Rigel Pharmaceuticals Enters Collaboration and License Agreement with Grifols, S.A. to Commercialize Fostamatinib in Europe
January 23, 2019 at 12:30 pm
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Rigel Pharmaceuticals, Inc. announced that it has entered into an exclusive license and supply agreement with Spain-based Grifols, S. A to commercialize fostamatinib disodium hexahydrate in all potential indications in Europe and Turkey. Grifols is a global healthcare company and a leading producer of plasma-derived medicines for the treatment of rare and chronic diseases, including intravenous immunoglobulin (IVIG) which is used in the treatment of ITP and AIHA. Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE® (fostamatinib disodium hexahydrate) and is the first and only SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Under terms of the agreement, Rigel will receive a $30 million upfront cash payment, with the potential for $297.5 million in payments related to regulatory and commercial milestones, which includes a $20 million payment for EMA approval of fostamatinib for the treatment of chronic ITP. Rigel will receive significant stepped double-digit royalty payments based on tiered net sales which may reach 30% of net sales. In return, Grifols receives exclusive rights to fostamatinib in human diseases, including chronic ITP, autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN), in Europe and Turkey. In the event that, in 2021, after the second anniversary of the agreement, fostamatinib has not been approved by the EMA for the treatment of ITP in Europe, Grifols will have the option during a six-month time-frame to terminate the entire agreement which would terminate all their rights to ITP, AIHA, and all other indications. In this limited circumstance, Rigel will pay Grifols $25 million and regain all rights to fostamatinib in Europe and other territories. Rigel retains the remaining global rights to fostamatinib outside the Grifols territories and those rights previously granted to Kissei Pharmaceuticals (in Japan, China, Taiwan and the Republic of Korea). On October 4, 2018, the EMA validated the marketing authorization application for fostamatinib in adult chronic ITP, which was submitted by Rigel. The company anticipates a decision from the EMA's Committee on Human Medicinal Products by the fourth quarter of 2019 and potential European approval by the end of 2019.
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. It is focused on products that address signaling pathways that are critical to disease mechanisms. Its first product is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the approved oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Its second product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Its GAVRETO (pralsetinib) product is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions.