Akebia Therapeutics, Inc., a biopharmaceutical company,  and Otsuka Pharmaceutical Co., Ltd., a global healthcare company, 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 anaemia 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. Left untreated, anaemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality.

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 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 Europe, sales of erythropoiesis stimulating agents (ESAs), the current standard of care for the treatment of renal anaemia, were approximately $1.5 billion.

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 US 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 US 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.