JW Pharma acquires domestic license for fostamatinib

Signs licensing agreement with Kissei Pharmaceutical to license development and commercialization rights in Korea

Fostamatinib has been approved by FDA in 2018, and is being sold in the U.S market

On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment.

 

Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and market fostamatinib in the domestic market.

 

Fostamatinib was originally developed by Rigel Pharmaceuticals, Inc., and Kissei acquired exclusive development and commercialization rights for fostamatinib in Japan, China, Korea, and Taiwan from Rigel in 2018.

 

Immune Thrombocytopenic Purpura (ITP) is a condition in which the body’s immune system attacks platelets, causing the platelet count to become lower than normal.

 

Patients with ITP are easily bruised, bleed easily, and have difficulty stopping bleeding.

 

In severe cases, it can lead to cerebral hemorrhage or upper gastrointestinal tract bleeding, and therefore is a rare blood condition with a high unmet need.

 

Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP in adult patients.

 

Contrary to existing treatments that boost blood platelet production, this first-in-class drug suppresses the destruction of platelets by macrophages and suppresses platelet depletion.

 

Fostamatinib was approved by the U.S.

 

FDA in 2018 for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment, and is sold under the name ‘Tavalisse.’ According to post hoc analysis results of Phase III clinical trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the use of fostamatinib as second-line therapy after treatment with corticosteroid showed a high treatment response rate in patients who have been diagnosed within a year.

 

Also, fostamatinib has less dietary interference and drug-drug interactions than other oral formulations and may be taken regardless of food intake or other medications.

 

JW Pharmaceutical plans to receive the orphan drug designation for fostamatinib in Korea to expand treatment opportunities for adult patients with thrombocytopenia.

 

An official from JW Pharmaceutical said, “The company was able to add a new drug for a rare disease in our lineup through the agreement.

 

We will work to progress the domestic approval process without any delay to provide treatment for patients suffering from chronic ITP.”