On November 5, 2018 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, "Kyowa Hakko Kirin"), reported the execution of a license agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan ("License Agreement"). ME-401 is MEI’s phosphatidylinositol 3-kinase ("PI3K") delta inhibitor being developed by MEI for the treatment of patients with B-cell malignancies (Press release, Kyowa Hakko Kirin, NOV 5, 2018, View Source [SID1234530724]). MEI is planning to initiate a Phase 2 study to evaluate patients with follicular lymphoma that is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.

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Under the terms of the License Agreement, MEI will receive a $10 million upfront payment and is eligible to receive additional development and commercialization milestones totaling up to $87.5 million. MEI is also eligible to receive tiered double-digit royalties extending into the mid-teens. The agreement grants Kyowa Hakko Kirin exclusive rights to ME-401 to develop and commercialize ME-401 in Japan. The initial indication for development and regulatory approval under the agreement is relapsed or refractory follicular lymphoma.

"Kyowa Hakko Kirin is a well-regarded leader in the development and commercialization of hematology and oncology therapies in Japan," said David M. Urso., J.D., Chief Operating Officer of MEI Pharma. "This agreement is important for MEI as an opportunity to expand the development of ME-401 as a potential best-in-class PI3K delta inhibitor outside of the U.S. and is consistent with our strategy to optimize value through partnering opportunities abroad while developing capabilities for domestic commercialization."

"I am delighted to enter into an agreement with MEI Pharma for the development and commercialization of ME-401 in Japan," said Wataru Murata, Executive Officer, Director of Corporate Strategy & Planning Department. "We believe that ME-401 will be an important drug candidate in our oncology pipeline."

Kyowa Hakko Kirin plans to initiate a Phase 1 study in Japan in 2019.

About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401 as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S. Food and Drug Administration.