- Companies finalize termination with an agreed-upon settlement
fee of $55M to be paid to Akebia
- Akebia to assume responsibility for regulatory review processes
previously led by Otsuka
CAMBRIDGE, Mass., June 30,
2022 /PRNewswire/ -- Akebia Therapeutics®,
Inc. (Nasdaq: AKBA), a biopharmaceutical company with the
purpose to better the lives of people impacted by kidney disease,
today announced that it has executed an agreement to terminate the
U.S. and ex-U.S. vadadustat Collaboration and License Agreements
with Otsuka Pharmaceutical Co., Ltd. (Otsuka). As part of the
termination, Otsuka has agreed to pay Akebia a settlement fee of
$55 million.
As a result of the termination of the agreements, Akebia is
regaining the rights from Otsuka for vadadustat, an investigational
oral hypoxia-inducible factor prolyl hydroxylase inhibitor, in
the United States, Europe, China, Russia, Canada, Australia, the Middle East, and certain other
territories.
"We continue to believe in the potential of vadadustat as an
oral treatment for patients with anemia due to chronic kidney
disease, and we are pleased to be regaining the full rights to the
product in these important markets," said John Butler, Chief Executive Officer of Akebia.
"Otsuka has been a strong partner for many years, and we appreciate
their desire to have an efficient transfer of the responsibilities
back to Akebia. We plan to continue to pursue approval for
vadadustat to make it available to patients in these territories,
and we are excited about the potential additional value this brings
to Akebia, as we continue to work to build the company into the
future."
In October 2021, Otsuka submitted
an initial marketing authorization application (MAA) to the
European Medicines Agency (EMA) for vadadustat for the treatment of
anemia associated with chronic kidney disease (CKD) in adults. The
review is in progress. Otsuka and Akebia will coordinate to
transfer the MAA to Akebia through processes outlined by the EMA.
Vadadustat is also under review in the United Kingdom, Switzerland, and Australia through the Access Consortium.
Responsibilities for that review will transfer to Akebia as well at
a date to be agreed upon.
In the U.S., Akebia received a Complete Response Letter from the
U.S. Food & Drug Administration (FDA) for vadadustat. Akebia
plans to evaluate and determine potential next steps for vadadustat
in the U.S. following the end of review conference with the
FDA.
In the U.S., Akebia separately has a distribution agreement in
place with Vifor Pharma, providing potential access to up to 60% of
U.S. dialysis patients through existing Vifor Pharma relationships.
Mitsubishi Tanabe Pharma Corporation owns development and
commercialization rights to vadadustat in Japan and certain other Asian counties.
About Akebia
Therapeutics
Akebia Therapeutics, Inc. is a fully integrated
biopharmaceutical company with the purpose to better the lives of
people impacted by kidney disease. The Company was founded in 2007
and is headquartered in Cambridge,
Massachusetts. For more information, please visit our
website at www.akebia.com, which does not form a part of this
release.
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl
hydroxylase inhibitor designed to mimic the physiologic effect of
altitude on oxygen availability. At higher altitudes, the body
responds to lower oxygen availability with stabilization of
hypoxia-inducible factor, which can lead to increased red blood
cell production and improved oxygen delivery to tissues. Vadadustat
is an investigational new drug and is not approved by the U.S. Food
and Drug Administration (FDA). On March 29,
2022, the FDA issued a complete response letter to Akebia's
New Drug Application for vadadustat for the treatment of anemia due
to chronic kidney disease (CKD). Vadadustat is currently under
review by the European Medicines Agency for the treatment of anemia
due to CKD in adults. In Japan,
vadadustat is approved as a treatment for anemia due to CKD in both
dialysis-dependent and non-dialysis dependent adult patients.
About Anemia due to Chronic Kidney
Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red
blood cells to carry adequate oxygen to the body's tissues. It
commonly occurs in people with CKD because their kidneys do not
produce enough erythropoietin (EPO), a hormone that helps regulate
production of red blood cells. Anemia due to CKD can have a
profound impact on a person's quality of life as it can cause
fatigue, dizziness, shortness of breath and cognitive dysfunction.
Left untreated, anemia leads to deterioration in health and is
associated with increased morbidity and mortality in people with
CKD.
Forward Looking
Statement
Statements in this press release regarding Akebia
Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects,
expectations, beliefs, intentions and goals are forward-looking
statements within the meaning of the U.S. Private
Securities Litigation Reform Act of 1995, as amended, and include,
but are not limited to, statements regarding: Akebia's belief
in vadadustat as an oral treatment for patients with anemia due to
chronic kidney disease; Akebia's plans to pursue approval for
vadadustat to make it available to patients in the U.S.,
Europe, China, Russia, Canada, Australia, the Middle East and certain other territories and
the associated value that would bring to Akebia; Akebia's future
plans with respect to its strategic growth and operating plans,
including as they relate to next steps for regulatory submissions
outside of the U.S. and plans to evaluate and determine
potential next steps for vadadustat in the U.S. following the end
of review conference with the U.S. Food and Drug Administration
("FDA"); and the number of U.S. dialysis patients that could be
accessed as a result of the distribution agreement in place with
Vifor Pharma. The terms "believe," "plan," "potential," "will,"
"continue," derivatives of these words, and similar references are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results, performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with: the implementation of the
provisions of the termination agreement with Otsuka, including the
ability of Akebia to pursue regulatory approval outside the U.S.;
decisions made by health authorities, such as the FDA and
the European Medicines Agency, with respect to regulatory
filings, including the New Drug Application for vadadustat; the
potential therapeutic benefits, safety profile, and effectiveness
of vadadustat; the impact of the workforce reduction on Akebia's
business; the ability of Akebia to attract and retain qualified
personnel; Akebia's ability to implement cost avoidance measures
and reduce overhead costs; the direct or indirect impact of the
COVID-19 pandemic on regulators and Akebia's business, operations,
and the markets and communities in which Akebia and its partners,
collaborators, vendors and customers operate. Other risks and
uncertainties include those identified under the heading "Risk
Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2022, and other
filings that Akebia may make with the U.S. Securities and
Exchange Commission in the future. These forward-looking
statements (except as otherwise noted) speak only as of the date of
this press release, and, except as required by law, Akebia does not
undertake, and specifically disclaims, any obligation to update any
forward-looking statements contained in this press release.
Akebia Therapeutics® is a registered trademark of
Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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