Announcement of Sales Partnership Agreement in Japan for New Osteoarthritis Treatment Agent
Teikoku Seiyaku Co., Ltd. (Headquarters: Kagawa, Japan; President & CEO: Misako Fujioka, hereinafter “Teikoku Seiyaku”) announces that it has entered into an Exclusive Commercialization License Agreement in Japan with MEDIPOST K.K. (Headquarters: Tokyo, Japan; CEO: Antonio Lee, hereinafter “MEDIPOST”), a wholly-owned Japanese subsidiary of MEDIPOST Co., Ltd. (Headquarters: Seongnam-si, Gyeonggi-do, Republic of Korea; CEO: Wonil Oh, Global President & Board Director: Antonio Lee) for the allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) therapy CARTISTEM® (hereinafter referred to as the “Product”) for the treatment of knee osteoarthritis.
The Product is a novel therapeutic agent being developed by MEDIPOST in Japan for the treatment of knee osteoarthritis. Last Patient Out of the Phase 3 clinical trial has been completed, and preparations are underway for the application for manufacturing and marketing authorization approval. Meanwhile, in South Korea, the Product was launched in 2012 under the brand name CARTISTEM® as a treatment for knee osteoarthritis and has been administered to over 35,000 patients to date.
Under this agreement, MEDIPOST is responsible for the manufacturing and marketing authorization approval for this product and will retain the manufacturing and marketing authorization rights, while Teikoku Seiyaku will handle distribution, sales, and information provision activities.
About the Product
The Product is an allogeneic stem cell therapy designed to treat moderate-to-severe knee osteoarthritis. The Product demonstrates the ability to regenerate cartilage in knee osteoarthritis patients and is developed as an osteoarthritis treatment agent by MEDIPOST.
The allogeneic human umbilical cord blood–derived mesenchymal stem/stromal cells (MSCs) used in this therapy respond to the inflammatory micro-environment of osteoarthritic joints by releasing a range of biologically active factors, including growth factors, cytokines, and ligands. *1, *2
Delivered surgically onto damaged cartilage within the joint space, these cells help decrease cartilage degradation, promote cartilage progenitor cell differentiation, and reduce inflammatory signaling. As a result, the therapy targets the underlying degenerative and inflammatory processes of knee osteoarthritis, supporting cartilage regeneration and long-term alleviation of pain.
About Teikoku Seiyaku
Founded in 1848, Teikoku Seiyaku is dedicated to its mission “For a World Without Pain.” Leveraging its expertise in transdermal drug delivery technology, the company develops, manufactures, and markets pharmaceutical products, including transdermal patches and medical narcotics.
For osteoarthritis, Teikoku Seiyaku has entered into a sales agreement with ReqMed Company, Ltd. regarding exclusive distribution rights in Japan for a subcutaneous injection formulation containing sodium pentosan polysulfate (NaPPS), which is currently in Phase 3 clinical trials in Japan.
Going forward, in orthopedics—one of its priority areas—Teikoku Seiyaku will further strengthen its efforts to deliver treatments for diseases with high unmet medical needs, including osteoarthritis, to patients. A large-scale expansion of the orthopedic team will be implemented bringing the number of dedicated personnel to approximately 100.
About MEDIPOST Co., Ltd.
Founded in 2000, MEDIPOST Co., Ltd. is a global stem cell therapy company with integrated capabilities spanning across discovery research with product and clinical development of allogeneic cell therapy pipelines, cord blood banking, and cell and gene therapy contract development and manufacturing (CDMO) business portfolios. MEDIPOST Co., Ltd. successfully commercialized the world's first regulatory-approved (2012) allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell (hUCB-MSC) therapy product, CARTISTEM®, for the treatment of knee osteoarthritis patients across all age groups.
For further information, please contact:
Teikoku Seiyaku Co., Ltd. General Affairs and HR Department,
TEL:+81-879-25-2221
MEDIPOST K.K.
TEL:+81‐3-5422-6273
*1 Caplan AI, Dennis JE. Mesenchymal stem cells as trophic mediators. J Cell Biochem. 2006; 98:1076–1084.
*2 Nauta AJ, Fibbe WE. Immunomodulatory properties of mesenchymal stromal cells. Blood. 2007; 110:3499–3506.
