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news.Kyowa Hakko Kirin has announced KHK and Amgen will terminate their licensing agreement in relation to mogamulizumab.
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Under the licensing agreement entered into on 6 March 2008, Amgen was granted exclusive rights to develop and commercialize Kyowa Hakko Kirin’s humanized monoclonal antibody mogamulizumab in all non-oncology indications worldwide, except in Japan, China, Korea and Taiwan.
After entering into the agreement, Amgen conducted clinical trials aimed at patients with asthma. Kyowa Hakko Kirin has completed a Phase I clinical trial in healthy Japanese adults, and will determine its future development policy after carefully considering the outcome of the Phase I results.
The termination of the agreement will have a minimal effect on Kyowa Hakko Kirin’s financial results (fiscal term ending December 2014).
Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target through potent antibody dependent cellular cytotoxicity (ADCC).
Mogamulizumab was launched in Japan with the brand name "POTELIGIO Injection 20 mg" on 29 May 2012 for treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL).
On 17 March 2014, mogamulizumab received approval for additional indication for treatment of patients with relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) from Japan’s Ministry of Health, Labour and Welfare.