CORPORATE PROFILE

Kasumigaseki Common Gate West Tower, 2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo 100-8585, Japan

http://www.teijin-pharma.com/ Product names and service names denoted with ® or TM are registered trademarks or trademarks of the Teijin Pharma Limited in Japan and/or other countries in this brochure. Product names and service names used are registered trademarks or trademarks of the Teijin Pharma Limited. Other product names and service names may be protected as their trademarks and/or trade names. 2014 Teijin Pharma Limited All Rights Reserved

Leading the Way to Global Wellness Originally founded as a healthcare-focused venture within the Teijin Group, Teijin Pharma has established itself as a leader in the industry by building on the Teijin DNA, which includes the spirit to challenge new fields and a dedication to developing unique solutions to complex issues. Since our establishment, Teijin Pharma has remained strongly focused on resolving some of the most difficult issues in the healthcare industry, including finding solutions for illnesses that have no established cure, illnesses for which treatment places a tremendous burden on patients, and illnesses which are not recognized as such. As a specialty healthcare company, it is our mission to develop innovative solutions to leading issues in the industry while working to improve patients’ quality of life.

Contents

Building our global presence as a specialty healthcare company with unique and innovative solutions

Message from the President

03

Industrial Technology

16

Corporate Philosophy

04

Customer & Market Services

18

Business Fields

06

Regulatory Compliance

20

Research & Development

14

Corporate Social Responsibility

22

The Pharmaceutical and Home Healthcare businesses are the most important features of Teijin Pharma, serving as the two pillars of our company. In addition to providing products and services focusing on bone and joint diseases, respiratory diseases, and cardiovascular and metabolic diseases, our aim is also to develop unique healthcare solutions by maximizing the synergy of these two businesses. The main focus of the Pharmaceutical business is maximizing the speed of growth of febuxostat, our hyperuricemia treatment developed in-house. The limitation on classifying febuxostat as a long-term prescription drug in Japan was lifted in April 2012, just in time to accelerate its sales growth. Global marketing of febuxostat began in 2009, starting with the US and Canada, then later growing to approximately 40 countries, including Taiwan, South Korea and 15 countries in Europe. Deployment of febuxostat is now planned to increase to a total of 117 countries, and testing facilities are being added to the pharmaceutical manufacturing plant at Iwakuni, Japan in preparation for production on a global scale. Also, in addition to being a market leader in the bone and joint domain, we will expand our focus to include the muscle domain. In the Home Healthcare business, where we are the leader in the Japanese market in Home Oxygen Therapy (HOT) and Sleep Apnea Syndrome (SAS) CPAP devices, we are working to improve the quality of life for patients with new products and services. Overseas, we are continuing to hold to our existing strategy, with business infrastructures being developed in the US, Spain and South Korea showing good performance.

Up to now, our main focus has been in the fields of respiratory diseases, bone and joint diseases, and metabolic and circulatory diseases. Now, however, we are looking to create new areas of business by building synergy between our work in the Pharmaceutical and Home Healthcare businesses. One challenge we are taking on is the development of new medical devices and regenerative medicines as solutions to aid in the rehabilitation of stroke patients. In addition, we are working to strengthen Group synergy through research that brings together Teijin’s medical and material technologies. Our strength as a material manufacturer enables us to take a unique approach to development in this regard. It is the achievements of the generations before us that have created the Teijin Pharma of today, and we have a responsibility to build upon those achievements by evolving all our global activities and never losing our entrepreneurial spirit. Also, as one of the core business groups of Teijin, we have a responsibility to meet the expectations of the Group as a whole. To do so, we must maximize our current businesses while taking care to properly nurture new ventures. We must look at medicine, medical devices and value-added services together as a whole. It is there that we are certain to find the possibilities of new healthcare solutions, and that is where we will find the unique value of Teijin Pharma. Hiroshi Uno, D.V.M.,Ph.D. President, Teijin Pharma Limited

Our Top Priority: Improving the Quality of Life At Teijin Pharma, we are keenly aware of patients’ strong desire for total health, both in body and mind. Over the years, such patients have taught us the joys of being thanked for the work we have accomplished. This type of hands-on connection with patients is one of the strengths of Teijin Pharma, which is involved with patients in both of our two core businesses of Pharmaceutical and Home Healthcare. Our goal is to help as many patients as possible acquire a positive life attitude and achieve happiness. Teijin Pharma continues to take on new challenges as we work to improve the quality of life, backed by not only the latest medical technology but also an emotional investment in patient health.

Teijin Group Synergies for Breakthrough Solutions Firmly aware that technological breakthroughs provide the platform for corporate growth, the Teijin Group has established a research and development strategy for the Group overall, and continues to strengthen the bonds between group companies. Healthcare has been appointed a priority technology area, and as such, the Teijin Group is pouring efforts into next-generation pharmaceuticals, new home healthcare devices and cuttingedge medical materials. In particular, we are endeavoring to achieve early market entry in the field of medical materials. Additionally, with a strong belief in the merits of joint technical research, Teijin Pharma has been conducting joint research with materials research teams of the Teijin Group. Among

products already developed through such joint research are Antup, a percutaneous tape preparation which utilizes materials from the Films Business Group, and Rhinocort, a treatment for allergic rhinitis developed through the use of plastics formation and mechanical engineering technology. In the Home Healthcare business, Teijin Pharma receives backup and support in the development of new devices, including computer simulations and evaluation of components through cooperation with the Teijin Group IT team. These types of synergistic collaborations among the Teijin Group companies provide a powerful asset for Teijin Pharma, and are leading to the development of breakthrough medical solutions.

Healthcare Business Group Teijin Pharma Limited Teijin Home Healthcare Ltd.

Teijin Group‘s Corporate Philosophy

High Performance Fibers Business Unit Carbon Fibers & Composites Business Unit

Quality of Life In Harmony with Society

The Teijin Group’s purpose is to enhance the quality of life through a deep insight into human nature and needs, together with the application of our creative abilities.

Electric Materials & Performance Polymer Products Business Group

Advanced Fibers & Composites Business Group

Films Business Unit Resin & Plastic Processing Business Unit

Empowering Our People

Products Converting Business Group

New Business Development Business Unit

IT Business Group

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Teijin Pharma is introducing unique medical solutions on a global scale in the three target categories of bone and joint diseases, respiratory diseases and cardiovascular and metabolic diseases, building on the organic ties between our Pharmaceutical and Home Healthcare businesses.

BUSINESS FIELDS Bone and Joint Diseases Respiratory Diseases Cardiovascular and Metabolic Diseases

From In-house Venture Business to Leading Company

Pharmaceutical Business Specialty Pharmaceuticals, from the Ground Up Teijin Pharma’s Pharmaceutical business was created through the bold vision and strong leadership of top management. We have been introducing aggressive initiatives for growth, including investing in R&D for new drugs, building new markets and so forth. Starting from nothing, Teijin Pharma has remained focused on its goals of providing the world with innovative treatments, and we have made clear progress as a research and development company. At present, we are focusing on the three target categories of bone and joint diseases, respiratory diseases and cardiovascular and metabolic diseases. We aim to provide unique solutions in each of these categories as a specialized pharmaceutical company.

Market Launch of Two New Products: Febuxostat and Somatuline ® Teijin Pharma has recently launched two breakthrough drugs: febuxostat, a drug developed in-house treating hyperuricemia, in May 2011, and Somatuline, a drug for treating acromegaly and pituitary gigantism, in January 2013. The first new drug to treat hyperuricemia in nearly 40 years, febuxostat is positioned as a key product in our global strategy, with plans to expand to 117 markets including China, Central and South America, the Middle East and North Africa. At the same time, expectations are high for this product to serve as the foundation for further synergies with our Home Healthcare business in the field of cardiovascular and metabolic diseases.

FUTURE & SYNERGY Our Rehabilitation Field: Born from Our Pursuit to Improve Patients’ Quality of Life (QOL)

06 • TEIJIN PHARMA •

Home Healthcare Business

Bone and Joint Diseases

Respiratory Diseases

Cardiovascular and Metabolic Diseases

3 Target Categories

In the 1970s, Teijin Pharma researchers began working on developing oxygen concentrators in response to demand for oxygen units that incorporated an oxygen enriching membrane. The project was a succession of challenges, not only in terms of product development but also due to the need to establish a service network and acquire approval for insurance coverage. The success of project members laid the foundation for home healthcare in Japan. And today, Teijin Pharma’s Home Oxygen Therapy (HOT) is considered a benchmark model in the domestic market, establishing Teijin Pharma as a leader in the home healthcare industry in Japan.

On Top in the Domestic Market, CPAP Is Now Making Fast Headway Overseas In addition to HOT, which holds the top position in the domestic market in terms of service and share, Continuous Positive Airway Pressure (CPAP) treatment for SAS is also exhibiting tremendous growth. CPAP is showing exciting potential in expanding our growth in the cardiovascular and metabolic diseases category, in hand with the new drug febuxostat, developed in-house. In addition to utilizing our networks in North America, Europe and Asia to participate in the existing markets of developed countries, we are also actively engaged in creating new markets in developing and newly industrialized nations.

Having full control of your limbs, walking and eating — motor skills which are essential for a good QOL. However, the medical treatment currently available in the field of bone and joint diseases doesn’t allow for the full recovery of motor skills of patients who have suffered damage to the central nervous system, even if bone and joint tissue has been successfully restored. Responding to this issue, we are expanding the treatment available in the field of bone and joint diseases to cover central nervous system damage as part of our pursuit to improve patients’ QOL. The first step of this process for our rehabilitation field began in April 2013 with the

marketing of WalkAide, an electrical stimulation device which supports and improves walking for those who suffer from foot drop due to strokes. At present, we are developing a robotic rehabilitation device to provide motor training to patients afflicted by paralysis in the upper limbs, and aim to market the device at the earliest possible opportunity. Furthermore, to meet expectations in the rehabilitation field for commercially viable regenerative treatments in the future, we will provide comprehensive solutions by synergizing our Pharmaceutical and Home Healthcare businesses.

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BUSINESS FIELDS

BONE AND JOINT DISEASES

As a leading company, Teijin Pharma has built a strong platform in the bone and joint diseases field over the past 30 years, including the recent launch of Synvisc® for the treatment of osteoarthritis knee pain, in addition to our core osteoporosis products. The introduction of SAFH SAFHS ® (Sonic Accelerated Fracture Healing System) achieves a synergy between our Pharmaceutical and Home Healthcare businesses.

Bone and Joint Diseases Respiratory Diseases Cardiovascular and Metabolic Diseases

Pharmaceutical Business

Sodium Hyaluronate Treatment

Onealfa, developed in-house as the first vitamin D 3 drug in tablet form, is a frontrunner in the field of osteoporosis drugs, while Bonalon, in-licensed from overseas, has become a first-class drug for treating osteoporosis. Furthermore, we have expanded the applicability of Bonalon through the in-house development of Bonalon Bag and Bonalon Jelly, and the addition of Synvisc, a sodium hyaluronate treatment to relieve osteoarthritis knee pain, has further strengthened our product pipeline in this field.

SAFHS ®: The Bridge between Our Two Core Businesses The impetus behind the product development of SAFHS was a presentation of venture businesses in New York. Although the working model for SAFHS had shown promising results, the mechanism behind its success was unknown. Thus, members from the Home Healthcare business requested that scientists in the Pharmaceutical business conduct basic research in this area, leading to the acquisition of key data for product

development. Furthermore, pharmaceutical medical representatives (MRs) who were well regarded in the field of bone and joint diseases handled product presentations to doctors. Both MRs and home healthcare managers provide explanations to patients, with home healtcare staff handling the management of equipment. Teijin Pharma believes that even for complex projects, it is best when the synergies between businesses can overcome organizational boundaries. That is the Teijin DNA.

Synvisc®

Onealfa ® and Bonalfa ® : Developed from Ideas Given by Physicians

Osteoporosis Treatment

Teiroc ® and Bonalon ® are trademarks of Merck Sharp & Dohme Corp. Synvisc ® is a trademark of Merck Genzyme Corp.

Onealfa®

Bonalon®

Home Healthcare Business Sonic Accelerated Fracture Healing System

TEIJIN DNA

SAFHS is the first fracture healing system in the world that utilizes sonic pulses to speed up healing. SAFHS has been recognized for its high efficacy in healing new fractures and complex fractures with just a short 20-minute treatment per day, as well as reducing the time needed to repair bone joints and contributing to the quick rehabilitation of patients.

The Onealfa project was started based on a comment from a physician, who suggested that if renal patients had low vitamin D activation function, it might be possible to treat them with a product using active vitamin D directly. The results of the research that followed led to the in-house development of an active vitamin D3 drug for treating not only patients with renal failure, but osteoporosis patients as well. Lots of feedback from doctors, who noted that patients using Onealfa experienced improvements in skin inflammation, led to

We Aim to Be a Leading Company in Locomotive Disorders through Further Synergies

the drug. The information provided by doctors encouraged Teijin Pharma to develop Bonalfa, an active vitamin D3 drug for treating skin disorders. Listening to comments from all sources is another vital part of the Teijin DNA.

Bonalfa® for psoriasis treatment

Bonalon® Jelly for the treatment of osteoporosis

Life Cycle Management of Products Initially, patients taking Bonalon once a day were required to take the prescription with a glass of water upon awakening, and refrain from lying down for 30 minutes, a requirement that led some patients to stop treatment. In an effort to reduce the burden on patients and increase efficacy, research was begun on ways to reduce the number of required doses, resulting in the development of Bonalon Once Weekly by a licenser. While, in addition to the completion of the in-house development of Bonalon Bag and Bonalon Jelly, we are also continuing to work on the production of pharmaceuticals that improve patient compliance.

With Onealfa and Bonalon, our two drugs for osteoporosis, and the sodium hyaluronate treatment Synvisc for osteoarthritis knee pain, Teijin Pharma has established itself as a leading pharmaceutical company in the field of bone and joint diseases. Our next step is to expand into the field of orthopedic disorders to include musculoskeletal disorders as well. As part of this effort, we are establishing a global research network, dispatching research scientists overseas and sponsoring symposiums that provide a forum where leading researchers in both basic and clinical science can meet to share ideas. Additionally, based on the success of SAFHS, we aim to create further synergies between the Pharmaceutical and Home Healthcare businesses, including new research in rehabilitation devices, aiming to be a world-leading company in the field of locomotive disorders as well.

SAFHS®

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BUSINESS FIELDS

RESPIRATORY DISEASES

In the field of respiratory diseases, Teijin Pharma’s Home Healthcare business stands out as an industry leader in providing Home Oxygen Therapy (HOT). In the Pharmaceutical business as well, Teijin Pharma has continued to develop key products for treating respiratory diseases, including Mucosolva Mucosolvan ®, which has successfully reached over 30 years of continuous sales.

Bone and Joint Diseases Respiratory Diseases Cardiovascular and Metabolic Diseases

TEIJIN DNA

Providing Patients with the Best Products in the World

Pharmaceutical Business Airway Mucolytic Agent Our strong pipeline of pharmaceuticals in the field of respiratory diseases includes the airway mucolytic agent Mucosolvan, which has maintained a solid position in the market for over 30 years, Alvesco, an inhaled corticosteroid for asthma, the bronchodilator Spiropent, and Atrovent, a treatment for bronchial constriction. We continue to develop drugs which cater to a wide range of respiratory diseases, such as asthma, COPD (chronic obstructive pulmonary disease) and allergic rhinitis.

Mild SansoTM

Continuous Improvements in Oxygen Concentrators

Working to Help Patients of All Ages

Alvesco®

Home Healthcare Business CPAP (Continuous Positive Airway Pressure) Device Therapeutic Oxygen Concentrator

SLEEPMATE®

NIP NASAL® V

patients with the best solutions in the world, without limiting ourselves to Teijin Pharma products. That is part of the Teijin DNA.

Inhaled Corticosteroid for Asthma

Mucosolvan®

NPPV (Noninvasive Positive Pressure Ventilation) Device

In the Home Healthcare business, Teijin Pharma enjoys the unique position of being both a manufacturer and a service provider. Our strong foundation in technology enables Teijin Pharma to discuss engineering issues on an equal foothold with our partner manufacturers, without sacrificing the flexibility to jump into new areas. Our aim is to build on the strengths of our partnerships to provide

Similar to HOT, Mucosolvan has been a key member of our lineup in the field of respiratory diseases for nearly 30 years. During research on the usage and clinical effects of this product, it was discovered that more than 60% of patients with chronic respiratory disorders such as COPD and asthma had difficulties expectorating morning phlegm. In response, we developed the Mucosolvan L Capsule, a sustained release capsule to be taken once a day after dinner for greater morning effectiveness. Likewise,

Developed in-house by Teijin Pharma, the Hi-Sanso series of oxygen concentrators has maintained a leading share in the HOT market. Other key products in our lineup include NIP NASAL (a series of noninvasive positive pressure ventilators), CPAP devices for SAS patients and monitoring equipment.

Home Healthcare Business Gets Underway in Countries Worldwide

we have developed an aerosol form of the inhaled corticosteroid Alvesco, so that it can be used even by children and the elderly, who often have reduced inhalation capabilities. We are working on a web site to share detailed product information, disease-related information and suggestions for effective pharmaceutical use. Working to improve life for all patients is also part of the Teijin DNA.

The first oxygen concentrator produced on the domestic market, Teijin Pharma’s Mild Sanso offered quiet operation and achieved impressive growth as a rental unit. This epoch-making product can be considered the fountainhead for the market of home healthcare in Japan. At the heart of this machine was oxygen membrane technology, developed in-house by Teijin Pharma. Over the years, models have become smaller, quieter and more energy efficient. Even today, Teijin Pharma continues to look for ways to further improve the market-leading Hi-Sanso series.

In 2008, Teijin Pharma acquired the three U.S. companies of Associated Healthcare Systems, Inc.; Braden Partners L.P.; and Home Therapy Equipment, Inc., enabling us to establish a sales network for home healthcare in the North American market. In 2009, Teijin Pharma established Esteve Teijin Healthcare S.L. as a joint venture with Spain’s Laboratorios del Dr. Esteve S.A., creating a focal point for respiratory disease-related home healthcare in the European market. In Asia, Teijin Pharma set up Yuyu Teijin Medicare Inc. as a joint venture with Korea’s Yuyu in 2006, marking Teijin’s first overseas foothold for the Home Healthcare business. Not only has this joint venture provided home healthcare treatment and successfully obtained national insurance coverage for such services, it has also helped Teijin Pharma acquire the No.1 share in the Korean HOT market. We plan to continue this insurance-focused strategy in other Asian countries as well.

Hi-SansoTM

10 • TEIJIN PHARMA •

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BUSINESS FIELDS

CARDIOVASCULAR AND METABOLIC DISEASES Bone and Joint Diseases Respiratory Diseases Cardiovascular and Metabolic Diseases

Cardiovascular and metabolic diseases are a key area where the synergistic effects of the Pharmaceutical and Home Healthcare businesses are expected. The hyperuricemia treatment febuxostat febuxosta and CPAP therapy for SAS, two major solutions in each area, are already setting the course for growth.

TEIJIN DNA

The Discovery of Febuxostat Began with a Liberal Research Environment

Pharmaceutical Business Teijin Pharma provides a wide-ranging product pipeline in the field of cardiovascular and metabolic diseases, starting with the hyperuricemia treatment febuxostat, a highly anticipated drug expected to play a key role in our global strategy, as well as Tricor and Solmiran to treat metabolic disorders and Antup, a percutaneous patch preparation for dilating coronary arteries in patients with angina or myocardial infarction.

Anti-hyperlipidemic Agent

pH Dependent Disintegrating EPA Agent

Tricor®

Solmiran®

Anti-hyperuricemia Agent

Air-permeable Tape for Ischemic Heart Disease

When research commenced on a new anti-hyperuricemia drug, our interest in the project was low due to the small size of the target market and lack of novelty in the drug mechanism. Only the strong enthusiasm of the participating researchers could keep the project going. After promising initial results were obtained, our interest in and awareness of the project began to snowball, inspiring further progress. One of the key factors to success was Teijin Pharma’s research

environment that encourages informal discussions and research networking. This liberal environment led to one small idea being transformed into a major new pharmaceutical. Respecting employees for their ideas is part of the Teijin DNA.

High Hopes for AutoSet CS-A as a New Treatment for Heart Failure

Feburic®

Antup®

Home Healthcare Business

Over the past few years, AutoSet CS-A has become a hot topic in the cardiovascular diseases field, as it may provide a new option for treating heart failure. Expected to improve the quality of life of patients suffering from chronic heart failure, AutoSet CS-A has received high marks from members of the medical field and

patients alike. It was the creative thinking and strong conviction of a single project manager that led to the development of treatment methods utilizing AutoSet CS-A. Keeping an ear tuned to latent medical needs and introducing novel solutions without clinging to tradition is also part of the Teijin DNA.

The Second Teijin Group Fellow The Teijin Group Fellow program was established by the Teijin Group to encourage research and technological developments and enhance employee motivation. In 2009, Mr. Shiro Kondo was recognized as the second Teijin Group Fellow for his contribution to the development of febuxostat. Researchers strive to be selected as Fellows, which is not only a tremendous honor but also promises an environment in which research can be conducted freely. At present, Fellow Kondo and his associates are conducting research on drug delivery systems and medical devices at the Kondo Research Lab.

Fellow Kondo (right) providing advice in the lab.

Adaptive Servo-Ventilator

CPAP Device with Automatic Pressure Adjustment

AutoSet CS-A

At present, our lineup focuses on CPAP devices for SAS therapy and the positive pressure ventilator AutoSet CS-A for the treatment of heart failure, two lines of equipment expected to expand our share in the cardiovascular diseases market. Additionally, public health insurance coverage for HOT, which has played a leading role in our market share thus far, was extended to cover chronic heart failure in 2004, further boosting opportunities for Teijin Pharma in the HOT market.

Revolutionary Drug Febuxostat Is Ready to Take on the World The potential of febuxostat is being felt around the world. Sales began in America in 2009 ULORIC, while the under the brand name ULORIC, drug has been launched in approximately 40 countries with plans to expand to 117 markets including China, Central and South America, the Middle East and North Africa. While only permitted for gout treatment overseas at the moment, the aim is to include hyperuricemia treatment in the future.

Adenuric ® Adenuri Europe, etc.

Ulori ® Uloric Middle East

North America Asia

North Africa

Feburic® Japan, Asia & Israel Central & South America Oceania

SLEEPMATE®

12 • TEIJIN PHARMA •

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RESEARCH & DEVELOPMENT Pharmaceutical Products Research Laboratories (Iwakuni, Yamaguchi Prefecture)

Development of a Monitoring System Using Information Technology One of the core themes of the Home Healthcare business is to provide the same level of comfort and safety at home as is available in the hospital. One example of this is HOT Mimamori-ban which provides 24-hour monitoring of the operational status of oxygen concentrators utilizing the cellular phone network. A further example is NemLink, which enables medical organizations to check the operational status of equipment for the treatment of SAS. At present, we are working on developing a system for tracking patients’ medical conditions at home through an expanded communications infrastructure utilizing IT technology.

We Are Tackling Diseases with a Two-pronged Approach of Pharmaceuticals and Medical Equipment It is the mission of Teijin Pharma to alleviate the symptoms of all patients, even those whose illnesses have not been categorized. Teijin Pharma’s unique insight on medicine and the strength of our two core business areas enable us to come up with creative solutions to medical issues, through both pharmaceutical products and medical devices.

actively engage in research and development. At the same time, we will promote alliances with partners in Japan and overseas to ensure we deliver innovative solutions resulting from crossovers between our two core businesses, focusing on medical devices in areas where pharmaceuticals are not effective, and curing illnesses with pharmaceuticals in areas where they show the best results.

Developing Pharmaceutical and Home Healthcare Solutions that Benefit Patients and Society In the past, neither SAS nor decreased bone density were considered illnesses. However, Teijin Pharma went forward in focusing on solutions to these health issues. Placing the utmost priority on making a positive contribution to patients and society, both our Pharmaceutical business and Home Healthcare business continued with research and development to provide unique products. Going forward, we will maintain efforts to

14 • TEIJIN PHARMA •

Promoting Research in Integrated Technology that Combines Pharmaceuticals and Materials Teijin Pharma makes use of the synergistic research within the Teijin Group, including discovering new technologies to combine pharmaceuticals and materials. Believing in the power of joint research, we collaborate with materials research teams to develop revolutionary products which go against conventional practice by making use of technologies from a wide range of

fields. Furthermore, the Teijin Group’s IT team is involved in developing systems in the Home Healthcare business through IT technologies, including inter-system coordination and the creation of contact networks between offices and hospitals.

A Strong Track Record and Deep Relationships Enhance Our Alliances with Overseas Partners Since its founding, Teijin Pharma has worked to build trust with its Japanese and international in-licensing and out-licensing partners while maximizing the fruits of its research and development labors through strategic alliances. We are convinced that breakthroughs emanate from collaborations with our partners in mutually synergistic relationships. Therefore, for early-phase and exploratory research, we proactively advance alliances with corporations and research institutions both in Japan and overseas to create innovative solutions.

HOT Monitoring System HOT Mimamori-ban ® NTT DOCOMO Center

Teijin Institute for Bio-Medical Research (Hino, Tokyo)

Home Healthcare Medical Devices [In-Licensed]

[Out-Licensed]

Product

Licenser’s Name

Product

Licenser’s Name

Hi-Sanso PortableTM SAFHS ® Air Watch®

AirSep

Hi-SansoTM 2U/3R/3N

Yuyu Teijin Medicare Inc.

NIP NASAL®/SLEEPMATE®/ AutoSet REMstar ®/Alice MORPHEUS ®/ SLEEPWATCHER ® WalkAide

®

Bioventus iMetrikus ResMed Philips Respironics Compumedics Innovative Neurotronics

Pharmaceuticals [In-Licensed] Product

[Out-Licensed] Licenser’s Name

Mucosolvan® Spiropent ® Atrovent ® Laxoberon® Bonalon®/Teiroc® Alvesco® Tricor ® Synvisc®

Product

Licenser’s Name

Alfacalcidol

Ilsung, Minapharm, Martin Dow, Astellas Pharma, Hind Wing, Berli Jucker, DIPA, Pharmacon, Somedico, Chanhduc, Sea Lion

Tacalcitol

Isdin/Esteve, Merck Sante, Abiogen, Almirall Hermal, Ilsung, Profex, Martin Dow

Nasal formulation technology

Takeda Pharmaceuticals International

Boehringer Ingelheim

Merck & Co. Takeda (Germany) Fournier, ASKA Sanofi

®

Somatuline PHA (ITM-058)*

Ipsen

Production technology for whooping cough vaccine

GlaxoSmithKline Biologicals, Sanofi Pasteur

CRTh2 antagonist (PTR-36)*

Pulmagen

Febuxostat (TMX-67)

Takeda Pharmaceuticals U.S.A., Ipsen, SK Chemicals, Astellas Pharma, Menarini, Algorithm, Neopharm

Others

Rottapharm, Angelini, Dong Wha, Shanghai Pharmaceuticals

*In development Transmission

Oxygen concentrator

Patient’s Home

Information Center

Dispatching Researchers to Top Labs of Cutting Edge Research

Bio-Medical Engineering Laboratories (Hino, Tokyo)

Teijin Pharma continuously sends researchers to collaborate with venture businesses, universities and research institutions abroad. Our researchers, who have accumulated extensive overseas experience, also actively work on global partnership projects. Talented scientists from around the world gather at top-notch, cutting-edge laboratories, and the relationships formed during their stay provide our researchers with a scientific network, leading to valuable information exchange for research activities. Moreover, leading scientists from both Japan and overseas, including Teijin Group Distinguished Fellow Dr. Ei-ichi Negishi, Teijin alumnus and 2010 Nobel Prize Laureate in Chemistry, provide research and technical strategy guidance on a regular basis. Receiving direct advice from front-line scientists is a powerful motivator for Teijin Pharma researchers.

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In Pursuit of a Better etter Production System for Exceptional Product Quality andd a Stable Supply In order to contribute to patients’ quality of life, we are constantly working to improve our production process in order to efficiently produce a stable supply of high-quality pharmaceuticals and medical devices.

Establishment of Seamless Technology from the R&D Stage to Production

INDUSTRIAL TECHNOLOGY

As a pharmaceutical project moves from the R&D stage to trial product production and then full-scale manufacturing, the production process requires an expansion of scale and the establishment of the ideal production system. In order to deliver high-quality pharmaceuticals to patients as quickly as possible, research facilities, technological development departments and production factories work in close contact to implement manufacturing technology that is both fast and accurate.

Iwakuni Pharmaceutical Factory

mented a system to assure product quality that conforms to the Good Manufacturing Practice quality control standards used worldwide.

Improving Product Quality through Tie-Ups with the World’s Top Manufacturers

The Importance of Supply Stability

In the production of medical devices as well, Teijin Pharma is dedicated to using the same high standards for product quality as are used in the production of pharmaceuticals. We are confident that our focus on product quality in medical devices is second to none. Not only are quality assurance activities implemented in our own factories, but we also make regular visits to the factories of our subcontractors who supply parts and products, allowing us to verify processes and quality. Feedback from Teijin Pharma contributes to the improved product quality of our suppliers, as well as a stronger relationship of trust.

It is the mission of Teijin Pharma to provide patients with a stable supply of the medical products they need. As part of our efforts, we have implemented a system for sourcing materials from multiple vendors whenever possible. Additionally, we have adopted a Business Continuity Plan that will help us maintain our production system even in emergency situations, such as following an earthquake or other natural disasters.

Proactive Research on New Manufacturing Technology and Systems for Ensuring Product Quality

Shift to Overseas Production and Development as Part of Our Global Strategy

16 • TEIJIN PHARMA •

Creating an Optimized Assembly System from the Ground Up In the medical devices production process, the human element has a tremendous impact on product quality. To achieve a “dedication-to-quality” mindset among manufacturing employees, we have implemented a consulting system for the production lines. Backed by specific advice from experts, factory employees have started taking independent action to improve their operational environment, including implementing more effective ways to assemble products and use tools. Such “Kaizen” efforts have led to constant improvements in line operations.

Production of oxygen concentration units utilizes the cell production method. Every effort has been made to improve the production environment, including the introduction of touch panels to display operational steps and quality requirements. Additionally, workstations can be adjusted to match the height of employees. Quality inspections of products from subcontractors are also conducted here.

Chemical technology and manufacturing technology are progressing day by day, and accreditation systems for product quality also continue to evolve. At Teijin Pharma, we have established a system for implementing cutting-edge technology and assuring product quality, with the goal of providing a stable supply of high-quality pharmaceuticals. We have also imple-

To prevent product contamination and to boost productivity, Laxoberon (above) is produced on a fully automated, dedicated production line from the materials mixing stage to packaging. A state-of-the-art inspection machine has been added to the packaging line for further improvements in quality control. We also place top priority on creating an environment where employees can produce pharmaceutical products safely.

Iwakuni Medical Factory

The new drug febuxostat is expected to play a key role in boosting Teijin Pharma’s role in the global market. In order to attain a stable supply of this product, we are establishing supply chains in multiple locations. In the Home Healthcare business, we have begun operations in earnest in the US, Spain and Korea, allowing us to obtain a firm grasp of local needs. The next step will be to determine how to promote Teijin Pharma to our greatest advantage with our subsidiaries and providers in each of these countries. In order to provide the most appropriate support in each region, we need to establish production and research bases overseas as well, rather than simply provide products and information from Japan. In our two core businesses of Pharmaceutical and Home Healthcare, Teijin Pharma is poised to take the next step: the globalization of production.

• TEIJIN PHARMA • 17

CUSTOMER & MARKET SERVICES

Providing Better Solutions through the Synergistic Effects of Our Two Businesses The collaboration between our Pharmaceutical and Home Healthcare businesses began with the integration of sales offices, which not only created an environment that facilitated information exchange, but also improved communication among employees. Particularly in the field of cardiovascular and metabolic diseases,

Gathering Information from the Field and Providing Appropriate Product Usage Information to the Market

Developing Comprehensive Services that Prove Our Worth as a Member of the Medical Team Drawing on the advantages of our two specialty Pharmaceutical and Home Healthcare businesses, we are maximizing the synergistic effects of these two businesses, while placing a strong emphasis on knowledge and communication, essential skills for on-site healthcare.

Developing Professional Staff Who Are Innovative Thinkers On the frontline of Teijin Pharma sales activities are 750 medical representatives (MRs) in the Pharmaceutical business and 350 field representatives in the Home Healthcare business. We place top priority on educating these 1,100 individuals to develop a truly professional team that can recommend the most effective uses for pharmaceuticals and medical devices, including diagnostic and treatment methods. Our home healthcare sales staff are composed of certified MRs. In the future, we plan to rotate sales staff between our two core businesses and foster human resources who are highly capable of recommending both pharmaceuticals and medical devices.

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To increase the effectiveness, safety and quality of pharmaceutical products, it is essential to obtain field data from clinical usage following market launch. At Teijin Pharma, product managers handle all the information related to products obtained from specialists in each field, healthcare specialists and patients. The information needed for proper product usage is provided to all medical personnel through close cooperation between drug development, product development, technology and sales divisions. We are also proactively compiling evidence required for proper product usage.

staff from both businesses work together to organize joint lectures and symposia, and also work in tandem when conducting explanatory meetings at medical offices. By providing information from two different perspectives, Teijin Pharma employees are able to provide a greater wealth of information, which not only broadens the range of treatment options but also allows for the discovery of more ideal medical solutions.

By jointly conducting lectures and symposia, employees from Teijin Pharma’s two core businesses are able to provide participants with a wider range of information.

Customer Centers for HOT, CPAP Devices and SAFHS®

Our Top Priority: Improving Patients’ Quality of Life

Teijin Pharma set up Customer Centers in Fukuoka and Osaka to enhance our support system in the Home Healthcare business. In addition to specialized operators who respond to questions and concerns regarding HOT, CPAP devices and SAFHS, permanent members of staff who possess extensive knowledge and experience, including former sales staff members, provide additional guidance and respond to difficult inquiries. A 24-hour, 365-day system has been set up to provide HOT support, with dedicated phone lines for oxygen cylinder orders.

The proper, continuous use of medical equipment is a key in preventing re-hospitalization, and thus can be considered essential for improving patients’ quality of life. As such, Teijin Pharma implements a wide range of support activities to ease patients’ minds and help them maintain a normal lifestyle. We recognize that initial support during installation of equipment is the key to encouraging proper and continuous usage. For HOT units, this guidance is provided by Teijin Pharma nurses, who visit the patient’s home and provides detailed instruction. We also provide phone support for CPAP devices and travel support services when needed.

Customer center staff members respond to inquiries and emergency situations.

Support is tailored to meet the needs of individual patients, improving their quality of life.

Home Healthcare Team Organization Our team, which is comprised of sales staff, home care staff, nurses, laboratory technicians and office staff, provides support to home healthcare professionals and patients. Sales staff are certified as MRs, while home care staff, who are tasked with setting up and checking equipment, are required to undergo training and in-house technical accreditation. Nurses are responsible for inspecting equipment usage and status at patients’ homes, and laboratory technicians, as SAS professionals, handle support for medical institutions and education for our staff.

Nurses

Home care staff

Sales staff

Laboratory technicians Information from doctors helps improve the safety and effectiveness of pharmaceutical products.

Office staff

Training System for Medical Representatives (MRs) To ensure MRs are of the standard they should be, Teijin Pharma continues building an MR training and professional development program designed to meet the needs of patients and medical personnel through MRs able to effectively provide information. Upon entering the company, new MRs are provided with introductory training spanning several months tailored to their experience and abilities. All MRs are required to attend monthly training sessions to obtain the latest industry information. We also offer a wide range of training based on years of work experience, particular products and selected institutions. To raise the effectiveness of on the job training, Teijin Pharma places great emphasis on the training of supervisors and tutors, who mentor and guide their junior counterparts.

Emergency Response System Leads to Enhanced Security and Trust Teijin Pharma has created an Emergency Response Manual based on our experiences in emergency response. In the event of a natural disaster or other emergencies, the Emergency Response Support IT System quickly compiles patient data. Patients can enjoy extra peace of mind knowing that response staff and spare oxygen cylinders are available at our service offices nationwide.

Delivery of oxygen cylinders commenced the day after the Tohoku earthquake in March 2011. Within two days, the oxygen cylinders had arrived in Sendai, with oxygen concentrators swiftly delivered to northern Japan for use at evacuation shelters with electric power or to replace damaged concentrators.

• TEIJIN PHARMA • 19

REGULATORY COMPLIANCE

Unified Management by Using a Global Database on Drug-related Side Effects

In full compliance with pharmaceutical laws, Teijin Pharma proactively compiles data on adverse drug reactions from medical institutions and partner companies in Japan and abroad, as well as from published articles. The collected data is compiled by the relevant division, and is

stored in a database to share with our main partner companies from around the world. Through this process, we are investigating all information regarding the safety and side effects of the products we produce and providing safety information around the world.

Safety and Quality Management System for Reliability Assurance for Pharmaceuticals and Medical Devices (Following Market Launch)

Teijin Pharma

Compliance Information

Medical institutions / consumers (domestic)

We Place Utmost Priority on Safety fety and Product ct Quality Q lity Assurance As ce At Teijin Pharma, we are serious about our commitment to compliance. An independent division under direct control of the president provides on-site support and is responsible for auditing and assessing product liability and quality assurance. Following market launch, we carry out research and regulatory compliance by compiling and managing information regarding the quality and side effects of our products.

Product Liability Assessment and Quality Assurance Begins at the R&D Stage Not only does Teijin Pharma strictly comply with laws, regulations and other official standards, we impose our own strict corporate rules to ensure compliance. As part of our regulations in the area of R&D management, we have implemented the Teijin Group Product Liability Assessment and Quality Assurance (PLQA) System, which functions as a quality assurance system for the research

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General Supervisor

Decisions on compliance action

Collection / transmission of data

Report Instruction

Safety Dept.

Quality Dept.

Sales offices

Customer service center

Partner companies (domestic/overseas) Literature

MHLW PMDA Overseas: FDA, EMA

FDA: Food and Drug Administration EMEA: European Medicines Agency

Sales and Compliance for Febuxostat Go Global and development stage. Evidence must be submitted for each aspect of R&D, and approval by the Compliance Division is only granted after the reliability of the data provided has been confirmed. Leading issues discussed at internal decisionmaking meeting must receive approval of PLQA assessment. This robust system of checks creates a solid foundation for assuring quality and reliability.

Reporting

Compliance Division

Efficacy ac • Safety/Quality/ Safet /Q ali Proper usage information

With the launch of our new drug febuxostat, we have expanded our network from the US and EU to all corners of the globe. Similar to the domestic market, risks in the global market include legal risks, product quality risks and safety risks. However, individual risks vary depending on the country and region, and thus it is essential to acquire the skills and information needed to handle risk management and response in each region. One absolute requirement for overseas risk management is to create partnerships with companies who are committed to the implementation of quality and safety assurances. We must also develop a system for the continuous monitoring of risk management activity implementation by these partners. For PLQA assessment as well, it is essential to monitor the risk management and risk response capabilities of our partners around the world. In line with the global launch of febuxostat, we are developing a true system of global compliance.

• TEIJIN PHARMA • 21

CORPORATE SOCIAL RESPONSIBILITY

We Are Committed to CSR Activities, with Environmental Stewardship as One of Our Leading Themes As a corporation dealing with products that are directly linked to patients’ lives, we are fully aware of the tremendous importance of conducting corporate social responsibility (CSR) activities. Following the CSR Basic Policy of the Teijin Group, we are striving to contribute to the creation of a sustainable society, strengthening our efforts to achieve environmental preservation and environment-friendly design in the pharmaceuticals and medical devices we produce, from R&D to manufacturing, sales and disposal.

Reducing the Environmental Burden of Each of Our Business Divisions In order to reduce CO2 emissions in the manufacturing process, we have introduced separate air conditioning units and high-efficiency production systems per production line in the clean rooms where pharmaceuticals and medical devices are produced. We have also taken steps to redesign our packaging to reduce waste. By replacing standard corporate cars with hybrid cars and compact cars, we are further reducing CO2 emissions and fuel consumption.

Commitment to Environmentfriendly Design Leads to Outstanding Eco Products In addition to creating people-friendly products that have universal designs, Teijin Pharma is redesigning all products to be more compact and energy-saving, while achieving a reduced environmental burden over the product life cycle through improved longevity and recyclability. One of Teijin Pharma’s Eco-Products is the Hi-Sanso 7R oxygen concentrator, which features not only a more compact design, but also offers improved operability and more energy-efficient performance.

Hi-SansoTM 7R

Efforts in and Impact of Teijin Group CSR Management The Teijin Group’s commitment to CSR began in 1993 with the establishment of a corporate philosophy which advocates “Enhancing the quality of life through a deep insight into human nature and needs,” “Growing and evolving in harmony with society” and “Empowering our people.” In order to fulfill these goals, we established a basic policy for CSR, promoting the systematic implementation of CSR activities throughout the organization. In April 2005, a Group CSR Officer position was created, and shortand medium-term goals were established for key CSR issues, such as compliance, risk management, ESH (environment, safety and health), social contributions and so forth, dividing these topics into

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the three categories of Basic CSR, Expansive CSR and Selective CSR. We also clarified CSR responsibilities and implemented activities that could be put into practice. In March 2011, we announced our participation in the United Nations Global Compact, a voluntary program that encourages businesses to comply with principles in the areas of human rights, labor, environment and anti-corruption. The CSR activities of the Teijin Group have received high marks internationally, as indicated by inclusion in the Dow Jones Sustainability Index, the FTSE4Good Index Series, and the Ethibel’s Investment Register.