Rigel Pharmaceuticals announced that it had entered into an exclusive license and supply agreement with Kissei Pharmaceutical Co., Ltd. (“Kissei”) to develop and commercialize TAVALISSE in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Kissei is a Japan-based pharmaceutical company addressing patients’ unmet medical needs through its research, development and commercialization efforts, as well as through collaborations with partners. TAVALISSE is commercially available in the U.S. for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
“Kissei is a leading Japanese pharmaceutical company with significant development experience and a track record of commercial success in Asian markets. Their commitment to develop TAVALISSE in ITP, and potential future indications in these territories, makes Kissei an optimal partner as we seek to expand the global market opportunity for this important new therapeutic,” said Raul Rodriguez, president and CEO of Rigel. “This agreement demonstrates our approach to entering strategic markets outside of the U.S. and emphasizes the unmet need that exists for chronic ITP, among other rare blood disorders.”
Under the terms of the agreement, Rigel will receive an upfront cash payment of $33 million, with the potential for an additional $147 million in development and commercial milestone payments, and will receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales for the exclusive supply of TAVALISSE. Kissei receives exclusive rights to TAVALISSE in ITP and all future indications in Japan, China, Taiwan, and the Republic of Korea. Rigel retains the global rights, excluding these Asian countries, to develop and commercialize TAVALISSE in ITP and any additional indications.
On May 29, 2018, TAVALISSE was launched for commercial use in the U.S. Kissei will initially seek local country approval for TAVALISSE in ITP and conduct clinical studies as required by the country’s Pharmaceuticals and Medical Devices Agency. Japan has the third highest prevalence of chronic ITP in the world behind the U.S. and EU. The EU is another significant market in which Rigel is exploring partnership opportunities.
“Our extensive experience with in-licensed and proprietary therapies provides the infrastructure and expertise needed to successfully commercialize fostamatinib in Japan, and other markets,” said Mutsuo Kanzawa, Chairman and CEO of Kissei. “We look forward to working closely with Rigel to demonstrate the value of this medication in addressing the significant unmet medical needs of patients with chronic ITP and other rare blood disorders.”