Akebia Therapeutics, Inc., a biopharmaceutical company, and Otsuka Pharmaceutical Co., Ltd. have entered into a collaboration and license agreement in the US for vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in development for the treatment of anaemia associated with chronic kidney disease (CKD).
Anaemia related to CKD affects an estimated 1.8 million patients in the US and arises from the kidney's failure to produce adequate amounts of erythropoietin, a key hormone stimulating the production of red blood cells. Left untreated, anaemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality.
The collaboration provides capital for the global development program for vadadustat, and commercial resources for a US launch of vadadustat upon approval by the Food and Drug Administration. Under the terms of the agreement, Akebia will receive $265 million in committed funds plus development and commercial milestones, representing a total transaction value that could exceed $1 billion. The companies intend to contribute equally to commercialization efforts and share equally all costs and revenue in the US, where sales of erythropoiesis stimulating agents (ESAs), the current standard of care, are estimated to be $3.5 billion.3 Akebia will continue to lead the ongoing global phase 3 development program for vadadustat.
"Vadadustat has the potential to significantly change the current standard of care for patients with anaemia associated with CKD and addresses a high unmet need for those suffering with this disease," said Tatsuo Higuchi, president and representative director of Otsuka. "With Akebia's renal expertise, this collaboration will enable Otsuka to expand our cardio-renal portfolio while demonstrating our commitment to delivering new treatment options to patients worldwide."
Under the terms of the agreement, Otsuka will pay $265 million or more in committed capital. This includes a payment of $125 million upon signing and a payment of approximately $35 million in the first quarter of 2017. The agreement also provides for Otsuka to pay $105 million or more of the costs of the global development programme for vadadustat. Additionally, Otsuka will pay potential development and commercial milestones up to $765 million.
"This collaboration achieves our goal of funding our global PRO2TECT and INNO2VATE phase 3 studies for vadadustat while retaining significant long-term value for Akebia," stated John P. Butler, president and chief executive officer of Akebia.
Butler added, "Our alliance with Otsuka, one of the world's innovative pharmaceutical leaders, also allows us to prepare an optimal launch of vadadustat, as we will equally share commercial responsibility. Otsuka brings a well-established commercial presence and infrastructure in the US, and we share a strong commitment to improving patients' lives by delivering important new therapeutic options. This deal also underscores the confidence that we and others have placed in the underlying value of vadadustat and in our ability to bring innovative therapies to patients."
In addition to the 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 other countries in Asia. For other geographies, including the European Union, Akebia continues advancing discussions with multiple parties regarding a potential collaboration.
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 mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
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.
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 for the treatment of diseases and nutraceutical products for the maintenance of everyday health.