January 7, 2025
Sub-licensing Agreement for the Oral Spleen Tyrosine Kinase Inhibitor TAVALISSE® with Tai Tien Pharmaceuticals in Taiwan
Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") announced that it has entered into a sub-license agreement with Tai Tien Pharmaceuticals Co., Ltd. (Head Office: Taiwan, General Manager: Tony Chu; "Tai Tien"), a consolidated subsidiary of Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka, Japan; Representative Director: Akihiro Tsujimura; "Mitsubishi Tanabe Pharma"), to license development and commercialization rights in Taiwan for Tavalisse® (fostamatinib disodium hexahydrate), a spleen tyrosine kinase (SYK) inhibitor discovered by Rigel Pharmaceuticals, Inc. (Headquarters: USA, President and CEO, Raul Rodriguez; "Rigel").
By executing this agreement, Tai Tien will gain the rights to develop and commercialize fostamatinib in Taiwan. Kissei will receive an upfront payment and milestone payments based on the progress of commercialization in Taiwan from Tai Tien and will supply the formulation to Tai Tien.
Tavalisse is an oral SYK inhibitor discovered by Rigel. It suppresses platelet destruction by macrophages and platelet depletion, thereby improving the bleeding symptoms caused by chronic idiopathic thrombocytopenic purpura (ITP). The product has been approved in the United States since 2018, under the brand name Tavalisse (fostamatinib disodium hexahydrate) and is indicated for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment. Product approvals have followed in Europe, Canada, and the Middle East.
In October 2018, Kissei acquired the development and commercialization rights for Tavalisse in Japan, China, South Korea, and Taiwan from Rigel.1 In Japan, Kissei launched Tavalisse in April 2023.2 Additionally, Kissei is engaged in partnering activities in the rights regions excluding Japan. In South Korea, Kissei granted the development and commercialization rights for Tavalisse to JW Pharmaceutical (South Korea) in June 2021.3
Kissei will continue to advance the development of Tavalisse in its licensed regions through collaboration with partner companies, striving to further contribute to the treatment of chronic ITP, an intractable disease.
The projected financial results for the fiscal year ending March 2025, which incorporate this progress, were disclosed during the announcement of the financial results on November 5, 2024.
1 News Release: October 30, 2018
Announcement of in-licensing of technology related to a small molecule tyrosine kinase inhibitor fostamatinib
2 News Release: April 6, 2023
Kissei Launches TAVALISSE® Tab. 100mg and 150mg, an Oral Spleen Tyrosine Kinase Inhibitor, in Japan for Chronic ITP
3 News Release: June 28, 2021
Sub-licensing Agreement for Spleen Tyrosine Kinase Inhibitor "Fostamatinib (R788)" with JW Pharmaceutical Corporation
《 Reference 》
About Idiopathic Thrombocytopenic Purpura (ITP)
ITP is a disease that causes serious bleeding events and bruising due to a decrease in platelet count below 100,000/μL, despite the absence of other obvious illnesses and medications that cause thrombocytopenia. ITP is classified into "acute ITP," in which the platelet count recovers normally within 6 months from the onset and "chronic ITP," in which thrombocytopenia continues for 6 months or more depending on the course of the medical condition. Fostamatinib is a treatment for chronic ITP.
The clinical symptoms of ITP include subcutaneous bleeding (petechiae or purpura) as well as bleeding from the gums or nose, blood in the urine or stool, and intracranial bleeding.
ITP is designated as an "intractable disease" by the Minister of Health, Labour and Welfare. The number of patients with ITP is estimated to be approximately 17,000* and 2.16 per 100,000** people are newly diagnosed with ITP every year in Japan. While the cause of ITP has still not been definitively elucidated, it is believed that the platelet count is decreased as a result of the production of autoantibodies against platelets, leading to the destruction of platelets by macrophages in the spleen. ITP is currently treated with corticosteroids or thrombopoietin (TPO) receptor agonists as well as surgical removal of the spleen.
*: Estimated based on the number of patients having certificates issued for specific disease treatment (designated intractable disease)
**: Int J Hematol, 2011, 93: 329-35
About Tai Tien Pharmaceuticals
Tai Tien Pharmaceuticals Co., Ltd was established in Taipei in 1987 and focuses on the field of lifestyle-related diseases with products such as HERBESSER®, CONCOR® (Japan name: Maintate®), LIVALO®, and CANAGLU®. In addition, Tai Tien is contributing to the treatment of patients with autoimmune diseases in Taiwan with the launches of SIMPONI® and REMICADE®.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit www.rigel.com.