We strive to develop and provide a stable supply of innovative, science-based pharmaceuticals.
Developing and Providing Pharmaceuticals
Renal Anemia Treatment Epogin®
20 Years of Contribution
Epogin® was the world's first treatment for renal anemia. Launched in April 1990, it has made substantial contributions to dialysis treatment since then, improving the quality of life for more than two million renal anemia patients on dialysis. Since the launching of Epogin®, Chugai has made a number of improvements in manufacturing and formulation and worked to add new indications. As a result, Epogin® is highly trusted by healthcare professionals, and the evidence of its effect on heart functions and prognosis in addition to improvement of renal anemia is fueling further expectations for this drug.
Syringe Parts Supplier Development Project for Stable Supply of Epogin®
Previously available only in vials, Epogin® has also been available in pre-filled syringes since 2001. Just before the launch, as we were working frantically to get the production facilities up and running in order to supply some 20 million syringes annually, we ran into quality issues with syringe parts supplied by an overseas manufacturer we had chosen. At that time, the production line was one of the world's fastest syringe filling lines and required high-quality, high-precision syringe parts for its stable operation. Even though the overseas syringe parts supplier had the largest global market share and supply capacity then, we could not dispel our concerns about their quality. Therefore, we started Syringe Parts Supplier Development Project to ensure continuous, stable supply of Epogin®.
We chose a domestic company as an additional supplier, taking into account their relationship of trust with Chugai and their level of technology. But since we decided to add another supplier after the start of mass production, the project ended up being much more difficult than we had originally anticipated. During breaks in the production employing parts from the overseas manufacturer, we repeatedly evaluated and tested the parts made by the domestic manufacturer. Four-and-a-half years after the start of the project, after going through a total of six integrated production line tests, we were finally able to procure syringe parts from two different companies.
The success of this project led to the establishment of double sourcing that allowed us with more ease to maintain continuous, stable supply of Epogin® to patients. Other benefits derived from the project were awareness of importance of building mutual trust with business partners and accumulation and application of extensive know-how with respect to stable procurement.
- Mobilizing Project Staff to Overcome Hurdles
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When you use syringe parts from different companies in one production line, any subtle differences in parts — their dimensions, weight, surface smoothness — can cause that production line to stop. The chief task of this project was to prevent such a problem in advance and ensure line compatibility enabling stable production with any company's parts. By mobilizing almost 50 project members from many departments — regulatory affairs, intellectual property, and analytical and formulation technology, as well as purchasing and production technology — and the manufacturing site, we carried out our primary mission of a manufacturing division in a pharmaceutical company: to stably supply medicines in the right amount at the right time, free from quality problems. More than anything, though, owing to the enthusiasm of everyone involved to do whatever required to fulfill our mission, we were able to overcome the tough challenge of line compatibility.
Tatsuo Saeki
PT Planning Department, Pharmaceutical Technology Division
Innovative R&D
Chugai is constantly working to develop innovative, original drug candidates with worldwide potential. The Company focuses on five main fields — oncology, renal diseases, bone & joint diseases, diabetes and infectious diseases — as it strives to build a strong, highly productive pipeline of pharmaceuticals under development. In particular, Chugai's research system ensures that resources are allocated first to projects that show the greatest promise of realizing highly original products.
Moreover, the Company has the strong technology platform required to develop entirely new drug candidates and also enjoy advantages in production technology for antibody drugs. For small-molecule compounds, Chugai engages in research of pioneering drugs by sharing research tools such as chemical compound banks and evaluation databases, research infrastructure and information with Roche. The Company also combines its expertise and innovation with the strengths of the Roche Group in areas including joint initiatives toward personalized healthcare. In addition, it works closely with R&D alliance partners Forerunner Pharma Research Co., Ltd., in Tokyo, PharmaLogicals Research Pte. Ltd. in Singapore, and C&C Research Laboratories in South Korea. Leveraging the benefits of a research network that includes joint research and alliances with universities, research institutions, and other firms in and outside Japan, Chugai is committed to pioneering research and the creation of groundbreaking technologies.
Ensuring a Stable Supply of High-Quality Pharmaceuticals
Stable procurement of raw materials and packaging materials
Raw material procurement plays a central role in providing a stable and continuous supply of consistently high-quality pharmaceuticals to healthcare providers and patients. However, stable procurement of raw materials is constantly exposed to risks such as discontinued production due to the merger or closing of suppliers, spikes in prices or problems with availability due to fluctuations in the balance of raw material supply and demand, or delays in delivery caused by accidents at suppliers. Chugai takes a number of measures to avoid these risks and maintain a stable supply of raw materials. For each raw material, it monitors market trends and the management conditions of suppliers; conducts quality assessments, price analysis and delivery management; and analyzes risks at production facilities, such as natural disasters. In this way, Chugai ensures a stable supply of pharmaceuticals to the market.
To further ensure the quality and stable procurement of raw materials, Chugai is optimizing supply chain management on a global basis and will strive for mutual trust and growth through even more detailed information sharing with suppliers.
Executing global supply chain management
Chugai has a mission as a supplier of Japan's first original antibody drug to provide a stable supply of this product to overseas markets. To achieve this, the Company established a global supply chain. Through its supply chain leader, Chugai shared worldwide demand information with Roche, and together the two companies developed a Global Demand & Supply Control System for suitable supply planning and management. This system got underway in 2008.
Conversely, when importing Roche products, Chugai must make purchase plans to meet Japanese demand and routinely monitor product temperature during transportation. Accordingly, supply chain management is becoming more complicated and globalized. Chugai is therefore strengthening its risk management, while constantly striving to provide a stable supply of medicines from and into Japan.
Reliable distribution of pharmaceuticals and promotional samples
All employees of Chugai Distribution Co., Ltd. faithfully carry out their jobs with a commitment to putting the delivery recipient first. The mission of this company is to consistently provide high-quality distribution services to pharmaceutical wholesalers and to Chugai's medical representatives (MRs). In order to ensure safe and reliable delivery, Chugai Distribution performs computerized inventory management. It also uses solutions devised by employees, such as special packaging for pharmaceuticals and promotional samples that make it easy for the recipient to tell the items apart and help prevent damage during transport.
Information sharing for quality and safety
Chugai's medicines are delivered to hospitals, clinics, other medical institutions and insurance pharmacies through Japan's pharmaceutical wholesalers. Chugai cooperates with these distribution partners in providing information to medical institutions and insurance pharmacies regarding the efficacy and safety of drugs, as well as details to ensure their proper use. Chugai strives to ensure a steady supply of pharmaceuticals reaches the patients who need them.
Ensuring traceability
Chugai provides many biologically derived products and pharmaceuticals requiring strict distribution management. In order to ensure the reliable delivery of these medicines to medical institutions and insurance pharmacies so that patients can use them safely, Chugai works with pharmaceutical wholesalers to ensure traceability. This effort includes careful management of expiration dates and distribution management numbers using bar codes, as well as safety measures relating to distribution processes.
Pre-shipment inspection
of sample packs
Packaging of sample packs
Sorting of case units
for shipment
Promotional sample shipping
Increasing Product Reliability
A Global-Standard Regulatory Compliance and Quality Assurance System
Chugai works hard to supply high-quality medicines and pharmaceuticals of superior efficacy and safety to healthcare providers around the world, and strives to ensure timely and accurate delivery of quality information on the proper use of its products.
The Company's fundamental views on reliability assurance are stated in the policy for regulatory compliance and quality assurance and in the regulatory compliance and quality assurance system, both of which came into effect in October 2007. This policy and system are based on our Mission Statement, which encompasses the Chugai Group's mission, Core Values, and Envisioned Future, and on the Chugai BCG, which describes our code of behavior.
Regulatory Compliance and Quality Assurance System
The policy for regulatory compliance and quality assurance places specific emphasis on the following four points for ensuring reliability. Through them, Chugai aims for ever tighter reliability assurance throughout each product's lifecycle.
- （1）Assurance of product quality
- （2）Assurance of product information quality
- （3）Assurance of business process quality
- （4）Assurance of staff suitability
Chugai is currently undertaking the following three activities to further improve its regulatory compliance and quality assurance system and to achieve consistency with Roche's global policies.
- Upgrading organizational and work structures related to product quality
Creation of a system that incorporates the ICH Q10 Pharmaceutical Quality System compiled by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use - Responding to the increasing number of global clinical trials and pharmaceutical safety regulations in Europe
Establishment of a global framework as well as operations that are consistent with those of Roche - Establishing an internal framework for responding to counterfeit pharmaceuticals
Establishment of an internal framework to coordinate with Roche in the event that counterfeit pharmaceuticals are discovered
Post-marketing All-patient Surveillance
Chugai has been conducting post-marketing all-patient surveillance for the anti-cancer agents Avastin® and Tarceva® and the rheumatoid arthritis agent Actemra®* to better ensure the safety of these medicines. In the surveillance, which was a condition for approval, therapeutic precautions have been shared with physicians depending on the severity of the patient's symptoms, and the occurrence of adverse drug reactions has been monitored. Updates on the surveillance status containing valuable therapeutic information have been provided to medical institutions as they become available.
Chugai is continuing its efforts to contribute to healthcare by providing innovative new drugs and new therapeutic options in oncology and other areas. In addition, the Company will strive to proactively provide accurate risk-benefit information so that patients and healthcare providers can use its medicines with peace of mind.
*Sold under the name RoActemra® in Europe.
Drug Information Center
Chugai's Drug Information Center supplies healthcare providers, patients and other consumers with information on our pharmaceuticals in response to telephone and e-mail inquiries. The center handles inquiries not only during regular business hours, but also on holidays and late at night, and provides accurate explanations that make even very specialized topics easy to understand.
The Drug Information Center received more than 50,000 telephone inquiries in 2010. Inquiries from outside the Company were down about 33 percent from 2009. There was an increase in inquiries about oncology products and mature products such as Mercazole®, Rohypnol® and Madopar®. Overall inquiries declined year on year because following the influenza A/H1N1 pandemic in 2009 there was no seasonal influenza outbreak in January through March of 2010. All of the center staff will continue striving to respond to every customer in a timely manner.
Number of Inquiries Received by the Drug Information Center
Inquiries by Treatment Area (2010)
Dedicated Phone Number for Tamiflu® Inquiries
Chugai set up a dedicated phone number in July 2010 to unify management of inquiries about Tamiflu®. With the cooperation of MRs, we informed medical institutions about it, and the number of inquiries has increased month by month. As the dedicated line was set up before the start of the influenza season, activity is not yet in full swing, but we will endeavor to provide information promptly to ensure customer satisfaction.
Contributing to Patient-Centered Healthcare
Supporting Cancer Patients
Chugai sponsored the cancer charity event
"Medicine and Humor" featuring rakugo
storyteller Dansyun Tatekawa.
Anti-Cancer Charity "Medicine and Humor"
Chugai sponsored this event for the sixth time in 2010. It is designed to enable cancer patient associations and the general public to interact with each other. In addition to providing an opportunity for the general public and Chugai to meet patients face-to-face, it is also becoming a forum for valuable exchanges among patient associations. In 2010, participants learned from a medical lecture by Professor Hideyuki Saya, M.D., PhD., of the Keio University School of Medicine, and enjoyed a one-man show by rakugo storyteller Dansyun Tatekawa. Exhibits by patient associations and Chugai and the lecture educated participants about cancer and conveyed the importance of early detection through cancer screenings.
Relay For Life
The Relay For Life is an awareness support campaign that forges ties in the fight against cancer. A 24-hour walk-a-thon in which cancer patients, their families and supporters compete as relay teams, this event was held in 20 locations throughout Japan in 2010. Chugai employees have participated in the Relay For Life as volunteers since 2007. More than 500 employees participated as "Team Chugai" at 14 locations in 2010. At ten of these locations, Chugai set up the Giant Colon exhibit to educate visitors about colon cancer.
"Relay For Life Japan 2010
in Shin-Yokohama"
"Relay For Life Shizuoka 2010
with Mt. Fuji"
Supporting the Pink Ribbon campaign
Breast cancer affects one out of every 16 Japanese women, and has the highest mortality rate among all types of cancer in Japanese women aged 30 to 64. Since 2005, Chugai has participated in the Pink Ribbon campaign to promote early diagnosis and treatment of breast cancer. In 2010, the Company once again co-sponsored events throughout Japan, including the Pink Ribbon Symposium 2010, and continued its tradition of in-house awareness by distributing pink ribbon badges to all employees.
Open seminars on rheumatism held at seven venues
To help provide the public with correct information on rheumatism, Chugai sponsored open seminars in seven prefectures across Japan entitled "Rheumatism Treatment Today" in cooperation with the Japan Rheumatism Friendship Association (JRFA) and local newspapers. At each venue, participants listened intently to the lectures on the latest medical information, which were given by local rheumatologists and Japanese opinion leaders. The lectures were followed by lively question-and-answer sessions, and participants examined with interest the JRFA's exhibit of mobility aids and journals.
Open seminar
Open seminar on chronic kidney disease (CKD)
Chugai sponsored a Nikkei Shimbun forum entitled "Stop CKD" in cooperation with the Japanese Society of Nephrology and the Japan Association of Kidney Disease Patients. Easy-to-understand lectures were given on lifestyle habits to help prevent kidneys from deteriorating, as well as on physical signs to look for and health screenings that can lead to early detection. Afterwards, specialist physicians gave lectures on the characteristics of therapeutic methods and precautions to take during treatment. Many participants showed a high level of interest, commenting that they had learned much and wanted events such as this to be held again.
NPO Shuhei Ogita Fund supporting patients with lymphatic malformations
For 20 years Chugai has provided Picibanil®, an anti-cancer agent and agent for treating lymphangiomas1 free of charge, to children worldwide suffering from incurable lymphatic malformations, working with the non-profit organization Shuhei Ogita Fund (http://www.fund-ogita.org/). In 1986, Dr. Shuhei Ogita, then a pediatric surgeon at Kyoto Prefectural University of Medicine, found that local injection of Picibanil® produced remarkable results in patients with lymphatic malformations, which until then had only been treatable with an extremely difficult surgical procedure. With that discovery, he set up the Little Carlos Fund2 to help children outside Japan suffering from lymphatic malformations. In honor of his achievements, and to abide by his wishes, it was renamed the Shuhei Ogita Fund in 2003, the year of his passing. The fund's activities are being carried out to make the treatment equally available to children around the world who suffer from this disease, regardless of their local medical situation or financial difficulties.
1. A rare disease in which lymphatic fluid abnormally pools in the lymphatic vessels and makes cysts in parts of the body. In many cases, it is found at birth. Unlike cancer, lymphatic malformations are benign, but can retard children's development, and occasionally the cysts compress the respiratory tract and become life-threatening.
2.A fund established by Dr. Ogita in 1992 after he learned about the travel expenses a family from Mexico had to come up with to get Picibanil® local injection therapy for their 14 month-old boy Carlos.
Roche 2010 Children's Walk
The Chugai Group participated in the Roche 2010 Children's Walk (formerly the AIDS Walk) held around the world on June 16, which UNICEF has designated as the Day of the African Child. This annual event raises funds to help children in the Republic of Malawi, Africa who have been orphaned by AIDS, and children in need of support around the world.
The Chugai Group has participated in the Children's Walk five consecutive times since 2005 (it was not held in 2009), and it has become a regular annual charity event. More than 4,000 Group employees helped raise donations in the event in 2010.
These funds were matched by Chugai and given to AIDS orphan support centers in Malawi.
Chugai Academy for Advanced Oncology Holds International Forum
The kick-off forum of the International Academy for Advanced Oncology (IAAO), one of the main activities of the Chugai Academy for Advanced Oncology3 (CHAAO), took place on March 26 and 27, 2010. Seven top-class specialists from around the world lectured on the latest information regarding cancer research and treatment. Participants engaged in a vigorous and productive exchange of opinions, not only during the question-and-answer period but also in an information exchange session. Approximately 100 doctors and researchers involved in oncology attended the forum, and commented that it was a good opportunity for personal interaction in addition to in-depth exchanges of academic and the latest medical information. The CHAAO will continue to contribute to the advancement of patient-centered cancer research and treatment by hosting nternational forums on a regular basis, as well as hosting and supporting the Focus Symposium, academic conferences and workshops.
3. Established in October 2009 to contribute to the establishment and advancement of infrastructure for cancer treatment in Japan. To bring cancer treatment in Japan to a world-class level, the CHAAO promotes deeper academic exchange between the world's top specialists in oncology and healthcare professionals who play a leading role in cutting-edge research and treatment of cancer in Japan.
Supporting Researchers from Asia
Established in 1960, the Tokyo Biochemical Research Foundation (TBRF) marked its 50th anniversary and made a new start on September 1, 2010 after receiving approval as a Public Interest Incorporated Foundation from the Cabinet Office. Chugai provides support for one of the TBRF's core grant functions, an international joint research fellowship program inviting young postdoctoral researchers from Asia to Japan to conduct joint research at universities and scientific research institutions for one to two years. Since this program was launched in 1995, it has supported 55 researchers from 12 Asian countries and regions.
In December 2010, prior to the event commemorating the TBRF's 50th anniversary, the 15th TBRF Research Outcomes Presentation was held. It included reports by seven postdoctoral fellows from China, Thailand, Bangladesh and Kazakhstan who are currently conducting research at institutions in Japan. Afterwards, the invited and host researchers also had a chance to mix with TBRF members. Five researchers from Korea, Thailand, Bangladesh and Egypt are scheduled to come to Japan in the fiscal year ending March 31, 2012.
Chugai will continue to enhance and develop this program that it entrusts to the TBRF to promote medical and pharmaceutical research in Asia with Japan at the center, and help to raise the level of basic research related to drug therapy and discovery of new drugs. (For further details on the program, please visit the TBRF website. URL: http://www.tokyobrf.or.jp/english/)
Participants at the TBRF Research Outcomes Presentation
