KUALA LUMPUR, April 15 -- MEI Pharma Inc and Kyowa Kirin Co Ltd have entered into a global licence, development and commercialisation agreement to further develop and commercialise MEI’s ME-401.
According to a statement, ME-401 is an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies.
Both companies will co-develop and co-promote ME-401 in the United States (US), with MEI booking all revenue from US sales. Kyowa Kirin has exclusive commercialisation rights outside of the US.
Under the terms of the agreement, MEI will receive a US$100 million upfront payment from Kyowa Kirin. MEI is also eligible to receive up to US$582.5 million in additional payments from Kyowa Kirin, depending on the achievement of certain US and ex-US development, regulatory and commercial milestones. (US$1 = RM4.322)
MEI and Kyowa Kirin will share US profits and costs (including development costs) on a 50-50 basis.
ME-401 is being studied in the ongoing Phase 2 TIDAL clinical trial evaluating patients with relapsed or refractory follicular lymphoma which, subject to results, may support an accelerated approval of a marketing application with the US Food and Drug Administration.
-- BERNAMA
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