MEI Pharma is expanding a 2018 deal with Japanese biopharma Kyowa Kirin giving the company the development and commercialization rights to one of its investigational blood cancer drugs in that country.
Kyowa has agreed to pay $100 million up front for rights to MEI-401 outside of the United States, and to jointly develop and—if approved—promote the drug in the US.
The partnership will help facilitate two MEI (NASDAQ: MEIP) objectives: accelerate the development of the drug candidate, and build the company’s domestic commercial capabilities, David Urso, chief operating officer and general counsel, said in a phone interview.
In addition to receiving $100 million now, San Diego-based MEI is eligible for up $582.5 million more from Kyowa tied to development, regulatory, and commercial goals both within and outside the US, plus royalties on any ex-US sales. In the US, the companies agreed to a 50-50 cost-sharing arrangement and an equal split of profits, if ME-401 reaches approval, according to the terms announced Tuesday.
The initial deal with Kyowa nabbed MEI $10 million upfront and put it in line for up to $87.5 million more tied to development and commercialization milestones, plus royalties. That pact has essentially folded into this larger agreement, Urso said.
The focus of the licensing pact is an oral, once-daily treatment being evaluated in a Phase 2 study as a treatment for follicular lymphoma, a trial that could potentially lead to an FDA submission. A Phase 1b trial of ME-401 by itself and in combination with other B-cell malignancy therapies is under way too.
The drug is a kinase inhibitor that blocks one variety of an enzyme, PI3, which is key to signaling pathways for cancer cell growth. MEI says its PI3 kinase blocker is designed to avoid some of the side effects associated with existing drugs that target the pathway.
“We think this is a really important of class of drugs for patients with B-cell malignancies and we think that there was a lot of hope for this class of drugs, but there were these tolerability issues that reared their head,” CEO Daniel Gold told Xconomy. “We really do believe that we’re well on our way to solving those tolerability issues, and hopefully the studies we’re doing now will bear that out, and this class of drugs will now take its place in the armamentarium of physicians.”
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