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