Amgen and Kyowa Kirin will jointly develop and commercialise KHK4083, the latter’s potential first-in-class, Phase 3-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.
In February, Kyowa Kirin announced positive results from a Phase 2 study of KHK4083 in patients with moderate-to-severe atopic dermatitis, which affects nearly 30 million people in major global markets1.
Amgen will lead the development, manufacturing, and commercialisation for KHK4083 for all markets globally, except Japan, where Kyowa Kirin will retain all rights.
Additionally, Kyowa Kirin will co-promote KHK4083 with Amgen in the US and have opt-in rights to co-promote KHK4083 in certain other markets outside the US, including in Europe and Asia.
Amgen will make a $400 million up-front payment to Kyowa Kirin and future contingent milestone payments potentially worth up to an additional $850 million, as well as significant royalty payments on future global sales.
Kyowa Kirin and Amgen will share global development costs, except in Japan, and US commercialisation costs.
Amgen will consolidate sales for KHK4083 in all markets globally, except for Japan.
Amgen also will leverage unique data from its deCODE Genetics subsidiary to inform the potential use of KHK4083 in indications beyond atopic dermatitis.
The closing of the transaction is conditioned on obtaining any necessary consents and approvals.
KHK4083 is an anti-OX40 fully human monoclonal antibody discovered by Kyowa Kirin and engineered with Kyowa Kirin’s patented POTELLIGENT defucosylation technology to enhance its antibody-dependent cellular cytotoxicity (ADCC) activity. KHK4083 has been shown to selectively deplete activated T cells that are critical in the development of atopic dermatitis.
Kyowa Kirin antibodies powered by POTELLIGENT technology with ADCC activity are currently marketed in therapeutic areas including Oncology and Asthma. This potent antibody-enhancement platform is also licensed to numerous third parties throughout the biopharmaceutical industry.