Late-stage pharmaceutical company MEI Pharma Inc. (MEIP:NASDAQ), which is focused on developing potential new therapies for cancer, and Kyowa Kirin Co. Ltd. (4151:TSE) jointly announced today that "the companies have entered into a global license, development and commercialization agreement to further develop and commercialize MEI's ME-401, an oral, once-daily, investigational drug-candidate, selective for phosphatidylinositol 3-kinase delta (PI3Kδ), in clinical development for the treatment of B-cell malignancies."
The two companies indicated that they will jointly develop and promote ME-401 in the U.S and that under the terms of the agreement, MEI will book all revenue from sales in the U.S., while Kyowa Kirin will be entitled to exclusive all commercialization rights outside of the U.S.
Under the terms of the agreement MEI will receive a $100 million upfront payment from Kyowa Kirin and is eligible to receive up to $582.5 million in additional payments if all specified development, regulatory and commercial milestones are successfully achieved.
MEI Pharma's COO & General Counsel David M. Urso commented, "This global partnership with Kyowa Kirin is a key step to achieving our goal of broadly developing and commercializing ME-401, optimizing the opportunity to benefit patients across multiple B-cell malignancies inside and outside the U.S., and also building value for our shareholders...The decision to expand our alliance with Kyowa Kirin is based on the successful relationship we've built working together to date under our 2018 Japan license agreement, and the respect we have for Kyowa Kirin and their ability to jointly execute our shared vision of ME-401 in the U.S. and around the world."
Tomohiro Sudo, executive officer, director of Strategic Product Planning Department for Kyowa Kirin, added, "I am delighted to expand our agreement with MEI Pharma for the development and commercialization of ME-401 all over the world...We believe that ME-401 may be an important new treatment option for patients and further enhances our global oncology pipeline."
MEI indicated that it is presently carrying out two ongoing clinical studies pertaining to ME-401. The first study is the Phase 2 TIDAL trial evaluating ME-401 as a monotherapy for the treatment of adults with relapsed or refractory follicular lymphoma, and the second study is a Phase 1b dose escalation and expansion trial evaluating ME-401 as a monotherapy and in combination with other therapies or investigational agents in patients with relapsed or refractory B-cell malignancies.
MEI Pharma is a late-stage pharmaceutical company based in San Diego, Calif., that concentrates its efforts on developing potential new cancer therapies and aims to build a leading oncology franchise. The company's drug candidate portfolio includes four clinical-stage assets including Pracinostat, an oral HDAC inhibitor; ME-401, an oral PI3K delta inhibitor; Voruciclib, an oral CDK inhibitor and ME-344, a mitochondrial inhibitor targeting the OXPHOS complex.
Kyowa Kirin is headquartered in Tokyo, Japan and stated that it is driven by state-of-the-art technologies and is committed to discovering innovative drugs. The company is focused on four primary therapeutic areas which include nephrology, oncology, immunology allergy and neurology. The company indicated that it under the Kyowa Kirin brand it operates 36 group companies across North America, EMEA and Asia Oceania that are endeavoring to address unmet medical needs.
MEI Pharma started the day with a market capitalization of around $177.0 million with approximately 106.0 million shares outstanding. MEIP shares opened 83% higher today at $3.06 (+$1.39, +83.23%) over yesterday's $1.67 closing price and reached a new 52-week high price this morning of $3.64. The stock has traded today between $2.31 and $3.64 per share and is currently trading at $2.48 (+$0.81, +48.50%).
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