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Rigel's fostamatinib Enters Phase 3 Clinical Trial in Japan with Kissei Pharmaceuticals for the Treatment of Chronic Immune Thrombocytopenia
SOUTH SAN FRANCISCO, Calif., Sept. 23, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that its collaboration partner, Kissei
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Sept. 23, 2019 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that its collaboration partner, Kissei Pharmaceuticals Co., Ltd. (\"Kissei\"), has initiated a Phase 3 trial in Japan of fostamatinib disodium hexahydrate in adult patients with chronic immune thrombocytopenia (ITP). The efficacy and safety of orally administered fostamatinib will be assessed by comparing it with placebo in a randomized, double-blind study. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment. \nKissei is a Japan-based pharmaceutical company addressing patients' unmet medical needs through its research, development and commercialization efforts, as well as through collaborations with partners. Earlier this year, Kissei submitted a Phase 3 trial design to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and it was recently accepted by the agency. The results of this trial will be used to support a new drug application (NDA) that Kissei plans to file in Japan in late 2021 or early 2022. Japan has the third highest prevalence of chronic ITP in the world behind the U.S. and EU. Currently a marketing authorization application for fostamatinib in chronic ITP in adult patients is being reviewed by the European Medicines Agency for potential approval in Europe. \nIn October 2018, Rigel and Kissei entered into an agreement for the development and commercialization of fostamatinib in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Under the terms of the agreement, Rigel received an upfront cash payment of $33 million, with the potential for an additional $147 million in development and commercial milestone payments and will receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales. \nAbout ITP In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current thera...