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Amgen and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis

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Amgen and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis | Pharmtech Focus

Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin’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 markets.

Under terms of the agreement, Amgen will lead the development, manufacturing, and commercialization 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 U.S. and have opt-in rights to co-promote KHK4083 in certain other markets outside the U.S., 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 U.S. commercialization 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.

“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,” says Masashi Miyamoto, Ph.D., president and chief executive officer at Kyowa Kirin. “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 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.

“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,” said Robert A. Bradway, chairman and chief executive officer at Amgen.  “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.”

Amgen is a global leader in treating inflammatory diseases, with a portfolio of marketed medicines that includes Otezla®, Enbrel®, AMGEVITA® (a biosimilar to Humira®), and AVSOLA® (a biosimilar to Remicade®).  Amgen’s pipeline of investigational therapies includes tezepelumab (filed for U.S. FDA approval in May 2021 as a potential first-in-class treatment for severe asthma), ABP 654 (a biosimilar to STELARA®), and several innovative molecules in Phase 2b development for systemic lupus erythematosus and celiac disease.

“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,” said Yoshifumi Torii, Ph.D., executive officer, vice president, Head of Global R&D Division at Kyowa Kirin. “Results from clinical trials for KHK4083, including Phase 2 data, show great promise and we look forward to initiating a late-stage global program with Amgen to deepen our understanding of this asset.”

In 1984, Amgen and Kirin Holdings Co., Ltd (former Kirin Brewery Co., Ltd), the parent company of Kyowa Kirin, established a 50-50 joint venture to develop and commercialize EPOGEN® (Japanese brand name: ESPO®), which, in 1989, became the first Amgen medicine approved in the U.S., and, in 1990, became the first Kirin medicine approved in Japan.  Over time, the joint venture expanded to include the development and commercialization of several other medicines, including NEUPOGEN® (GRAN® in Japan), Neulasta® (G-Lasta® in Japan), Aranesp® (NESP® in Japan), and Nplate® (Romiplate® in Japan).  In 2017, the companies announced that the joint venture would become a wholly owned subsidiary of Amgen, with Kyowa Kirin in-licensing certain Amgen medicines in the Asia-Pacific region.  

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