SAN DIEGO, and TOKYO, Nov. 5,
2018 /PRNewswire/ -- MEI Pharma, Inc. (NASDAQ: MEIP)
and Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, "Kyowa Hakko Kirin"), today
announced the execution of a license agreement granting Kyowa Hakko
Kirin exclusive rights to develop and commercialize ME-401 in
Japan ("License Agreement").
ME-401 is MEI's phosphatidylinositol 3-kinase ("PI3K") delta
inhibitor being developed by MEI for the treatment of patients with
B-cell malignancies. MEI is planning to initiate a Phase 2 study to
evaluate patients with follicular lymphoma that is intended to
support an accelerated approval marketing application with the U.S.
Food and Drug Administration.
Under the terms of the License Agreement, MEI will receive a
$10 million upfront payment and is
eligible to receive additional development and commercialization
milestones totaling up to $87.5
million. MEI is also eligible to receive tiered double-digit
royalties extending into the mid-teens. The agreement grants Kyowa
Hakko Kirin exclusive rights to ME-401 to develop and commercialize
ME-401 in Japan. The initial
indication for development and regulatory approval under the
agreement is relapsed or refractory follicular lymphoma.
"Kyowa Hakko Kirin is a well-regarded leader in the development
and commercialization of hematology and oncology therapies in
Japan," said David M. Urso.,
J.D., Chief Operating Officer of MEI Pharma. "This agreement is
important for MEI as an opportunity to expand the development of
ME-401 as a potential best-in-class PI3K delta inhibitor outside of
the U.S. and is consistent with our strategy to optimize value
through partnering opportunities abroad while developing
capabilities for domestic commercialization."
"I am delighted to enter into an agreement with MEI Pharma for
the development and commercialization of ME-401 in Japan," said Wataru
Murata, Executive Officer, Director of Corporate Strategy
& Planning Department. "We believe that ME-401 will be an
important drug candidate in our oncology pipeline."
Kyowa Hakko Kirin plans to initiate a Phase 1 study in
Japan in 2019.
About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase
("PI3K") delta inhibitor; PI3K delta is often overexpressed in
cancer cells and plays a key role in the proliferation and survival
of hematologic cancer cells. ME-401 displays high selectivity for
the PI3K delta isoform and has distinct pharmaceutical properties
from other PI3K delta inhibitors. It is being clinically evaluated
in patients with various B-cell malignancies. MEI is initiating a
Phase 2 study to evaluate the efficacy, safety, and tolerability of
ME-401 as a single agent in patients with follicular lymphoma after
failure of at least two prior systemic therapies including
chemotherapy and an anti-CD20 antibody. The Phase 2 study is
intended to support an accelerated approval marketing application
with the U.S. Food and Drug Administration.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is
a San Diego-based pharmaceutical company focused on leveraging
its extensive development and oncology expertise to identify and
advance new therapies for cancer. The Company's portfolio of drug
candidates includes pracinostat, an oral HDAC inhibitor that is
partnered with Helsinn Healthcare, SA. Pracinostat has been granted
Breakthrough Therapy Designation from the U.S. Food and Drug
Administration for use in combination with azacitidine for the
treatment of patients with newly diagnosed acute myeloid leukemia
(AML) who are unfit for intensive chemotherapy. Pracinostat is also
being developed in combination with azacitidine for the treatment
of patients with high and very high-risk myelodysplastic syndrome
(MDS). MEI Pharma's clinical development pipeline also includes
ME-401, a highly differentiated oral PI3K delta inhibitor currently
in a Phase 1b study in patients with relapsed refractory
follicular lymphoma or CLL, and voruciclib, an oral, selective CDK
inhibitor shown to suppress MCL1, a known mechanism of resistance
to BCL2 inhibitors. The Company is also developing ME-344, a novel
mitochondrial inhibitor currently in an investigator-initiated
study in combination with bevacizumab evaluating patients with
HER2-negative breast cancer. Pracinostat, ME-401, ME-344 and
voruciclib are investigational agents and are not approved for use
in the U.S. For more information, please
visit www.meipharma.com.
About Kyowa Hakko Kirin Co., Ltd.
Kyowa Hakko
Kirin Co., Ltd. is a research-based life sciences company, with
special strengths in biotechnologies. In the core therapeutic areas
of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin
leverages leading-edge biotechnologies centered on antibody
technologies, to continually discover innovative new drugs and to
develop and market those drugs world-wide. In this way, the company
is working to realize its vision of becoming a Japan-based global specialty pharmaceutical
company that contributes to the health and wellbeing of people
around the world.
You can learn more about the business at: www.kyowa-kirin.com.
Forward-Looking Statements
Under U.S. law, a new drug cannot be marketed until it has been
investigated in clinical studies and approved by the FDA as being
safe and effective for the intended use. Statements included in
this press release that are not historical in nature are
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements,
which are based on management's current expectations and are
subject to a number of risks and uncertainties, including, but not
limited to, our failure to successfully commercialize our product
candidates; costs and delays in the development and/or FDA
approval, or the failure to obtain such approval, of our product
candidates; uncertainties or differences in interpretation in
clinical trial results; our inability to maintain or enter into,
and the risks resulting from our dependence upon, collaboration or
contractual arrangements necessary for the development,
manufacture, commercialization, marketing, sales and distribution
of any products; competitive factors; our inability to protect our
patents or proprietary rights and obtain necessary rights to third
party patents and intellectual property to operate our business;
our inability to operate our business without infringing the
patents and proprietary rights of others; general economic
conditions; the failure of any products to gain market acceptance;
our inability to obtain any additional required financing;
technological changes; government regulation; changes in industry
practice; and one-time events. We do not intend to update any of
these factors or to publicly announce the results of any revisions
to these forward-looking statements.
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SOURCE MEI Pharma, Inc.