January 23, 2019
Grifols Announces Collaboration and License Agreement with Rigel Pharmaceuticals
Grifols gains exclusive rights to fostamatinib (TAVALISSE®) in chronic immune thrombocytopenia (ITP) and other indications
- Grifols gains exclusive rights to fostamatinib (TAVALISSE®) in chronic immune thrombocytopenia (ITP) and other indications
- Rigel receives a $30M upfront payment from Grifols, with the potential to receive up to $297.5 million in payments related to regulatory and commercial milestones, which includes a $20M payment upon EMA approval
- Potential European approval of fostamatinib for the treatment of chronic ITP is expected by the end of 2019
- This agreement represents an opportunity to further complement Grifols Bioscience Division portfolio to treat more chronic and rare diseases, since fostamatinib has potential in multiple indications in addition to ITP
Barcelona (Spain), January 23, 2019.- Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), one of world's top three producers of plasma-derived medicines and a forerunner in the research and development of therapeutic alternatives that drive scientific and social advancements has entered into an exclusive license agreement with the US-based biotechnology company Rigel Pharmaceuticals (NASDAQ: RIGL) to commercialize fostamatinib disodium hexahydrate in all potential future indications in Europe and Turkey.
Fostamatinib is commercially available in the U.S. under the brand name TAVALISSE®, which is the first and only SYK (spleen tyrosine kinase) inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Rigel marketing authorization application for fostamatinib in chronic ITP is currently under review by the European Medicines Agency (EMA). 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 Committee on Human Medicinal Products by the fourth quarter of 2019 and potential European approval by the end of 2019.
Under terms of the agreement, Rigel will receive from Grifols a $30 million upfront cash payment, with the potential to receive up to $297.5 million in payments related to regulatory and commercial milestones, which includes a $20 million payment upon EMA approval of fostamatinib for the treatment of chronic ITP.
Rigel will receive several stepped royalty payments based on tiered net sales. In return, Grifols receives exclusive rights to fostamatinib in chronic ITP, autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN) in Europe and Turkey.
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).
About the chronic immune thrombocytopenia (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 therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.