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 disorders such as 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 |
---|---|
LATUDA® | Atypical antipsychotic |
XEPLION®, XEPLION TRI® | long-acting antipsychotic medication |
LONASEN® Tape | Atypical antipsychotic |
TWYMEEG® | Therapeutic agent for type 2 Diabetes |
Ozempic® Subcutaneous Injection | Therapeutic agent for type 2 Diabetes |
Equa® | Therapeutic agent for type 2 Diabetes |
EquMet® | Therapeutic agent for type 2 Diabetes |
METGLUCO® | Therapeutic agent for type 2 Diabetes |
Wegovy® Subcutaneous Injection | Treatment for Obesity Disease |
Agalsidase Beta BS I.V. Infusion [JCR] | Therapeutic agent for Fabry disease |
IZCARGO® | Recombinant Therapeutic for Mucopolysaccharidosis Type II |
Research and Development
With a focus on the Psychiatry & Neurology and Oncology disease areas, where unmet medical needs are high, the Sumitomo Pharma Group will make the utmost of the experience and knowledge that we have acquired so far to continue making active efforts for research and development of pharmaceuticals, regenerative medicine/cell therapy, and otherwise. In other areas, too, we will tap into assets at hand and make steady R&D efforts to deliver solid value to patients.
Oncology Area
Through our R&D activities to date, we have gained a variety of
knowledge, strengthened our drug discovery capabilities, and created
multiple development pipelines with distinctive features. Making use
of these achievements, we continue to focus on research and
development in the area of oncology, where there are high unmet
medical needs.
In drug discovery, we aim to create innovative
new drugs by enhancing our competitiveness through the development
of modalities using our new technologies as well as initiatives,
such as joint research with academia.
In the development stage,
we aim to improve the probability of success by carefully evaluating
data from short-term, small-scale studies to identify optimum cancer
types and product value for multiple development pipelines
undergoing initial clinical evaluation. In particular, we are
concentrating our resources on enzomenib (DSP-5336) and nuvisertib
(TP-3654) , aiming for obtaining early approval and maximizing their
value.
Psychiatry & Neurology (CNS) Area
We promote competitive drug discovery research based on our proprietary drug discovery platform, which we have built up by incorporating cutting-edge technologies. In the CNS area, we are committed to continuous value creation by focusing on neurological disorders with high unmet medical needs, including neurodegenerative and rare diseases. In particular, we aim to develop innovative new drugs—such as disease-modifying treatments—by applying our proprietary small molecule drug discovery technologies with strong CNS penetration to targets closely linked to clinical pathology. We are also leveraging non-clinical models with high relevance, such as iPS cells, while further enhancing our accumulated translational technologies, including EEG and imaging, to improve the probability of R&D success. 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.
Other Areas
We tap into assets at hand and make steady R&D efforts to deliver solid value to patients.
- To contribute to global health and pandemic preparedness, we are promoting research and development of a universal influenza vaccine and a drug for antimicrobial resistant bacterial infections.
Regenerative medicine / Cell therapy
The regenerative medicine/cell therapy business aims to provide new value that can only be created through regenerative medicine by utilizing our strengths in networking through open innovation with academia, startup companies, and other industries; accumulated technologies for the practical application of iPS cells, as represented by the differentiation induction technology from pluripotent stem cells; and abundant manufacturing capabilities and manufacturing methods, infrastructure, and human resources related to cell production. We have been engaged in research activities in regenerative medicine and cell therapy since the 1990s, drawing on foundational knowledge and intellectual property obtained through Sumitomo Chemical’s basic research using human ES cells, as well as Sumitomo Chemical’s joint research with RIKEN in the ophthalmology area. In FY2024, to accelerate business development in this area, Sumitomo Chemical and Sumitomo Pharma established a joint venture company, RACTHERA . Together, we are promoting efforts to rapidly commercialize iPS cell-derived products, with the goal of becoming the first in the world to launch iPS cell-derived dopaminergic neural progenitor cells for the treatment of Parkinson’s disease.
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 Business Development & Management, 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.
Key initiatives for the Japan business under Reboot 2027
Secure revenues through our strengths and key products, and make regenerative medicine and cell therapy our core business
Maximize the value of key products and new products
- Maximize product value by leveraging the sales base and relationships in the areas of strength (CNS/diabetes/rare diseases)
- Prepare for the launch of the oncology business
- Improve customer satisfaction through omni-channel information and conduct evidence-based medical activities
Focus on launching and expanding the regenerative medicine and cell therapy business
- Smooth launch of CT1-DAP001/DSP-1083 (Parkinson’s disease) business
- Contribution to clinical studies for CT1-DAP001/DSP-1083 approval
- Contribution to the next products (HLCR011、DSP-3077)
Adapt operations to change
- Build and operate a system that adapts to changes in product and workforce mix
- Respond flexibly to changes in healthcare policy
- Strategic alliances to ensure business continuity
USA
Sumitomo Pharma America, Inc. is engaged in R&D, manufacturing
and sales of pharmaceuticals.
Sumitomo Pharma America, Inc.
launched in July 2023, through consolidation the functions and human
resources of seven U.S. group companies, Sunovion Pharmaceuticals
Inc., Sumitomo Pharma America Holdings, Inc., Sumitomo Pharma
Oncology, Inc., Sumitovant Biopharma, Inc., Myovant Sciences, Inc.,
Urovant Sciences, Inc., and Enzyvant Therapeutics, Inc.
Sumitomo Pharma America, Inc. Product Lineup
Major Pharmaceutical Products | Therapeutic Indication |
---|---|
ORGOVYX® | Therapeutic agent for advanced prostate cancer |
MYFEMBREE® | Therapeutic agent for uterine fibroids and endometriosis |
GEMTESA® | Therapeutic agent for overactive bladder (OAB) |
RETHYMIC® | Cultured thymus tissue for pediatric congenital athymia |
Key initiatives for the North American business under Reboot 2027
Maximizing the value of existing products
- Three key products: Maximizing sales and product profitability through the execution of strong sales strategies with excellent return on investment
- RETHYMIC®: Enhancing product supply to patients through the establishment of in-house processing facilities
Pursuing continuous operational efficiency improvements
- Continuing rigorous cost management
- Simplifying the governance structure
- Maintaining efficient commercial structure to support approval and launch of enzomenib