Rigel Enters Collaboration and License Agreement with Grifols to Commercialize Fostamatinib in Europe
Rigel Pharmaceuticals announced that it has entered into an exclusive license and supply agreement with Spain-based Grifols 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.
“Grifols has a broad presence in Europe and an established position in the hematology commercial landscape, which supports our goal of bringing fostamatinib to patients in these countries,” said Raul Rodriguez, President and CEO of Rigel. “Our marketing authorization application for fostamatinib in chronic ITP is currently under review by the European Medicines Agency, and we anticipate a decision by the end of 2019. This provides a potential opportunity for fostamatinib to begin generating revenue in the European market in 2020.”
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).
“Given our global leadership position as a manufacturer of plasma medicines and our in-depth knowledge and expertise in blood disorders, adding fostamatinib to our portfolio is a natural fit for Grifols,” said Joel Abelson, President, Bioscience Commercial Division of Grifols. “Its potential in multiple indications, including ITP, may provide significant benefit for patients and is a valuable addition to our portfolio.”
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.