- Medice brings extensive expertise in nephrology and an
established European dialysis business
- Akebia to receive a $10 million
upfront payment, potential for up to $100
million in commercial milestone payments, and tiered
royalties up to 30% of net sales in dialysis
- Akebia retains majority of economics in non-dialysis indication
if approved by EMA and retains rights to all other
indications
CAMBRIDGE, Mass., May 25, 2023
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a
biopharmaceutical company with the purpose to better the lives of
people impacted by kidney disease, today announced an
agreement with MEDICE Arzneimittel Pütter GmbH&Co.KG
(Medice – The Health Family), for Medice to market
Vafseo® (vadadustat), an oral hypoxia-inducible factor
prolyl hydroxylase (HIF-PH) inhibitor developed by Akebia to treat
anemia due to chronic kidney disease (CKD), in Europe. Akebia is retaining the rights to
develop and commercialize in Europe for all other indications. The
exclusive license agreement grants Medice the rights to market and
sell Vafseo in the European Economic Area in addition to the
United Kingdom, Switzerland and Australia. Akebia will receive an upfront
payment of $10 million, commercial
milestone payments up to $100
million, and tiered royalty payments up to 30% of net
sales.
"We are thrilled to partner with Medice to bring Vafseo to
market in Europe this year," said
John P. Butler, Chief Executive
Officer of Akebia. "Medice specializes in renal and anemia care and
has deep commercial expertise gained by building a successful
portfolio in the dialysis space. We believe Vafseo has the
potential to be a centerpiece of Medice's portfolio of products for
dialysis patients. Our collaboration also provides the flexibility
to pursue additional indications to maximize value for Akebia while
potentially serving many more patients."
"We're eager to bring Vafseo to market in Europe as we believe dialysis patients with
anemia due to CKD could benefit from additional therapeutic
options," said Dr. Richard Ammer,
Chief Executive Officer of Medice. "We look forward to working
closely with Akebia as we prepare for a commercial launch in
dialysis this year."
Anemia associated with CKD, common in patients on dialysis, is a
debilitating condition which may be associated with many adverse
clinical outcomes. Throughout Europe, we estimate that more than 325,000
dialysis patients are currently treated for anemia associated with
CKD.
Under the terms of the agreement, in addition to the
$10 million upfront payment and
commercial milestones of up to $100
million, Akebia will receive tiered royalties from 10% to
30% of net sales. Vafseo is currently approved in Europe and the United Kingdom for the treatment of
symptomatic anemia associated with CKD in adults on chronic
maintenance dialysis. Under the agreement, Akebia has the right to
develop Vafseo for use as a treatment of anemia due to CKD in
adults not on dialysis. If Akebia exercises this right, Medice will
commercialize Vafseo for both indications in the defined territory
and Akebia would retain 70% of the net profit margin generated by
use in the non-dialysis population, or alternative equivalent
financial terms to be negotiated by the parties.
Akebia retains rights to vadadustat for all other indications.
If Akebia chooses to develop vadadustat for any other indication
and seeks a collaboration partner in the territory, Medice has a
right of first offer to collaborate on the development and
commercialization of Vafseo in such defined territory.
Vadadustat is approved in 33 countries and regulatory opinions
are expected in Switzerland and
Australia later this year.
Important Safety Information
For safety information,
view the European Summary of Product Characteristics (SPC/SmPC) for
Vafseo™ (vadadustat) at
https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf.
The full Summary of Product Characteristics (SPC/SmPC) for
Vafseo® (vadadustat) will be available on the UK MHRA website at
https://products.mhra.gov.uk/.
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 not approved by the U.S. Food and Drug
Administration. In April 2023 and
May 2023 respectively, the European
Commission and United Kingdom Medicines and Healthcare products
Regulatory Agency granted marketing authorization for vadadustat
for the treatment of symptomatic anemia associated with chronic
kidney disease in adults on chronic maintenance dialysis. In
Japan, vadadustat is approved as a
treatment for anemia due to CKD in both dialysis-dependent and
non-dialysis dependent adult patients.
About Medice
MEDICE Arzneimittel Pütter
GmbH&Co.KG, founded in 1949 and headquartered in Iserlohn
(Germany), is a fully integrated
pharmaceutical company with own GxP capabilities in development,
manufacturing and pan-European and international distribution of
pharmaceuticals and medical devices. It is the core of "MEDICE –
The Health Family" aiming to improve patient management by offering
high quality innovative drugs, non-pharmacological interventions
and value adding services. For more information, please visit
www.medice.eu, which does not form a part of this release.
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 plans and expectations with respect to
commercializing Vafseo in Europe,
including the timing thereof; Akebia's expectations on the timing
for certain regulatory decisions for vadadustat by regulatory
authorities in Switzerland and
Australia; statements regarding
the potential market opportunity of vadadustat and beliefs about
the benefits that vadadustat could provide to dialysis patients;
statements about Akebia's ability to serve more patients while
pursuing additional indications for vadadustat and maximizing
value; and beliefs about Vafseo becoming the centerpiece of
Medice's portfolio of products for dialysis patients. The terms
"expect," "intend," "believe," "plan," "goal," "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 potential demand and
market potential and acceptance of, as well as coverage and
reimbursement related to, vadadustat; decisions made by health
authorities, such as the FDA, with respect to regulatory filings;
the results of preclinical and clinical research; the potential
therapeutic benefits, safety profile, and effectiveness of
vadadustat; 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; manufacturing, supply chain and
quality matters and any recalls, write-downs, impairments or other
related consequences or potential consequences; early termination
of any of Akebia's collaborations; and the competitive landscape
for vadadustat, if approved. 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, 2023, 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® and Vafseo® are registered
trademarks of Akebia Therapeutics, Inc.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
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