On May 24, 2022 Knight Therapeutics Inc. (TSX: GUD), a pan-American (ex-USA) specialty pharmaceutical company, reported that it has entered into exclusive license and supply agreements with Rigel Pharmaceuticals granting Knight the rights to commercialize fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in Latin America (Press release, Knight Therapeutics, MAY 24, 2022, View Source [SID1234614990]).
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Fostamatinib is commercially available in the United States under the brand name TAVALISSE (fostamatinib disodium hexahydrate) and in Europe under the brand name TAVLESSE for the treatment of chronic immune thrombocytopenia (ITP). Fostamatinib is also currently being studied in a Phase 3 clinical trial for the treatment of warm autoimmune hemolytic anemia (wAIHA)1 and in two Phase 3 clinical trials for the treatment of hospitalized patients with COVID-19.2,3
Under the terms of the agreement, Rigel will receive an upfront cash payment, with the potential for additional regulatory and commercial milestones, and stepped-up royalties based on tiered net sales. In return, Knight receives exclusive rights to fostamatinib in all potential indications, including chronic ITP, wAIHA, and COVID-19 in Latin America.
"This partnership represents the continued execution of our strategy of leveraging our solid platform and expertise to bring innovative medicines to our markets," said Samira Sakhia, President and CEO of Knight. "We are excited to be working with Rigel to provide access to an innovative, first-in-class treatment option to patients across Latin America with chronic ITP."
"We consider Knight to be the partner of choice in Latin America and look forward to a productive collaboration that further expands TAVALISSE’s global reach to patients in need," said Raul Rodriguez, President and CEO of Rigel. "TAVALISSE is already available in several countries around the world for the treatment of chronic ITP, and we look forward to pivotal readouts from our Phase 3 clinical trials with fostamatinib in wAIHA and COVID-19."
About ITP
In patients with ITP (immune thrombocytopenia), 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 (TPO-RAs), 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.
About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that lead to the destruction of the body’s own red blood cells. Warm antibody AIHA (wAIHA), which is the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature. To date, there are no disease-targeted therapies approved for wAIHA, despite the unmet medical need that exists for these patients.
About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.4 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.5
SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.6,7,8,9 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.