KHK4083 is an anti-OX40 fully human monoclonal antibody, developed by Kyowa Kirin to treat atopic dermatitis and other autoimmune diseases

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Amgen Thousand Oaks campus Building 27. (Credit: Amgen Inc.)

Amgen and Kyowa Kirin have agreed to jointly develop and commercialise the latter’s investigational atopic dermatitis treatment KHK4083.

Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialisation for KHK4083 for global markets, excluding Japan.

Kyowa Kirin will retain all rights, co-promote KHK4083 with Amgen in the US and holds opt-in rights to co-promote KHK4083 in certain other markets outside the US.

Amgen will make an up-front payment of $400m to Kyowa Kirin and additional contingent milestone payments of up to $850m in future, along with royalty payments.

Also, Kyowa Kirin and Amgen have agreed to share global development costs, excluding Japan, and US commercialisation costs.

Kyowa Kirin president and CEO Masashi Miyamoto said: “Kyowa Kirin has a long legacy of partnering with other companies to deliver the full value of our scientific discoveries and novel medicines for patients. KHK4083 is an important asset in our global pipeline.

“We know Amgen well, and this alliance will build on the past success and trust we have, bringing additional resources and therapeutic expertise to KHK4083’s development and commercialization, to meet the needs of patients living with atopic dermatitis who seek alternative treatment options.”

KHK4083 is a Phase 3-ready anti-OX40 fully human monoclonal antibody, being developed for the treatment of atopic dermatitis, with potential in other autoimmune diseases.

The drug works by depleting OX40-Expressing T cells that are associated with atopic dermatitis and various other inflammatory diseases.

In Phase 2 clinical study conducted by Kyowa Kirin in February this year, in the US, Japan, Canada, and Germany, KHK4083 has met the primary endpoint.

Treatment using KHK4083 showed superior results in patients with moderate-to-severe atopic dermatitis, who were not adequately controlled with topical agents.

Amgen intends to leverage advanced data from its deCODE Genetics subsidiary to inform the potential use of KHK4083 in indications beyond atopic dermatitis.

The closing of the transaction is subject to receipt of required consents and approvals.

Amgen chairman and CEO Robert Bradway said: “Kyowa Kirin was one of Amgen’s very first collaborators and we are delighted to be joining forces with them once again to advance this promising late-stage asset to treat atopic dermatitis.

“We will take advantage of our two decades of experience in inflammatory disease, as well as our industry-leading human genetics capabilities, to help realise the full potential of KHK4083 as quickly as possible.”