MEI Pharma nabs $100M upfront and weighty biobucks in upgraded Kyowa Kirin cancer drug deal

Tokyo-based Kyowa Kirin is doubling down on its 2018 MEI Pharma pact. (Pixabay)

San Diego biotech MEI Pharma has upped its pact with Tokyo-based Kyowa Kirin in a cost-sharing deal centered on MEI’s experimental oncology asset.

The drug, ME-401, works as a phosphatidylinositol 3-kinase (PI3K) delta inhibitor and is currently in midstage tests for relapsed or refractory follicular lymphoma, which the biotech hopes can help it toward a speedy FDA review and approval.

As well as the so-called TIDAL phase 2, the drug is also in earlier combo trials for patients with B-cell malignancies. Back in 2018, Kyowa Kirin signed on with MEI in a deal worth $10 million upfront for rights to develop and commercialize ME-401 in Japan.

The Japanese company said at the time it would stump up a maximum of $87.5 million more if the drug hit certain milestones. Now, the Japanese company is looking to double down, paying $100 million upfront in an upgraded pact to co-develop and co-promote ME-401 in the U.S.

Under the deal, MEI will book U.S. sales on 50-50 profit and cost sharing, while Kyowa Kirin obtains exclusive rights to sell the med outside the U.S. and MEI nabs escalating tiered royalty payments on these sales. As well as the upfront cash bundle, the biobucks potential has now swollen to $582.5 million.

“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,” said David Urso, chief operating officer and general counsel of MEI Pharma.

“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.”

“I am delighted to expand our agreement with MEI Pharma for the development and commercialization of ME-401 all over the world,” added Tomohiro Sudo, executive officer at Kyowa Kirin. “We believe that ME-401 may be an important new treatment option for patients and further enhances our global oncology pipeline.”

The companies added that they “have agreed to a development plan designed to broadly evaluate ME-401 in patients with various B-cell malignancies, including in combination with other agents.”

PI3K inhibitors have seen a roller coaster of interest and flops over the years, with some pharmas selling off unwanted PI3Ks while others have seen positive data and approvals: Gilead Sciences' Zydelig was the first to reach the market but was beset by safety issues.

Bayer’s Aliqopa and Verastem’s Copiktra have seen approvals in the past few years alongside some more positive data from other experimental versions of this pathway.