pollutant Load in Wastewater 2008

2009

2010

2011

2012

■エーザイ株式会社 ■エーザイ株式会社 ■エーザイ株式会社 ■エーザイ株式会社 ■エーザイ株式会社 ■国内グループ企業 ■国内グループ企業 ■国内グループ企業 ■国内グループ企業 ■国内グループ企業

■Air Pollutant Emissions FY2008

■Air Pollutant Emissions in Fiscal 2012 by Site

FY2009

FY2010

FY2011

FY2012

■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan

0

5

■Magnified scale

10

15

20

1.3 0

Eisai Co.,Ltd.

0.9 0 0.9 0 0.7 0

0

2

SOx （kg）

NOx （kg）

503

1,437

6,938

Misato Plant

−

−

−

Honjo Facility

−

−

−

Kashima Plant

Kawashima Plant (tons)

1.0 0

Soot and dust

Soot and dust (kg)

Operational site/ Company

Category

4

2.4 0


2.9 0 SOx 2.3 0 2.3 0

−

−

−

Tsukuba Research Laboratories

182

312

2,853

Sannova Co., Ltd.

9

0

1,911

EIDIA Co., Ltd. Ibaraki Plant

5

42

58

Note: “–” indicates that no measurement was taken.

1.8 0 1.4

16.4

1.7

15.4

2.5

14.4

NOx

2.0

10.4 9.8

2.0

■Pollutant Load in Wastewater FY2008

FY2009

■Pollutant Load in Wastewater in Fiscal 2012 by Site

FY2010

FY2011

FY2012

■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Eisai Co., Ltd. ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan ■Group companies in Japan

0

3

6

9

12

10.2 9.4 BOD 6.4 3.1 COD 1.7

(tons)

Eisai Co., Ltd.

0.5 0.3

9.4

0.3

0.5

0.6

2.8

0.6

2.8

0.6

0.5 5.0 4.5 4.5 4.1

1.0

0.7 0.7

0.2

0.3

0.2

0.4

0.2

0.1

0.2 0.1 0

50

Eisai Co., Ltd.

52.7

Honjo Facility

481.1

−

104.2

24.2

Kashima Plant

236.1

276.3

−

−

Tsukuba Research 2,623.8 Laboratories

−

−

−

442.7

163.0

266.6

91.6

70.0

302.3

52.4

11.5

7.0

9.9

25.0

0.2

22.6

−

−

−

Note: “–” indicates that no measurement was taken.

0.3

■Magnified scale

Phosphorus

385.5 1,439.3 1,046.2

Sunplanet Co., Ltd., Misato Laboratories (includes Misato Headquarters)

1.2

5.7 Nitrogen

Misato Plant

EIDIA Co., Ltd. Ibaraki Plant

2,668.4

COD Nitrogen Phosphorus （kg）（kg）（kg） 61.3

Sannova Co., Ltd. Group companies in Japan

BOD （kg）

− 2,902.8

Eisai Seikaken Co., Ltd. Kumamoto Plant

0.7

2.7

Operational site/ Company Kawashima Plant

15

0.3

9.4

Category

0.1 0.1 0.5

1

Resource Input and Environmental Impact (Group Companies outside Japan) ■Eisai Inc., North Carolina Plant (North Carolina, U.S.)

■Eisai Inc., Andover Research Institute (Massachusetts, U.S.)

FY2010 FY2011 FY2012 Energy consumption Electricity (MWh) Natural gas (decatherms*1)

FY2010 FY2011 FY2012 Energy consumption

26,697

26,492

27,229

161,379 154,460 155,531 29

Light oil (kl)

10

10

Waste treatment

Electricity (MWh) Natural gas (thousand m3) Light oil (kl)

14,600

14,400

14,600

2,313

2,164

2,305

12

6

6

Amount generated (U.S. tons*2)

769

404

366

Amount generated (U.S. tons)

237

210

224

Recycled amount (U.S. tons)

496

179

160

Recycled amount (U.S. tons)

75

32

58

Amount sent to landfill (U.S. tons)

238

176

193

Amount sent to landfill (U.S. tons)

0

0

0

■European Knowledge Centre (Hertfordshire, U.K.)

FY2010 FY2011 FY2012 Energy consumption Electricity (MWh)

8,215

8,732

766

722

681

8,206

8,869

8,824

Liquefied natural gas (LNG) (tons) Industrial steam (tons)


8,505

Waste treatment

Electricity (MWh)

7,623

7,273

6,955

Natural gas (thousand m3)

1,093

935

979

0

0

0

Light oil (kl) Waste treatment


115

133

186


287

315

291

Recycled amount (tons)

90

106

146


163

94

52

0

0

0


124

36

0


■Eisai Taiwan Inc., Tainan Plant (Tainan, Taiwan)

■Eisai Knowledge Centre, India (Andhra Pradesh, India)



2,200

2,627

2,896

Hot water (GJ)

31

36

38

Fuel oil A (kl)

463

663

435

Cold water (GJ)

183

223

224

Light oil (kl)

81

135

3

Electricity (MWh)

Waste treatment

Electricity (MWh)

FY2011 FY2012 North Carolina Plant

Waste treatment

■Eisai China Inc., Suzhou Plant (Jiangsu, China)

Principal Chemical Substances Used

8,470

10,316

8,650

113.9

90.5

Isopropanol (tons)

0.3

0.6

Methanol (tons)

0.7

0.5

Acetonitrile (tons)

0.2

0.2

Sodium hydroxide (tons)

1.4

1.4

Ethanol (tons)

Suzhou Plant 12.1

16.6

Methanol (tons)

0.4

0.4

Acetonitrile (tons)

0.3

0.3

Ethyl acetate (tons)

0.0

0.1

Hydrochloric acid (tons)

0.0

0.0

Methanol (tons)

0.33

0.34

Acetonitrile (tons)

0.20

0.16

Ethanol(tons)

0.02

0.02

Hydrochloric acid (tons)

0.01

0.01

Acetic acid (tons)

0.01

0.01

Methanol (tons)

216.0

220.0

Acetonitrile (tons)

136.0

107.0

Anhydrous ethanol (l)

15.0

43.0

Isoamyl alcohol (tons)

10.0

12.9

Glacial acetic acid (l)

12.5

9.2

Ethanol (tons)

Tainan Plant

Bogor Plant

Andover Research Institute 20.3

16.6


5.8

11.3

Acetonitrile (tons)

3.5

5.6

Toluene (tons)

3.3

4.9

Dichloromethane (tons)

6.1

3.9

Methanol (tons)

European Knowledge Centre

Waste treatment


26

29

23


7

114

233


14

18

12

80

187

2.0

Recycled amount

3

1.8


Hexane (tons)

0

0

0

34

46

1.7

Amount incinerated (tons)

4

1.6

Acetonitrile (tons)

1.0

1.2

Dichloromethane (tons)

1.1

1.0

Acetone (tons)

0.6

0.7


35.4

62.9

Acetone (tons)

50.2

50.0

Ethylbenzene (tons)

13.7

22.5

Methanol (tons)

29.4

19.4

Ethanol (tons)

37.9

15.7

Aluminum chloride (tons)

5.5

10.1

2-Butanol (tons)

5.0

9.2

Piperidine hydrochloride (tons)

4.5

8.7

Propionyl chloride (tons)

5.2

6.8


Eisai Knowledge Centre, India

■PT Eisai Indonesia, Bogor Plant (West Java, Indonesia) FY2010 FY2011 FY2012 Energy consumption Electricity (MWh)

1,282

1,974

1,423

1

1

5

1

1

1

Fuel oil A (kl) Liquefied petroleum gas (LPG) (tons) Waste treatment Amount generated (tons)

21

21

20


21

21

20

0

0

0


*1 One decatherm = 1,050 MJ

*2 One U.S. ton = 0.907185 metric tons

14.3

4.1

Paraformaldehyde (tons)

1.3

2.6

Dimethylsulfoxide (tons)

5.9

2.6

N, N-Dimethylformaldehyde (tons)

2.3

1.0

Tetrahydrofuran (tons)


51


Opinion from an Environmental Expert

Reviewing Eisai's Environmental and Social Report 2013 The word “environment” arguably has a wide variety of meanings ranging from the natural environment to human society, necessities such as food, clothing and shelter, and interpersonal relationships. Global-wide healthcare problems are intricately linked to environmental problems and, needless to say, long-term initiatives based on a broad perspective are essential in this regard. The Eisai Group undertakes its corporate activities based on giving due consideration to the ways that people throughout the world live, enhancing patient value and “addressing diverse healthcare needs worldwide.” This year’s report also emphasizes the importance of these corporate activities and is again filled with examples of various activities to improve the environment. Firstly, the positive results of the Group’s efforts to reduce its environmental impact continue to be clearly apparent. These include making related progress through various activities, attaining zero emissions for the fifth consecutive year, recycling waste into resources, and reducing total waste generated, all of which are being carried out based on the Group’s waste reduction plan. Regarding the increasingly important issue of CO2 emissions, higher emissions volumes and coefficient values at its overseas operational sites compared with those in Japan highlight the importance of implementing CO2 reduction initiatives on a Group-wide basis. At the same time, mediumterm CO2 reduction targets toward fiscal 2020 have been established while measures for seriously addressing the needs of customers and markets have been implemented as part of an approach that emphasizes balance. Overall, as with the previous year, improvements continue to be made in all the areas mentioned above. Various data and figures have been ascertained and thorough analyses performed accordingly. Based on these results, feasible countermeasures are also being established. I believe the Eisai Group’s defining qualities are being effectively utilized in this sense, which is highly commendable. I look forward to seeing its medium- and long-term targets concretely incorporated and implemented in other categories as well. Furthermore, judging from the forward-looking plans and activities now being undertaken locally as described in the reports from the Group’s overseas operational sites, I have also observed increased depth in overseas figures, including those related to items covered in previous reports. Aside from Eisai’s activities in Japan, the activities of other Group sites around the world have also been positively evaluated, one example being a major award that was presented to one of the Group’s plants in India. I would like very much for the Eisai Group to continue promoting its future business development in accordance with the unique needs of each local community. In considering the responsibilities of Japanese companies, there are viable ways of providing services and expanding overseas through the establishment of production sites and other strategies while still making a contribution to solving various global issues and challenges worldwide. In Japan, for example, Eisai already conducts onsite inspections of

52

Eisai Co., Ltd.

Ms. Manami Yamaguchi Representative Director Control Union Japan Co., Ltd. In her work, Ms. Manami Yamaguchi strives to achieve balance between the natural environment and social and economic systems. Following stints at research institutes and so forth, she established FEM Co., Ltd., where she is engaged in research, evaluation and educational activities pertaining to the environment, CSR and certification, with a focus on suggestions for lifestyles considerate of the environment and society. She is also Representative Director of Control Union Japan Co., Ltd., an international inspection and certification body. The Control Union World Group (Headquarters: the Netherlands), comprising a network of international inspection and certification bodies in some 60 countries, is engaged in international inspection and certification across a wide range of sectors, including organic farming, textiles, forestry, agriculture and fair trade. Master of Environmental Economics and Sciences. President of Environmental Business Research Institute. Also serves as a member of other NPOs.

potential new waste-processing contractors and only awards contracts to those companies that have been confirmed to engage in excellent industrial waste processing practices. In the future, though, it will probably be necessary to expand this initiative to also include suppliers and business partners that have excellent track records in terms of being environmentally and socially conscious. In emerging countries in particular, while there are a growing number of people involved in economic development, there are undeniably many instances in which environmental and social aspects such as exploitation of labor are neglected, and it is often the case that any possible method may be employed in order to achieve development. For these reasons, this selection process carries with it enormous responsibility. The ways that development should ideally be undertaken across the world are now being called into question. Contemporary Japanese society has been built on the tireless efforts and achievements of our predecessors as well as various experiences in how to deal with environmental pollution and other problems. Moreover, it is only by sheer chance that we as Japanese were born in a country where people are able to benefit from advanced health care and medicine even when suffering from difficult-to-treat diseases. In contrast, there are people around the world who are born into harsh circumstances and are unable to freely live out their lives. This is not a problem we can separate from our own lives, as all things in this world are connected. Both in Japan and overseas, Eisai’s activities provide indiscriminate support, including for those who do not necessarily interact with the Group directly. As also stated by Mr. Naito in the “Message from the President” section of this report, with economies and markets now reaching a dramatic turning point, I, too, would like to see the Eisai Group further fulfill its hhc philosophy by leading the world on various points in order to help address diverse global healthcare and environmental issues.


Social Responsibility Index and Distribution of Added Value Aiming for Fair and Transparent Management The Eisai Group publishes a social responsibility index and a breakdown of the economic added value distributed to its stakeholders to make a comprehensive assessment of its corporate activities from an objective viewpoint.

Scope of data

Social Responsibility Index

■Eisai Group

The Eisai Group has established a set of indices to objectively assess the performance of its social responsibility activities. The indices are categorized as shown below, and used for validating the Group’s initiatives in each fiscal year.

(Eisai Co., Ltd. and 48 group companies in and outside Japan)

■Eisai Co., Ltd. ■Eisai Group in Japan 　(Eisai Co., Ltd. and 10 group companies in Japan)

■Involvement with Patients Index

Period

FY2010

FY2011

FY2012

Japan

Annually

5

5

3

Overseas

Annually

4

5

3

Japan

Annually

7

6

5

Overseas

Annually

4

1

3

Annually

151

125

109

Number of inquiries to hhc Hotline*3

Annually

98,650

103,675

108,298

　　Number of inquiries via the online inquiry form

Annually

1,581

1,080

995

　　Number of complaints (concerning product quality)

Annually

238

256

222

Number of Product Complaint Committee meetings held

Annually

10

9

12

At fiscal year end

5,768

5,752

5,750

Number of prescription drugs under review for approval application Number of prescription drugs approved Number of patents (number of patent applications)

Hospitals

Number of customers

Clinics

At fiscal year end

95,928

95,655

95,043

Dispensing pharmacies

At fiscal year end

9,433

9,660

10,042

Drugstores, etc.

At fiscal year end

70,839

80,488

Distributors

At fiscal year end

86

84

83

Vendors

At fiscal year end

207

236

241

Annually

76

71

50

Number of vendor validations

−＊1

88,300 −＊2

*1 Includes additional indications and formulations. *2 Starting from FY2010, includes convenience stores and other outlets with which Eisai Co., Ltd. does business. *3 Since April 2013, the Customer Hotline has been renamed the hhc Hotline.

■Involvement with Society Index

Period

FY2010

FY2011

FY2012

Number of discussions held (Kawashima Plant area)

Annually

1

1

１

Number of people in attendance (Kawashima Plant area)

Annually

12

12

18

Number of discussions held (Misato Plant area)

Annually

1

１

1

Number of people in attendance (Misato Plant area)

Annually

13

12

11

Amount of funds donated

Annually

¥3,583 million

¥2,185 million

¥1,988 million

Amount of tax paid

Annually

¥38,483 million

¥43,602 million

¥26,677 million

Visitors to the Naito Museum of Pharmaceutical Science and Industry

Annually

41,980

38,035

37,276

Kawashima Plant

Annually

4,748

5,459

4,859

Misato Plant

Annually

1,050

631

423

Misato Plant

Annually

10,686

8,965

8,693

Roundtable discussions with communities neighboring Eisai Co., Ltd.’s domestic production sites

Number of participants in plant tours Number of users of recreational facilities at plants and research facilities


53

Eisai’s Social Activities ■Corporate Governance and Compliance Index

Period

FY2010

FY2011

FY2012

Number of directors

At fiscal year end

11

11

11

Number of outside directors

At fiscal year end

７

７

７

Ratio of outside directors to all directors

At fiscal year end

63.6%

63.6%

63.6%

Number of corporate officers

At fiscal year end

18

18

19

Average age of corporate officers

At fiscal year end

54.8

52.9

52.9

Remuneration (base salary, bonuses, retirement benefits)

Directors (internal)

At fiscal year end

¥115.71 million

¥117.54 million

Directors (outside)

At fiscal year end

¥86.68 million

¥85.12 million

¥86.29 million

Corporate officers

At fiscal year end ¥1,137.81 million

¥875.74 million

¥872.32 million

¥118.02 million

Number of times offered

Annually

70

84

120

Number of executive training courses

Annually

2

2

2 Approx. 8,500

Number of times compliance training offered

Total participants

Annually

Approx. 6,000

Approx. 6,000

Number of times offered

Annually

23

15

28

Participants

Annually

16,370

5,096

3,123

Average percentage of employees completing compliance e-learning courses

Annually

95.7%

94.2%

91.8%

Number of times Compliance Counter was accessed

Annually

797

1,114

1,648 −＊1

Number of GUIDEA consultations

Annually

108

130

108 −＊2

Number of times human rights training offered

*1 Number of times internal compliance consultation service accessed *2 Number of times compliance consultation service operated by outside consultant utilized

■Involvement with Employees Index

Period

FY2010

FY2011

FY2012

At fiscal year end

11,560

10,730

10,495

Japan

At fiscal year end

5,636

5,472

5,320

Americas

At fiscal year end

2,559

1,843

1,815

EMEA

At fiscal year end

1,015

872

830

Asia, etc. (excluding Japan) At fiscal year end

2,350

2,543

2,530

Total

At fiscal year end

4,415

4,305

4,163

Male

At fiscal year end

3,393

3,331

3,228

Female

At fiscal year end

1,022

974

935

Management

At fiscal year end

1,463

1,454

1,442

Ratio of women in management roles to total management

At fiscal year end

2.9%

3.0%

3.7%

Average age

At fiscal year end

42.3

42.8

43.4

Average years of employment

At fiscal year end

18.5

19.0

19.5

Turnover rate

Annually

1.4%

2.4%

1.6%

Number of users of nursing care leave

Annually

25

24

22

Number of users of caregiver leave

Annually

9

2

3

Number of users of shortened working hours system for nursing care

Annually

1

1

0

Number of employees

Number of employees by region

Number of regular employees

Number of users of short-term nursing care leave

Annually

154

141

142

Total

Annually

70

76

78

Male

Annually

1

0

1

Female

Annually

69

76

77

Number of users of shortened working hours system for childcare

Annually

80

79

82

Average annual salary (according to the annual securities report)

Annually

¥10,936 thousand

¥11,094 thousand

¥11,063 thousand

Percentage of employees with disabilities

Annually

2.02%

2.03%

2.37%

Number of new employees per year

Annually

104

60

28

Normal working hours (per person per year)

Annually

1,895

1,904

1,895

Annually

35

31

42

Number of users of childcare leave

Number of work-related accidents Percentage of employees who undergo health checks

Annually

99.76%

99.93%

99.75%

Family members

Annually

71.88%

73.22%

72.01% −＊2

At fiscal year end

99.41%

99.16%

99.23%

Annually

13.7

13.9

12.7

Employee

Annually

2,400

2,077

2,429

Spouse

Annually

800

535

Average number of paid vacation days taken (per union member)

853 −＊3

*1 Based on the number of regular Eisai Co., Ltd. employees.The number of regular Eisai Co., Ltd. employees stated here differs from the number of nonconsolidated Eisai Co., Ltd. employees listed on page 1. *2 Health check eligibility included dependent spouses up until FY2009, and from FY2010 includes dependent spouses as well as nondependent family members 40 years of age or older. *3 Spouses became eligible for participation from FY2010.

54

Eisai Co., Ltd.

−＊1

Employee

Percentage of unionized employees

Number of Walking Mileage Plus participants (See page 37)

−＊1

■Involvement with the Environment Index

Period

FY2010

FY2011

FY2012

Amount of CO2 emissions

Annually

82,082* tons

91,797 tons

91,311 tons

Amount of waste generated

Annually

6,568 tons

7,346 tons

6,289 tons

Amount of substances subject to the PRTR system handled (reported amount)

Annually

645 tons

876 tons

559 tons

Amount of green purchasing

Annually

4,591 million

3,686 million

3,418 million

Waste-recycling rate

Annually

43.96%

34.64%

36.11%

* Data reported for the amount of emissions were revised due to a change in the emissions coefficients; the amount of emissions was recalculated based on the receiving-end electricity carbon emissions coefficient.

■Involvement with Shareholders Index

Period

FY2010

FY2011

FY2012

Number of shareholders

At fiscal year end

133,389

111,387

95,835

Number of shares issued

At fiscal year end

296,566 thousand

296,566 thousand

296,566 thousand

Percentage of holdings by foreign companies, etc.

At fiscal year end

15.1%

19.0%

21.1%

Percentage of holdings by individuals and others

At fiscal year end

98.5%

98.3%

98.2%

Return on equity (ROE)

Annually

16.4%

14.3%

10.9%

Dividend payout ratio (DPR)

Annually

63.4%

73.1%

88.6%

Dividend on equity (DOE)

Annually

10.4%

10.4%

9.6%

Total dividends paid

Annually

¥42,740 million

¥42,744 million

¥42,748 million

Dividends per share

Annually

¥150

¥150

¥150

Distribution of Added Value to Stakeholders The Eisai Group is committed to providing high-quality pharmaceuticals all over the world, and our customers compensate the Group for our performance on this pledge. After paying suppliers and distributors for their services, the economic added value created is shared with various stakeholders—employees, shareholders, national and municipal governments, and society as a whole. A portion of these funds is invested in research and development for the purpose of creating new pharmaceuticals that generate both social and economic added value. Through

the continuous application of this economic process, we are able to create new drugs and carry out our corporate mission to satisfy unmet medical needs.

Note: In calculating distributions, Eisai has appropriately reclassified the account titles used in our financial accounting to ensure the reliability of the figures, with reference to SPI-Finance 2002, R-BEC007 CSR Accounting Guidelines, and other guidance.

Society 0.94% National and municipal governments 12.64%

(million yen)

Expenditures 583,471

Revenue 583,471

Net sales 573,658

Creditors 3.17%

*

Expenses Other expenses and losses 3 required for operation 4 2,159 370,193

*

Distribution of Added Value

(million yen)

Employees

125,661

Officers Shareholders

Distributions to stakeholders 2 Other 211,119 revenue 1 9,812

*

Retained earnings 2.62%

*

*1 Combined total of non-operating income, special gain, and gain on disposal of treasury stock *2 Revenue minus expenses required for operation and other expenses and losses *3 Non-operating expenses minus interest paid, plus special loss *4 Selling, general & administrative expenses, and cost of sales minus personnel expenses and donations

Employees 59.52%

Shareholders 20.38% Officers 0.74%

Creditors National and municipal governments

1,555 43,022 6,688 26,677

Society

1,988

Retained earnings

5,526

Employees:

Combined total of selling, general and administrative expenses, and personnel expenses included in the cost of sales (salaries, bonuses, and benefits) 社会内部留保 800000 Officers: Salaries paid to directors and corporate officers 0.88% 6.37% Shareholders: Combined total of dividends and minority interests 700000国・地方自治体 Creditors: Interest expenses （行政） National and municipal governments: Income taxes-current, income taxes-deferred, and 600000 17.62% other taxes and duties 500000 Society: Donations 従業員債権者 4000002.79%

54.28%

300000

株主

20000017.45% 100000 0

役員

0.61%


55

4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan http://www.eisai.com