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 collect and share safety information and provide the requisite and specialized information to medical professionals via our MRs (Medical Representatives) and multiple media outlets. Our aim is to earn greater confidence among medical professionals and to contribute to the betterment of healthcare and fuller lives of patients through daily information provision activities.

Focus areas for the Japan business

In Japan, we collect and provide professional information primarily in the Psychiatry & Neurology, Diabetes, and Specialty 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 Diabetes area, we offer several drugs with different mechanisms of action and respond to a wide range of medical needs. Furthermore, in the Specialty area (an area with high unmet medical needs in which intensive specialization is required), we contribute to the medical care in such fields as rare diseases, hematologic disorders, and liver diseases.

Product lineup

Major pharmaceutical productsTherapeutic indication
TRERIEF® Therapeutic agent for Parkinson's disease
LONASEN® Atypical antipsychotic
EFFEXOR® Therapeutic agent for depression
Trulicity® Therapeutic agent for type 2 Diabetes
SUREPOST® Therapeutic agent for type 2 Diabetes
METGLUCO® Therapeutic agent for type 2 Diabetes
REPLAGAL® Anderson-Fabry disease drug
AmBisome® Therapeutic agent for systemic fungal infection
REMITCH® Therapeutic agent for pruritus

Research and Development

The Group remains committed to research and development by taking every available opportunity to assimilate cutting-edge technologies through combinations of a wide variety of avenues, including in-house research, technology in-licensing, and joint research with biotech companies and academia, with the aim of continually discovering excellent pharmaceutical products with Psychiatry & Neurology, Oncology, and Regenerative Medicine and Cell Therapy as its focus therapeutic areas.

Psychiatry and Neurology

In the early stages of research, the Company is working to apply cutting-edge scientific technologies including high-performance computer-based in-silico drug discovery technology and utilization of iPS cells to drug discovery.
Under our ONE TEAM operating structure for the Global Clinical Development linking our Japan and U.S. units, we focus on late-stage clinical development products to obtain fast approval.

Oncology

Under a global research and development framework comprising Boston Biomedical, Inc. (U.S.), Tolero Pharmaceuticals, Inc. (U.S.), and the DSP Cancer Institute (Japan), our fundamental research and development strategy is to deliver unique, previously unavailable products with a focus on cancer stemness inhibitors, cancer peptide vaccines, and kinase inhibitors.
We are also proactively forming external research collaboration with leading institutions, including universities both within and outside Japan.

Regenerative medicine/cell therapy

The Company aims to achieve early commercialization of regenerative medicine and cell therapy products. In order to overcome one of the greatest bottlenecks hindering this goal, namely, the development of a production system for such products, the Company completed the Sumitomo Dainippon Manufacturing Plant for Regenerative Medicine & Cell Therapy (SMaRT) in March 2018 as the world's first facility dedicated to the commercial manufacturing of regenerative medicine and cell therapy products derived from allogeneic iPS cells.
The Company will remain committed to promoting the regenerative medicine and cell therapy business using allogenetic iPS cells for age-related macular degeneration, Parkinson's disease, retinitis pigmentosa, and spinal cord injury.

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.
Revenue of the North America segment 240.8 billion yen (FY2017)
Employees 1,711 persons (including 830 MRs) (as of March 31, 2018)

Product lineup

Major pharmaceutical productsTherapeutic indication
LATUDA® Atypical antipsychotic
APTIOM® Antiepileptic
LONHALA MAGNAIR Therapeutic agent for COPD
UTIBRON NEOHALER® Therapeutic agent for COPD
SEEBRI NEOHALER® Therapeutic agent for COPD
ARCAPTA® NEOHALER® Therapeutic agent for COPD
BROVANA® Therapeutic agent for COPD

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 five products locally including MEPEM®. The plant at Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. currently packages our products for sale in the local market. 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
Revenue of the China segment 23.4 billion yen (FY2017)
Employees 665 persons (including 330 MRs) (as of March 31, 2018)

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
LONASEN® Atypical antipsychotic