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 DSP, 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 and to contribute via our daily MR activities to the betterment of healthcare and fuller lives of patients.

Focus marketing areas and key products

We have positioned central nervous system (CNS), cardiovascular/diabetes and cancer/infectious diseases as our focus marketing areas and we are progressing sales activities.

In the CNS area, we offer a number of therapeutic drugs covering a wide range of diseases from schizophrenia to Parkinson's disease, anxiety disorders and epilepsy. Our hypertension therapeutic products include an angiotensin II receptor blocker (ARB), calcium antagonist, diuretic, angiotensin-converting enzyme (ACE) inhibitors and an alpha-beta blocker thus enabling us to participate effectively in the treatment of hypertension. We also have a rich product line-up covering other areas in order to respond to a wide range of medical needs. In addition, we aim to maximize earnings by concentrating sales resources on strategic products AVAPRO®, LONASEN®, PRORENAL® and TRERIEF®, and new products, MIRIPLA®, METGLUCO®, SUREPOST®, Paxil® CR, and AIMIX®.

Strategic products	Therapeutic indication
AVAPRO®	Therapeutic agent for hypertension
LONASEN®	Atypical antipsychotic
PRORENAL®	Vasodilator
TRERIEF®	Therapeutic agent for Parkinson's disease

New products	Therapeutic indication
MIRIPLA® (January 2010)	Therapeutic agent for hepatocellular carcinoma
METGLUCO® (May 2010)	Biguanide oral hypoglycemic
SUREPOST® (May 2011)	Rapid-acting insulin secretagogue
Paxil® CR (June 2012) *	Antidepressant
AIMIX® (December 2012)	Anti-hypertension drug

Major Focus products	Therapeutic indication
AMLODIN®	Therapeutic agent for hypertension and angina pectoris
GASMOTIN®	Gastroprokine
MEROPEN®	Carbapenem antibiotic
AmBisome®	Therapeutic agent for systemic fungal infection

R&D

Aiming for the continuous creation of new drugs

At the DSP Group, we position the CNS area as our focus therapeutic area. DSP has also chosen specialty areas as its challenge therapeutic areas. Specialty areas are those that have significant unmet medical needs and that demand a high degree of specialization in R&D and marketing functions. In both focus and challenging therapeutic areas, we are targeting the creation of innovative pharmaceuticals. In addition, we are also proactively engaged in in-licensing products in clinical development.

In the early research stage, the DSP Group implements measures to increase the efficiency of research by taking advantage of genomics, proteomics, metabolomics, and other proprietary advanced technologies. With regard to nucleic acid drugs, antibody drugs, and other biopharmaceuticals, the DSP Group has been conducting research with specialized research groups. In the CNS area, the Neuropsychiatry Drug Discovery Consortium (NDDC) established with five departments of the Graduate School of Medicine and Graduate School of Pharmaceutical Sciences of Osaka University transferred to its second stage in October 2011. In addition, the Laboratory for Malignancy Control Research (the DSK Project), a collaborative project with Kyoto University to invent innovative anti-cancer drugs started in April 2011. As above, the DSP Group also proactively promotes the formation of alliances with research institutes and other pertinent entities, including domestic and foreign universities in order to create innovative therapeutic pharmaceuticals.
In later research stages and during the development stage, the research and development portfolio of the DSP Group is optimized accordingly from a global perspective. In addition, the DSP Group takes a proactive approach to the development of dosage formulations and other aspects of product life-cycle management in order to maximize product values.

Full-scale Participation in Oncology

The DSP Group is enhancing its presence in oncology with the aim of making it a future core business area next to CNS. In April 2012, DSP 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 (Location: Osaka Research Center). Additionally, by the end of 2012 we plan to establish a Global Oncology R&D Center in Cambridge, Massachusetts, U.S.

Setting global development as a basic strategy

The DSP Group has R&D bases in the four regions, of Japan, the U.S., China and the U.K. that engage in collaborative activities. The DSP Group established the Global Business Strategy Committee (GBSC) and the Global R&D Committee (GRDC) in April 2012 in order to more efficiently build a network for conducting global R&D. GBSC works to optimize the DSP 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. GRDC discusses the promotion of projects in early development stages and other issues with a global perspective.

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 DSP 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 DSP 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 DSP 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. The main products at Suzuka are LONASEN®, an atypical antipsychotic, PRORENAL®, a vasodilator, GASMOTIN®, a gastroprokinetic, and EBASTEL®, an antiallergic.

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 a broad range of dosage forms, including solid dosages, powders, tablets, capsules, injections and ointments.

Ehime Plant

Ehime Plant manufactures biopharmaceutical products, and boasts the industry's largest cell culture facilities in terms of the number and size of cell-culture vessels. Under strict quality control system, the plant produces crude intermediate solution of SUMIFERON®, a natural alpha interferon product and the anti-malignant tumor antibiotic CALSED®, a sterile freeze-dried formulation.

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 for products such as AMLODIN®, a therapeutic agent for hypertension and angina pectoris; DOPS®, a noradrenaline-activating neural function ameliorant; and CALSED®. MEROPEN®, a carbapenem antibiotic, is manufactured from its active ingredient to the final product in an integrated way for use in Japan and overseas.

North America

Sunovion Pharmaceuticals Inc.

The DSP Group made U.S. company, Sepracor Inc. (Current Sunovion Pharmaceuticals Inc.) a subsidiary in October 2009, and then merged it with our affiliate Dainippon Sumitomo Pharma America Inc. in April 2010 and changed the company name to Sunovion Pharmaceuticals Inc. (Sunovion). Currently, Sunovion is assuming the North American business of the DSP Group.
Sunovion aims to quickly 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, marketing and sale of ethical pharmaceuticals for the CNS and respiratory areas.

Foundation	January 1984
Head office location	Marlborough, Massachusetts, U.S.A.
Net sales of the North America segment	108.4 billion yen (from January to December 2012)
Employees	2,216 persons (including 1,190 MRs) (as of March 31 2012)

Product lineup

Major pharmaceutical products	Therapeutic indication
LATUDA®	Atypical antipsychotic
LUNESTA®	Sedative hypnotic
XOPENEX®	Short-acting Beta-agonist
BROVANA®	Long-acting Beta-agonist
ALVESCO®	Inhaled corticosteroid
OMNARIS®	Corticosteroid nasal spray

China

Sumitomo Pharmaceuticals (Suzhou) Co., Ltd.

The DSP Group is positively deploying business in China by setting it as an important growing market. In this market, Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. is currently our affiliate in charge of operations, from the production to sale of four products locally starting with MEPEM®. The plant at Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. serves as our own production facility, and packages products for sale in the local market. Fully integrated production, from formulation to packaging, is scheduled to start in 2014. By bringing new products in addition to existing products to the market, we aim at sales of 10 billion yen from this overseas subsidiary in fiscal 2014.

Corporate Profile

Foundation	December 2003
Head office location	Suzhou Industrial Park, Jiangsu Province, People's Republic of China
Net sales of the China segment	6.5 billion yen (from January to December 2012)
Employees	626 persons (including 330 MRs) (as of March 31, 2012)

Product lineup

Major pharmaceutical products	Therapeutic indication
MEPEM® (sold in Japan as MEROPEN)	Carbapenem antibiotic
ALMARL®	Therapeutic agent for hypertension, angina pectoris and arrhythmia
SEDIEL®	Serotonin - agonist antianxiety drug
GASMOTIN®	Gastroprokine