Press Release
Akebia and Otsuka Expand Relationship with Collaboration to Develop and Commercialize Vadadustat in Europe, China and Other Territories
Maximizes Efficiency of
Total Committed Development Funding from all of Akebia's Vadadustat
Collaborations Plus Cash Exceeds
Akebia to Host Conference Call at
This agreement follows a previously announced collaboration between the
companies in which they equally share the costs of developing and
commercializing vadadustat in
Under the terms of this collaboration agreement, Akebia will receive
Mr.
"We are very pleased to expand our strategic relationship with Otsuka, a
company who shares our vision to improve the lives of patients with
kidney disease," stated
Akebia has established three significant collaborations for vadadustat
in a little over a year, which together total more than
Conference Call and Webcast
Akebia management will host a conference call to review the details of
the transaction beginning at
To access the conference call, follow these instructions:
Dial: (877) 458-0977 (
Conference
ID: 12787133
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in 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.
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.5 The prevalence of anemia increases with the severity of CKD and is higher in people with CKD who are over age 60.
About
About Otsuka
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.
All Otsuka stories start by taking the road less travelled. Learn more
about Otsuka in the
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 if approved by regulatory authorities, anticipated
contributions from Otsuka pursuant to the Collaboration and License
Agreement, Otsuka's responsibilities pursuant to the Agreement, and the
amount of collaboration-related funds able to be realized by 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 ability of Akebia to successfully complete
the clinical development program for vadadustat; the funding required to
develop Akebia's product candidates and operate the company, and the
actual expenses associated therewith; the actual costs incurred in the
global Phase 3 studies of vadadustat and the availability of financing
to cover such costs; the timing of any additional studies initiated by
Akebia or its collaborators for vadadustat; the timing and content of
decisions made by regulatory authorities; the rate of enrollment in
clinical studies of vadadustat; the actual time it takes to initiate and
complete clinical studies; Akebia's ability to satisfy its obligations
under the Collaboration and License Agreement; early termination of the
Collaboration and License Agreement by Akebia or Otsuka, 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 around the world. Other risks and
uncertainties include those identified under the heading "Risk Factors"
in Akebia's Annual Report on Form 10-K for the year ended
_________________
1Iseki K and Kohagura K. Anemia as a
risk factor for chronic kidney disease. Kidney Int Suppl. 2007;107: S4-9.
2Culleton
B, Manns B, Zhang J, et al. Impact of anemia on hospitalization and
mortality in older adults. Blood. 2006;107(10): 3841-3846.
3Portolés
J, Gorriz J, Rubio E, et al. The development of anemia is associated to
poor prognosis in NKF/KDOQI stage 3 chronic kidney disease. BMC
Nephrology. 2013;14 (1):2.
4IMS MIDAS, 2016.
5Singh
AK. What is causing the mortality in treating the anemia of chronic
kidney disease: erythropoietin dose or hemoglobin level? Curr Opin
Nephrol Hypertens. 2010;19:420-424.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170425006640/en/
Akebia
SVP, Corporate
Communications and Investor Relations
tmcneely@akebia.com
or
(In Japan)
Leader,
Pharmaceutical Public Relations
Gilbert.jeffrey@otsuka.jp
or
(In
the US)
Corporate Communications
kimberly.whitefield@otsuka-us.com
Source:
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Cambridge, MA 02142
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+1 617.871.2099 fax