Akebia Therapeutics
Dec 14, 2015

Akebia and Mitsubishi Tanabe Pharma Announce Collaboration to Develop and Commercialize Vadadustat in Asia

- Agreement Includes Total Upfront and Milestone Payments of up to $350 Million, Including $100 Million in Upfront and Development Payments, as well as Tiered Double Digit Royalties -

- Akebia to Host Conference Call at 8:30 AM Eastern Time Today -

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Akebia Therapeutics, Inc. (NASDAQ:AKBA), and Mitsubishi Tanabe Pharma Corporation (TSE:4508) (MTPC) announced today that they have entered into a development and commercialization agreement for vadadustat (formerly AKB-6548), an oral therapy for the treatment of anemia related to chronic kidney disease (CKD), in Japan and certain other countries in Asia.

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Under the terms of the agreement, MTPC will make payments totaling $100 million for costs associated with the global Phase 3 program for vadadustat, including $40 million upon signing. In addition, Akebia is eligible to receive up to approximately $250 million in additional milestone payments, based upon achievement of certain development and sales milestones. MTPC will also make tiered royalty payments, from low teens up to twenty percent, on sales of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and other Asian countries.

"Vadadustat offers a new paradigm for the treatment of anemia for CKD patients. This partnership with MTPC validates vadadustat's therapeutic potential and helps ensure that its potential is realized in Asia," said John P. Butler, President and CEO of Akebia. "MTPC is one of the largest, most successful pharmaceutical companies in Japan with a substantial presence in these Asian markets. They are committed to the development and commercialization of innovative products, with a strategic focus on products for renal disease and diabetes, making them an ideal partner for Akebia."

"A safer treatment for managing anemia related to chronic kidney disease remains a significant unmet need globally," stated Masayuki Mitsuka, President and Representative Director, CEO of Mitsubishi Tanabe Pharma Corporation. "We see great potential in vadadustat to advance the care of chronic kidney disease patients. We look forward to our collaboration with Akebia."

Conference Call and Webcast

Date:     December 14, 2015
Time: 8:30 AM ET

Telephone Access:

Domestic callers: dial (877) 458-0977
International callers: dial (484) 653-6724
Please reference the Akebia conference call
Passcode: 527-4042

Online Access:

Go to the Investor Relations section of the Akebia website and follow
instructions for accessing the live webcast. Please connect to the website at
least 15 minutes prior to the start of the conference call to ensure adequate
time for any software download that may be necessary.

 

About Vadadustat

Vadadustat is an oral therapy currently in development for the treatment of anemia related to chronic kidney disease (CKD). Vadadustat is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. Vadadustat exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. The body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.

As a HIF stabilizer with best-in-class potential, vadadustat raises hemoglobin levels predictably and sustainably, with a dosing regimen that allows for a gradual and controlled titration. Vadadustat has been shown to improve iron mobilization, potentially reducing the need for iron supplementation.

About Anemia Related to CKD

Approximately 30 million people in the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body's inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD. Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable recombinant erythropoiesis-stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.

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 HIF biology. The company has completed Phase 2 development of its lead product candidate, vadadustat, an oral therapy for the treatment of anemia related to CKD in both non-dialysis and dialysis patients, and plans to initiate its Phase 3 program in 2015. http://akebia.com

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation is a research-driven pharmaceutical company based in Osaka, Japan. MTPC is taking on the challenge of drug discovery in the fields of autoimmune disorders, central nervous system diseases, diabetes and kidney diseases, and vaccines. To those ends, MTPC is strengthening its R&D pipeline. MTPC contributes to the healthier lives of people around the world through the creation of pharmaceuticals. http://www.mt-pharma.co.jp/e.

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, dosing and benefits of vadadustat, the development plan for vadadustat, and the expected payments from MTPC to Akebia. 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 existing preclinical and clinical data may not be predictive of the results of ongoing or later clinical trials; the funding required to develop vadadustat 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 ability of Akebia and MTPC to successfully complete the clinical development of vadadustat; the timing and scope of regulatory and reimbursement approvals in Japan and other countries included in the territory; the timing and content of decisions made by the FDA, PMDA and other regulatory authorities; Akebia's ability to manufacture and supply vadadustat to MTPC; the ability of MTPC to perform its obligations under the Collaboration Agreement; MTPC's ability to distribute, promote, market and sell vadadustat in Japan and the other countries included in the territory; the success of competitors in developing product candidates for diseases for which Akebia is currently developing its product candidates; 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, 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.

Investors:
Akebia Therapeutics, Inc.
Ed Joyce, 617-844-6130
ejoyce@akebia.com
or
Media:
Argot Partners
Eliza Schleifstein, 917-763-8106
Eliza@argotpartners.com
or
Investors / Media:
Mitsubishi Tanabe Pharma
+81-6-6205-5211

Source: Akebia Therapeutics, Inc.

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