- Maximises Efficiency of Global Development
and Commercialisation -
- 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 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) stabiliser
currently in Phase 3 development for the treatment of anaemia
associated with chronic kidney disease (CKD). Anaemia 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, anaemia 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 commercialising vadadustat in the U.S., as well as
the profits from potential future sales of vadadustat in the $3.5
billion renal anaemia 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 the European Union, sales of erythropoiesis
stimulating agents (ESAs), the current standard of care for the
treatment of renal anaemia, 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 anaemia. 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, maximising the
efficiency of our global Phase 3 development programme and
ultimately the commercialisation of vadadustat. We are able to
accomplish this while obtaining substantial funding for our
vadadustat development programme 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 commercialisation of vadadustat
in Japan, Taiwan, South Korea, Indonesia, India and select other
countries in Asia.
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer
currently in development for the treatment of anaemia 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 mobilisation and erythropoietin
production to increase red blood cell production and, ultimately,
improve oxygen delivery.
About Anaemia Associated with CKD
Anaemia 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, anaemia significantly accelerates
patients' overall deterioration of health with increased morbidity
and mortality. Anaemia 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 anaemia 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 anaemia related to chronic kidney disease in both
non-dialysis and dialysis patients. Akebia’s global Phase 3
programme for vadadustat, which includes the PRO2TECT studies for
non-dialysis patients with anaemia 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.
Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co.,
Ltd., headquartered in Tokyo, Japan, with 2016 consolidated sales
of approximately EUR 9.9 billion.
Otsuka established a presence in Europe in 1974 and today Otsuka
Pharmaceutical Europe Ltd. (OPEL) employs over 600 people who
channel their passion and energy into converting the latest science
into much-needed medicines. OPEL has a particular focus on
therapies in mental health, oncology, cardio-renal and nephrology,
as well as on medical devices. Otsuka is also exploring how digital
health technology can provide additional options for patients,
caregivers and healthcare professionals.
All Otsuka stories start by taking the road less travelled.
Learn more about Otsuka in the EU at https://www.otsuka-europe.com.
and about Otsuka globally at www.otsuka.co.jp/en/.
_________________
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170425006262/en/
Otsuka PharmaceuticalOtsuka Pharmaceutical Europe
Ltd.Alison Ross, +44 7768337128aross@Otsuka-Europe.comOtsuka
Pharmaceutical Co., Ltd.Jeffrey Gilbert,
81-3-6361-7379LeaderPharmaceutical Public
RelationsGilbert.jeffrey@otsuka.jporAkebiaTheresa McNeely,
1-617-844-6113SVPCorporate Communications and Investor
Relationstmcneely@akebia.com
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