Rigel’s Fostamatinib and Kissei Pharmaceuticals progress with a Phase III trial of their medicine for Chronic Immune Thrombocytopenia patients

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). By comparing it with placebo in randomized, double-blind research the effectiveness and safety of orally administered fostamatinib. For the treatment of adult patients with a chronic ITP with an insufficient response to previous treatment, Fostamatinib is available commercially under the brand name TAVALISSE ® in the U.S.
Kissei is a Japanese pharmaceutical firm that, in its studies, growth, marketing and cooperation with partners, addresses the unmet medical requirements of patients. At the beginning of this year, Kissei provided the PMDA with a Phase 3 trial design, which was lately approved by the Japan Pharmaceuticals and Medical Devices Agency.
This trial will be used to support a new NDA that Kissei plans to submit in Japan by the end of 2021 or by the beginning of 2022. Japan, behind the United States and the EU, has the third-largest chronic ITP incidence in the globe. The European Medicines Agency is currently examining for possible approval in Europe a marketing authorization request for fostamatinib in chronic ITP for adult patients.
In October 2018, in all the current and potential indications in Japan, China, Taïwan and the Republic of Korea, Rigel and Kissei signed an Agreement for the production of and commercialization of Fostamatinib. In accordance with this agreement, Rigel was awarded an up-front cash payment in the amount of $33 M, with potential development and business milestone payments for an additional $147 M, and will receive mid to above 20% product transfer cost payments based on tiered net sales.

, , ,