JW Pharmaceutical said Monday that it has acquired exclusive rights of fostamatinib, a treatment for thrombocytopenia, from Japan’s Kissei Pharmaceutical to develop and market the drug in Korea, strengthening its hemato-oncology portfolio.
The company also plans to receive orphan drug status from the Ministry of Food and Drug Safety to provide more therapeutic options for people with a low platelet count.
Kissei Pharmaceutical gained the rights to supply and develop fostamatinib, a first-in-class drug originally developed by Rigel Pharmaceuticals, exclusively in Korea, Japan, China, and Taiwan in 2018. Under the accord, JW Pharmaceutical can develop, obtain regulatory approval, and begin marketing the drug in the domestic market.
Patients can take fostamatinib orally, which works as a tyrosine kinase inhibitor that targets the underlying cause of immune thrombocytopenic purpura (ITP) in adult patients. Unlike the existing therapies that promote platelet generation in the body, fostamatinib limits platelet destruction.
Chronic ITP is a condition in which the body's immune system attacks platelets, causing the platelet count to drop lower than the normal level. It is a rare blood disease with high medical demand as patients suffer from bruises and bleeding, and the illness could lead to brain hemorrhage or upper gastrointestinal tract bleeding in severe cases.
In 2018, the U.S. Food and Drug Administration authorized the use of fostamatinib under the brand name Tavalisse in all ITP patients who have not responded very well to the existing medications.
American Society of Hematology (ASH) presented an analysis of phase 3 clinical trial in 2019 that early-stage ITP patients with less than a year of onset showed a high therapeutic response when they received fostamatinib as second-line therapy after undergoing treatment with corticosteroids.
"We have added a new drug to our portfolio for rare diseases and will prepare the domestic approval process without any setbacks to provide treatments for those with chronic ITP," a JW Pharmaceutical official said.
According to a U.K. market researching company, GlobalData, the global ITP drug market is expected to reach $1 billion by 2025.