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.
https://www.fiercebiotech.com/biotech/mei-pharma-nabs-100m-upfront-and-weighty-biobucks-upgraded-kyowa-kirin-cancer-drug-deal
