MEDIPOST has announced a multi-year exclusive partnership with Teikoku Seiyaku to commercialise CARTISTEM, an allogeneic stem cell therapy for moderate to severe knee osteoarthritis, in Japan.
The agreement covers the promotion license, sales, and distribution of CARTISTEM.
MEDIPOST will supply the drug substance and retain manufacturing rights, while the exclusive rights for the Japanese market will be managed by Teikoku Seiyaku.
Under this agreement, MEDIPOST’s Japanese subsidiary receive a short-term regulatory milestone payment of $10m, an upfront payment of $8m, and additional undisclosed sales-based long-term milestone payments.
Teikoku Seiyaku intends to use its network of orthopaedic clinics and hospitals to support the adoption and distribution of CARTISTEM among patients with moderate to severe knee osteoarthritis.
The company is preparing to expand its medical representative division in advance of regulatory approval, with the aim of addressing unmet medical needs in knee osteoarthritis treatment in Japan.
CARTISTEM is designed to regenerate cartilage in patients with knee osteoarthritis and holds the potential as a disease-modifying osteoarthritis drug (DMOAD).
Since its regulatory approval in South Korea in 2012, CARTISTEM has been used in more than 35,000 patients over 13 years. The therapy is based on allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cells (hUCB-MSC).
MEDIPOST’s integrated operations includes cell and gene therapy contract development and manufacturing; research, product and clinical development; and cord blood banking. The company introduced CARTISTEM, the first allogeneic hUCB-MSC therapy product to receive regulatory approval for treating knee osteoarthritis in patients of all ages.
Teikoku Seiyaku is focused on transdermal drug delivery and pain management. The company has also signed a basic sales agreement with ReqMed Company for exclusive distribution rights in Japan for a sodium pentosan polysulfate subcutaneous injection, which is in Phase III clinical trials.
It intends to grow its orthopaedics team to 100 members and enhance efforts to provide therapies for conditions with significant unmet medical needs.
