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 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 Rare diseases 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.
Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| TRERIEF® | Therapeutic agent for Parkinson's disease |
| LATUDA® | Atypical antipsychotic |
| 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 |
| TWYMEEG® | Therapeutic agent for type 2 Diabetes |
| AmBisome® | Therapeutic agent for systemic fungal infection |
| REMITCH® | Therapeutic agent for pruritus |
| Agalsidase Beta BS I.V. Infusion [JCR] | Therapeutic agent for Fabry disease |
Research and Development
The Group has been committed to the research and development of drugs by taking every available opportunity to incorporate cutting-edge technologies through a combination of in-house research, technology in-licensing, and joint research with biotech companies and academia institutions. The Group aims to continually discover exceptional pharmaceutical products in the focus areas of Psychiatry & Neurology, Oncology, and Regenerative Medicine and Cell Therapy. In order to contribute to global health, the Group is also working on tackling Infectious diseases.
Psychiatry and Neurology
We are promoting competitive drug discovery research based on our proprietary drug discovery platforms established by continuously incorporating cutting-edge technologies. For psychiatric disorders, including schizophrenia, depression, and psychiatric symptoms related to neurological disorders, we aim to create innovative therapeutic agents that meet unmet medical needs through drug discovery based on neural circuit pathology, whereas for neurological disorders, including dementia, Parkinson's disease, and rare diseases, we seek to develop drugs for radical treatments of neurodegenerative diseases and other indications through drug discovery based on molecular pathological mechanisms. Every effort is being made to raise the success rate of research and development by applying the wealth of knowledge gained from clinical data of our products and development candidates, to translational research and by selecting appropriate drug discovery targets and biomarkers through the use of big data, such as genome information, brain waves, and imaging data.
In FY2017, we introduced a new Research Project System, under which researchers who have devised project themes take the lead in their projects up to the initial clinical development stage as a general rule. In FY2021, the System yielded appreciable results, including the advancement of two products into clinical studies and many candidate drugs into the preclinical phase. Going forward, we will make the most of this System to push ahead with research and development.
In the development stages, the Company is working closely with its U.S. subsidiaries under the global clinical development framework to expedite the receipt of approvals from regulatory authorities by efficiently promoting clinical development according to strategic development planning.
Oncology
The Group has created multiple distinctive development pipelines as we gained a diverse array of knowledge to fortify drug discovery through our research and development efforts thus far. We leverage these unique pipelines to continue focusing on research and development of drugs in the Oncology area, where unmet medical needs are high.
For drug discovery, we aim to create innovative new drugs as we enhance our competitive edge by exploring new modalities with our proprietary technologies and conducting joint research with universities and research institutions.
In the development stage, we seek to improve the success rate and obtain early approval for several products in our development pipeline that are under initial clinical evaluations by, for example, carefully assessing data in short-term, small-scale studies to identify cancer types optimally treated by them and determine the value of such products.
Regenerative medicine / Cell therapy
We are promoting multiple research and development projects with a view toward early commercializing of our pipeline assets by developing a unique growth model wherein we pursue advanced industrialization/manufacturing technologies and state-of-the-art science through open innovation strategy. While steadily advancing projects in the Neurology and Ophthalmology areas, we are setting our sights on global opportunities in Japan, the U.S., and other Asian countries, plotting a trajectory for the development of next-generation regenerative medicine, including organ regeneration. Our current target is to have these projects start contributing to earnings mainly in Japan and the U.S. during the period of the Next Mid-term Business Plan (FY2023-2027).
Infectious Diseases
In a bid to contribute to global health and precautions against future pandemics by way of, for example, promoting joint research for the treatment of antimicrobial resistance (AMR), malaria vaccines, and a universal influenza vaccine, we will remain committed to ongoing research and development projects, which we hope to commercialize during the period of the Next Mid-term Business Plan (FY2023-2027).
Others
The Group is moving forward with the development of value-oriented, best-in-class pharmaceutical products, in a bid to sustain the Group's business growth after the expiration of the exclusive marketing period of LATUDA® in the U.S.
Pharmaceuticals Production
We have built a stable supply structure for our products, which are manufactured mainly at our own plants in Japan and also in collaboration with partners in Japan and other countries. Our plants have worked hard to increase the precision of their production plans by strengthening collaboration with the Sales & Marketing Division, the International Business Management Department, overseas subsidiaries, and business partners. We have also made proactive efforts such as double sourcing of active pharmaceutical ingredients and optimizing the supply chains regarding the formulation and packaging of products. To further strengthen our competitiveness, we continuously work on cost reduction activities, as well as actively striving to increase productivity in our plants, such as by reducing lead times.
Suzuka Plant
The Suzuka Plant is Sumitomo Pharma's core formulation plant, equipped with integrated pharmaceutical manufacturing facilities capable of a full range of operations from the production of active pharmaceutical ingredients to the formulation and packaging of products. It includes a state-of-the-art solid dosage formulation facility fully compliant with cGMP (the latest U.S. GMP) and supplies products globally.
Oita Plant
The Oita Plant is Sumitomo Pharma's principal facility for the production of active pharmaceutical ingredients and its equipment is cGMP-compliant. It operates 24 hours a day, 365 days a year to ensure stable production of active pharmaceutical ingredients.
USA
Under the umbrella of Sumitomo Pharma America Holdings, Inc., a wholly owned holding company, Sunovion Pharmaceuticals Inc. is engaged in manufacturing and sales of pharmaceuticals; Sumitomo Pharma Oncology, Inc. in R&D activities and related marketing preparations in the oncology area.
Under Sumitovant Biopharma, a holding company established in December 2019, Myovant Sciences, Urovant Sciences, Enzyvant Therapeutics, Altavant Sciences, and Spirovant Sciences, all consolidated subsidiaries of Sumitomo Pharma, are engaging in pharmaceutical R&D.
Sunovion Pharmaceuticals Inc. Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| LATUDA® | Atypical antipsychotic |
| APTIOM® | Antiepileptic |
| KYNMOBI® | Therapeutic agent for OFF episodes associated with Parkinson's disease |
| LONHALA® MAGNAIR® | Therapeutic agent for COPD |
Myovant Sciences Ltd. Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| ORGOVYX® | Therapeutic agent for advanced prostate cancer |
| MYFEMBREE® | Therapeutic agent for uterine fibroids and endometriosis |
Urovant Sciences Ltd. Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| GEMTESA® | Therapeutic agent for overactive bladder (OAB) |
Enzyvant Therapeutics Ltd. Product Lineup
| Major Pharmaceutical Products | Therapeutic Indication |
|---|---|
| RETHYMIC® | Cultured thymus tissue for pediatric congenital athymia |
China
Sumitomo Pharma (Suzhou)Co., Ltd. is engaged in manufacturing (subdivided packaging) and sales of pharmaceuticals.
Sumitomo Pharma (Suzhou)Co., Ltd. Product Lineup
| Major Pharmaceutical Products | Therapeutic 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 |