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 and key products

We have positioned Cardiovascular/Diabetes, Psychiatry & Neurology,and Speciality areas as our focus marketing areas and we are progressing sales activities in Japan.

In the Cardiovascular and Diabetes area, our hypertension therapeutic products include an angiotensin II receptor blocker (ARB), calcium channel blocker (CCB), combination product of ARB and CCB, diuretic, angiotensin-converting enzyme (ACE) inhibitors and an alpha-beta blocker thus enabling us to participate effectively in the treatment of hypertension. In the diabetes area, we also promote several products which have different mechanisms of action for type 2 diabetes in order to respond to a wide range of medical needs. In the Psychiatry & Neurology areas, we offer a number of therapeutic drugs covering a wide range of diseases from schizophrenia to Parkinson's disease, anxiety disorders and epilepsy. In addition, in our Speciality areas (areas with high unmet medical needs where high specialization is required), we respond to a wide range of medical needs through the promotion of a therapeutic agent for systemic fungal infection, an Anderson-Fabry disease drug and a therapeutic agent for hepatocellular carcinoma.

We aim to maximize earnings by concentrating sales resources on major pharmaceutical products.

Product lineup

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

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.

At the initial stage of research, Sumitomo Dainippon Pharma is not only endeavoring to improve research efficiency by making use of advanced technologies it owns, such as genomics, proteomics, and metabolomics, as well as the K Supercomputer, that started functioning in September 2012, but also making efforts to apply state-of-the-art science, such as iPS cells, to drug discovery. Sumitomo Dainippon Pharma is currently promoting joint research with the Center for iPS Cell Research and Application (CiRA), Kyoto University, aiming to create new treatments for rare intractable diseases, and actively participating in a cooperative industry-government-academia project, Research on Intractable Diseases Making Use of Disease-Specific iPS Cells.

At the latter stage of research and at the development stage, Sumitomo Dainippon Pharma is optimizing the portfolio of the entire Sumitomo Dainippon Pharma Group from a global point of view, focusing on key therapeutic areas and including other areas as well. In addition, Sumitomo Dainippon Pharma is actively implementing product life cycle management, including the development of formulations that aims to maximize product values.

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

Sunovion is a pharmaceutical company that possesses all of the functions of such an enterprise including R&D, manufacturing, and sale of ethical pharmaceuticals for the Psychiatry & Neurology and respiratory areas.

Established January 1984
Head office location Marlborough, Massachusetts, U.S.A.
Net sales of the North America segment 184.9 billion yen (FY2015)
Employees 1,620 persons (including 710 MRs) (as of March 31, 2016)

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 18.4 billion yen (FY2015)
Employees 635 persons (including 300 MRs) (as of March 31, 2016)

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