Pharmaceutical Business review

Amgen, Kyowa Kirin partner to develop antibody for atopic dermatitis

Amgen headquarters in Thousand Oaks, California. Credit: Coolcaesar.

Amgen has signed an agreement with Japanese pharmaceutical firm Kyowa Kirin to jointly develop and commercialise Phase III-ready antibody for treating atopic dermatitis.

Discovered by Kyowa Kirin, the anti-OX40 fully human monoclonal antibody KHK4083 has been engineered with the company’s patented Potelligent defucosylation technology.

As per the terms of the deal, Amgen will be responsible for the development, manufacture, and commercialisation of KHK4083 all over the world except in Japan, where Kyowa Kirin will retain all rights of the antibody.

Kyowa Kirin will receive an up-front payment of $400m from Amgen as well as future contingent milestone payments of additional $850m and significant royalty payments on future global sales of the product.

Additionally, Kyowa Kirin and Amgen will co-promote KHK4083 in the US and have opt-in rights to co-promote it in other markets outside the US, including Europe and Asia.

Amgen stated that KHK4083 met the primary endpoint in a Phase II trial which included 274 patients with moderate-to-severe atopic dermatitis in February this year.

Kyowa Kirin Global R&D Division executive officer, vice-president and head Yoshifumi Torii said: “KHK4083 is another example of our world-leading expertise in antibody engineering, applied target selection and optimization. We are proud to be a science-led organization whose research capabilities continue to produce meaningful discoveries, while also taking advantage of open innovation, that offers potential for improving treatment paradigms.

“Results from clinical trials for KHK4083, including Phase II data, show great promise and we look forward to initiating a late-stage global program with Amgen to deepen our understanding of this asset.”

KHK4083 is in development for atopic dermatitis treatment, with potential in other autoimmune diseases.