Maximizes Efficiency of Global Development and
Commercialization
Committed Capital and Potential Milestone
Payments from Otsuka of up to $865 Million, Including $208 million
or More in Upfront Payment and Development Funding, as well as
Tiered, Double-Digit Royalties
Total Committed Development Funding from all of
Akebia’s Vadadustat Collaborations Plus Cash Exceeds $600
Million
Akebia to Host Conference Call at 4:30 p.m.
Eastern Time Today
Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Otsuka
Pharmaceutical Co., Ltd. today announced that they have expanded
their collaboration for vadadustat by entering into a collaboration
and license agreement for Europe, China and other territories.
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). Anemia related to CKD
arises from the kidney’s failure to produce adequate amounts of
erythropoietin, a key hormone stimulating the production of red
blood cells.1 Left untreated, anemia significantly accelerates
patients' overall deterioration of health with increased morbidity
and mortality.2, 3
This agreement follows a previously announced collaboration
between the companies in which they equally share the costs of
developing and commercializing vadadustat in the United States, as
well as the profits from potential future sales of vadadustat in
the $3.5 billion renal anemia market. The total committed
development funding from all vadadustat collaborations, combined
with Akebia’s cash, is expected to exceed $600 million.
Under the terms of this collaboration agreement, Akebia will
receive $208 million or more in committed capital from Otsuka,
including $73 million upon signing and $135 million or more of
development funding. In addition, Akebia is eligible to receive up
to $657 million in milestone payments, representing a total
transaction value of approximately $865 million. Otsuka will also
make tiered, double-digit royalty payments of up to 30% on net
sales of vadadustat in Otsuka’s territory, which includes Europe,
Russia, China, Canada, Australia and the Middle East, but excludes
Latin America and other previously licensed countries. In the five
major markets in Europe, sales of erythropoiesis stimulating agents
(ESAs), the current standard of care for the treatment of renal
anemia, were approximately $1.5 billion.4
Mr. Tatsuo Higuchi, president and representative director of
Otsuka Pharmaceutical Co., Ltd., commented, “Thanks to Akebia’s
expertise in developing vadadustat, we anticipate that it holds
significant promise for renal anemia. We are also convinced that by
strengthening our cardio-renal portfolio with a drug candidate like
this, following our own tolvaptan, we can contribute to changing
the standard of care worldwide for patients with complex kidney
diseases."
“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 John P. Butler, President and
Chief Executive Officer of Akebia. “We now have a single, strong
collaborator for the two largest markets, the U.S. and Europe. This
simplifies governance and decision making, maximizing the
efficiency of our global Phase 3 development program and ultimately
the commercialization of vadadustat. We are able to accomplish this
while obtaining substantial funding for our vadadustat development
program and retaining significant long-term value for Akebia.”
Akebia has established three significant collaborations for
vadadustat in a little over a year, which together total more than
$2.2 billion in potential value and include $573 million or more in
upfront payments and committed development funding. In addition to
this agreement and the U.S. collaboration with Otsuka, Akebia has
established a collaboration with Mitsubishi Tanabe Pharma
Corporation for the development and commercialization of vadadustat
in Japan, Taiwan, South Korea, Indonesia, India and select other
countries in Asia.
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, Tuesday, April 25, 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: 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 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 Otsuka
Otsuka Pharmaceutical is a global healthcare company with the
corporate philosophy: “Otsuka – people creating new products for
better health worldwide.” Otsuka researches, develops, manufactures
and markets innovative and original products, with a focus on
pharmaceutical products to meet unmet medical needs and
nutraceutical products for the maintenance of everyday health.
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.
Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co.,
Ltd., headquartered in Tokyo, Japan, with 2016 consolidated sales
of approximately $11 billion.
All Otsuka stories start by taking the road less travelled.
Learn more about Otsuka in the U.S. at www.otsuka-us.com and
connect with us on LinkedIn and Twitter at @OtsukaUS. Otsuka
Pharmaceutical Co., Ltd.’s global website is accessible at
www.otsuka.co.jp/en/.
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 December 31, 2016,
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.
_________________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/
AkebiaTheresa McNeely, 617-844-6113SVP, Corporate
Communications and Investor Relationstmcneely@akebia.comorOtsuka
Pharmaceutical(In Japan)Jeffrey Gilbert, 81-3-6361-7379Leader,
Pharmaceutical Public RelationsGilbert.jeffrey@otsuka.jpor(In the
US)Otsuka America Pharmaceutical, Inc.Kimberly Whitefield,
+1-609-535-9259Corporate
Communicationskimberly.whitefield@otsuka-us.com
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