Amgen reunited with longtime developmental partner Japan’s Kyowa Kirin to develop a Phase III-ready atopic dermatitis treatment.
This morning, California-based Amgen announced it will make a $400 million upfront payment to Kyowa Kirin to partner on the development and potential commercialization of KHK4083, the company’s potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis.
The companies believe KHK4083 also has potential as a therapy for other autoimmune diseases. After a four-year break, Amgen returned to partnering with Kyowa Kirin following positive Phase II data that showed significant potential in addressing atopic dermatitis, which impacts nearly 30 million people across the globe.
The two companies first partnered in 1984 to develop Epogen, an anemia treatment. Epogen was approved by the U.S. Food and Drug Administration in 1989, the first Amgen drug to win regulatory approval in the U.S. The companies worked on the development of other drugs, including Neupogen, Neulasta and Nplate.
Amgen, which has a strong portfolio of inflammatory disease treatments, sees KHK4083 as a good fit for its current pipeline of inflammatory drugs, including tezepelumab, a potential treatment for asthma for which the company is seeking regulatory approval.
Robert Bradway, chairman and chief executive officer at Amgen, said Kyowa Kirin was one of Amgen’s first collaboration partners.
Bradway said he is excited about joining forces with the Japanese company again to advance KHK4083, which he called a “promising late-stage asset” for atopic dermatitis. Kyowa Kirin KHK4083 is an anti-OX40 fully human monoclonal antibody that has been shown to selectively deplete activated T cells that are critical in the development of atopic dermatitis. The drug has been engineered with Kyowa Kirin’s Potelligent defucosylation technology to enhance its antibody-dependent cellular cytotoxicity activity.
“We will take advantage of our two decades of experience in inflammatory disease, as well as our industry-leading human genetics capabilities, to help realize the full potential of KHK4083 as quickly as possible,” Bradway said in a statement.
Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083 for all global markets globally, with the exception of Japan. Kyowa Kirin will co-promote KHK4083 in the U.S.
The company also has opt-in rights to co-promote KHK4083 in other markets outside the U.S., including in Europe and Asia. Amgen will make an upfront payment of $400 million. Kyowa Kirin will be eligible for milestone payments potentially worth up to an additional $850 million, as well as significant royalty payments on future global sales.
Masashi Miyamoto, president and CEO of Kyowa Kirin, called KHK4083 a vital asset in the company’s 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,” Miyamoto said in a statement.
Published: Jun 01, 2021 By Alex Keown