– Vifor Pharma Commits to Exclusive
Distribution of Vadadustat to Fresenius Medical Care North America
for Use in its Dialysis Facilities and Invests $50 Million in
Akebia at a Premium –
– Additional Funds Support Vadadustat Global
Development Program to Data −
– Akebia to Host Conference Call at 4:30 p.m.
Eastern Time Today –
Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Vifor Pharma Group.
today announced they have entered into an exclusive license
agreement to sell vadadustat to Fresenius Medical Care dialysis
clinics in the United States upon approval by the U.S. Food and
Drug Administration (FDA). Vifor Pharma will also make a $50
million equity investment in Akebia at $14 per share. Vadadustat is
an oral hypoxia-inducible factor (HIF) stabilizer currently in
Phase 3 development for the treatment of anemia associated with
chronic kidney disease (CKD).
“Vadadustat could represent a significant advancement in the
treatment of renal anemia with the potential to establish a new
treatment paradigm and overcome the limitations of current
therapies for patients with chronic kidney disease. We believe that
vadadustat may also be a potential solution for hyporesponder
patients who do not respond well to erythropoiesis stimulating
agents,” stated Stefan Schulze, President of the Executive
Committee and Chief Operating Officer of Vifor Pharma. “This
transaction strengthens the nephrology product portfolio of Vifor
Pharma, and is consistent with our ongoing commitment to deliver
innovative products that can improve the lives of patients
suffering with chronic kidney disease.”
Under the terms of the agreement, Vifor Pharma will exclusively
distribute vadadustat to Fresenius Medical Care North America for
use solely within its dialysis facilities in the U.S. to meet their
need for a HIF-based treatment for anemia associated with CKD.
Fresenius Medical Care is the largest kidney dialysis provider in
the U.S. and, in 2016, treated over 185,000 dialysis patients, or
nearly 40% of the U.S. dialysis patients. This agreement is
structured as a profit-sharing arrangement between Akebia and Vifor
Pharma. It is subject to approval of vadadustat by the FDA and
inclusion of vadadustat in a bundled reimbursement model, upon
which Akebia will receive a $20 million payment from Vifor Pharma.
Akebia’s revenue from the profit share and the milestone payment
will be shared with Otsuka Pharmaceutical Co. Ltd., Akebia’s U.S.
collaborator. Akebia, in collaboration with Otsuka, plans to
commercialize vadadustat in other dialysis organizations and
centers and in the non-dialysis market in the U.S.
“This agreement provides the opportunity to build greater
commercial momentum for vadadustat in the U.S. rapidly upon
launch,” said John P. Butler, President and Chief Executive Officer
of Akebia. “We are pleased that Vifor Pharma has selected
vadadustat as its exclusive HIF product for
distribution to Fresenius Medical Care, one of the largest dialysis
providers. We believe that this commitment provides significant
further validation of vadadustat’s potential.”
Conference Call and WebcastAkebia management will
host a conference call to review the details of the transaction
beginning at 4:30 p.m. Eastern Time today, Monday, May 15,
2017. A live audio webcast of the presentation will be available on
the company's website at http://ir.akebia.com/events.cfm. An
archived presentation will be available for 90 days.
To access the conference call, follow these instructions:Dial:
(877) 458-0977 (U.S.); (484) 653-6724 (international)Conference ID:
23256278
About VadadustatVadadustat is an oral, investigational
hypoxia-inducible factor (HIF) stabilizer currently in Phase 3
development for the treatment of anemia related to chronic kidney
disease. Vadadustat exploits the same mechanism of action used by
the body to adapt naturally to lower oxygen availability associated
with a moderate increase in altitude. At higher altitudes, the body
responds to lower oxygen availability with increased production of
HIF, which coordinates the interdependent processes of iron
mobilization and erythropoietin production to increase red blood
cell production and, ultimately, improve oxygen delivery.
Vadadustat has not been approved by the FDA or any other regulatory
authority.
About Anemia Associated with CKDAnemia results from the
body's inability to coordinate red blood cell production in
response to lower oxygen levels due to the progressive loss of
kidney function with inadequate erythropoietin production. Left
untreated, anemia significantly accelerates patients' overall
deterioration of health with increased morbidity and mortality.
Anemia is currently treated with injectable recombinant
erythropoiesis stimulating agents, which are associated with
inconsistent hemoglobin responses and well-documented safety risks.
The prevalence of anemia increases with the severity of CKD and is
higher in people with CKD who are over age 60.
About Akebia TherapeuticsAkebia Therapeutics, Inc. is a
biopharmaceutical company headquartered in Cambridge,
Massachusetts, focused on delivering innovative therapies to
patients with kidney disease through hypoxia-inducible factor
biology. Akebia’s lead product candidate, vadadustat, is an oral,
investigational therapy in development for the treatment of anemia
related to chronic kidney disease in both non-dialysis and dialysis
patients. Akebia’s global Phase 3 program for vadadustat, which
includes the PRO2TECT studies for non-dialysis patients with anemia
secondary to chronic kidney disease and the INNO2VATE studies for
dialysis-dependent patients, is currently ongoing. For more
information, please visit our website at www.akebia.com.
About Vifor PharmaVifor Pharma Group, formerly Galenica
Group, is a global specialty pharmaceuticals company. It aims to
become the global leader in iron deficiency, nephrology and
cardio-renal therapies. The company is the partner of choice for
specialty pharmaceuticals and innovative patient-focused solutions.
Vifor Pharma Group strives to help patients around the world with
severe and chronic diseases lead better, healthier lives. The
company develops, manufactures and markets pharmaceutical products
for precision patient care. The Vifor Pharma Group holds a leading
position in all their core business activities and consists of the
following companies: Vifor Pharma; Vifor Fresenius Medical Care
Renal Pharma, a joint company with Fresenius Medical Care; Relypsa
and OM Pharma. Vifor Pharma Group is headquartered in Zurich,
Switzerland and listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN). For more information, visit
www.viforpharma.com.
Forward-Looking StatementsThis press release includes
forward-looking statements. Such forward-looking statements include
those about Akebia's strategy, future plans and prospects,
including statements regarding the potential indications and
benefits of vadadustat, the potential commercialization of
vadadustat and the anticipated financial contributions and other
benefits of the license agreement with Vifor Pharma. The words
“anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statement, including the risk that
Akebia will not achieve the milestone; existing preclinical and
clinical data may not be predictive of the results of ongoing or
later clinical trials; the ability of Akebia to successfully
complete the clinical development of vadadustat; the funding
required to develop Akebia's product candidates and operate the
company, and the actual expenses associated therewith; the cost of
the Phase 3 studies of vadadustat and the availability of financing
to cover such costs; the timing and content of decisions made by
the FDA and other regulatory authorities; the rate of enrollment in
clinical studies of vadadustat; the actual time it takes to
initiate and complete clinical studies; the success of competitors
in developing product candidates for diseases for which Akebia is
currently developing its product candidates; early termination of
the exclusive license agreement by Akebia or Vifor Pharma; and
Akebia's ability to obtain, maintain and enforce patent and other
intellectual property protection for vadadustat. Other risks and
uncertainties include those identified under the heading “Risk
Factors” in Akebia's Annual Report on Form 10-Q for the quarter
ended March 31, 2017, and other filings that Akebia may make with
the Securities and Exchange Commission in the future. Akebia does
not undertake, and specifically disclaims, any obligation to update
any forward-looking statements contained in this press release.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170515006585/en/
AkebiaTheresa McNeely, 617-844-6113SVP, Corporate
Communications andInvestor Relationstmcneely@akebia.comorVifor
PharmaBeatrix Benz, +41 58 851 80 16Head of Global
Communications & Public
Affairsmedia@viforpharma.comorInvestor RelationsJulien
Vignot, +41 58 851 66 90Head of Investor
Relationsinvestors@viforpharma.com
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