Pharmaceutical Business

Japan

Information provision activities

New drugs are delivered to patients after passing a long process that includes basic research, clinical studies and review by the government for regulatory approvals. Even after drug products are launched and used by a large number of patients, safety and efficacy are continually checked resulting in safe and secure, useful pharmaceuticals. It is only after proper usage has been established based on safety and efficacy information that the pharmaceuticals can fulfill their desired function of contributing effectively to human health requirements.
At Sumitomo Dainippon Pharma, we use our MR (Medical Representatives) to provide all of the requisite highly specialized information to personnel engaged in medical care. Our aim is to improve the confidence of medical personnel in Sumitomo Dainippon Pharma and to contribute via our daily MR activities to the betterment of healthcare and fuller lives of patients.

Domestic pharmaceuticals: Focus marketing areas

In Japan, we are progressing sales activities primarily in the Psychiatry & Neurology, Cardiovascular/Diabetes, and Speciality areas.

In the Psychiatry & Neurology area, we have therapeutic drugs for Parkinson's disease and schizophrenia and we aim to contribute to the treatment of psychiatric and neurological diseases as a medical partner.
In the Cardiovascular/Diabetes area, we offer several products which have different mechanisms of action for hypertension and type 2 diabetes in order to respond to a wide range of medical needs. In addition, in the Speciality area (those with high unmet medical needs where intensive specialization is required), we contribute to the fields of Anderson-Fabry disease, systemic fungal infection, and pruritus in chronic liver disease.

Product lineup

Major pharmaceutical productsTherapeutic indication
TRERIEF® Therapeutic agent for Parkinson's disease
LONASEN® Atypical antipsychotic
AIMIX® Therapeutic agent for hypertension
AVAPRO® Therapeutic agent for hypertension
Trulicity® GLP-1 receptor agonist
SUREPOST® Rapid-acting insulin secretagogue
METGLUCO® Biguanide oral hypoglycemic
REPLAGAL® Anderson-Fabry disease drug
AmBisome® Therapeutic agent for systemic fungal infection
REMITCH® Therapeutic agent for pruritus
MIRIPLA® Therapeutic agent for hepatocellular carcinoma

R&D

Aiming for the continual creation of new drugs

At the Sumitomo Dainippon Pharma Group, we position the Psychiatry & Neurology and Oncology areas, both of which have high unmet medical needs, as our focus therapeutic areas where we are targeting the creation of innovative pharmaceuticals.

In the Psychiatry & Neurology areas, the Sumitomo Dainippon Pharma Group focuses on the improvement of current treatments that do not sufficiently result in adequate symptom relief, as well as the treatment of patients who do not respond enough to existing medicines, and promote research and development of therapeutic agents in schizophrenia, depression, Alzheimer's disease, and other disorders. In the Oncology area, under the global R&D system established by Boston Biomedical, Tolero Pharmaceuticals, and the DSP Cancer Institute, the Sumitomo Dainippon Pharma Group aims to lead the world in the cancer stem cell and hematologic malignancies, and continually create innovative products. In addition, the Sumitomo Dainippon Pharma Group will apply leading-edge science, such as iPS cells to drug discovery, while strengthening activities in regenerative medicines and cell therapy to develop therapeutics for refractory diseases.

In the initial research stage, the Sumitomo Dainippon Pharma Group is working to apply leading-edge scientific technologies, including supercomputer-assisted in silico methods and iPS cells, to drug discovery and regenerative medicine/cell therapy. The Sumitomo Dainippon Pharma Group also proactively seeks external research collaboration with universities and other research institutions throughout the globe. During FY2016, the second term of the joint research project with Kyoto University (DSK Project), which aims to discover innovative anti-cancer drugs, was launched. Meanwhile, under the Partnership to Realize Innovative Seeds and Medicines (PRISM) framework, which is an open innovation program launched in FY2015 whereby research institutions and researchers in Japan are invited to submit ideas that meet the Sumitomo Dainippon Pharma's drug discovery research needs, joint research agreements were signed on multiple ideas during FY2016.

In the latter research stage and the development stage, a global perspective is taken to optimize the project portfolio for the Sumitomo Dainippon Pharma Group's focus therapeutic areas and newer fields, as well as other areas. The Sumitomo Dainippon Pharma Group is also committed to product life cycle management and drug repositioning by developing dosage forms in ways that maximize product value.

Full-scale Entry into Oncology

The Sumitomo Dainippon Pharma Group is enhancing its presence in Oncology with the aim of making it a future core business area in addition to Psychiatry & Neurology. In April 2012, Sumitomo Dainippon Pharma acquired U.S. biotechnology company Boston Biomedical, Inc., which specializes in the area of Oncology. With this acquisition, we made a full-scale start on our global expansion in Oncology.
With the aim to create innovative new drugs, in September 2012 we established the DSP Cancer Institute in Japan (Location: Osaka Research Center) as an organization independent from the Drug Research Division under the direct control of the president. In February 2013 we set up a new base in Cambridge, Massachusetts, U.S in order to expand the scale of research activities of Boston Biomedical. In January 2017, we acquired Tolero Pharmaceuticals, Inc., which generates unique compounds expecting potential options for hematologic malignancies, and expand our global cancer research and development system.

Setting global development as a basic strategy

The Sumitomo Dainippon Pharma Group has R&D bases in the three regions of Japan, the U.S. and China that engage in collaborative activities under the management of the Chief Scientific Officer (CSO). The Sumitomo Dainippon Pharma Group established the Global Business Strategy Committee (GBSC). GBSC works to optimize the Sumitomo Dainippon Pharma Group's overall portfolio with a global perspective by discussing issues including global business strategy, licensing proposals, and strategic prioritization and resource allocation for R&D, in addition, discusses the promotion of projects in early development stages and other issues with a global perspective. As for clinical development, the Sumitomo Dainippon Pharma Group will strengthen the global seamless management and promote development in a speedier and more efficient manner under the Head of Global Clinical Development.

Pharmaceuticals production

Recognizing that pharmaceuticals play a vital role in maintaining human health, we are dedicated to assuring that all pharmaceutical products have their designed quality. Manufacturing and quality control of pharmaceuticals are required to be carried out strictly in accordance with Good Manufacturing Practice (GMP) standards in each country.
The pharmaceuticals manufactured by the Sumitomo Dainippon Pharma Group are exported around the world after obtaining approval from the regulatory authorities of importing nations, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Australia's Therapeutic Goods Administration (TGA). Therefore, operating standards in the Sumitomo Dainippon Pharma Group are consistent with the GMP standards of Europe and the United States. Furthermore, we have established a high level of facility design and a quality assurance system to meet strict quality standards at the global level, including audits by overseas partner companies and the guidelines of the International Conference on Harmonisation (ICH), which deliberates the harmonization of EU, U.S. and Japanese pharmaceutical regulations.
Global standards for quality assurance are expected to become increasingly rigorous. The Sumitomo Dainippon Pharma Group is therefore making proactive investments in manufacturing facilities -- including a new solid dosage form facility and a restricted access barrier system (RABS) that increases the level of sterility assurance -- to meet future standards. Our manufacturing, quality assurance and other related divisions will work in concert to continue to provide pharmaceuticals of the highest quality.

Manufacturing Bases

Suzuka Plant

As a production site focusing on efficiency, Suzuka Plant maintains integrated pharmaceutical manufacturing facilities at which a full range of operations are conducted, from production of active pharmaceutical ingredients and finished products to packaging.

Ibaraki Plant

Since Technology Research and Development Division's Formulation Technology Research Department is located in the Ibaraki Plant, from manufacturing technology research to manufacturing and quality control practice, as an R&D-driven pharmaceuticals plant able to flexibly accommodate new products and technologies, this plant produces drugs in dosage forms, including solid dosages, powders, tablets, capsules and injections.

Ehime Plant

Ehime Plant manufactures sterile injectables under strict quality control system.

Oita Plant

Oita Plant is our core facility for active pharmaceutical ingredients. Operating 24 hours a day, 365 days a year, the plant manufactures active ingredients.

North America

Sunovion Pharmaceuticals Inc.

Sumitomo Dainippon Pharma acquired U.S. company, Sepracor Inc. (Current Sunovion Pharmaceuticals Inc.) in October 2009, and then merged it with our subsidiary Dainippon Sumitomo Pharma America Inc. in April 2010 and changed the company name to Sunovion Pharmaceuticals Inc. (Sunovion). Currently, Sunovion plays a major role in the North American business of the Sumitomo Dainippon Pharma Group.
Sunovion aims to maximize earnings from LATUDA® (launched in February 2011) in addition to optimizing the field force structure for existing products.

Corporate Profile
Established January 1984
Head office location Marlborough, Massachusetts, U.S.A.
Net sales of the North America segment 197.9 billion yen (FY2016)
Employees 1,723 persons (including 870 MRs) (as of March 31, 2017)

Product lineup

Major pharmaceutical productsTherapeutic indication
LATUDA® Atypical antipsychotic
APTIOM® Antiepileptic
UTIBRON NEOHALER® Long-acting beta-agonist/
Long-acting muscarinic-antagonist
BROVANA® Long-acting beta-agonist
LUNESTA® Sedative hypnotic
XOPENEX HFA® Short-acting beta-agonist
OMNARIS® Corticosteroid nasal spray
ZETONNA® Corticosteroid nasal spray
ALVESCO® Inhaled corticosteroid

China

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

The Sumitomo Dainippon Pharma Group is positively deploying business in China by setting it as an important growing market. In this market, our subsidiary Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. is in charge of operations, from the production to sale of four products locally including MEPEM®. The plant at Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. currently packages our products for sale in the local market. Fully integrated production, from formulation to packaging, is currently being prepared. By bringing new products in addition to existing products to the market, we are aiming for steady growth.

Corporate Profile
Established December 2003
Head office location Suzhou Industrial Park, Jiangsu Province, People's Republic of China
Net sales of the China segment 17.6 billion yen (FY2016)
Employees 676 persons (including 340 MRs) (as of March 31, 2017)

Product lineup

Major pharmaceutical productsTherapeutic indication
MEPEM® (Brand name in Japan: MEROPEN®) Carbapenem antibiotic
ALMARL® (Brand name in Japan: Arotinolol Hydrochloride) Therapeutic agent for hypertension, angina pectoris and arrhythmia
SEDIEL® Serotonin - agonist antianxiety drug
GASMOTIN® Gastroprokine