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Vifor Pharma and Akebia Therapeutics Announce Expansion of License Agreement

April 9, 2019 Off By BusinessWire

Expanded license creates opportunity for vadadustat to be provided to
up to 60% of U.S. dialysis patients, subject to FDA approval

ZURICH & CAMBRIDGE, Mass.–(BUSINESS WIRE)–The Vifor Pharma Group (SIX: VIFN) and Akebia Therapeutics, Inc.
(Nasdaq: AKBA) today announced that the companies have amended the terms
of their license agreement to sell vadadustat to Fresenius Medical Care
North America dialysis clinics in the United States, subject to its
approval by the U.S. Food and Drug Administration (FDA).

Under the terms of the agreement signed in May 2017, Akebia granted
Vifor Pharma a license to sell vadadustat to Fresenius Medical Care
North America for use solely within its dialysis clinics in the U.S.,
subject to FDA approval. The license has now been amended to allow Vifor
Pharma to also sell vadadustat to certain third-party dialysis
organizations, for use in the U.S., thereby expanding the potential
opportunity for vadadustat under the agreement to up to 60% of U.S.
dialysis patients.

The license, which is subject to vadadustat’s approval by the FDA and
inclusion in the Centres for Medicare & Medicaid (CMS) End Stage Renal
Disease Prospective Payment System (ESRD PPS), also referred to as the
ESRD bundle, will now also be effective during the Transitional Drug
Add-on Payment Adjustment (TDAPA) two-year period that is expected to
precede the ESRD bundle period.

Under the terms of the amended agreement, Akebia is eligible to receive
an additional $5 million payment, which means Akebia is eligible to
receive a total payment of $25 million from Vifor Pharma upon approval
of vadadustat by the FDA and the earlier of CMS’s determination that
vadadustat will be reimbursed under the TDAPA or included in the ESRD
bundle.

Vadadustat is an investigational oral hypoxia-inducible factor prolyl
hydroxylase inhibitor currently in Phase III development for the
treatment of anemia due to chronic kidney disease (CKD). Vifor Pharma
and Akebia believe that vadadustat has the potential to set a new oral
standard of care for patients with anemia due to CKD.

Stefan Schulze, President of the Executive Committee and COO at Vifor
Pharma said “We are very pleased to have amended our license agreement
with Akebia. We believe that vadadustat has the potential to play an
important role in the future treatment of anemia due to CKD and we will
work closely with our strategic partner Fresenius Medical Care to
maximize this opportunity.”

“We believe the expansion of this agreement reflects enthusiasm about
our development program and the potential for vadadustat to treat anemia
due to CKD,” stated John P. Butler, President and Chief Executive
Officer of Akebia Therapeutics, Inc. “We are excited to be building on
our relationship with Vifor Pharma to facilitate access to vadadustat to
a larger group of dialysis patients, subject to its approval by the FDA.”

The Vifor Pharma Group is a global 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
pharmaceuticals and innovative patient-focused solutions. The 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 its 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. The Vifor Pharma Group
is headquartered in Switzerland, and listed on the Swiss Stock Exchange
(SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information,
please visit www.viforpharma.com.

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical
company focused on the development and commercialisation of therapeutics
for patients with 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.

Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl
hydroxylase inhibitor currently in global Phase III development for the
treatment of anemia due to CKD. Vadadustat’s proposed mechanism of
action is designed to mimic the physiologic effect of altitude on oxygen
availability. At higher altitudes, the body responds to lower oxygen
availability with increased production of HIF, which coordinates the
interdependent processes of iron mobilisation and erythropoietin
production to increase red blood cell production and, ultimately,
improve oxygen delivery. Vadadustat is an investigational therapy and is
not approved by the FDA or any regulatory authority.

Forward-Looking Statements: This document contains
forward-looking statements within the meaning of the federal securities
laws. Such statements are based upon current plans, estimates and
expectations that are subject to various risks and uncertainties. The
inclusion of forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as “anticipate,” “create,” “expect,” “believe,”
“may,” “will,” “should,” “plan,” “could,” “target,” “contemplate,”
“estimate,” “position,” “predict,” “potential,” “opportunity,” “working
to,” “look forward” and words and terms of similar substance used in
connection with any discussion of future plans, actions or events
identify forward-looking statements. All statements, other than
historical facts, including regarding vadadustat’s potential to set a
new standard of care, vadadustat’s therapeutic potential, and
vadadustat’s market and growth opportunity and potential, are
forward-looking statements. Important factors that could cause actual
results to differ materially from Akebia’s plans, estimates or
expectations could include, but are not limited to: the results of
Akebia’s clinical trials; the timing and content of interactions with
and decisions made by regulatory authorities; and success of others in
developing competing products. Other risks and uncertainties include
those identified under the heading “Risk Factors” in Akebia’s most
recently filed Annual Report on Form 10-K, and other filings that Akebia
may make with the U.S. 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.