– Kissei gains exclusive rights to fostamatinib in all current and potential indications in Japan and other Asian countries
– Rigel receives an upfront cash payment of $33 million with the potential for up to $147 million in development and commercial milestone payments
– Rigel to receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales for exclusive supply of TAVALISSE
SOUTH SAN FRANCISCO, CA, USA I October 29, 2018 I Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today 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.”
About 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.
About TAVALISSE
Indication
TAVALISSE™ (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel’s clinical programs include an upcoming Phase 3 study of fostamatinib in autoimmune hemolytic anemia and an ongoing Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
About Kissei (https://www.kissei.co.jp)
Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. Kissei aims to develop innovative pharmaceutical products that contribute to the improvement of medicine and the health of people around the world by aggressive incorporation of leading-edge technology and joint research and collaborations with our foreign and domestic partners.
SOURCE: Rigel Pharmaceuticals
Post Views: 11
– Kissei gains exclusive rights to fostamatinib in all current and potential indications in Japan and other Asian countries
– Rigel receives an upfront cash payment of $33 million with the potential for up to $147 million in development and commercial milestone payments
– Rigel to receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales for exclusive supply of TAVALISSE
SOUTH SAN FRANCISCO, CA, USA I October 29, 2018 I Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today 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.”
About 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.
About TAVALISSE
Indication
TAVALISSE™ (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s first FDA approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigel’s clinical programs include an upcoming Phase 3 study of fostamatinib in autoimmune hemolytic anemia and an ongoing Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. In addition, Rigel has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics.
About Kissei (https://www.kissei.co.jp)
Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. Kissei aims to develop innovative pharmaceutical products that contribute to the improvement of medicine and the health of people around the world by aggressive incorporation of leading-edge technology and joint research and collaborations with our foreign and domestic partners.
SOURCE: Rigel Pharmaceuticals
Post Views: 11
