- 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 -

CAMBRIDGE, Mass. & ZURICH--(BUSINESS WIRE)--

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 Webcast
Akebia 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 Vadadustat
Vadadustat 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 CKD
Anemia 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 Therapeutics
Akebia 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 Pharma
Vifor 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 Statements
This 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/

Akebia
Theresa McNeely, 617-844-6113
SVP, Corporate

Communications and
Investor Relations
tmcneely@akebia.com
or
Vifor Pharma
Beatrix Benz, +41 58 851 80 16
Head of Global

Communications & Public Affairs
media@viforpharma.com
or
Investor Relations
Julien Vignot, +41 58 851 66 90
Head of Investor

Relations
investors@viforpharma.com

Source: Akebia Therapeutics, Inc.

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