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® Tape Atypical antipsychotic
EFFEXOR® Therapeutic agent for depression
Trulicity® Therapeutic agent for type 2 Diabetes
Equa® Therapeutic agent for type 2 Diabetes
EquMet® Therapeutic agent for type 2 Diabetes
SUREPOST® Therapeutic agent for type 2 Diabetes
METGLUCO® Therapeutic agent for type 2 Diabetes
REPLAGAL® Therapeutic agent for 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. The aim is continually discover excellent pharmaceutical products in the focus areas; Psychiatry & Neurology, Oncology, and Regenerative Medicine and Cell Therapy. In a bid to contribute to global health, the Group is also working on the Infectious Diseases area. Furthermore, with the aim of providing new solutions to social issues in healthcare areas other than pharmaceuticals, we are working toward launching frontier businesses.

Psychiatry and Neurology

The Company is leveraging its core competencies to forge ahead with drug discovery research based on its proprietary drug discovery platforms established by constantly incorporating cutting-edge technologies. Every effort is being made to boost the success rate of R&D by applying a wealth of knowledge, gained from clinical study data of in-house products, to translational research and by selecting drug discovery targets and biomarkers through the use of big data, such as genome information and image pictures. In the development stages, the Company is working closely with its U.S. subsidiaries under the global clinical development framework to efficiently promote clinical development according to strategic development planning, aiming at quickly obtaining regulatory approvals.

Oncology

The Group aims to create innovative new drugs by conducting research projects that focus on cell-cell interaction in the tumor microenvironment as part of its efforts to work on unique seeds and themes. By accelerating collaborative R&D efforts, integrating its subsidiaries in North America and external parties, the Group aims to swiftly move the outcomes of the projects to clinical trials through seamless collaboration between research and development. In the development stages, the Group is working proactively on early-stage clinical development, while steadily advancing development of late-stage products.

Regenerative medicine/cell therapy

The Company is promoting multiple R&D projects with a view toward quickly commercializing regenerative medicine and cell therapy by developing a unique growth model where we pursue advanced industrialization/manufacturing technologies and cutting-edge science through the open innovation strategy. While steadily advancing projects, which are mostly in the neurology and ophthalmology areas, the Company is setting its eyes on the global opportunities that this therapeutic area offers with a view toward embarking on development of next-generation regenerative medicine that also targets regeneration of 3-dimensional organs.

Infectious Diseases area

Through joint research with academic institutions, the Company is conducting drug discovery research of treatments for antimicrobial-resistant bacterial infections, and of malaria vaccines and universal influenza vaccines based on its adjuvant technologies.

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.

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.

USA

Under the umbrella of Sumitomo Dainippon Pharma America, Inc., a wholly owned holding company, Sunovion Pharmaceuticals Inc. is engaged in manufacturing and sales of pharmaceuticals; Boston Biomedical, Inc. in R&D activities and related marketing preparations in the oncology area; and Tolero Pharmaceuticals, Inc. in R&D activities in the areas of oncology and hematologic malignancy.

Sunovion Pharmaceuticals Inc. Product lineup

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

China

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. is engaged in manufacturing (subdivided packaging) and sales of pharmaceuticals.

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. 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
LONASEN® Atypical antipsychotic
LATUDA® Atypical antipsychotic