-Fostamatinib is a first-in-class oral spleen tyrosine kinase (SYK) inhibitor, to treat chronic immune thrombocytopenic purpura (ITP), which has a mechanism of action that inhibits platelet destruction.
-A new treatment option which is differentiated from existing treatments and expected to improve patient platelet counts.
June, 2021
JWP announced on June 28th, 2021 that a licensing agreement had been signed with Kissei Pharmaceutical Co., Ltd. (“Kissei”) to develop and commercialize fostamatinib for the treatment of ITP in Korea.
This licensing agreement will enable JW Pharmaceutical Corporation (“JWP”) to develop and commercialize fostamatinib in Korea and to strengthen its hemato-oncology product portfolio.
Chronic ITP refers to a condition in which the immune system attacks platelets, which leads to a lower than normal platelet count. Chronic ITP is a rare blood disorder with a high medical need, as it causes easy bruising or bleeding, makes it difficult to stop such bleeding and, in severe cases, cerebral hemorrhage and hematemesis may occur.
Fostamatinib is an oral SYK inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Unlike existing treatments which promote platelet production, it is a first-in-class drug with a mechanism of action that inhibits antibody-mediated platelet destruction.
Fostamatinib, approved by the US Food and Drug Administration in 2018, is indicated for adult patients with chronic ITP who have had an insufficient response to previous treatment. Fostamatinib is marketed in the United States under the brand name TAVALISSE®.
The results of a post-hoc data analysis from the Phase 3 clinical program, presented at the American Society of Hematology (ASH) 2019 Annual Meeting, revealed that a high therapeutic response rate is seen in patients with early-stage disease who received fostamatinib within 1 year of the onset of ITP as second-line therapy after treatment with corticosteroids.
In comparison with other oral formulations, fostamatinib exhibits lower drug-drug interactions (DDIs) and food-drug interactions, which suggests that it can be taken with or without food and regardless of the use of most other drugs.
In 2018, Kissei gained rights to develop and commercialize fostamatinib in Korea, Japan, China, and Taiwan from Rigel Pharmaceuticals, Inc., located in the United States, who originally developed this drug. Starting with this licensing agreement between JWP and Kissei, JWP will proceed with the development, regulatory approval process, and marketing of fostamatinib in Korea.
JWP will seek orphan-drug designation for fostamatinib in Korea in order to provide more treatment opportunities to adult patients with ITP.
JWP official commented that, “We secure a novel new drug for an orphan disease area through this licensing agreement” and “We will make every effort to prepare for a smooth marketing approval process to ensure that patients suffering from chronic ITP can receive sufficient treatment.”
GlobalData Plc, an UK-based data analytics and consulting company, anticipates that the global ITP market will reach about US$ 1 billion (about KRW 1 trillion) in 2025.
About Kissei Pharmaceutical Co., Ltd
Kissei Pharmaceutical Co., Ltd is a Japanese pharmaceutical company with approximately 70 years of history. It provides unique innovative pharmaceutical products as a drug discovery and R&D-oriented company for patients in the world with a special focus on urology, renal diseases, dialysis, and other therapeutics areas with high unmet medical needs. For more details, please visit https://www.kissei.co.jp/
About Rigel Pharmaceuticals, Inc.,
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Rigel is headquartered in South San Francisco, California, U.S.A. For more details, please visit https://www.rigel.com